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.  

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

Vice President, Clinical Operations

ROLE SUMMARY

  • The Vice President of Clinical Operations will be responsible for building and leading a team of clinical operations professionals who will oversee the strategy for implementation as well as execution of all TP Therapeutics sponsored clinical trials. Working with cross-functional leaders, the successful candidate will ensure the appropriate department infrastructure is in place to support the Company’s clinical trial programs. This individual will be responsible for leading all operational aspects of the Company’s clinical trials conduct from study concept through to report writing in support of license applications.
  • This position will report into the EVP, Chief Medical Officer

ROLE RESPONSIBILITIES

  • Provide strategic and technical guidance to ensure clinical trials are properly defined, planned and executed.
  • Lead and direct the clinical operations team responsible for management and execution of all clinical trials. This includes ensuring cost/budget, quality, vendors are managed; timelines of multiple programs are met and site qualifications and initiation.
  • Lead and directs the building of department infrastructure, including developing, and retaining the clinical operations team; ensures prioritization of activities and resourcing is in line with clinical development programs.
  • Optimize and implement SOPs, processes, communication, and infrastructure within Clinical Operations Department to support company goals including Regulatory filings.
  • Maintain real-time, live dashboards for management review of program status, risk plans and mitigation, and document control.

QUALIFICATIONS

  • BA/BS in related life sciences field
  • 15+ years of progressive clinical operations experience in pharmaceutical/drug development and including at least 10 years of strong hands-on experience leading and managing clinical operations team and trials execution, preferably in oncology globally.
  • Expertise in the areas of drug development, operations and strategic planning; experienced with submissions from investigational new drug through new drug application filings and managing pre-clinical through all clinical phases.
  • Proven track record of planning, conducting & managing clinical operations for Phase 1-3 studies
  • Expert and comprehensive understanding of country specific pharmaceutical standards, FDA, ICH, and GCP requirements (and/or equivalents), principles, concepts, industry practices, and standards, as well as a thorough understanding of cross-functional clinical processes including data management, biostatistics, medical writing, pharmacovigilance, and regulatory affairs
  • Thorough knowledge of data management, data review and analysis, and drug safety and pharmacovigilance

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, Biostatistics

ROLE SUMMARY

  • Partner with senior management, clinicians, clinical pharmacologists, translational medicine, and other scientists to support early clinical development for Oncology.
  • The statistician will be involved in the design, execution, analysis, and reporting phases of clinical protocols and provide statistical expertise on regulatory submissions and ensure the quality and appropriateness of submission deliverables.
  • She/he will support the development of innovative and efficient plans for developing new medicines in a variety of cancer indications.  She/he will review scientific literature, promote innovation, efficient design and quantitative decision-making within research and in partnership with other lines, reducing the time and cost of drug development.

ROLE RESPONSIBILITIES

  • Core member of our scientific team responsible for determining strategy and delivering results in a timely and high quality manner.
  • Leader to bring innovative statistical thinking and methods to help drive the enhanced quantitative drug discovery and development paradigm.  Central to this approach is the systematic review of prior information, statistical model building and simulation, utilizing Bayesian methods as appropriate, to design more effective studies.
  • Frequently interact with regulatory agencies regarding accelerated clinical development options for indications that have substantial unmet medical need.
  • In depth knowledge of more than one area of statistics, all commonly used, that enables to exert broad influence via advice to numerous project statisticians. 
  • Leads initiatives to improve understanding and application of statistical methods
  • Strong insight into the business needs and seek out areas where statistics adds most value, influencing others to ensure we focus our efforts on these key areas.

