Our client is a biotechnology company dedicated to developing first-in-class and best-in-class targeted cancer therapies.
We are seeking a highly strategic and visionary VP/Senior Vice President, Biological Development to lead our dynamic team in advancing our pipeline of innovative targeted cancer therapies. As our Head of Biologics Development, you will play a pivotal role in advancing our innovative pipeline through all stages of development. The ideal candidate will possess extensive experience and understanding of antibodies and antibody drug conjugates (ADCs) in early and late-stage development with expertise in regulatory submission processes and a proven experience leading multiple development programs.
Key Responsibilities
- Leadership and Strategy: Develop and execute the overall strategy for the biologics development function, including guiding teams through early and late-stage development processes. Lead and oversee all outsourced development and manufacturing operations activities for the company’s portfolio. Develop and execute regulatory strategies for biologics development programs and ensuring alignment with global regulatory requirements. Build, lead, manage and develop a best-in-class, high-performance team.
- Technical expertise: Apply specialized knowledge and expert experience in the development of antibodies (naked and conjugated), including optimizing strategies and addressing unique challenges associated with ADCs. Oversee the preparation and submission of regulatory documents, including Investigational New Drug (IND) applications, New Drug Applications (NDAs) Marketing Authorization Applications (MAAs) and Biologic License Applications (BLAs).
- Program Management: Lead multiple programs cross-functionally from early stages through successful development of biological drug candidates. Provide business updates to executive management including the tracking and communication of results compared to key performance targets.
- Cross-functional Collaboration: Develop and implement integrated CMC regulatory strategies for pipeline projects. Collaborate with discovery, chemical development, analytical development, quality assurance, and manufacturing teams to ensure seamless coordination of activities. Foster strong collaborations with internal and external stakeholders.
- Innovation: Stay abreast of the latest advancements in antibody science, proactively identify new technologies and methodologies to enhance our capabilities. Advances our client’s intellectual property portfolio.
- Quality and Compliance: Ensure compliance with relevant regulatory guidelines and industry standards throughout biological development lifecycle. Uphold high-quality standards and address any compliance issues.
Key Requirements
- Ph.D. in biological science or related field.
- Minimum of 15+ years of industry experience in biologics development with a focus on ADCs and leading programs with at least 10 years in a leadership position.
- Proven leadership experience in biologics development and building development functions, with a focus on antibodies (naked and conjugated).
- Experience successfully leading cross-functional teams through all stages of drug development.
- Strong understanding of the overall development pathway and operating with cross-functional partners in program development teams.
- Extensive experience in regulatory submission processes, including successful submissions for biological drug candidates.
- Excellent judgment and agility to be “hands-on” while moving seamlessly between strategic and operational roles.
- Comfort with ambiguity and uncertainty; adapts swiftly and leads others through complex situations.
- In-depth knowledge of quality assurance principles and compliance with GMP standards.
- Excellent interpersonal and communication skills.
- Ability to solve complex scientific problems and make data-driven decisions.
- Position may require occasional evening and/or weekend commitment.
- Position may require domestic and international travel (between 20 to 40%)
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