Career Openings

Thank you for your interest in TP Therapeutics (TP).  TP is a clinical-stage structure-based drug design company for the discovery and development of precision medicines for cancer and other diseases.  We are focusing on the design of novel chemical identities for established oncogene drivers with secondary resistant mutations, newly identified disease-driven targets, and potential targets regulating tumor microenvironment and tumor immunity.  

Director, Pharmacovigilance/Safety MD

ROLE RESPONSIBILITIES

  • Organize, manage and actively carry out as appropriate, adverse event monitoring, safety reporting, risk management, local safety monitoring activities as required, local contractual agreements, process documentation and training, inspection preparedness, and any other required safety activity
  • Carry out all case management activities as appropriate
  • Ensure regulatory compliance with timelines for individual expedited case report submissions and timely delivery of information for aggregate reports and other regulatory documents as requested
  • Review processed cases to verify accuracy, consistency and compliance with process requirements, and review case data for special scenarios
  • Determine if appropriate case follow-up has been considered. Conduct follow-up activities when needed
  • Consistently apply regulatory requirements and TP Therapeutics policies
  • Analyze and monitor activities, define and implement corrective actions, where applicable
  • Develop and maintain expertise of all assigned products, of applicable corporate policies and local regulations, guidelines, Standard Operating Procedures and writing practices, of data entry conventions, and of search functions in the safety database
  • Provide oversight and team mentoring on case handling aspects, data extraction and analyses
  • Leverage and apply required judgment, issue resolution and negotiation skill-sets necessary to play a leadership role as a subject matter expert and/or project lead across the organization
  • Act as subject matter expert for the DSUR
  • Act as subject matter expert for suppliers and stakeholders, locally, concerning safety-related issues; and, liaise with key partners regarding safety data collection and handling

QUALIFICATIONS

  • Education: MD or DVM
  • Experience: Two to three years of clinical research and protocol management experience preferred.

EEO & Employment Eligibility

  • TP Therapeutics is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.  TP Therapeutics also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.   TP Therapeutics is an E-Verify employer.

 

To apply, please submit your resume to hr@tptherapeutics.com

Director/Senior Director, DMPK

ROLE SUMMARY

TP Therapeutics is seeking a Director/Senior Director of DMPK who will be an integral member of a team responsible for characterizing the DMPK properties of these transformative cancer medicines both in vitro and in vivo. This position reports to the SVP of Pre-clinical Development.

ROLE RESPONSIBILITIES

  • Leadership in preclinical and early clinical studies, including but not limited to in vitro and in vivo ADME assays, PK/TK support, M&S.
  • Representing DMPK function in cross functional project team and provide critical feedbacks to project teams from DMPK point of view.
  • Leading regulatory related activities in DMPK areas for R&D and generating and reviewing documents such as investigator’s brochures, INDs & CTAs, and providing scientific support on all licensing activities.
  • Managing collaborations with CRO/CMO for outsourcing activities.
  • Ensuring reporting timelines for all DMPK related reports. Expected to review, edit, and offer critical feedbacks to the reports generated by CROs.

QUALIFICATIONS

  • Ph.D. degree in relevant discipline with 10+ years of industrial experience with 3+ years of experience as project leader or project representative.
  • Experience managing DMPK CROs.
  • Experience with preparation of regulatory documents, such as IND, CTA, NDA, etc.
  • Broad background knowledge in DMPK with strong expertise in PK, drug metabolism.
  • Ability to perform modeling & simulation.
  • Working knowledge of DMPK related regulations and regulatory guidelines from ICH, FDA and EMA.
  • Track record of contribution to project teams enabling achievement of milestones in a time efficient manner.
  • Excellent communication, presentation skills, and attention to detail.

EEO & Employment Eligibility

TP Therapeutics is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.  TP Therapeutics also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.   TP Therapeutics is an E-Verify employer.

To apply, please submit your resume to hr@tptherapeutics.com

Director, Clinical Operations

ROLE SUMMARY

We are seeking a highly motivated individual to join TP Therapeutics as a Director, Clinical Operations reporting into the VP of Clinical Operations.  The Director, Clinical Operations will support the clinical development programs for the investigational lead drug candidates in company sponsored and/or investigator-sponsored trials.

As a key member of the Clinical Operations team, the successful candidate will work closely with the Vice President of Clinical Operations and will provide leadership, project management, and oversight to plan and conduct one or more high quality clinical trials concurrently in accordance with CFR, EMA, and ICH GCP regulations in support of regulatory authority submissions.

This position also provides an opportunity to join a growing organization and contribute substantially to how the company will operationalize oncology trials in the future. In addition, there is an opportunity to expand your knowledge through day-to-day activities and close interactions with the Medical, Translational Sciences, Research and Discovery teams within TP Therapeutics.