QUALIFICATIONS

  • The qualified candidate must have a M.S. or Ph.D. in Statistics, Biostatistics, or related field, as well as a minimum of ten years experience in applying statistics in a pharmaceutical or related industry.
  • Ideally, this experience would include exposure to the design and analysis of clinical studies in oncology early clinical development.
  • The preferred candidate will have excellent statistical knowledge with the ability to apply this to scientific and clinical problems with experience in computational simulation, analysis of biomarkers, and Bayesian statistics.
  • The preferred candidate will have a proven ability to manage multiple complex projects with a track record of influencing external environment through contributions to scholarship, working parties etc., as evidenced by committee membership, presentations and publications with demonstrated scientific productivity in advancing the state-of-the-art in applied statistical methodologies.
  • Strong communication skills with the ability to influence widely and work collaboratively with clinical project teams and senior management are 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 Clinical Trial Manager

ROLE SUMMARY

  • The Clinical Trial Manager will be responsible for the day-to-day management of a diverse program of clinical trials, including management of contract CROs conducting company sponsored clinical trials.

ROLE RESPONSIBILITIES

  • Work with CROs to ensure that patient enrollment and data collection are completed in accordance with study timelines and objectives; escalates risk to timelines and budget as needed.
  • 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; attend co-monitoring visits as required.
  • Monitor study progress: ensuring compliance with relevant regulations and guidelines by maintaining regular contact with external vendors, including CRAs as applicable.
  • Review and contribute to study Protocols, eCRF design and completion guidelines, laboratory manuals, Informed Consent Forms, and other study-related documents.
  • Coordinate/plan investigator meetings and/or site and CRA training.
  • Perform financial management, including review and approval of site and vendor invoices.
  • Track and coordinate trial related materials, including clinical trial supplies and laboratory samples.
  • Perform review and QC central clinical files and 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; review investigator contracts and site payments.
  • Travel to CRO/vendor facilities and/or investigative sites to train and assess study team and CRAs.
  • Organize and manage internal team meetings and other trial-specific meetings.
  • Participating in the development, review and implementation of departmental SOPs and processes.

QUALIFICATIONS

  • Bachelors or Masters degree or equivalent 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; initiating the trail that includes protocol writing, ICF generation, site feasibility/start up training, contract and budget negotiation, vendor management, CRF design, maintaining a trial and study close out.

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 of Clinical Development MD

ROLE SUMMARY

  • To develop clinical development plan from first in human clinical trial to proof-of-concept, including assessment of appropriate combinations, as well as evaluation of potential predictive and pharmacodynamics biomarker plans
  • To work collaboratively with the functional groups within Oncology Clinical Development.  
  • To ensure the clinical components of the clinical plans and clinical expertise are provided to project teams, including medical monitoring of clinical trials. 
  • To support projects from Research to Proof of Concept (typically phase 2).  To provide and utilize innovative methods to integrate knowledge, patient characteristics and diseases for rational development strategies and decisions.

ROLE RESPONSIBILITIES

  • Provides leadership to the clinical function for preparation of critical documents, including but not limited to clinical protocol, clinical development plan, investigator brochure, statistical analysis plan, and regulatory documents.
  • He/she will closely work in a team environment, including other clinicians, statisticians, clinical pharmacologists, translational biologists and others. The candidate will work on clinical projects and will support the development and provide consultation regarding multiple research projects.
  • Provide administrative and technical oversight of clinical function within his/her Group
  • Ensure that all activities are conducted in compliance with relevant regulatory requirements.
  • Monitor and report on implementation of clinical initiatives in his/her group
  • Develop charters, resource utilization and project plans to achieve clinical project specific goals
  • Implement site organizational design and develop succession planning for clinical area.
  • Develop people, including recruitment, retention, and career development as directed by management.
  • Ensures development of and adherence to a Safety Review Plan (SRP).  Consistent with the SRP, performs regular review of individual subject safety data, and performs review of cumulative safety data with the safety risk lead or as delegated by the clinical leader. As appropriate, the Senior Director may delegate these responsibilities to a physician study clinician identified in the SRP.
  • Be accountable for clinical analyses, programmed outputs, and integrated scientific reports for clinical trial results and support for publication activities, for assigned projects.
  • Implement strategies to ensure that the clinicians are collaborative, strategic partners with scientific and clinical colleagues.
  • Implement strategies to ensure appropriate consistent processes in strong collaboration with partners.
  • Develop effective collaborations with Clinical Leads in Oncology Research & Development and Global Product Development organizations, and external regulatory, industry, professional and academic organizations.
  • Implement aligned strategies and consistent processes to optimize the use of corporate standards

