Title: Senior Medical Director of Clinical Development & Medical Affairs
Location: New Jersey, USA OR Remote (Continental USA only)
A mid-size pharmaceutical company is hiring a Senior Medical Director to join the Global Clinical Development and Medical Affairs team. As Senior Medical Director, you will have oversight of a multi-disciplinary team and will lead the strategic planning and execution of a Clinical Development program, as well as the development of Medical Affairs strategy and publications planning for global product launches.
Responsibilities:
- Oversee clinical trial design and execution (especially Phase 3 and Phase 4 studies)
- Lead Advisory Board meetings and KOL/Expert panels
- Provide medical and scientific expertise to the development of product, R&D, and Clinical Development plans
- Identify prospective principal investigators and key opinion leaders
- Contribute to regulatory dossiers and NDA submissions, participate in interactions/meetings with FDA, EMA, and other regulatory agencies
- Program management including people leadership, budget management, risk and contingency planning, etc.
- Contribute to publication planning; author publications as needed or applicable
Skills & Qualifications:
- MD (or equivalent), PhD, or PharmD is required
- 5+ years of Clinical Development experience is required
- Expertise in Hepatology, Nephrology, Pulmonology, or Critical Care is strongly preferred
- Direct Medical Affairs experience is strongly preferred
- Experience working with global regulatory bodies (FDA, EMA, etc.) is required
- Experience in a Medical Device company is strongly preferred
Compensation & Benefits
- Base Salary: $240,000-$260,000
- Annual Bonus: 25%
- Long-Term Incentive package comprised of company stock (estimated value $60,000)
- Option for 100% remote (open to candidates in the continental USA)
- Excellent medical, dental, vision, and life insurance
- Generous PTO and sick leave policy