ROLE RESPONSIBILITIES

  • Align with the VP of Clinical Operations on strategy for successful implementation and execution of TP Therapeutics clinical trials.
  • Manage and drive excellence in the overall clinical operational activities for multiple clinical trials. Also responsible for CRO selection, efficiencies and oversight, to ensure quality conduct of trials and data integrity.
  • Provide functional expertise for Clin Ops strategies and tactical implementation of the studies by managing timelines, deliverables, budget forecasting, etc.
  • Oversee the operational aspects for the development and delivery of standard study protocols, informed consents, vendor selection/management, site/country selection, etc.
  • Consistent with Safety Management Plan (SMP), perform and document regular review of individual subject safety data and performs review of cumulative safety data in collaboration with the Medical Monitor.
  • Develop a Data Management Plan (DMP) with CRO and cross functional team members within Medical, Data Management and Statistics.
  • Ensure oversight and study-specific Risk Management Plans (RMP) (e.g., milestones, metrics, and critical path), ensuring appropriate escalation when required. Evaluate study-level issues for broader impact (e.g., cross-study, cross-program etc.) and ensure resolution.
  • Provide Senior Management with timely updates on progress (including any changes in scope, schedule, and resources across the program).
  • Depending on experience may contribute to or may independently design protocols and/or amendments.
  • Depending on experience, may contribute to or be primarily responsible for formulation of a Clinical Development Plan (CDP).
  • Develop site recruitment, enrollment and engagement strategies for all clinical trials.
  • Collaborate with cross functional team members to prepare strategy presentations, present and discuss data at relevant meetings, external consultants, KOLs and potentially regulatory meetings as well as author sections of regulatory documents (IB, Annual Reports, IND sections, CSR).
  • Ensure effective communications to internal and external stakeholders through meetings, presentations, and other methods. Manage content, agenda, and discussions at clinical operations sub-teams and ensures action items are closed.
  • Participate in resource prioritization to ensure department and corporate goals and milestones are achieved.
  • Collaborate with Clinical Quality Assurance to develop a strategic plan for CRO and vendor audits.
  • May hold line management responsibilities, including hiring talent, performance development, and mentoring.
  • Influence and lead ClinOps and cross functional team members to deliver quality results in a timely manner.
  • Demonstrate experience with GCP and the ability to develop and apply internal policies and SOPs. Evaluate, recommend, and present standard practices and process improvements for TPT clinical trial implementation.

QUALIFICATIONS

  • Advanced scientific degree preferred (PhD, PharmD, MA); Degree in Life Sciences preferred.
  • Alternatively, B.A/B.S. plus 10+ years in relevant experience.
  • Experience considered relevant includes clinical or basic research in a Biotech, Pharmaceutical company, Academic Research Organization (ARO) or Contract Research Organization (CRO).
  • Demonstrated experience in oncology drug development; familiarity with related disciplines (biostatistics, regulatory, data management, safety, QA).
  • Excellent organizational and leadership skills with strong experience in executing all phases of clinical trials.
  • Demonstrated scientific writing and strong communication skills.
  • Some travel may be required; approximately 20% travel.

EEO & Employment Eligibility

  • TP Therapeutics is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.  TP Therapeutics also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.   TP Therapeutics is an E-Verify employer.

To apply, please submit your resume to hr@tptherapeutics.com

Associate Director/Director, Regulatory CMC

ROLE SUMMARY

TP Therapeutics is seeking an Associate Director/Director, Regulatory CMC, who will report directly to the Vice President, CMC Operations. The Associate Director/Director, Regulatory CMC will be responsible for working in a fast growing, highly dynamic biotechnology environment, closely interacting with our in-house Regulatory Group, CMC Operations and Quality teams as well as contract manufacturing organizations, external experts and strategic partners. The incumbent will serve to provide a strong Regulatory leadership perspective in support of developing innovative CMC regulatory strategies for small molecule drug products in current and future clinical development. The position will also be responsible for hands on management of the collaborative preparation and submission of high‑quality CMC sections of INDs, IMPDs, and NDA.

ROLE RESPONSIBILITIES

  • Develop and implement regulatory strategies for development projects to achieve optimal submission/approval results and ensure regulatory compliance including filing of all appropriate regulatory submissions for assigned programs.
  • Coordinate all aspects of regulatory CMC submissions relevant to assigned projects or programs.
  • Communicate CMC regulatory strategy, key issues and remediation activities needed throughout the project/product lifecycle, to project teams and appropriate management levels within and outside of CMC operations.
  • Influence and negotiate within cross-functional teams to ensure quality submission planning and decision-making.
  • Identify and assess regulatory risks associated with product development for assigned programs.
  • Assist in defining strategies to mitigate risks.
  • Guide the organization and preparation of high-quality submissions to ensure strategic direction and regulatory compliance with the current Guidelines and Regulations are met.
  • Collect documentation from other line functions to support submission preparation.
  • Perform CMC document management tasks including file transfer, storage, tracking, and archival of Regulatory CMC submission documentation to ensure databases are maintained to compliance by collaborating with regulatory affairs and regulatory operations function.
  • Responsible for leading Agency meetings related to CMC sections.
  • Monitor and analyze appropriate regulatory agency activities in areas of interest to the company.

QUALIFICATIONS

  • Degree in a life science discipline (e.g. Chemistry, Pharmaceutics, Biochemistry, Biotechnology, Biology) or equivalent.
  • 5+ years in regulatory CMC in biopharmaceuticals preferred.
  • Working knowledge of chemistry/biotechnology, analytics or pharmaceutical technology.
  • Knowledge of the drug development process desirable. Ability to critically evaluate data from a broad range of scientific disciplines.
  • Knowledge/experience of regulations, guidelines for NCEs and product lifecycle maintenance desirable.
  • Ability to work successfully with extended, multinational project teams and coordinate activities simultaneously on multiple projects under pressure of time and workload.
  • Effective planning, organizational and interpersonal skills.
  • Reasonable approach to risk assessment.
  • Excellent written/spoken communication and negotiation skills.
  • Computer literacy.

EEO & Employment Eligibility

TP Therapeutics is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.  TP Therapeutics also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.   TP Therapeutics is an E-Verify employer.

