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Medical Director - Executive Medical Director
158564
Posted:
17/01/2025
Lead the design and implementation of Phase 1–3 clinical trials, ensuring alignment with regulatory requirements and scientific standards.
Serve as the medical expert in protocol development, patient eligibility criteria, and endpoint selection.
Oversee safety monitoring, data interpretation, and decision-making related to ongoing studies.
Partner with key opinion leaders (KOLs), clinical investigators, and regulatory authorities to advance clinical programs.
Represent the company at external meetings, advisory boards, and scientific conferences.
Collaborate closely with internal teams, including clinical operations, regulatory affairs, and translational research.
Contribute to regulatory filings, including INDs, CTAs, and future BLA submissions.
Ensure clinical programs adhere to GCP standards, ethical considerations, and company policies.
- 250000 USD - 350000 USD
- San Diego, United States
- Permanent
Job Description: Medical Director - Executive Medical Director, Clinical Development
Position Overview
We are seeking a highly skilled and motivated Medical Director or Executive Medical Director to lead clinical development efforts in cell therapies for autoimmune diseases at a pioneering biotech company. This role offers the opportunity to drive clinical strategy and trial execution for transformative therapies that address critical unmet needs in autoimmune conditions. The ideal candidate will bring deep expertise in clinical development, a passion for innovation, and a collaborative approach to advancing the company’s mission.
Key Responsibilities
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Strategic Leadership:
- Develop and execute the clinical development strategy for cell therapy programs targeting autoimmune diseases.
- Provide medical and scientific leadership across all stages of clinical development, from early research to pivotal trials.
Clinical Trial Design and Oversight:
Collaboration and Stakeholder Engagement:
Regulatory and Compliance:
Qualifications
- MD, DO, or equivalent medical degree with board certification in immunology, rheumatology, or a related field.
- A minimum of 7–10 years of clinical development experience in the biotech or pharmaceutical industry.
- Demonstrated expertise in autoimmune diseases and/or cell therapies is highly preferred.
- Proven success in designing and managing clinical trials, including early and late-stage programs.
- Strong knowledge of regulatory pathways and experience in regulatory interactions.
- Exceptional leadership and communication skills, with the ability to inspire and collaborate across diverse teams.
Preferred Experience
- Experience in cell therapy development for autoimmune diseases.
- Involvement in IND and BLA filings for innovative therapies.
- Familiarity with biomarkers, novel endpoints, and translational research in autoimmune indications.
Location and Travel
- This role offers flexibility for remote or hybrid work arrangements, depending on the candidate’s location in the United States.
- Travel is estimated at 10–20% for investigator meetings, regulatory interactions, and conferences.