QUALIFICATIONS

  • Requires MD/PhD or MD and demonstrated depth and breadth of knowledge and experience in clinical research in the academic, clinical practice or industry setting.
  • Prior specialized training in Medical Oncology; Board Certification in Oncology is desirable
  • At least 3 or more years’ experience in the pharmaceutical industry with a track record in early phase drug development through to phase 2 Proof of Concept.
  • Experience in the development of therapeutics in Oncology
  • Understanding of related disciplines (e.g. biostatistics, regulatory, pre-clinical pharmacology, pharmaceutical sciences). 
  • Demonstrated scientific productivity (publications, abstracts, etc.)
  • Proven scientific writing skills and good communication skills
  • Proven leadership skills with ability to defend the clinical plan at governance meetings is essential
  • Capacity to adapt to a fast-paced and changing environment

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

  • The Executive Administrative Assistant position will provide administrative support to the senior executives of TP Therapeutics. This includes coordination of daily schedules, meetings, agendas, presentations, travel arrangements, and expense reports for the executives. It will also include support and coordination for key members of the organization.
  • This is a demanding, high visibility role, and will interface with senior leaders inside and outside of TP Therapeutics.

ROLE RESPONSIBILITIES

  • The candidate must have excellent administrative, coordination, and communication skills and be capable of working independently.
  • Attention to detail is a must, as is the ability to maintain confidentiality.
  • The candidate will be working in a fast-paced environment.
  • Candidates should possess strong interpersonal skills, leadership, negotiation, analytical and problem-solving skills to support the needs of the executives and other team members.
  • Strong organizational skills are a must.
  • Advanced computer skills including word processing, spreadsheet, presentation and database software will be used every day.
  • This position requires full time presence on site, the ability to effectively multi-task and to solve problems within the scope of this role.

QUALIFICATIONS

  • A minimum of a High School diploma is required.
  • A Bachelor’s Degree is preferred.
  • A minimum of 6 (six) years of administrative or related experience is required.
  • Experience in an executive environment, supporting leaders and executives as well as their teams, 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 are required.
  • Excellent verbal and written communication skills are required to properly draft and edit memorandums, correspondence and presentations and interface with senior leaders.
  • Organizational skills, exemplary stakeholder service 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 requiring discretion is required.
  • Demonstrated excellent judgment and the ability to solve problems proactively is required.
  • Acute attention to detail 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

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

Director or Senior Director, Clinical Operations

ROLE SUMMARY

  • The Clinician is responsible for working collaboratively with the members of the development team (including a medically qualified individual) to establish the clinical development plan(s) for one or more compounds from lead development in discovery to Phase I-II clinical trials, and for designing/executing and reporting protocols for studies included in the development plan.
  • This job role does not require individual to be medically qualified.

ROLE RESPONSIBILITIES

  • Depending on experience, may contribute to or be primarily responsible for formulation of clinical development plans. Contributes to or may independently design protocols, amendments and conduct data review, analysis and interpretation.
  • Consistent with Safety Review Plan, performs and documents regular review of individual subject safety data and performs review of cumulative safety data with the Safety Risk Lead or medically qualified individual.
  • May contribute to or be primarily responsible for Go-No recommendations for the compound, including recommendation to advance to FIH after review of the preclinical package and involvement with transition and preparation to Phase III.
  • In conjunction with members of the development team may prepare strategy presentations, present and discuss data at relevant team, governance, external consultants, KOLs and potentially regulatory meetings as well as author clinical sections of regulatory documents (IB, Annual Reports, IND sections, CSR). Must have proven scientific writing skills and good communication skills.
  • Interface with discovery, safety sciences, statistics, PK/PD, CRO’s, regulatory, research, development operations, other members of the project team(s), external experts and regulators.
  • In conjunction with study team is responsible for the on-time and within-budget execution of protocols.
  • May have functional responsibility for other clinicians assigned to the project and may supervise and develop other colleagues.
  • May transition early development clinical programs into late stage development.
  • Demonstrated experience with GCP and the ability to apply internal policies and SOPs