To apply, please submit your resume to hr@tptherapeutics.com

Manager, Clinical Quality Assurance

ROLE SUMMARY

Turning Point Therapeutics is looking for an experienced Manager, Clinical Quality Assurance, who will take a leadership role in developing the Clinical Quality Assurance (CQA) systems that will ensure GCP compliance.

The ideal candidate will have hands-on experience in clinical audits, regulatory inspections and come from a clinical Quality Assurance background.  He/she will provide the vision and drive the implementation of the systems required to ensure GCP compliance and inspection readiness through process improvements across clinical development, clinical audits/inspections, the implementation of corrective and preventive actions (CAPAs), and revision/implementation of essential standard operating procedures (SOPs). This position reports to the Senior Director, Quality Assurance.

ROLE RESPONSIBILITIES

  • Perform audits of investigational sites, CROs/Service Providers, documents and internal system and processes, in order to ensure compliance with regulatory requirements and company policies and procedures; Organizes, leads and  participates in contracted audits
  • Prepare written audit reports and communicates findings and recommendations and evaluate the adequacy and completeness of corrective and preventative action plans.
  • Act as the primary point of contact with clinical development and clinical operations teams to provide GCP and process related guidance and support; works with teams to investigate and resolve clinical study related GCP compliance, deviations and process related issues, providing recommendations for solutions and CAPAs as needed.
  • Perform regular, in-depth GCP audits of study data, documentation, informed consents, clinical study reports, data management, statistical analyses, and ethics committee submissions as appropriate and partner with Clinical Operations colleagues to report metrics, findings, and trends.
  • Participate in the review of clinical protocols and clinical source data to ensure compliant execution of clinical studies.
  • Establish GCP system/process training needs, develop appropriate training materials and deliver and document training compliance.
  • Support CQA system and process improvement initiatives; assist in developing appropriate tools and standard operating procedures to further enhance CQA activities.
  • Maintain required knowledge of applicable regulations, guidelines and company standards and procedures.
  • Contribute to continuous process improvement within clinical development by providing CQA recommendations and representation on project work-streams as required.

QUALIFICATIONS

  • Bachelor’s degree in a life science or related field.
  • Minimum 8 – 10 years’ experience in the pharmaceutical industry.
  • Minimum 5 years experience in Clinical Operations, Clinical QA and GCP auditing.
  • Demonstrated understanding through prior experience of GCP regulations and knowledge of international and national regulations and guidelines related to the conduct of clinical research.
  • Excellent communication and interpersonal skills to build key networks and business relationships across all levels of the business.
  • Proven experience in working with clinical trial teams; working in a multidisciplinary environment.
  • Ability to analyze complex issues, problem solve and take appropriate decisions and actions.
  • Excellent computer skills (MS office, Word, Excel, Visio).

EEO & Employment Eligibility

TP Therapeutics is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.  TP Therapeutics also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.   TP Therapeutics is an E-Verify employer.

To apply, please submit your resume to hr@tptherapeutics.com

Senior Medical Writer

ROLE SUMMARY

The Senior Medical Writer creates documents pertaining to clinical data to support product development and license applications in conjunction with corresponding project teams. Some examples of such documents include briefing documents to support meetings with regulatory agencies, clinical documents for marketing authorization applications, and responses to clinical and safety questions from regulatory authorities.

ROLE RESPONSIBILITIES

  • Provide project teams with expertise on regulatory requirements and corporate policies governing documents for regulatory submission. Provide project teams with expertise and strategic guidance on analysis and presentation of clinical and safety data and on benefit-risk assessment in documents.
  • Assess document requirements, gauge document complexity, and identify information gaps or other potential issues. In collaboration with the relevant project team, the author proposes or contributes to strategies to resolve any identified issues.
  • Support project teams by providing analyses of clinical data.
  • Communicate position on resource and timeline needs for assigned documents to project team members, and keeping management informed.
  • Ensure assigned documents are produced in accordance with relevant internal SOPs and external regulatory guidance, alerting project teams and management in a timely manner of any definite or potential deviations.
  • Drive document strategies and messages in a collaborative way with relevant project team. Ensure clear, factual, effective, and appropriately concise presentation of analyses and associated discussions in assigned documents.
  • Deliver assigned documents on or before deadline, alerting project teams and management in a timely manner of any anticipated delays, information gaps or potential shortcomings in quality.
  • Produce documents in conjunction with external vendors. Review documents produced by vendors and help evaluate vendor performance.
  • Understand relationships and dependencies between documents and analyses produced for regulators.
  • Collaborate with project team, ensuring the accuracy and quality of information presented in assigned documents.
  • Identify potential areas for process improvements and possible solutions, and communicate these management.

QUALIFICATIONS
Education

  • Master’s degree or doctorate or qualification in life sciences preferred. Alternatively, bachelor’s degree in life sciences field with transferable skills and pharmaceutical industry experience, ideally in safety, regulatory or clinical areas.


Experience and Ability

  • BS/BA +15 years, MS/MA +13 years, PhD +10 years of relevant experience in the pharmaceutical or biotech industry with demonstrated experience leading the medical writing portion of regulatory submissions (NDAs and MAAs).
  • Able to interpret complex analyses of data supporting regulatory submissions.
  • Ability to serve as an authority on the interpretation of regulatory guidance and their significance in a broad range of situations.
  • Expert ability to synthesize clearly written analyses of integrated patient data from single pivotal and multiple studies.
  • Advanced understanding of medical concepts of the disease and extensive knowledge of current standard treatments in the disease area.
  • Ability to contribute to discussions of benefit/risk assessment and regulatory impact of documents and analyses. Ability to make decisions by identifying innovative options or multiple solutions to complex problems.
  • Recommends courses of action to management and senior leaders that impact the discipline, department or line.

