Our client, a leading biotechnology company dedicated to pioneering targeted cancer therapies, is seeking an innovative and strategic VP/Senior Vice President, Biological Development. In this pivotal role, you will lead our dynamic team in advancing a robust pipeline of groundbreaking therapies.
Key Responsibilities
Leadership and Strategy:
Develop and execute the strategic vision for biologics development, guiding teams through both early and late-stage processes.
Oversee all outsourced development and manufacturing operations, ensuring alignment with portfolio objectives.
Strategize and execute regulatory pathways for biologics, maintaining global compliance standards.
Build and lead a high-performance team committed to excellence.
Technical Expertise:
Utilize extensive expertise in antibodies and antibody drug conjugates (ADCs) to optimize development strategies and navigate challenges.
Lead the preparation and submission of regulatory documents, including INDs, NDAs, MAAs, and BLAs.
Program Management:
Drive cross-functional programs from inception to successful biological candidate development.
Provide executive updates on program performance against key targets.
Cross-functional Collaboration:
Develop integrated CMC regulatory strategies, fostering collaboration across discovery, development, and manufacturing teams.
Cultivate strong relationships with internal and external stakeholders to ensure seamless project execution.
Innovation:
Stay abreast of advancements in antibody science, identifying and integrating new technologies to enhance capabilities and intellectual property.
Quality and Compliance:
Uphold rigorous quality standards and ensure compliance with regulatory guidelines throughout the development lifecycle.
Key Requirements
Ph.D. in biological sciences or related field.
Minimum 15+ years of biologics development experience, with a focus on ADCs, including 10+ years in leadership roles.
Proven success in leading cross-functional teams through full drug development cycles.
Expertise in regulatory submissions for biological products.
Strong problem-solving ability and data-driven decision-making skills.
Excellent interpersonal and communication skills.
Comfort with ambiguity and ability to navigate complex situations.
Additional Information
Occasional evening and/or weekend commitments may be required.
Travel, both domestic and international, may be necessary (20-40%).
Employment Type: Full-Time
Salary: $ 150,000.00 200,000.00 Per Year