QUALIFICATIONS

  • Advanced scientific degree preferred (PhD, PharmD, MA); Degree in Life Sciences preferred. demonstrated experience in oncology drug development, early development preferred; familiarity with related disciplines (biostatistics, regulatory, pre-clinical pharmacology, pharmaceutical sciences); demonstrated scientific writing skills and good communication skills
  • 10+ years in clinical development
  • 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 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

Project Management, Director or Senior Director

ROLE SUMMARY

  • We are looking for an experienced Director or Senior Director for our Project Management Team. The successful candidate will be responsible for managing multiple highly complex development projects; co-lead early stage development team(s) to drive preclinical assets into the clinic. Work closely with the project team members representing preclinical, clinical, regulatory, and operations, CMC, quality, legal departments in a team environment to develop concise strategic development proposals, integrated project plans, and manage and track key project deliverables. Provide regular project team deliverables and progress updates to Senior Management.

ROLE RESPONSIBILITIES

  • Proactively facilitate and lead team discussions on project strategies, short-term and long-term project planning, opportunities for expediting timelines, identification of resource constraints, and proactively identify complex project issues and risks, and assure appropriate escalation.
  • Manage Project Team meetings and facilitate discussions using meeting management best practices to drive project strategy, scenario planning, cross-functional communication, timely and effective decision-making, and successful execution of program objectives. Develop agendas and summarize key meeting discussions and decisions (meeting minutes).
  • Develop, track and maintain project development timelines (integrated project plans), project deliverables and milestones; including understanding and communicating inter-dependencies and critical path activities.
  • Work closely with and build strong working relationships with cross-functional team members to develop a collaborative team environment and manage timelines for regulatory submissions (IND/NDA/BLA/MAA, etc.).
  • Develop, track and maintain project publication plans, work with teams to identify key conferences and journals, coordinate publication development and publication gap analysis.
  • Assists in the review of project team regulatory documents and SOP revisions, if relevant.
  • Work closely Senior Management in ongoing enhancements and development of team processes, structures, and project reporting tools.

QUALIFICATIONS

  • BS in a scientific field required; Master’s degree preferred.
  • Strong understanding of Drug Development process and US and EU Regulatory requirements.
  • Minimum of 8+ years of project management experience in drug development
  • Exposure to early-stage programs (pre-clinical through Phase I/II proof-of-concept) essential; and exposure to late-stage programs (Phase II/III pivotal) a plus.
  • Able to work independently and creatively with minimal oversight
  • Proven ability to analyze complex activities and information to help guide decision-making that meets the overall objectives and long-range plans of projects and the organization
  • Strong ability to proactively predict issues and solve problems, identify risks.
  • Strong ability to drive decision-making within a multi-disciplinary, multi-regional, matrix team.
  • Proven ability to balance the strategic needs of the program with tactical day-to-day activities.
  • Excellent people (soft) skills, conflict resolution, diplomacy and positive influencing abilities.
  • Outstanding communication, planning and organizational skills.
  • Highly collaborative team player who fosters open communication and able to facilitate urgent needs.
  • Successful track record of creating and managing accurate integrated project plans/timelines and the use of project software (Microsoft Project, Visio, PowerPoint and 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

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, DVM or Graduate of an accredited school of nursing, BSN preferred
  • License/Certification: NP or RN
  • Experience: Three years of progressively more responsible nursing experience is required. 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

Senior Research Associate Biology/Pharmacology

POSITION DESCRIPTION

  • We are looking for Senior Research Associate/Scientist to join the TP Therapeutics biology group. The successful applicant will play a key role in In Vivo Studies supporting drug development. Direct responsibilities include contributing to study designs, executing experimental activities, generating and analyzing the experimental data, and presenting the data to the research team. Other responsibilities include day-to-day vivarium operations, keeping accurate records of data in laboratory notebooks.

