Senior Medical Director-Renal, Medical Affairs

 

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Senior Medical Director-Renal, Medical Affairs 

 

 

The Medical Director, Renal, US Medical Affairs, is responsible for developing and leading medical strategy for pre-commercial and marketed renal programs. The Medical Director will lead the development of strategy and tactical execution of activities across the renal portfolio, while engaging and aligning with US and global cross-functional teams

 

YOUR TASKS AND RESPONSIBILITIES

 

The primary responsibilities of this role, Sr Medical Director-Renal, Medical Affairs, are to:

 

• Under the guidance of the TA VP, lead the development of strategy for marketed Renal assets;
• Lead the execution of associated tactical activities specifically related to all current and future LCM (Life Cycle Management) activities focused on kidney disease;
• Participate in the planning and administration of activities concerned with the clinical evaluation of drugs in development for the purpose of obtaining an approved IND or NDA;
• Participate as a medical and clinical expert in BD & L activities as appropriate;
• Review and evaluation of products relative to current standard of care and alternative treatments;
• Support completion of annual NDA reports for respective brands through evaluation of clinical data and literature and provide USMA input in the preparation of key medical documents for INDs and NDAs. This includes ensuring appropriate USMA input in interactions with the FDA and providing appropriate medical leadership for any interactions;
• Plan, lead and execute advisory meetings to gather feedback on relevant question identified for assigned products;
• Active participation and effective interaction with global teams to ensure and support appropriate US direction of LCM strategy;
• Interface with both internal and external (KOLs, advisors, consultants) experts and medical organizations to develop and maintain productive contacts, develop collaborative research projects, and publish scientific papers with high clinical impact;
• Engage members of USMA Renal team to assist with completion of assigned responsibilities, as needed.

 

WHO YOU ARE

 

Your success will be driven by your demonstration of our LIFE values.  More specifically related to this position, Bayer seeks an incumbent who possesses the following:

 

Required Qualifications:

• M.D, DO or MBBS Degree required;
• Previous experience in data generation, management, and publications;
• A solid understanding of clinical study design, analysis and interpretation as well as the principles of observational studies and health economics;
• Proven ability to identify and resolve complex problems;
• Ability to collaborate with a variety of teams and personnel as well as a proven ability to interact effectively with key opinion leaders;
• Highly developed ethics and integrity, with demonstrated ethical medical decision making skills;
• Ability to work well within teams as well as ability to assume leadership of a team;
• Strong negotiation and influencing skills;
• Proven ability to implement successful clinical strategies and programs;
• Effective communicator with strong oral and written communications skills;
• Demonstrated success in leading both internal and cross functional project teams including contractors and consultants as well as performing successfully under stringent timelines and with competing priorities;
• Proven ability to achieve timely approval of dossiers and regulatory submissions and to be able to develop highly successful clinical strategies and programs.

 

Preferred Qualifications:

• Nephrology or cardiology expertise is preferred;
• 3+ years of clinically relevant or independent research experience or equivalent OR 2+ years’ experience in the pharmaceutical or related industry or of extensive collaboration with the industry (e.g., lead PI and consultant, FDA employee or advisor).

 

 

 

 

 

#LI-US

    YOUR APPLICATION      

Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the require