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.  

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

Senior/Principal Statistical Programmer

ROLE SUMMARY

The Senior/Principal Statistical Programmer will be working with the statisticians, data managers, and clinical team members to support statistical programming efforts for specific projects including the creation of tables, figures, and listings (TFLs), SDTM domains, and ADaM datasets for clinical studies, IB, DSUR, publications, and ad hoc analyses. He/she will be responsible for developing, testing, maintaining, validating, and documenting SAS programs.  This person will provide technical expertise for the development of SAS programming specifications, standards, and procedures to meet regulatory submission requirements. We are looking for a candidate who is enthusiastic, independent, efficient, and hard-working to ensure a high quality job while meeting timelines. This position will report directly to the Senior Director of Biostatistics.

ROLE RESPONSIBILITIES

  • Generate TFLs to support the statistical analysis of data for clinical studies, regulatory submissions and publications.
  • Generate SDTM domains, ADaM datasets, and define.xml files.
  • Interact directly and independently with Biostatisticians, Data Managers, Statistical Programmers, Clinical Development staff and management as a fully functioning member of the clinical programming team.
  • Create or review and approve programming plans at study and project levels.
  • Provide input on key study-related documents produced by other functions (e.g. CRFs, Data Management Plan, Analytics, SAPs, etc.).
  • Communicate effectively with other stake-holders in translating concepts and requirements into technical specifications and providing multi-disciplinary teams with sensible programming solutions.
  • Provide hands-on programming and validation support for statistical programming tasks that are required for various deliverables such as CSR, DSUR, IB, publications, etc.
  • Maintain complete and auditable documentation of all programming activities.
  • Review output across SAS programs to ensure consistency.
  • Provide statistical programming support to supplemental or exploratory analyses to meet any other internal and external ad-hoc requests.
  • Assist in programming, testing, and documenting SAS global utility programs and tools in accordance with standards and validation procedures.
  • Participate in the development and/or maintenance of departmental procedures and standards.
  • Participate in monitoring CRO activities and reviewing and validating CRO deliverables, as necessary.
  • Assist in creation of TFL shells/mockups, and programming specifications under supervision of biostatisticians.

QUALIFICATIONS

  • Master’s degree in Statistics, Biostatistics, Mathematics, or Computer Science or in a related field.
  • Minimum of 7 years Biotechnology/Pharmaceutical/CRO industry experience as a clinical trial SAS Programmer.
  • Knowledge of Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL and SAS/ODS.
  • Demonstrates extensive knowledge with industry standards, such as the ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA guidelines.
  • Excellent organizationaland time management skills, and ability to coordinate workload and meet established deadlines.
  • Excellent communication and interpersonal skills to effectively interface with others.

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 Director/Director, Clinical Pharmacology

ROLE SUMMARY

The Senior Director/Director, Clinical Pharmacology will report to the SVP, Clinical Operations and Regulatory Affairs, and will provide clinical pharmacology strategy on our drug development.  The successful candidate will be a subject matter expert in clinical pharmacology who has experience providing scientific/technical guidance in decision-making. The Senior Director/Director will represent clinical pharmacology on cross-functional teams and will serve as a liaison for information on PK, drug metabolism, toxicokinetics, and bioanalysis within the organization and externally to regulatory authorities and CROs. The individual will maintain knowledge of current GCP, regulatory guidelines and company SOPs and policies and ensure compliance in performing job duties, including those performed by subordinates and/or contractors. Strong interpersonal and outstanding written and verbal communication skills are essential.   Technical skills including design, execution, analysis and reporting of clinical pharmacology plan and clinical pharmacology studies, modeling of pharmacodynamics (PD) and population PK/PD are required.

