Senior Medical Director, Clinical Devlopment - Bridgewater, United States - EPM Scientific
Description
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
#J-18808-Ljbffr