The Technical Development Leader (TDL) leads technical development team(s) in developing and implementing CMC strategies and activities associated with large or small molecule clinical candidates, from pre-entry into humans until launch. He/she 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. He/she represents CMC functions with stakeholders, on Project Teams and when interacting with external partners. The TDL also ensures adequate information flow between team members, to functional management, and to governance committees to ensure transparency, informed decision making, and optimal alignment of all technical deliverables with the Project Team strategy and Clinical Development plan. He/she is also accountable for all project planning, scheduling, resourcing and reporting for the team.
Leads technical development teams in developing and implementing CMC strategies and activities associated with large and 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 or large molecule technical functions and key stakeholders within the Research, Development and Technical Operations organizations globally.
Provides regular updates to the Project Team and the relevant governance committees; communicates the CMC strategy and activities to external partners as needed.
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 resource forecasts as previously defined in Technical Development Agreements and in agreement with license partners (if any).
Supervises technical development team members in a matrix environment.
Establishes 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.
B.S./M.S/Ph.D. degree in chemistry, pharmaceutics, chemical engineering or related field
12 or more years experience in the pharmaceutical industry with prior experience as a CMC team leader, combined with a strong technical knowledge of small and/or large molecule process development and a sound knowledge of the drug development process.
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 and strategic thinking ability
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