ROLE RESPONSIBILITIES

  • Major contributor to the scientific/technical aspects of assigned clinical pharmacology studies from conception through final report, including first-in-human, bioavailability/bioequivalence, drug-drug interactions, PK in special population, ADME, and population studies
  • Represent clinical pharmacology on cross-functional teams; identify and communicate potential project hurdles, suggest solutions, and leverage the clinical pharmacology leadership to establish priorities and contingency plans
  • Contribute to regulatory submissions, including INDs, IBs, NDAs, MAAs and pediatric plans
  • Collaborate with clinicians, biostatisticians, regulatory affairs, and clinical operations to ensure appropriate study designs are achieved for successful implementation of data analyses and accomplishment of intended study outcomes
  • Articulate clinical pharmacology plans and study results to development teams and/or senior management
  • Identify and manage external vendors and consultants supporting the clinical pharmacology function
  • Conduct/supervise NCA PK analyses using WinNonlin software and population PK/PD analyses with NONMEM software
  • Liaise with KOLs and academic collaborators on clinical pharmacology and author/review abstracts/manuscripts generating high-quality presentations/publications

QUALIFICATIONS

  • PharmD with relevant post-doctoral training in clinical pharmacology, pharmacometrics, or related field
  • 10+ years of relevant industry experience in clinical pharmacology, pharmacometrics, or related discipline(s).
  • Experience in oncology drug development
  • Experience in preparation, submission and response to INDs, NDAs, CTDs, and MAAs
  • Proficient at conducting population PK, PK/PD, PBPK analyses using vendor-based software (Simcyp, GastroPlus, WinNonlin NONMEM, SPLUS, R, etc.)
  • Proven track-record in drug development, clinical pharmacology and pharmacokinetics, and clinical research concepts and practices
  • Strong publication record in the area of clinical ADME/PK coupled with a high level of scientific insight and analytical thinking 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

Senior Clinical Trial Manager

ROLE SUMMARY

  • We are seeking a highly motivated individual to join TP Therapeutics as a Senior 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.
• Drive and 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: 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: Efficiently 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.
• Manage 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.
• Plan and present at 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.
• Clinicaltrials.gov: Act as administrator for the Protocol Registration System (PRS) & get internal agreements for entries, register studies & submit results on PRS. Responsible for keeping information updated for ongoing clinical trials.
• Participate in risk management discussions with the cross-functional study team and contribute to maintenance of a comprehensive risk management plan throughout the study lifecycle
• 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 5-7 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 for 3+ years
• 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
• Developed leadership skills to manage a clinical study team
• Comfortable in a fast-paced small biotech company environment and able to adjust workload based on changing priorities
• Expert 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 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 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

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

Associate Director/Senior Manager, Regulatory Affairs

ROLE SUMMARY

The Associate Director/Senior Manager, Regulatory Affairs will work in a matrix environment and possess the credentials to be the US and global lead in providing both strategic input and day to day guidance for the projects assigned.

ROLE RESPONSIBILITIES

  • Provide regulatory guidance to cross-functional teams ensuring the project assigned progresses from IND stage to launch within company agreed timelines.
  • Ensure regulatory compliance with relevant regulations and effectively managing timely submissions to the appropriate regulatory authorities
  • Manage the preparation of applications and subsequent regulatory documents, pre and post approval in accordance with agreed timeframes
  • Ensure submission-readiness of all regulatory documents related to the project
  • Ensure that documents to be submitted to the health authorities are compliant with eCTD submission requirements.
  • Format documents
  • Assist in developing junior regulatory affairs staff.
  • Determine risk assessment and implement regulatory strategies for products in pre and post-approval stages.
  • Build long term effective relationships and open communication with cross functional teams in order to provide accurate information and timeframes.
  • Participate in R&D meetings to discuss project issues and develop priorities to produce clear project plans.
  • Participate in inter-departmental meetings to discuss project issues and priorities and develop clear plans to achieve the required goals.
  • Develop and maintain a positive working rapport with the regulatory agencies
  • Develop and maintain standard operating procedures or local working practices
  • Maintain current knowledge of relevant regulations, including proposed and final rules

