The Medical Scientific Director, Oncology Pipeline will lead development and execution of US Medical Affairs (USMA) strategy for Oncology pipeline programs, providing US Medical Affairs input into development and life cycle management plans, investigator selection, and US Medical Affairs support for study execution. The incumbent in this role will also ensure US Medical Affairs Oncology team awareness and understanding of pipeline programs, including scientific rationale, status, and development strategies as well as lead development and execution of internal and external pipeline focused educational activities, and ensure the USMA Oncology team is fully trained to discuss pipeline programs. The incumbent in this role will also perform medical evaluations and due diligence as needed on pharmaceutical products for in-licensing, including review of investigator brochures, clinical study reports, regulatory submissions, and field medical materials. The Senior Medical Director will work closely with the Senior Medical Director - Oncology Strategy, Evidence Generation, and Communications, the USMA Oncology Leadership Team, the USMA Oncology Field Medical team, as well as Research and Early Development (RED) Oncology, Clinical Development, the US and Global Commercial team, Global Medical Affairs, and Business Development and Licensing.

YOUR TASKS AND RESPONSIBILITIES

The primary responsibilities of this role, Medical Scientific Director, Oncology Pipeline (US Medical Affairs) are to:

• Lead the development and execution of US Medical Affairs (USMA) strategy for oncology pipeline programs and ensure appropriate USMA support for oncology pipeline clinical trials;
• Apply deep knowledge of the oncology landscape to identify, explore, and evaluate new product ideas and opportunities for pipeline development;
• Perform medical evaluation and due diligence as needed on pharmaceutical products for in-licensing, including investigator brochures, clinical study reports, regulatory submissions;
• Maintain scientific and medical expertise on pipeline assets and associated diseases through conferences, scientific literature, and other training while sharing that expertise with internal partners;
• Assist Clinical Development colleagues as needed in the design and implementation of pipeline drug development strategies, projected trial timelines, site selection, and go/no-go decisions regarding future development. In this partnership, apply an understanding of Good Clinical Practices, pharmacovigilance, and other quality standards;
• Collaborate effectively with US and other regional or global cross-functional teams and leaders, including but not limited to medical, clinical development, regulatory, and commercial. Incorporate these stakeholders' perspectives into the USMA Oncology pipeline strategy;
• Develop and maintain strong relationships with key opinion leaders;
• Educate the USMA oncology team on the current status of all pipeline programs, including scientific rationale and development strategies. Also, participate in external pipeline focused education and scientific exchange;
• Facilitate field medical's efficient response to external requests for pipeline information by refining the associated SOP, and ensuring the team is capable to respond effectively;
• Lead development and execution of US Medical Affairs (USMA) strategy for oncology pipeline programs, ensuring US medical affairs input into development programs and investigator selection, and US medical affairs support for study execution;
• Ensure US medical affairs oncology team awareness and understanding of pipeline programs, including scientific rationale, status and development strategies, and participate in internal and external pipeline focused educational activities.
• Facilitate the efficient and expedient conduct of clinical development programs, align those programs with strategic priorities, and provide strategic consultation on go/no-go decisions to maximize cost-effectiveness;
• Increase Thought Leader awareness of Bayer Oncology's pipeline;
• Serve as an internal medical/scientific expert on key regulatory and strategy decisions in order to encourage successful drug development.

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:

• MD, PhD, PharmD or other doctorate level degree with relevant medical affairs experience;
• Relevant experience in the Oncology therapeutic area;
• Applicants with independent research experience or extensive experience collaborating with the biopharmaceutical industry (eg, lead investigator, consultant, FDA employee or advisor) will be considered;
• Ability to develop and implement successful medical affairs strategies and programs;
• Ability to be able to develop highly successful clinical strategies and programs;
• Strong oral and written communications skills;
• Strong negotiation and influencing skills;
• Strategic thinking ability;
• Strong initiative and innovation;
• Ability to identify and resolve complex problems;
• Ability to collaborate effectively with US and global cross functional teams and functions, including but not limited to clinical development, commercial and regulatory functions;
• Proven ability to interact effectively with key opinion leaders, patient advocacy and professional organizations;
• Solid understanding of drug development, clinical study design, analysis, and interpretation as well as the principles of observational studies and health economics;
• Understanding of the product planning process, regulatory environment, and commercialization;
• Ability to critically review clinical trial data, investigator brochures, clinical study reports, and regulatory submissions;
• 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;
• Demonstrated success in leading cross-functional teams as well as performing successfully under stringent timelines and with competing priorities;
• Ability to travel 30-40% of the time.

Preferred Qualifications:

• Seven years of relevant medical affairs experience;
• At least 5 years of relevant experience in the Oncology therapeutic area;
• Team leadership experience;
• Clinical development experience;
• Experience designing and leading preclinical and clinical research projects;
• Extensive training in graduate-level research statistics;
• Experience working at or with government, public-sector, and private-sector research institutions.