US Lead, Executive Medical Director, Medical Affairs

US Lead, Executive Medical Director, Medical Affairs

Job Title: US Lead, Executive Medical Director, Medical Affairs
Contract Type: Permanent
Location: New Jersey, USA
Salary: Negotiable
Start Date: ASAP
Reference: 351577_1535391160
Contact Name: Reece Mitellas
Contact Email:
Job Published: August 27, 2018 18:32

Job Description

Responsibilities include but are not limited to:

1. Medical Affairs Strategic Plans: The incumbent will work with key stakeholders, management, and functional area leads to develop strategic and aligned US Medical Affairs Plans for the therapeutic area and will be expected to communicate and represent these plans to upper management/senior leadership. This includes responsibility for continuously updating plans and informing stakeholders of progress.

2. Phase IV clinical studies: Direct and design strategies, planning and implementation of Phase IV clinical development programs for assigned products. Provide medical oversight for protocol development, interpretation of trial results, final study report conclusions and publications. Serve as study director for trials. Provide critical medical input into the lifecycle management strategies in responsible therapeutic areas.

3. Medical/Scientific subject matter expert: Serve as medical leader and subject matter expert providing direction for assigned products including (but not limited to) CRC, scientific communications, publication planning/review, advisory boards, health outcomes plans, MSL activities, speaker programs, investigator-initiated research and CME grant reviews or other internal key business processes. Other responsibilities include approval of the medical and scientific content of Regulatory, Safety, Scientific Affairs, Medical Affairs and Commercial outputs for assigned therapeutic areas.

4. External leadership: Provide leadership and strategic direction to stakeholders in interactions and communications with external customers, thought leaders, strategic alliances, key organizations, and institutions. Maintain external orientation by participating actively in external events and activities.

Must Know:

*Therapeutic Area Expertise including standards of care, current medical options for diagnosis and treatment of relevant conditions based upon franchise products
*Understanding Medical Affairs activities preferred
*Understanding of Marketing concepts/strategies preferred
*Knowledge of the pharmaceutical marketplace
*FDA regulations/ICH guidelines regarding conduct of clinical studies in relevant therapeutic area
* Knowledge of regulatory guidance regarding marketing/sales promotional materials
* Strong overall written and verbal communication skills
* Must have requisite skills to function in a complex and dynamic environment, including flexibility and ability to negotiate.
* ICMJE guidance/general publication practices
* Current ACCME guidelines
* Sound computer skills including Microsoft Word, and PowerPoint
* Familiarity with statistical methodology
* PhRMA Code
* Travel 35%