Senior Director, Development Sciences Licensing & Acquisitions
AbbVie
2 months ago
Remote friendly (North Chicago, IL)
United States
Corporate Functions
Senior Director, Development Sciences Licensing & Acquisitions
Responsibilities:
- Build and manage a high-performing team for technical evaluation of novel drug substances, drug products, devices, and platforms; partner with technical SMEs to assess opportunities and technical impact.
- Lead CMC due diligence, including comprehensive technical assessments, risk mitigation, and integration of CMC strategy with clinical development plans for business development opportunities.
- Serve as the primary CMC representative in cross-functional evaluations with R&D, Regulatory Affairs, Operations, Quality, Finance, and Commercial teams; influence decision-making and integrate CMC perspectives into business strategy.
- Prepare and present balanced technical recommendations, risk analyses, and findings to senior management and governance forums.
- Ensure seamless transition and knowledge transfer of externally sourced assets into internal product development pipelines; coordinate with project management and technical teams.
- Support post-deal integration and development/resource planning to ensure clinical continuity.
- Monitor industry and regulatory developments in CMC, manufacturing, and compliance; adapt strategies as needed.
- Manage multiple concurrent CMC diligence projects across asset types and therapeutic areas in a fast-paced environment.
- Build and maintain licensing and acquisition processes; recommend dismissing ideas early and effectively.
Qualifications:
- Advanced degree (PhD or MS preferred) in Chemistry, Biochemistry, Chemical Engineering, Pharmaceutical Sciences, or related field.
- 12+ years of CMC experience in pharma/biotech with significant exposure to due diligence and external innovation.
- Proven technical team leadership and cross-functional project management.
- Deep knowledge of drug development, manufacturing, and regulatory requirements for small molecules, biologics, peptides, and combination products.
- Strong analytical, strategic problem-solving, communication, and stakeholder management skills.
- Experience presenting recommendations and influencing senior executives and governance bodies.
Responsibilities:
- Build and manage a high-performing team for technical evaluation of novel drug substances, drug products, devices, and platforms; partner with technical SMEs to assess opportunities and technical impact.
- Lead CMC due diligence, including comprehensive technical assessments, risk mitigation, and integration of CMC strategy with clinical development plans for business development opportunities.
- Serve as the primary CMC representative in cross-functional evaluations with R&D, Regulatory Affairs, Operations, Quality, Finance, and Commercial teams; influence decision-making and integrate CMC perspectives into business strategy.
- Prepare and present balanced technical recommendations, risk analyses, and findings to senior management and governance forums.
- Ensure seamless transition and knowledge transfer of externally sourced assets into internal product development pipelines; coordinate with project management and technical teams.
- Support post-deal integration and development/resource planning to ensure clinical continuity.
- Monitor industry and regulatory developments in CMC, manufacturing, and compliance; adapt strategies as needed.
- Manage multiple concurrent CMC diligence projects across asset types and therapeutic areas in a fast-paced environment.
- Build and maintain licensing and acquisition processes; recommend dismissing ideas early and effectively.
Qualifications:
- Advanced degree (PhD or MS preferred) in Chemistry, Biochemistry, Chemical Engineering, Pharmaceutical Sciences, or related field.
- 12+ years of CMC experience in pharma/biotech with significant exposure to due diligence and external innovation.
- Proven technical team leadership and cross-functional project management.
- Deep knowledge of drug development, manufacturing, and regulatory requirements for small molecules, biologics, peptides, and combination products.
- Strong analytical, strategic problem-solving, communication, and stakeholder management skills.
- Experience presenting recommendations and influencing senior executives and governance bodies.