JOB RESPONSIBILITIES AND QUALIFICATIONS

  • B.S. or M.S. with 5 years of in vivo pharmacology experience, preferably in a biotech or pharmaceutical industry setting.
  • Proficiency with standard in vivo techniques, including dosing and sampling routes (e.g., po, ip, sc, iv dosing; submandibular, retro-orbital, cardiac bleeds; necropsy and organ/tumor harvest) is required.
  • Experience in tissue culture, immunoblotting and cell viability assays.
  • Experience working with rodent models of oncology and other disease is preferred.
  • Experience in generating engineered and/or drug resistant cell lines is desired.
  • Expertise in data analysis software: MS Powerpoint, MS Excel, MS Word is required.
  • Attention to detail, proficient reasoning skills in experimental design, data analysis and interpretation are required.
  • Able to work interdependently, meet deadlines with a sense of urgency, multitask and adjust to shifting priority.
  • Must be a team player with positive thinking and the ability to thrive in a fast paced, highly collaborative environment focused on results and the common good.

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, Companion Diagnostics and Biomarkers

ROLE SUMMARY

  • Oncology is a key therapeutic area for TP Therapeutics, Inc.  TP is expanding its oncology team focused the discovery and development of novel oncology therapies. This position is based at San Diego, CA location.  We are seeking a creative and highly motivated leader to develop and implement companion diagnostic and biomarker strategies to enable and support the development and commercialization of current and incoming clinical trials in oncology. The successful candidate will have the opportunity to work in a highly collaborative environment and will participate as a member of multidisciplinary development management team.

ESSENTIAL DUTIES AND JOB FUNCTIONS

  • Develop and coordinate the overarching Biomarker and CDx strategy in targeted therapeutic areas, with the focus on technologies including next-generation sequencing, FISH, IHC, etc.
  • Guide the CDx regulatory submission and QA processes for clinical trails
  • Lead the development and implementation of biomarker and diagnostic strategies for individual projects and/or therapeutic areas.
  • Direct the co-development, outsourcing and validation of Companion Diagnostics.
  • Guide the development, outsourcing and validation of clinically applicable biomarker assays (including pharmacodynamic, predictive, prognostic, safety and other biomarkers)
  • Design, implement and oversee biomarker and diagnostic testing and data analysis.
  • Provide expertise to development project teams to ensure access to state of the art thinking on appropriate biomarker and diagnostic technologies, evaluating their scientific basis and clinical applicability, the validation status and any technical or statistical issues related to the proposed biomarkers and/or companion diagnostics.

DESIRED SKILLS AND EXPERIENCE

  • Highly experienced biomedical leader (PhD or MD/PhD) with a minimum of 15 years of post-doctoral and relevant industry experience with expertise in oncology biomarker and companion diagnostic development (NGS-based CDx experience preferred).
  • Demonstrated excellence in developing and implementing overarching therapeutic area CDx strategies and/or biomarker.
  • Demonstrated excellence in independently leading and conducting research and ability to evaluate, interpret and present complex scientific data.
  • In depth experience with the discovery, characterization, clinical validation and utilization of innovative biomarkers and companion diagnostics.
  • Experience in human translational research with biomarker application in clinical trials and awareness of the challenges of implementing biomarker and diagnostic technologies in the clinical setting.
  • Excellent leadership skills including motivation and delegation.
  • Excellent verbal and written communication and presentation skills in English.
  • High level of initiative and ability to work independently and in management team.
  • High level of business awareness.

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