Ensure the highest possible quality of input into significant requests for proposals (RFPs)
Development strategy and regulatory issues
Drug class issues
Protocol and indication considerations, including safety
Team education on indication
Interactions with client’s physicians and/or client area indication leaders prior to and during bid defenses
Identify business opportunities for the PPD clinical research business
Support outstanding input into other areas of the PPD clinical research business activities
Pro-active client engagement: peer-to-peer interactions with therapeutic area leaders and senior directors of companies
Strategic alliance development & support
Client governance and advisory boards
Provide Industry gold standard product development plans, and top-level design of clinical trial protocols
Provide therapeutic and developmental expertise to internal teams
Indication specific training for clinical teams
Guidance during clinical trials executions
Investigator Brochure, clinical study report, NDA/MAA clinical packages development, and other regulatory briefing documents authoring and review
Contribute to design and reporting of feasibility studies
Liaise with investigators and KOLs
Mentor and supervise clinical scientists
Participate in multidisciplinary teams and working groups to contribute to innovative initiatives based on their specific knowledge, expertise and interest
Requirements
MD required; board certification preferred
At least 7 years of experience in the pharmaceutical industry leading dermatology clinical development programs, including advancement of at least one asset from discovery through registration
Active medical license preferred but not required
Knowledge, Skills and Abilities: Able to work in a matrix organization, demonstrate key high-level high-performance behaviors: decisive, customer driven, flexible thinking, smart-risk taking and continuous improvement, lead and motivate staff, strong in presenting and communicating complex information clearly, able to deal with sensitive and confidential issues, possess a “can do” attitude, proficient in spoken and written English, flexibility to travel domestically and internationally
Benefits
Competitive salary and benefits
Work diversity, exposure to several assets in different stages of clinical development from several clients
Mentorship and training
Exciting work environment
VP, Medical Science and Strategy – Dermatology at Thermo Fisher Scientific | JobVerse