Senior Director, Global Regulatory Leader-IVD

The Senior Director, Global Regulatory Leader-IVD acts as a regulatory strategy lead primarily for Cell & Gene Therapy (CGT) but also for other precision medicine programs with in vitro diagnostic (IVD), companion or complementary diagnostic (CDx) component, manages multiple relationships with diagnostic co-development partners and leads 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, or development of alternative strategies.

YOUR TASKS AND RESPONSIBILITIES

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

Develop and execute appropriate strategies for CGT/Oncology products with potential IVD/CDx component, in clinical trial and marketing application stages:

• Develop and maintain the IVD/CDx regulatory strategy for the CGT and other precision medicine assets (In case of potential immunogenicity based IVDs, develop optimal strategies for product development that may or may not result in a need for the IVD or CDx for approval);
• Advise on IVD/CDx strategies on optimal regulatory pathway (exploratory vs. patient selection for clinical trials and CDx/IVD 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 Project Teams;
• Preparation and leadership of dialogue with HA representatives to support the acceptance of the IVD/CDx strategy globally.

Manage multiple IVD/CDx development partnerships:

• Provide regulatory feedback on partnership contracts;
• Build and maintain relationships with regulatory colleagues from Bayer CGT subsidiaries and 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 or Ethics Committees/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:

• Establish and coordinate knowledge sharing platform within Regulatory and cross-functionally with Bayer’s CGT unit and subsidiaries;
• Establish IVD/CDx Regulatory group, contribute to Biomarker groups;
• 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

Bayer seeks an incumbent who possesses the following:

Required Qualifications:

• Minimum, BS degree with extensive experience in biomarker/IVD / drug-related development / medical research activities;
• 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 is required;
• Solid experience leading regulatory submissions for IVD/CDx, including for use in drug clinical trials;
• 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;
• Excellent communication skills, verbal and written, and ability to effectively communicate with cross-functional teams are required;
• Excellent collaboration skills are required;
• 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;
• Fluency in the English language.

Preferred Qualifications:

• Advanced technical degree (Ph.D., DVM, MD or Pharm D) in biology, chemistry, or related sciences preferred with 10+ years in biomarker/IVD/ regulatory affairs / drug-related development / medical research activities or MS degree with 13+ years of biomarker/IVD / regulatory affairs / drug- related development / medical research activities or BS degree with 15+ years of biomarker/IVD / drug-related development / medical research activities is preferred;
• Minimum of 10 years of research/regulatory experience in Biomarker/IVD strategy development. Experience in cell and gene therapy is preferred;
• Broad knowledge of immunology, analytical chemistry, and antibody analysis desired;
• Familiarity with regulatory issues and challenges associated with Drug/Diagnostic co-development is preferred;
• 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 is preferred.

This posting will be available for application until at least:

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