Overview
We are seeking a highly experienced and motivated Medical Director to provide medical and scientific leadership across clinical development programs from Phase 1 through Phase 3. The Medical Director will play a key role in the strategic planning, design, execution, and interpretation of clinical trials, as well as in regulatory submissions and cross-functional collaborations.
The ideal candidate will bring a strong background in oncology, with experience in both early- and late-stage clinical development. A deep understanding of solid tumor malignancies and, ideally, hematologic oncology (including myeloma) is preferred. The position requires exceptional scientific acumen, regulatory awareness, and leadership within a fast-paced, cross-functional environment.
Key Responsibilities:
Clinical Development Strategy
- Provide strategic input into the design and execution of clinical development plans and clinical trials in oncology.
- Serve as the medical lead on cross-functional product teams, guiding clinical and scientific direction.
- Support clinical trial site identification, investigator engagement, and relationships with KOLs, professional societies, and advocacy groups.
Trial Execution
- Oversee medical aspects of ongoing clinical studies, including real-time review of safety and efficacy data.
- Lead the development, review, and approval of study protocols, investigator brochures, and related clinical documents.
- Collaborate with Clinical Operations, Biostatistics, Regulatory, and other teams to ensure timely and high-quality study delivery.
Data Analysis and Reporting
- Contribute to statistical analysis of plans and interpretation of trial outcomes.
- Lead the preparation and review of clinical study reports, abstracts, congress presentations, and manuscripts.
Regulatory and Safety
- Partner with Regulatory Affairs to support global regulatory interactions (e.g., FDA, EMA, PMDA) and submissions (IND, NDA, BLA).
- Collaborate with Safety/Pharmacovigilance to assess safety data, support DMCs, and prepare required safety updates (e.g., DSUR).
Scientific Communication
- Represent the organization at scientific and medical conferences, presenting study data and insights.
- Provide clinical input for external collaborations and business development activities.
Requirements:
- MD with board certification or eligibility in Oncology, Hematology, or related subspecialty.
- Proven experience leading early- and late-stage clinical trials and providing medical oversight in a global setting.
- Strong understanding of GCP, ICH, and global regulatory guidelines.
- Demonstrated leadership and ability to work collaboratively in cross-functional teams.
- Excellent communication skills, with proficiency in scientific writing and medical data presentation.
- Experience with novel therapeutic modalities (e.g., immuno-oncology, ADCs, cell or gene therapy).
- Direct involvement in successful regulatory filings (IND, NDA, or BLA).
- Familiarity with biomarker-driven and translational medicine.
