Senior Director, Global Regulatory Leader-IVD

Bayer (Schweiz) AG; Cambridge (MA); On-site; USD 150,000 - 200,000; Full time

Job summary

Join a leading company as a Senior Director, Global Regulatory Leader-IVD, focusing on regulatory strategy for Cell & Gene Therapy and precision medicine. This role involves managing partnerships, developing strategies, and ensuring compliance for clinical development and marketing applications. Ideal candidates will have extensive experience in regulatory affairs and strong leadership skills. Be part of a mission-driven team aiming for 'Health for all, Hunger for none'.

Qualifications

• Minimum 10 years of research/regulatory experience in Biomarker/IVD strategy development.
• Fluency in the English language.

Responsibilities

• Develop and execute regulatory strategies for CGT/Oncology products.
• Manage multiple IVD/CDx development partnerships.
• Lead preparation and review of regulatory submissions.

Skills

Communication

Collaboration

Analytical Skills

Leadership

Education

BS degree

Ph.D. or advanced technical degree

Job description

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 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:

#LI-US

YOUR APPLICATION

Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and want to impact our mission Science for a better life, we encourage you to apply now. Be part of something bigger. Be you. Be Bayer. To all recruitment agencies: Bayer does not accept unsolicited third party resumes. Bayer is an Equal Opportunity Employer/Disabled/Veterans Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below.
Bayer is an E-Verify Employer.
Location:	United States : New Jersey : Whippany || United States : Massachusetts : Cambridge
Division:	Pharmaceuticals
Reference Code:	845893

Contact Us
Email:	[e-mail]