As a US Medical Director, CKD, you will be a member of the Core Medical Team (CMT) and is ideally a board-certified physician who has a history of clinical practice and significant experience in the metabolic disease therapeutic area. 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 management of chronic kidney disease and hyperkalemia and would thrive on proactively engaging internal and external leaders. This person reports into the U.S. Sr. Medical Director – CKD and is accountable for the development and execution of the Brand Medical Plans.
In addition, an ideal Medical Director will have strong business aptitude and/or experience, including proven ability to translate and align commercial and scientific goals and objectives.
What You'll Do:
Medical input into brand strategy as a core member of Core Medical Team (CMT)
Collaborate with commercial team and alliance partners to develop overall brand strategy
As part of the Medical Plan, ensure comprehensive engagement plan with external leaders and key stakeholders, e.g., Managed Care Organizations, Key Opinion Leaders, Key Institutions and Hospital Systems, 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
Collaborate with medical and payer evidence directors to define research strategy and design of studies that address both clinical effectiveness and health
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
Provide medical review in concert with cross functional team members for medical and promotional materials
Maintain key links into global clinical activities by maintaining collaborative working relationship with TA medical physicians and other clinical team members.
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 AZ corporate policies
Essential For The Role:
Advanced scientific degree (MD or PharmD), preferably with clinical experience in the nephrology space
Background in academic medicine, clinical research, and familiarity with biostatistics and epidemiology
Excellent written and oral communication, interpersonal and organization skills
Highest level of ethics and integrity
Ability to travel nationally and internationally. Travel will be ~30% of the time (post Covid-19)
Desirable:
MD Board certification/eligibility preferred in nephrology
Strong business acumen, including working knowledge of changing U.S. payer and provider landscape
Pharmaceutical industry experience or other experience in related areas including academic institutions
Proven ability to interact productively with both commercial and scientific colleagues
Demonstrated ability to work collaboratively in cross functional teams
Experience developing and/or launching a new pharmaceutical product
Familiarity with OPDP, PhRMA code, and key regulations in the pharmaceutical industry
Working knowledge of FDA requirements