EEO & Employment Eligibility

  • TP Therapeutics is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.  TP Therapeutics also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.   TP Therapeutics is an E-Verify employer.

 

To apply, please submit your resume to hr@tptherapeutics.com

Clinical Scientist, Clinical Development

ROLE SUMMARY

  • Translate preclinical discoveries into viable oncology therapeutics by supporting clinical development trials and programs within TP Therapeutics’ portfolio
  • Support corporate strategy and clinical development department deliverables for clinical trials and programs by helping with design of scientifically sound clinical protocols and ensuring decision quality clinical data is being generated on an ongoing and timely basis
  • Support clinical development deliverables of determining and measuring optimal pharmacodynamic outputs and enhancing science based patient selection strategies
  • Support the program’s medical monitor/director in the design, conduct, and assessment of the clinical studies including assessment of safety signals as required
  • Develop and maintain strong working relationships with investigators and KOL’s and conduct thorough analyses of current standard of care in focused therapeutic areas to support advisory boards and development plans
  • Conduct literature searches, draft regulated clinical documents, publication abstracts, presentations and publications
  • Support the execution of clinical trials on time by working in a multi-disciplinary team setting with members from within company, CROs and consultants
  • This job role does not require individual to be medically qualified.

ROLE RESPONSIBILITIES

  • Scientific writing: Author or contribute to production of high-quality documents or sections thereof that are scientifically sound:
  • Clinical protocols and amendments
  • Clinical study reports
  • Investigator brochure
  • Documents to support health authority interactions including DSURs
  • Publications including abstracts and congress presentations
  • Translational medicine: Support development of target/pathway engagement assays for selecting therapeutically relevant doses and schedules; support development of stratification biomarkers.
  • Decision quality data generation:
    • Partner with data management and study medical monitor/ director for CRF design, instructions, data review plan and conduct frequent clinical data listing review
    • Partner with biostatistics and study medical monitor/director for statistical analysis plan review and finalization
  • In conjunction with study medical monitor create and/or review slides for internal and external meetings such as investigator meetings, SIVs, company-wide meetings
  • Participate in long-term clinical development and planning a pathway to regulatory registration for assigned therapeutic area(s)
  • Serve as clinical science representative on cross-function teams as assigned
  • Be able to multi-task, prioritize and be a self-starter

QUALIFICATIONS

  • This is an important, high profile role in a fast growing clinical development organization.
  • An advanced science degree (eg. PhD, PharmD)
  • 0-3 years of clinical trial experience in industry; experience working on cross-functional teams, closing a clinical study and authoring a clinical study report preferred
  • Highly motivated entry-level candidates will be considered with commensurate experience in working in industry in cross-functional teams, working on research protocols in industry setting and adhering to tight timelines; course-work covering fundamentals of GVP, ICH and familiarity with FDA guidelines preferred
  • Strong communication skills and ability to work effectively across multiple multidisciplinary teams.
  • Excellent oral and written communication skills.

EEO & Employment Eligibility

  • TP Therapeutics is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.  TP Therapeutics also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.   TP Therapeutics is an E-Verify employer.

 

To apply, please submit your resume to hr@tptherapeutics.com

Clinical Trial Supplies Manager

ROLE SUMMARY

TP Therapeutics is seeking a Clinical Trials Supplies Manager (CTSM) with strong clinical trial supply management experience who will report directly to the VP of Clinical Operations. The mission of TP Therapeutic’s CTSM is to define and execute an optimal clinical trial supply strategy for all TP Therapeutic’s clinical trials including effective risk management to ensure supply continuity to patients. The CTSM has operational end to end responsibility for assigned study activities and leads and manages all clinical trials supplies vendors and systems.

ROLE RESPONSIBILITIES

  • Represents clinical trial supplies as a core member of the Clinical Trial Team (CTT); defines and advises the CTT on the optimal clinical trial supply strategy in terms of, but not limited to, packaging design, technical and timeline feasibility, efficiency and risk management.
  • Reviews all clinical trial protocols/protocol amendments and provides inputs to develop optimal packaging design, clinical trial supply design and visit schedule (key study parameters and milestones, patient screening and enrollment projections, with appropriate overage).
  • Creates and drives finalization of the packaging design and generates labels that comply with global regulatory agencies for investigational new drugs.
  • Provides interpretation of regulatory guidance documents, regulations and directives and advice regarding their applicability and impact on internal labeling runs.
  • Manages batch record review and batch release of labeling activities.
  • Participates in the selection, evaluation and approval of third party contractors for packaging, labeling and distribution activities.
  • Manages internal and third-party deviations, customer complaints, and change controls to support cGMP labeling and distribution activities.
  • Designs, configures, and reviews IWRS/IVRS system(s) for drug supply management, accountability, and enrollment of global clinical studies. Initiates subsequent updates throughout the duration of the clinical trial.
  • Triggers and tracks shipments of Investigational Medicinal Products (IMPs) from central depot(s) to regional hubs and local depots, globally.
  • Develops, maintains and executes an optimal resupply strategy with proactive planning, appropriate lead-time and replenishment quantities to ensure compliance and continuity of clinical supplies, including proactive expiry management of clinical supplies.
  • Develops and executes a clinical supplies trial-level project plan (timeline) together with all other relevant functional areas.
  • Identifies, assesses and proactively communicates supply risks to all relevant stakeholders along with appropriate mitigation strategies to ensure supply continuity.
  • Collaborates with all relevant functional departments for country submission and approval timelines (including IND/IMPD amendment) to develop optimal supply strategy.
  • Is responsible to work with Clinical Operations Study Lead on the management of the clinical trial supply budget(s) (e.g. labels, packaging, distribution and comparators).
  • Proactively communicates key issues and any critical topic in a timely manner to the appropriate management level and to/or any other relevant project team members.
  • Provides guidance and technical training as Subject Matter Expert or recognized technical expert.
  • Ensures/develops adequate documentation, processes and systems are available and followed for labeling, distribution, returns, reconciliation and destruction of clinical trial materials activities (SOPs / Protocols review /approval).
  • Supports product development and QA in ensuring an acceptable outcome of all audits and inspections, especially those by government agencies, as they pertain to labeling and distribution practices.
  • Monitors and reports Key Performance Indicators (KPI) for clinical trials supplies management, to enable strategic objectives to be met or corrective action to be taken.

