Pfizer Senior Director Oncology, Clinician Lead Early Clinical Development (nonMD) in Boulder, Colorado
As the Director Oncology, Clinical Lead-Early Clinical Development for the Boulder Research and Development Unit of Pfizer, you will be responsible for establishing the initial clinical development plan for one or more targeted, small molecule anti-cancer therapies, from the discovery of lead compounds through clinical proof-of-concept. You will serve as the primary clinical resource for internal and external stakeholders, including scientists, operations specialists, regulatory experts, KOLs and investigators.
Your key responsibility will be to design, execute and be accountable for innovative and seamless first-in-human clinical trials that ensure the safety of enrolled patients and enable a clear and efficient assessment of PK, toxicity and preliminary clinical activity in clearly defined patient populations with unmet need.
Your studies should support an initial regulatory approval, should the clinical activity and specific medical need be sufficient; clearly identify the appropriate patient population(s) for further study in later-stage trials; and enable a data-driven "No Go" decision if the risk: benefit ratio is unfavorable.
In this role, you will work alongside chemists and biologists comprising one of the leading cancer drug development teams anywhere, responsible for the creation of multiple first- and best-in-class small molecule cancer medicines.
The Boulder R&D unit it located in Boulder, CO, a mecca for the biomedical sciences and routinely selected for "top ten" lists for recreation, culture, health and overall quality of life.
While previous experience with early phase clinical trials is helpful, we are especially interested in clinicians and clinician-scientists at any stage of their careers driven by curiosity, enthusiasm, a desire to make a difference and a growth mindset. By applying critical thinking, diligence, clear communication and a willingness to gain new expertise, make mistakes and learn from them, you will contribute significantly to patients fighting their cancers while developing your passion for the entire drug development process.
Provides leadership on the clinical aspects of the development program. This includes formulating the overall clinical development plan, designing key study documents (e.g., protocols, IBs, amendments, regulatory documents and SOPs); identifying key sites for study participation; conducting data review, analysis and interpretation of trials results; organizing and presenting at advisory boards, investigator meetings and medical meetings; and developing strong relationships with investigators and study staff.
Accountable for safety across the study by real-time review of individual patient safety data, performance of cumulative safety review and timely communication about safety issues with the internal safety risk team, investigators, study staff, IRBs and regulatory authorities.
Contributes clinical expertise at all stages of drug development: identifies the critical unmet clinical needs for pipeline candidates; determines the key questions to ask and how to answer them directly through clinical trials; assembles and analyzes safety, PK and efficacy data as it emerges; and contributes to Go-No Go recommendations for the compound, including recommendation to advance to FIH after review of the preclinical package and involvement with transition to Phase III.
In collaboration with members of the development team, authors and presents data at relevant team, strategy, governance, KOL, regulatory and medical meetings; authors preclinical/clinical sections of regulatory documents (Annual Reports, IND sections, CSR, briefing books); and contributes to manuscripts for publication.
Interfaces with key internal and external stakeholders: discovery, safety sciences, statistics, PK/PD, marketing, regulatory, outcomes research, development operations, governance, external experts, regulators, investigators and study staff.
Participates in CRO diligence and selection; works collaboratively with the study team and CRO to develop the ECD and manage the trial; develops and delivers protocol training for investigator site(s), Pfizer personnel, and CRO staff.
In conjunction with study team, 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 act as the clinical representative in in-licensing activities such as due diligence reviews and reports.
Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
DPharm, nursing or other equivalent degree with demonstrated depth and breadth of knowledge and a minimum of 5 years of experience in clinical care and research in the academic, clinical practice and/or industry setting.
Training in Clinical Medicine, including Internal Medicine, Oncology, Pharmacology, Pharmacy, is desirable; other relevant, specialized medical training (e.g., surgical oncology, infectious disease, critical care) will be considered.
Broad clinical knowledge and an ability to apply it from bench-to-bedside and back.
Curiosity and a willingness to try new things.
Understanding of related disciplines (e.g., biology, chemistry, translational medicine, biostatistics, regulatory, pharmacology), or a willingness to achieve understanding through independent study.
Demonstrated scientific thinking and writing skills, and good communication skills.
Demonstrated leadership, ability to work collaboratively, enjoys and is able to adapt to a fast-paced and changing environment.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Travel to study sites (internationally) for study qualification, protocol teaching, quality assurance and relationship development may be required.
Travel to advisory boards, medical meetings and regulatory authorities may be required.
The individual should be able to work on site in Boulder, COI for most days. Remote location may be considered if the individual can work on site regularly for a significant number of days each month.
Other Job Details:
Eligible for Relocation Package
Eligible for Employee Referral Bonus
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