QUALIFICATIONS

  • BA/BS and 8 years, MA/MS and 6 years, or PhD/PharmD and 3 years of relevant US regulatory (FDA) / drug development experience
  • Good communication skills – both oral and written
  • Organizational skills – detail oriented and can deal with frequent changes in product activity
  • Strong knowledge of eCTD elements and structure
  • Strong team player that has a customer service approach and is solution oriented
  • Must be able to work on multiple projects simultaneously and demonstrate organizational, prioritization, and time management proficiencies
  • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
  • High level of proficiency in relevant software (i.e., MS Word, MS Office or similar systems, Adobe)
  • Expertise with templates and formatting tools
  • High energy level and a positive outlook coupled with the requisite “can do” attitude and a willingness to do what it takes to achieve personal and organizational goals and overcome obstacles
  • Willingness to think outside of the box and adapt best practices to our small, but growing environment
  • Ability to adapt in a constantly evolving environment
  • Self-motivated with a strong sense of ownership in areas of responsibility
  • High degree of professionalism, ethics and integrity
  • Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities

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

Safety MD, DVM, or RN

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

Vice President, Clinical Development (MD Required)

ROLE SUMMARY

  • Oversee execution of early and late clinical development strategies
  • Development spans pre-IND, First in patient through Approval and Commercialization.
  • Work collaboratively with multiple internal groups to develop clinical development plans.
  • Collaborate with the Senior Management and other line function heads to help streamline asset development plans and to lead clinical development teams.
  • Work collaboratively with other line function heads to drive early Candidate Selection of early pipeline assets and establish best path forward for their INDs and development plans.
  • Oversee and mentor medical monitors within the organization, and potentially other internal functions (depending on qualifications and desires)
  • This position will report into the EVP, Chief Medical Officer and be a key member of the clinical organization

ROLE RESPONSIBILITIES

  • Develop innovative clinical development plans that drive early decision making based upon objective clinical safety and efficacy response measures.
  • Work collaboratively to develop expedited Proof of Concept programs that lead to seamless late stage development.
  • Collaborate with external experts to drive innovation in early and late clinical development plans and translational/precision medicine.
  • Represent TP Therapeutics at critical regulatory interactions.
  • Ensure highest level of rigor and scientific integrity of clinical programs and protocols.
  • Function as the Team Leader for at least one clinical asset and work in partnership with other team Leader(s) to ensure delivery of high-quality, cost-effective programs that are delivered on time and within budget, while maintaining the necessary resources needed to deliver the program.
  • Meet regularly with senior leaders, including Chief Medical Officer
  • Identify and escalate issues in a timely manner as appropriate.
  • Meet with Senior Management as requested to keep them fully informed of issues of high priority related to Oncology.

QUALIFICATIONS

  • MD, MD/PhD or equivalent with extensive clinical experience.
  • At least 10 years of oncology development experience within the Biotech or Pharmaceuticals industry, with focus in early development in Oncology (preferred).
  • Ability to collaborate across multiple functions within the organization
  • Ability to lead in a team environment.
  • Understanding of the drug development continuum from pre-POC to post-POC and commercialization.
  • Understanding of related disciplines (e.g. biostatistics, regulatory, pre-clinical pharmacology, pharmaceutical sciences).
  • Demonstrated scientific productivity (publications, abstracts, etc.).
  • A thorough understanding of Oncology and cancer biology and its relationship to drug development.
  • Experience in functioning effectively as a member of a multidisciplinary team.
  • Insight into and understanding of principles related to evaluating business deal structures including commercial collaborations, acquisitions, and divestitures.
  • Experience in budgetary management and decision making.
  • Demonstrated effectiveness in people management, communication and colleague development.
  • Demonstrated effective negotiating, influencing, interpersonal and leadership skills.
  • Exceptional verbal and written communication and presentation 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