QUALIFICATIONS

  • Minimum BS in scientific discipline.
  • Experience in managing clinical trial material packaging, labeling and logistics required.
  • Minimum 5 years of experience in the pharma/biotech industry.
  • Ability to effectively organize and prioritize tasks to achieve established deadlines.
  • Strong verbal and written communication skills.
  • Good presentation skills.
  • Ability to work effectively in cross functional environment.
  • Strong knowledge of current Good Manufacturing Practices (cGMP) and relevant regulatory requirements (e.g., US, Asia, Europe and Latin America) and an ability to interpret current regulations and requirements in the labeling context is essential.

EEO & Employment Eligibility

  • TP Therapeutics is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.  TP Therapeutics also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.   TP Therapeutics is an E-Verify employer.

To apply, please submit your resume to hr@tptherapeutics.com

Scientist/Senior Scientist

ROLE SUMMARY

TP Therapeutics is seeking a Scientist/Senior Scientist to join the in vivo pharmacology group. The successful applicant will play key roles in In Vivo Studies to supporting the drug discovery and development effort of the company. This position will report to the Director, Pharmacology & Toxicology.

ROLE RESPONSIBILITIES

  • Contribute to study designs and conducting efficacy/MOA/PK/biodistribution studies in support of preclinical and translational oncology programs.
  • Performe routine procedures such as tumor measurement, dosing, bleeding, tissue collections, inoculations and necropsies, monitor animal health, collect and record data.
  • Tissue culture of various cancer cells and other cells.
  • Ex vivo analysis following in vivo studies.
  • Analyze the experimental data.
  • Present the data to the research team.
  • Perform in vitro cell-based assays.
  • Keep accurate records and up-to-date laboratory notebooks.

QUALIFICATIONS

  • Bachelor of Science in scientific discipline such as Biology, Chemistry or Biochemisty.
  • Experience in managing clinical trial material packaging, labeling and logistics required.
  • Minimum 5 years of experience in the pharma/biotech industry.
  • Ability to effectively organize and prioritize tasks to achieve established deadlines.
  • Strong verbal and written communication skills.
  • Excellent presentation skills.
  • Ability to work effectively in cross functional environment.
  • Strong knowledge of current Good Manufacturing Practices (cGMP) and relevant regulatory requirements (e.g., US, Asia, Europe and Latin America) and an ability to interpret current regulations and requirements in the labeling context is essential.

EEO & Employment Eligibility

  • TP Therapeutics is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.  TP Therapeutics also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.   TP Therapeutics is an E-Verify employer.

To apply, please submit your resume to hr@tptherapeutics.com

Clinical Data Manager

ROLE SUMMARY

  • The Clinical Data Monitor (CDM) is responsible for the clinical data review of one or more studies/programs, most often within a submission timeline.
  • The studies supported by the CDM are complex comparative safety and efficacy trials that are high-enrolling and require robust data capture.  In addition, the CDM ensures data readiness for important milestones including, but not limited to, interim analysis, final analysis, snapshots to support submissions, Data Monitoring Committee reviews and publications. 
  • Review tasks performed by the CDM include both point-to-point data checks and interpretive analysis.

ROLE RESPONSIBILITIES

  • The CDM will use data review best practices and associated data review tools to identify trends and any safety signals.
  • The CDM routinely provides functional management of studies and or compounds being reviewed.
  • The CDM will perform and coordinate the data review deliverables across studies and at the program level.
  • Follows relevant SOPs and regulations, has an excellent understanding of and complies with applicable training requirements, constantly seeking further improvements in quality and efficiency of clinical procedures.
  • Provides data review subject matter expertise support for studies, as needed, within Clinical Sciences group.

Qualifications

  • At least 7 years of clinical experience in pharmaceutical industry.
  • Extensive understanding of the processes associated with reviewing and delivering quality data.
  • Strong field monitoring experience an asset
  • Extensive Clinical Research experience, ideally on the side of the sponsor and with a track record of successful regulatory submissions
  • Strong background in Oncology
  • Strong technical data review skills and comfortable with the review of large sets of clinical data under often challenging timelines.
  • Familiar with database systems; technically competent with Microsoft Excel and ideally, Access.
  • Possesses at least basic knowledge of data management including case report form design, workings of electronic edit checks, implementation of data handling conventions and interpretation of data status reports.

QUALIFICATIONS

  • Bachelor’s degree in one of the disciplines related to life sciences, drug development or business.
  • Advanced degree is desirable.
  • At least 7 years of clinical experience in pharmaceutical industry.
  • Extensive understanding of the processes associated with reviewing and delivering quality data.
    • Some travel may be required

EEO & Employment Eligibility

TP Therapeutics is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.  TP Therapeutics also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.   TP Therapeutics is an E-Verify employer.

