Job Information
Job Description
YOUR TASKS AND RESPONSIBILITIES
The primary responsibilities of this role, Associate Medical Director, Cardiovascular are to:
Provide support as medical expert for marketed CVR assets in execution of strategic plans and associated tactical activities;
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 New Drug Application (NDA);
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;
Provide USMA input in the preparation of key medical documents for INDs and NDAs;
Ensuring appropriate USMA input in interactions with the Food and Drug Administration (FDA) and providing appropriate medical leadership for any interactions;
Plan and execute advisory meetings to gather feedback on relevant question identified for assigned products;
Active participation and effective interaction with global teams to assure and support appropriate US direction of the Life-Cycle Management (LCM) strategy;
Interface with both internal and external (Key Opinion Leaders (KOLs), advisors, consultants) experts and medical organizations to develop and maintain productive contacts.
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 andlicensure in Cardiovasculae Diseases (active);
At least two years of clinically relevant or independent research experience or equivalent, or two 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);
Proven ability to identify and resolve complex problems;
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 well on 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:
Heart failure/Thrombosis experience;
Experience with Real World Evidence (RWE) studies and/or clinical trials.
Bayer is an Equal Opportunity Employer/Disabled/Veterans
Company Information
Our business success is largely attributable to the knowledge, skills and commitment of our employees. It is their ability to innovate and their willingness to embrace continuous development that drives our position as a world-class innovation company.
Sustained success is only possible if we create working conditions that allow all employees to utilize their talents optimally. This is why we value diverse perspectives and provide our employees with the ongoing training they need to remain at the top of their respective fields.
Hanover, NJ 07981