Medical Director to join the Clinical Development organization to provide medical/scientific expertise to advance our innovative product candidates. In this role, you will lead the clinical design and conduct for assigned studies or programs, direct KOL engagement and be the medical lead on multidisciplinary clinical teams.
- The Medical Director will manage, develop and oversee key clinical programs by working closely with the Chief Medical Officer, VP of Clinical Development, other internal stakeholders (such as Clinical Operations, DMPK, Biostats, Regulatory) and other external networks (vendors, KOLs, etc.), to drive the design, planning, and implementation of clinical program/s and study protocols in all phases of development.
- This clinical development expert may also support regulatory and pharmacovigilance activities, and corporate goals, by contributing clinical, scientific and development expertise to all business development initiatives.
- Oversee clinical development plans, including design, author, and execute clinical trials for clinical programs across development phases to ensure execution of high-quality clinical trials that meet key milestones, maintain timelines and stay within budget.
- Provide clinical leadership in preparation of clinical protocols, regulatory documents, and regulatory agency interactions, including an active presence in internal portfolio committees.
- Play a key role in the development of analysis plans, and in the review, interpretation and communication of clinical trial data, safety and efficacy trials.
- Establish strong external networks of thought leaders in collaboration with members in clinical and R&D, to support clinical development strategies and help optimize program plans and protocols.
- Contribute actively to the Clinical Development leadership team, relevant governance bodies, and process improvement initiatives.
- MD or equivalent with 3+ years of pharmaceutical/biotech-industry clinical development experience.
- Prior experience with clinical protocol development and study conduct
- Excellent interpersonal and collaborative skills
- Superior communication and facilitation ability
- Proven ability to influence, persuade, and lead others
- Self-motivated critical thinker with the ability to work independently
- Strong analytical, decision-making, project management and problem-solving skills.
Can be REMOTE – But VITAL need clinical , pharmacovigilance activities.
If you are interested, please send resume to:
resume AT contractstaffingrecruiters dot com