Job Title: Executive Director, Clinical Development Physician (Oncology)
(Other Clinical Development Roles Available)
Location: Hybrid – Princeton, New Jersey
Position Overview:
We are seeking an experienced Clinical Development Physician to join our client's dynamic biotech team, focusing on innovative oncology therapeutics. This hybrid role, based in Princeton, New Jersey, will be critical in driving the clinical development of our oncology pipeline, from early-phase trials through late-stage development. The successful candidate will possess strong expertise in clinical oncology, drug development, and medical leadership.
Key Responsibilities:
- Provide medical and clinical oversight for oncology programs, including design and execution of clinical trials (Phases I-IV).
- Collaborate with cross-functional teams (clinical operations, regulatory, translational research, and more) to ensure the successful execution of clinical development strategies.
- Serve as the medical expert on clinical development teams, contributing to the interpretation of clinical data and the preparation of regulatory submissions (INDs, NDAs, BLAs).
- Lead and present at advisory boards, investigator meetings, and conferences, engaging with Key Opinion Leaders (KOLs) and clinical investigators.
- Oversee protocol development, amendments, and clinical trial data review, ensuring trials meet ethical and regulatory standards.
- Act as a liaison between clinical operations and external stakeholders, including contract research organizations (CROs) and regulatory authorities.
- Work closely with regulatory affairs to ensure timely submissions, responses to regulatory queries, and adherence to international regulatory guidelines.
- Stay up-to-date on advancements in oncology research and emerging therapeutic modalities, incorporating novel insights into development strategies.
Qualifications:
- MD degree (or equivalent) required, with board certification or eligibility in Oncology or Hematology/Oncology strongly preferred.
- A minimum of 3-5 years of clinical development experience in the biotech or pharmaceutical industry, with a focus on oncology drug development.
- Deep understanding of oncology clinical trials, regulatory processes, and industry standards.
- Proven track record of successful clinical trial design and execution, particularly in early-stage oncology programs.
- Strong leadership and communication skills, with the ability to work collaboratively in a cross-functional, matrixed environment.
- Ability to interpret and present complex scientific and clinical data to internal teams, regulatory agencies, and external stakeholders.
- Prior experience with regulatory submissions (IND, NDA, BLA) and interactions with regulatory authorities (FDA, EMA) is highly desirable.
- Experience in academic research or previous clinical practice in oncology is a plus.
Working Conditions:
- This role is a hybrid position based in Princeton, NJ, with the flexibility to work remotely part-time.
- Occasional travel may be required for investigator meetings, conferences, or site visits.
Why Join Us?
- Be part of a cutting-edge biotech company at the forefront of oncology innovation.
- Collaborate with a passionate and driven team dedicated to transforming cancer care.
- Enjoy a flexible working environment with opportunities for professional growth and development.
If you are a physician with a passion for oncology and drug development and are eager to contribute to life-changing therapies for cancer patients, we encourage you to apply!
