Medical Director

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Location
DE
Salary
$1 - $1
Job Type
Direct Hire
Date
Nov 15, 2018
Job ID
2600072

Three Medical Directors needed
The Medical Director is a board-certified physician who has a history of clinical practice, and has significant experience in the cardio therapeutic area, Endocrinology or Renal, Nephrology therapeutic areas.
The Medical Director is knowledgeable of the actions of regulatory bodies, in particular FDA, and has experience in clinical trials. An ideal candidate should have significant experience in renal cardio disease management and would thrive on proactively engaging internal and external leaders. S/he is accountable for the development and execution of the Brand Medical Plans. It is preferred that the candidate will have a network of Nephrologist External Experts, and/or Cardiology External Experts and/or Endocrinologist and Professional Society relationships. In addition, an ideal Medical Affairs Medical Director will have strong commercial aptitude and/or experience, including proven ability to translate and align commercial and scientific goals and objectives. 

Typical Accountabilities:
  • Medical input into brand strategy as a core member of Core Medical Team
  • Interact with leaders of groups identified as strategic partners, including both payer and provider groups
  • Collaborate with commercial team to develop brand strategy
  • Interact with external leaders in the therapy area (External Experts, Academic Institutions, Professional Societies)
  • Play an integral role in the planning and participation of national and regional medical advisory boards
  • Play an integral role in the planning and providing of training for external medical/scientific speakers
  • Provide clinical education and training for internal stakeholders such as Field Medical Team and members of product sales teams
  • Provide and lead the strategy and development of clinical studies to obtain promotional claims and/or advance the scientific knowledge of our products
  • Provide input into Life Cycle Management studies and Phase 4 Study strategy/design
  • Provide medical review in concert with cross functional team members for Externally Sponsored Scientific Research proposals
  • Provide medical input into the publication strategy and review/comment for medical accuracy of publications
  • Maintain key links into global brand clinical activities by maintaining collaborative working relationship with TA medical physicians including Medical Science Director (MSD) and Clinical Research Scientists.
  • Supply medical input into safety profile of the product in collaboration with Patient Safety (PS) physicians
  • Act as medical spokesperson for US Brand as needed for media inquiries or other external groups.
  • Ensure compliance with all COMPANY corporate policies
  • As part of Medical Plan, ensure comprehensive engagement plan with customers and key stakeholders, e.g., Managed Care Organizations, Key Opinion Leaders, Key Institutions and Hospital Systems, Professional Societies
  • Develop and maintain relationships with key external and internal customers.
  • Lead Advisory Boards and input into strategy
  • Collaborate with HEOR Director to define research strategy and design of studies that address both clinical effectiveness and health
Essential Requirements:
  • Graduate of a recognized medical school and recipient of an MD/DO degree
  • Background in academic medicine, clinical research, and familiarity with biostatistics and epidemiology
  • Excellent written and oral communication, interpersonal, and organization skills
  • Ability to travel nationally and internationally. Travel will be ~30% of time
Desirable Requirements:
  • Board certification/eligibility preferred in Nephrology or related relevant specialty.
  • Strong business acumen, including working knowledge of changing U.S. payer and provider landscape
  • Proven ability to interact productively with both commercial and scientific colleagues
  • Demonstrated ability to work collaboratively in cross functional teams
  • Familiarity with OPDP, PhRMA code, and key regulations in the pharmaceutical industry
  • Highest level of ethics and integrity
  • Medical Directors preferred to have at least 3 years of pharmaceutical industry or other related areas of experience including Academic Institution
  • Experience developing and/or launching a new pharmaceutical product/biologic product in the ideal candidate
  • Broad cross-functional pharmaceutical and cross-functional general management experience
  • Minimum 5 years' experience in a strategy-setting role within Medical Affairs
  • Global experience within the pharmaceutical industry
  • Working knowledge of FDA requirements