What are the responsibilities and job description for the Medical Director position at NWRPros?
Apply at NWRPros Here
Our Client is a biopharmaceutical company based in the San Francisco Bay Area. The company specializes in antibody discovery and engineering, advancing innovative therapies designed to to treat cancer. Clinical programs are conducted in Australia, the United States, UK and the EU. These programs show promising efficacy in lung, pancreatic, and gastroesophageal cancers.
Our Client is seeking an experienced and driven Medical Director to lead and support the clinical development of their oncology pipeline programs from Phase1-Phase 3. This individual will play several key parts in the clinical development program, helping lead the design, planning, execution, and interpretation of clinical trials and contributing to multiple regulatory submissions and interactions.
The ideal candidate will bring a deep understanding of solid tumor malignancies, ideally with some heme/myeloma background.
Experience in both early and late-stage clinical development and a proven ability to work cross-functionally, in a fast-paced biotech environment are essential.
KEY RESPONSIBILITIES:
Clinical Development Strategy
Provide strategic input into the design and execution of oncology clinical development plans and clinical trials across myriad disease states.
Serve as the clinical expert on cross-functional product teams, contributing to the execution of overall program goals.
Support geostrategy, site identification and selection, investigator engagement, and relationships with KOL’s, professional organizations, and advocacy groups.
Trial Execution
Provide medical oversight for ongoing clinical studies, including real-time review of safety and efficacy data and sponsor-side leadership of key committees (SRC’s, Steering Committees, etc.).
Subject matter leadership of the creation and revision of study protocols, investigator brochures, and other key documents.
Collaborate with Clinical Operations, Biostatistics, Regulatory, and other functional teams to ensure timely and high-quality trial conduct.
Data Analysis and Reporting
Contribute to statistical analysis plans and interpretation of clinical trial results.
Lead the drafting and review of clinical study reports, abstracts/congress presentations, and manuscript submissions.
Regulatory and Safety
Partner with Regulatory Affairs to formulate regulatory strategy, prepare for and participate in regulatory interactions (e.g., FDA, EMA, PMDA), and produce high quality regulatory submissions (e.g., IND, NDA, BLA).
Work with Safety/Pharmacovigilance to monitor and assess safety data, support DMCs, respond to safety-related issues, and prepare requisite safety updates (eg. DSUR).
Scientific Communication
Represent the company at public and private scientific and medical meetings, including presenting clinical data to external stakeholders.
Provide medical input on business development activities and other external facing documents and interactions.
Qualifications
Required:
MD or MD/PhD required, with board certification or eligibility in oncology, and/or hematology, or a related sub-specialty preferred.
Minimum of 5–8 years of industry experience in oncology drug development, including comprehensive medical monitoring experience and functional leadership of early and late-stage clinical trials.
Demonstrated leadership in the execution of global oncology clinical development plans and deep familiarity with regulatory pathways and submissions.
Strong knowledge of GCP, ICH guidelines, and applicable regulatory requirements.
Post-graduate direct experience in the care of cancer patients preferred.
Excellent written and verbal communication skills; strong scientific writing ability.
Proven ability to work in cross-functional teams and in a fast-paced, collaborative biotech environment.
Preferred:
Experience with novel therapeutic modalities (e.g., immuno-oncology, ADCs, cell therapy).
Prior direct involvement in successful regulatory filings (e.g., IND, NDA, BLA).
Familiarity with biomarker-driven drug development and translational medicine.
Compensation and Benefits Include:
- Competitive base salary, bonus, and equity for all employees
- Salary Range: $200,000 to $220,000 -This reflects the company’s pay scale for the role. Actual compensation may vary depending on factors such as location, skills, experience, and performance.
- 401(k) retirement plan with employer matching contributions.
- Comprehensive medical, dental, and vision insurance.
Apply at NWRPros Here
Salary : $200,000 - $220,000