Senior / Principal Technical Development Leader
About The Position
The Technical Development Leader (TDL) is responsible for leading Technical Development Teams (TDTs) in crafting and driving Chemistry, Manufacturing, and Control (CMC) strategies for clinical drug candidates from early human trials through product launch. The TDL ensures successful achievement of TDT goals, effective risk mitigation, and seamless communication across teams and cross-functional collaborators. This role involves comprehensive project planning, scheduling, resourcing, and reporting. This position requires proven ability to effectively lead teams and work in situations with a high degree of ambiguity and challenges and to solve complex problems/manage highly complex projects.
Requirements
- B.S./M.S/Ph.D. degree in chemistry, pharmaceutics, chemical engineering or related field
- 10-15+ years of experience in the pharmaceutical industry, with prior experience as a CMC team leader and strong technical knowledge of large molecule process and product development.
- Advanced understanding of the drug development process and a history of successful innovation, recognized as a thought leader in CMC/product development.
- Excellent communication, collaboration, strategic and critical thinking, decision-making, negotiating, and influencing skills, along with the ability to lead complex projects and solve intricate problems.
Nice To Haves
- Demonstrated ability to handle complex, cross-functional programs and innovate new ideas and approaches.
- Ability to work proactively and think strategically.
- Strong negotiation and decision-making skills.
- Effective collaborating with team members and senior management.
- Successful experience working with third parties.
- Excellent verbal and written communication skills, with a history of influencing others in cross-functional areas.
Responsibilities
- Lead scientific and technical teams throughout the asset lifecycle, from preclinical development to product launch, ensuring the scientific integrity of the CMC strategy.
- Develop and implement multifaceted technology strategies essential for product success, including manufacturing processes, drug product and device configurations, supply chains and regulatory submissions.
- Provide strategic insights and ensure customer focus in project deliverables; Maintain regular updates to project teams, senior management, and governance committees, ensuring transparent and informed decision-making.
- Design novel strategies for licensure of new modalities and efficient development of standard therapeutics, building new company capabilities.
- Represent Pharma Technical functions on asset/lifecycle teams and partner with various team leaders to align CMC strategy with broader goals of the company. May act as a consultant to top executives.
- Oversee manufacturing and delivery of clinical supplies, manage CMC development costs, and ensure adherence to timelines, milestones and resource forecasts. Anticipate and resolve issues, developing contingency and risk mitigation plans.
- Serve as the primary decision-maker for CMC development, investments, and risk management, employing effective decision-making processes.
Benefits
- Relocation benefits are available for this job posting.
- A discretionary annual bonus may be available based on individual and Company performance.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Ph.D. or professional degree
