Senior Medical Director, Heart Failure, US Medical Affairs

 

At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where 'Health for all Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.

 

Senior Medical Director, Heart Failure, US Medical Affairs 

 

The Senior Medical Director, Heart Failure, US Medical Affairs, is responsible for developing and leading medical strategy for pre-commercial and marketed Heart Failure (HF) programs. The Senior Medical Director will lead the development of strategy and tactical execution of activities across the heart failure portfolio (focus on Kerendia) while engaging and aligning with US and global cross-functional teams while providing medical expertise for post marketing activities for currently approved and/or marketed products and new clinical indications of existing drug This individual will have direct accountability for strategy development and tactical execution.

 

YOUR TASKS AND RESPONSIBILITIES

 

The primary responsibilities of this role, Senior Medical Director, Heart Failure, US Medical Affairs, are to:

 

• Lead the development of strategy for marketed and pre-marketed HF assets (Kerendia), ensuring alignment with company CVR growth targets and goals;
• Provide oversight of medical and clinical guidance to US regulatory authorities and coordinate overall regulatory strategy with cross-functional partners;
• Develop and defend HF budget requests with global medical affairs and commercial leadership teams;
• Serve as key point of scientific and clinical contact for external medical stakeholders;
• Develop and deliver scientific presentations at medical conferences, for payer audiences, and for internal and external scientific and non-scientific audiences including direction in the development of educational materials, monitoring of published literature and review of company documents to ensure scientific accuracy;
• Lead the execution of associated tactical activities specifically related to all current and future LCM activities focused on heart failure;
• 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;
• Active participation as cardiovascular expert for BD&L  activities as appropriate;
• Review and evaluation of products relative to current standard of care and alternative treatments;
• Provides direction and expert TA opinion for 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;
• Engage members of USMA Renal/Cardiorenal 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. Degree or equivalent, with US Board certification in Internal Medicine and licensure (active), required;
• Experience in the pharmaceutical / biotechnology industry or of extensive collaboration with the industry (eg, lead PI and consultant, FDA employee or advisor);
• Strong professional network within the US heart failure community;
• Proven ability to identify and resolve complex problems;
• A solid understanding of clinical study design, analysis and interpretation as well as the principles of observational studies and health economics;
• 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