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Sr Director Global Regulatory Strategist In Vitro Diagnostics

YOUR TASKS AND RESPONSIBILITIES

Acts as Bayer’s regulatory strategy lead in drug- Invitro Diagnostics (IVD)/ Companion Diagnostics (CDx) co-development for the entire Cell & Gene Therapy (CGT) product portfolio; managing multiple relationships with diagnostic co-development partners and leading the development of diagnostic regulatory strategy in multiple projects in clinical development and marketing application for global markets. This role is critical to ensure integrated drug and diagnostic development for the optimal and timely clinical development and marketing approvals.

The primary responsibilities of this role, Senior Director Global Regulatory Leader-In Vitro Diagnostics, are to:

• Advise on IVD/CDx strategies on optimal regulatory pathway (exploratory vs. patient selection for clinical trials and CDx/IVD/genomic profiling for marketing applications) that are aligned with drug development
• Coordinate regulatory consultancy input into IVD/CDx regulatory strategies
• Provide IVD/CDx regulatory input to multiple development projects:
• Advise GRSs on individual IVD/CDx regulatory strategies as part of the broader project regulatory strategy
• Contribute to CDx TPP development
• Provide IVD/CDx regulatory advice to Early Development Project Leaders / Biomarker Project Leaders / Early Clinical Leaders and the respective late development roles
• Provide specialist IVD/CDx input and reports to early and late GPTs
• Preparation and leadership of dialogue with HA representatives to support the acceptance of the IVD/CDx strategy
• Manage multiple IVD/CDx development partnerships:
• Provide regulatory feedback on partnership contracts
• Build and maintain relationships with regulatory colleagues from the CDx partner companies
• Substitute for Regulatory representative on Joint Collaboration Committees, as needed
• Participate in project review meetings
• Propose ideas to facilitate improved collaboration
• Lead the preparation and/or review of IVD/CDx regulatory submissions (SRD, 510(k), IDE, PMA/CE-marking) to support clinical development and marketing applications of IVD/CDx or as part of the drug submissions:
• Submissions to Health Authorities (HA) or Ethics Committees (EC)/IRB for clinical trials and marketing applications
• Responses to HA and EC questions related to diagnostic testing
• Ensure partner IVD/CDx labeling, and Instructions for Use is consistent with Bayer target labeling
• Contribute to internal regulatory IVD/CDx expertise development
• Develop and share Bayer Case Studies Design, prepare and implement training programs
• Monitor key changes in the global regulatory environment in the area of personalized medicine, with special focus on diagnostic tests relevant for cell and gene therapy
• Build the internal and external network; represent Bayer in relevant industry associations
• Monitor and contribute to guidance in key regions including US and Europe, Japan and China
• Provide regular updates to all GRSs and other stakeholders / internal groups
• Identify priority areas and provide input to Regulatory Policy

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:

• Conferred College Degree in Life Science Discipline
• At least 5 years of research experience in Biomarker/IVD strategy development.

• Working knowledge of US, EU, and international medical device (regulatory requirements; demonstrated experience with health authority interactions and submissions)
• Good knowledge of registration files for Medical Devices and/or In Vitro Diagnostics
• Solid experience leading regulatory submissions for IVD/CDx, including for use in drug clinical trials.
• Fluency in the English language

• Excellent communication skills, verbal and written, and ability to effectively communicate with cross-functional teams
• Strong analytical skills are required; ability to find effective solutions for varied and complex problems
• Demonstrated leadership and project management skills, working across cultures, interpersonal and influence-management skills

Preferred qualifications:

• Advanced technical degree (Ph.D., DVM, MD or Pharm D) in biological, chemistry, or related sciences preferred
• At least 10 years of experience
• Experience in cell and gene therapy
• Familiarity with regulatory issues and challenges associated with Drug/Diagnostic co-development
• Good understanding of IVD development process is required, recent experience with IVD/drug co-development projects and understanding of drug development process for cell and gene therapy
• Ability to knowledgeably discuss and effectively deal with issues such as product safety and drug/device regulation and compliance with internal and external strategic partners

Employees can expect to be paid a salary of approximately between $201’600 to $ 302’400. Additional compensation may include a bonus or commission (if relevant). Additional benefits include health care, vision, dental, retirement, PTO, sick leave, etc. This salary range is merely an estimate and may vary based on an applicant’s location, market data/ranges, an applicant’s skills and prior relevant experience, certain degrees and certifications, and other relevant factors.

The successful candidate may be based in Germany: Berlin; Netherlands : Maastricht ; Netherlands Hoofddorp; or United States: East Coast residency based

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