 

To apply, please submit your resume to hr@tptherapeutics.com

Clinical Trial Manager

ROLE SUMMARY

We are seeking a highly motivated individual to join TP Therapeutics as a Clinical Trial Manager (CTM), Clinical Operations reporting into the VP of Clinical Operations.  The Clinical Trial Manager functions as the clinical study team leader to plan, organize, and coordinate all operational aspects of a clinical study from protocol development through database lock. The CTM ensures timely conduct of clinical studies according to protocols, Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), and all applicable regulations governing the conduct of clinical trials. The scope of this position requires excellent organizational, communication, and leadership skills, with strong experience in executing all phases of clinical trials

 

ROLE RESPONSIBILITIES

  • Drives all aspects of clinical trial management and processes from initiation, planning, execution, maintenance and close-out.
  • Oversees project timelines, CRO and vendor performance to meet departmental and corporate goals.
  • Ensure that patient enrollment and data collection are completed in accordance with study timelines and objectives; escalates risk to timelines and budget as needed.
  • CRO Selection: Solicit and review proposals from CROs, review CROs’ SOPs, prepare and recommend CRO to management.
  • CRO/Vendor Management: Daily communication/oversight of Vendors/CROs, primary point of contact for questions; follow up on issues or outstanding items. Resolve issues and escalate to management as needed.
  • CRO Oversight: Work with CRO to revise scope of service agreements, budgets, plans and detailed timelines, and ensure that performance expectations are met. Oversee monitoring activities at clinical CROs by reviewing visit reports, protocol deviations and CAPAs.
  • Site selection/Visit report review: Review Qualification Visits as a priority and inform CRO whether site is approved for selection. Review Initiation Visit Reports and Interim Monitoring Visit Reports on an ongoing basis.
  • Contract/Budget Oversight and Management: CTM will track spending of clinical trials against company budget. Review and approve invoices from vendors/consultants as per contract. Obtain executive team management approval of changes to contracts/budgets.
  • Coordinate the design, format and content of CRFs, study guides, study reference binders, patient diaries, and forms including participating in the EDC and IxRS specification process and UAT.
  • Medical Writing: Contribute to and/or author protocols, protocol amendments, clinical study reports, initial IND and annual IND updates, Investigators Brochure and updates, ICF etc.
  • Data Monitoring Committee (DMC): Work with CRO/Vendor to select DMC members, develop the DMC Charter, obtain internal review of DMC documents and plan DMC meetings.
  • Monitor study progress: Ensure compliance with relevant regulations and guidelines by maintaining regular contact with external vendors, including CRO CRAs as applicable.
  • Coordinate/plan Investigator Meetings and/or Site and CRA trainings.
  • Participates in study strategic development, Line Listing Review and Clinical Study Report preparation, as appropriate.
  • Coordinate the oversight of sample collection, process and analysis (i.e., tissue samples, lab samples, scans, PK samples).
  • Track and coordinate trial related materials, including study drug and other clinical trial supplies
  • Perform periodic reviews and QC of the Trial Master File.
  • Identify potential study issues and recommend and implement solutions or corrective actions as needed.
  • Serve as a liaison and resource for investigational sites.
  • Participate in Site Initiation Visits and Co-monitoring Visits for adherence to protocol and GCP as required.
  • Travel as required to carry out responsibilities.
  • Organize and manage internal team meetings and other trial-specific meetings.
  • Participate in the development, review and implementation of departmental SOPs and processes.

 

QUALIFICATIONS

  • Bachelors in a scientific or health care field is required
  • Minimum of 3-5 years of clinical trial management experience, including CRO/vendor management, monitoring of budget scope, clinical site monitoring, and knowledge of basic data management/biostatistics processes and pharmacovigilance
  • Experience in managing oncology clinical trials and/or orphan disease indications preferred.
  • Someone with biotech or pharmaceutical experience as an in-house CTM
  • Clinical operations experience at a small or mid-size company
  • Experience in running a trial from start to finish; protocol writing, ICF generation, site feasibility/start up training, contract and budget negotiation, vendor management, CRF design, maintaining a trial and study close out
  • Comfortable in a fast-paced small biotech company environment and able to adjust workload based on changing priorities
  • Strong knowledge of ICH/GCP guidelines, regulatory requirements and clinical trial operations.
  • A strong communicator with excellent verbal and written communication skills
  • A highly collaborative person who is able to respond to changing circumstances and needs
  • Ability to travel up to approximately 20-25%.

 

EEO & Employment Eligibility

TP Therapeutics is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.  TP Therapeutics also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.   TP Therapeutics is an E-Verify employer.

To apply, please submit your resume to hr@tptherapeutics.com

Clinical Research Associate

ROLE SUMMARY

We are seeking a highly motivated individual to join TP Therapeutics as a Clinical Research Associate (CRA) within the Clinical Operations Team, reporting into the Director of Clinical Operations.  The Clinical Research Associate supports the Clinical Trial Managers and Director of Clinical Operations in the conduct of one or more clinical studies.  The CRA will interact with the Clinical Operations team and collaborate effectively with CROs, vendors and clinical trial sites.  The CRA supports the timely conduct of clinical studies according to protocols, Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), and all applicable regulations governing the conduct of clinical trials.

