Senior/Executive Medical Director, CVR

 

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/Executive Medical Director, CVR 

 

As a critical member of the US Medical Affairs team, the Senior/Executive Medical Director, CVR, will be responsible for the development and execution of high-quality medical strategy for the disease area(s) which they are responsible for and connecting the vision for the brand(s) throughout their lifecycles.

 

Bayer Medical Directors ensure that all internal customers receive a high level of scientific and medical support for their business needs, while ensuring adherence to the highest standards of ethics and compliance. External stakeholders are supported by Medical Directors through dissemination and communication of scientific and clinical data. The Senior/Executive Medical Director will also maintain responsibility for the incorporation of customer insights into the development and implementation that is in line with US strategy.

 

As an Senior/Executive Medical Director, the individual filling this role is expected to draw upon extensive medical affairs, clinical, and scientific experience to lead independently and with minimal oversight and direction. The successful applicant will have clearly demonstrated evidence of problem-solving, negotiation skills, and objective success including launch and pre-launch experience.

 

Title commensurate with work experience and skills.

 

YOUR TASKS AND RESPONSIBILITIES

 

The primary responsibilities of this role, Senior/Executive Medical Director, CVR, are to:

 

• Provide expertise in the development and execution of the overarching medical strategies within their therapeutic area, offering critical inputs during design and throughout the end-to-end execution of programs;
• Actively lead in the planning and administration of activities concerned with the clinical evaluation of drugs in development for the purpose of obtaining an approved Investigational New Drug (IND) or New Drug Application (NDA);
• Active participation and effective leadership with global teams to assure and support appropriate US direction of the Life Cycle Management strategy;
• Develop and implement the Integrated Evidence Plans and functional programs to improve the value proposition for the portfolio and impact of Bayer medicines;
• Serve as a disease area medical expert for stakeholders across internal functions, as well as, connect with external customers, including health care professionals, and patient advocacy groups;
• Provide medical scientific input for brand and program documents, including integrated disease area plans, medical information documents, drug safety reporting documents, etc, while ensuring design and execution of all medical activities are according to internal and external compliance guidelines;
• Support completion of annual New Drug Application (NDA) reports for respective brands through evaluation of clinical data and literature and provide US Medical Affairs input in the preparation of key medical documents for INDs and NDAs. This includes ensuring appropriate US Medical Affairs input in interactions with the FDA and providing appropriate medical leadership for any interactions;
• Develop and guide local Thought Leader (TL) management strategy, together with marketing;
• Responsible together with the therapeutic area VP to ensure that the personnel of the local team are adequately trained on the processes related to Drug Safety and Product Quality (handling of adverse effect reports and / or product quality complaints). Will act as a coach / mentor to less experienced medical team members;