We are looking for an Associate Director – CMC / Sr. Technical Integrator in Leiden for one of our leading biotechnology clients. The position is 1 year contract with extension expected.
- Contributes to dossier strategy/complex product development plan creation at a compound level and to limited degree at a functional level
- Communicates and executes dossier strategy/product development plan with high level of autonomy and accountability
- Direct responsibility for project budgets
- Leads and supervises dossier authoring activities for early and late stage projects with limited or no guidance from manager
- Identifies business improvement areas and leads implementation of improvements
- Drives structured improvements of functional processes (quality, cost, time, asset utilization) in line with business or operational strategy.
- With limited or no guidance, interfaces directly with CMC/Tech team members, Regulatory, JSC, external service providers and internal VPAD customers
- Interfaces with internal and external functional stakeholders
- Influences or persuades others to accept new ideas, approaches or concepts or gains alignment on divergent issues with limited guidance and occasionally at multiple levels of management
- Combines technical expertise with management skills. May select and manage external consultants
- Manages several complex projects with potentially accelerated priority OR leads complex Phase 3 clinical program.
- Challenges status quo and identifies innovative approaches to improve products/processes
- Scope is a mix of incremental and transformational innovation, within own dept/team and function
- Independently resolves isolated cross-functional issues
- Appropriately identifies and manages key stakeholders and escalates when needed to obtain senior management support. With limited guidance, takes day-to-day decisions on operational priorities for his/her team, and allocates resources accordingly
- Works independently on a day to day basis, checks in with supervisor as needed for identified high-priority issues
- Manages functional or project teams with up to 15 members
- Strong input on promotions, recruitment strategy and team structure
- Acts as a mentor to one or more individuals
- May coach project teams
- +5 years experience with CMC
- PhD with Post-doc experience with 6+ years relevant experience
- OR University degree with 8+ years relevant experience
- OR Equivalent by experience
If you are interested in the above description, apply with your CV.
For more information please contact Selin Ozbeden on +31 (0)20 20 44 502
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