ROLE RESPONSIBILITIES

  • Assist in overseeing TP Therapeutics’ clinical trials from initiation, planning, execution, maintenance and close-out.
  • Coordinate investigational site startup activities, including the creation, preparation, and shipment of documentation (e.g., ICFs, CRFs, study manuals, study binders, etc.), Ethics Committee submissions and approvals, reviewing/approving Essential document packages, reviewing site changes to ICFs, facilitating completion of clinical study agreements and budgets, and shipment of clinical supplies.
  • Coordinate contract vendors and Clinical Research Organization activities to ensure all are conducted according to study plans, timelines, budgets, and relevant SOPs.
  • Review invoices from vendors/consultants as per contract.
  • Coordinate and maintain relevant tracking systems for subject screening, enrollment, study visits, data entry, query resolution.
  • Review and approve Site selection/Visit reports: Qualification Visits, Initiation Visit Reports and Interim Monitoring Visit Reports on an ongoing basis.
  • Participate in Site Initiation Visits.
  • Conduct co-monitoring visits to oversee CRO personnel and study conduct at the site.
  • Support in the review of CRFs, study guides, study reference binders, patient diaries, and forms including participating in the EDC and IxRS specification process and UAT.
  • Assist in the planning of Investigator Meetings and/or Site and CRA trainings.
  • Assist with protocol, case report form, source document template development, internal SOP/guideline development, final report preparation.
  • Review clinical databases on a real time basis to identify/resolve data entry issues, tracks the query process to identify/report evolving trends in the data.
  • Coordinate the oversight of sample collection (i.e., tissue samples, lab samples, scans, PK samples).
  • Coordinate the exchange of TMF documents with external service providers as applicable and periodic reviews and QC of the Trial Master File to ensure audit and inspection readiness.
  • Serve as a liaison and resource for investigational sites.
  • Additional Operations activities may be assigned as appropriate.
  • Travel as required to carry out responsibilities.
  • Participate in the development, review and implementation of departmental SOPs and processes.

QUALIFICATIONS

  • Bachelors or equivalent in a scientific or health care field required.
  • Minimum of 2-3 years of CRA experience in the biotechnology or pharmaceutical industry required.
  • Experience in oncology clinical trials preferred.
  • Clinical operations experience at a small or mid-size company preferred.
  • Comfortable in a fast-paced small biotech company environment and able to adjust workload based on changing priorities.
  • Strong Knowledge of ICH/GCP guidelines, regulatory requirements and clinical trial operations.
  • Excellent verbal and written communication skills.
  • Ability to collaborate and respond to changing circumstances and needs.
  • Ability to travel up to approximately 25-30%.

EEO & Employment Eligibility

TP Therapeutics is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.  TP Therapeutics also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.   TP Therapeutics is an E-Verify employer.

To apply, please submit your resume to hr@tptherapeutics.com

Clinical Trial Associate

ROLE SUMMARY

We are seeking a highly motivated individual to join TP Therapeutics as a Clinical Trial Associate (CTA) within the Clinical Operations Team, reporting into the Director of Clinical Operations.  The Clinical Trial Associate is responsible for the oversight and management of clinical operations activities or projects. The CTA will interact with Clinical Operations teams and collaborate effectively with CROs, vendors and clinical trial sites.  The CTA supports the timely conduct of clinical studies according to protocols, Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), and all applicable regulations governing the conduct of clinical trials.

ROLE RESPONSIBILITIES

  • Support all aspects of TP Therapeutics’ clinical trials from initiation, planning, execution, maintenance and close-out.
  • Collaborate/Interact with CROs, vendors and clinical study sites
  • Support patient enrollment and data collection are completed in accordance with study timelines and objectives.
  • Review and assess study documents required for site activation and investigational product release.
  • Review Site selection/Visit reports: Qualification Visits, Initiation Visit Reports and Interim Monitoring Visit Reports on an ongoing basis.
  • Schedule, set- up and minute study team and vendor meetings, as applicable.
  • Maintain metrics on results of study documentation reviews.
  • Support in the review of invoices from vendors/consultants as per contract.
  • Support in the review of CRFs, study guides, study reference binders, patient diaries, and forms including participating in the EDC and IxRS specification process and UAT.
  • Support the planning of Investigator Meetings and/or Site and CRA trainings.
  • Manage the oversight of sample collection (i.e., tissue samples, lab samples, scans, PK samples).
  • Ensure all relevant documents are uploaded into the Electronic Trial Master File (eTMF).
  • Manage the exchange of TMF documents with external service providers, as applicable.
  • Perform periodic reviews and QC of the Trial Master File.
  • Provide applicable essential documents to Regulatory for submission to the FDA.
  • Serve as a liaison and resource for investigational sites.
  • Participate in Site Initiation Visits and Co-monitoring Visits, as required.
  • Additional Operations activities may be assigned as appropriate.
  • Travel as required to carry out responsibilities.
  • Participate in the development, review and implementation of departmental SOPs and processes.

QUALIFICATIONS

  • Bachelors or equivalent in a scientific or health care field preferred.
  • Minimum of 1-3 years of relevant experience required.
  • Experience in oncology clinical trials preferred.
  • Clinical operations experience at a small or mid-size company.
  • Comfortable in a fast-paced small biotech company environment and able to adjust workload based on changing priorities.
  • Knowledge of ICH/GCP guidelines, regulatory requirements and clinical trial operations.
  • Excellent verbal and written communication skills.
  • Ability to collaborate and respond to changing circumstances and needs.
  • Ability to travel up to approximately 15-20%.

EEO & Employment Eligibility

TP Therapeutics is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.  TP Therapeutics also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.   TP Therapeutics is an E-Verify employer.

