The technical development leader (TDL) leads multiple interdisciplinary technical development teams (TDT) in developing and implementing CMC strategies and activities associated with small molecule clinical candidates. TDL is the primary advocate for development programs on CMC strategies, activities and issues and is accountable for ensuring that Technical Development Teams are successful in achieving their goals. The TDL may be assigned to lead gRED projects at any development stage from discovery to launch, depending on the needs of the portfolio. As a member of the group of US Technical Development Leaders, the candidate will interface with the Small Molecule Pharmaceutical Sciences (SMPS) and Pharma Technical Development (PTD) either as an extended leadership member or as a point of contact to provide input on new technologies, strategies, and identify opportunities of CI and innovation.
- Leads technical development teams in developing and implementing CMC strategies and activities associated with small molecule programs from pre-EIH, during preparation of major regulatory filings and approval in major countries.
- Represents the technical development functions on the Project Team; collaborates closely with other Project Team members to define and deliver the project strategy, objectives and plans; ensures that the TDT strategy is aligned with the Project Team objectives and corporate goals.
- Interacts closely with the small molecule technical functions and key stakeholders within the Research, Development and Technical Operations organizations globally.
- Ensures effective leadership of gRED small molecule projects through appropriate governance structures, as well as managing interactions between TDTs and TPTs to plan and execute the transition of assigned projects to full-scale commercial manufacture and launch
- Ensures the scientific integrity of the technical development process, CMC strategy, and TDT deliverables
- Ensures the TDT is successful in making progress toward its goals and adheres to timelines, milestones, and budget forecasts as previously defined in Technical Development Agreements and in agreement with license partners.
- Contributes to continuous improvement efforts within PTDM through various activities and initiatives, and mentoring other TDLs and team members
- Supervises technical development team members in a matrix environment.
- Employs effective decision-making and risk management processes.
- Monitors, tracks and reports progress against team goals and approved plans.
- Leads TDT meetings and manages the team
- Anticipates and identifies issues, develops contingency and risk mitigation plans, and communicates the potential impact to the relevant governance committees.
- Partners with functional area management and seeks input from functional area forums and committees to ensure that technical expertise is provided as necessary.
- Contributes to the development of department business initiatives and facilitates their implementation.
- M.S or Ph.D. (Preferred) degree in chemistry, pharmaceutics, chemical engineering or related field
- 12 or more years of experience in the pharmaceutical industry with prior experience as a CMC team leader, combined with a strong technical knowledge of small molecule process development and a sound knowledge of the drug development process.
- Requires excellent communication, collaboration, organization, strategic thinking, negotiating skills and influencing abilities.
- Proven track record of technical accomplishments.
- Demonstrated ability to build and lead cross-functional teams
- Excellent verbal and written communication skills with success in influencing others in cross-functional areas
- Proven ability to work with cross-functional teams and senior management
- Strong collaborative and relationship-building skills
- Proven ability to work proactively and think strategically
- Experience working with third parties
- Strong decision-making skills