To apply, please submit your resume to hr@tptherapeutics.com

Clinical Biomarker Operations Associate

ROLE SUMMARY

As a member of the Biomarker Operations team, the Clinical Biomarkers Operations Associate will be accountable to establish operational processes for the appropriate collection of biospecimens from clinical trials and vendors to support biomarker testing and companion diagnostic development. The individual will assist in developing biomarker plans to support pre-clinical and clinical programs, including the strategy and goals, experimental validation, timelines and budget. The incumbent is expected to have deep scientific expertise in technology platforms relevant to biomarker testing and development, as represented by publications. This position reports to the Vice President, CDx & Biomarker Development.

The successful candidate will have the opportunity to work closely with Clinical Operations, Translational Medicine, CROs and clinical sites to coordinate and manage the sample collection (tissue/blood) for on-going and planned clinical trials.

ROLE RESPONSIBILITIES

  • Biomarker (including PK, PD, prognostic and predictive markers) sample logistics, vendor and data management.
  • Track the collection and shipment of clinical samples from the clinical site to biobanks or 3rd party laboratories for testing; working closely with Clinical Operations, CROs and Translational Medicine to ensure all samples are collected, shipped and received according to schedule.
  • Work closely with Clinical Operations, CROs and/or clinical sites to resolve sample related issues in a timely manner.
  • Manage retrieval of samples from tissue repositories/participating centers.
  • Coordinate sample logistics and data transfers with Diagnostic Development partners.
  • Manage kit preparation, sample collection procedures, shipping requirements, data collection/reporting.
  • Ensure and verify that collaborators have appropriate documentation, processes, and procedures in place to ensure appropriate samples collection.
  • Developing and updating current data transfer specifications by gathering input from biomarker leads, data management and data scientists to ensure consistent data transfers.
  • Ensure vendors keep to the schedule of data transfers and the data format is consistent with internal infrastructure.
  • Clear understanding of programs’ clinical biomarker plan, which enables the review of laboratory manuals, informed consents, analytical plans, and SOWs.
  • Ensure review of study files (the protocol and any amendments, ICFs for sample/tissue collection, correspondence with the IRB, and other study-related documents).

QUALIFICATIONS

  • Advanced degree within a clinical and/or scientific profession (or an equivalent level of professional, clinical and/or scientific education, training and experience) required.
  • Minimum of 2-5 years of experience and success within other biotech/pharmaceutical companies, with three or more years in biomarker areas is required.
  • Experience in developing Informed Consent Forms for biospecimen acquisition is required.
  • Development of lab manuals and clinical trial protocol language is required.
  • A working knowledge of preanalytical biospecimen processing is required.
  • Knowledge of GLP/GCP framework and clinical database is desired.
  • Knowledge of oncology drug development is preferred.
  • Experience with the development and support of related SOPs and ICF’s is required.
  • Experience with partnerships and strategic alliances preferred.
  • Experience working in global environment preferred.
  • Prior experience with vendor selection and management expected.
  • Excellent people skills with ability to interface with multiple cross-functional teams and groups including Clinical Operations, clinical sites and CROs.
  • Excellent and proactive verbal and written communication as well as judgment and problem-solving skills.
  • Skilled in multiple computer-based tools, in addition to software programs such as Word, Project, PowerPoint, Excel, etc.

EEO & Employment Eligibility

TP Therapeutics is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.  TP Therapeutics also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.   TP Therapeutics is an E-Verify employer.

To apply, please submit your resume to hr@tptherapeutics.com

Executive Assistant

ROLE SUMMARY

We are seeking an experienced Executive Assistant to provide administrative support to the Clinical Development, Regulatory Affairs, and Clinical Operations executives at TP Therapeutics. The Executive Assistant will coordinate daily schedules, meetings, agendas, presentations, travel arrangements, and expense reports for the executives. This is a demanding, high visibility role, and will interface with senior leaders inside and outside of the Company.

 

ROLE RESPONSIBILITIES

  • Maintain and coordinate calendars, make travel arrangements, schedule meetings, and complete expense reports for senior leaders.
  • Organize large scope meetings and visits (agenda, reservations, logistics)
  • Create, edit, and format written material such as presentations, spreadsheets, and other documents.
  • Serve as a departmental subject matter expert on TP’s administrative procedures and processes.
  • Proactively and independently organize and expedite workflow and initiate follow-up when necessary to ensure schedules and deadlines are met, particularly when leader is travelling.
  • Use appropriate discretion in the management of information and stakeholders.
  • Provide project management assistance and proactively prepare materials for external meetings.
  • Open, review, and route mail, replying to routine correspondence.
  • Set-up and maintain project and general correspondence files.
  • Organize and maintain electronic and hard copy files.

QUALIFICATIONS

  • A Bachelor’s Degree is preferred.
  • A minimum of five years of executive administrative support experience in a life science company is required.
  • Advanced computer skills (MS Office, including word processing, spreadsheet, presentation and database software) are required.
  • Experience with making international and domestic travel arrangements and coordinating on/offsite meetings is required.
  • Must possess a high level of professionalism.
  • Outstanding verbal and written communication skills are required to properly draft and edit correspondence and presentations, and interface with senior leaders.
  • Organizational skills, the ability to handle multiple tasks and priorities simultaneously, and the ability to work with independence and minimal supervision is required.
  • Demonstrated team player attitude, with a record of proactively taking initiative as appropriate is required.
  • Ability to handle confidential matters with the utmost discretion is required.

EEO & Employment Eligibility

TP Therapeutics is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.  TP Therapeutics also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.   TP Therapeutics is an E-Verify employer.

To apply, please submit your resume to hr@tptherapeutics.com