Assoc Dir, Clinical Supply Integrator
vor 1 Monat
Johnson & Johnson Innovative Medicine Supply Chain is recruiting for a(n) Associate Director, Clinical Supply Integrator, located in Zug, Switzerland.
Clinical Supply Chain (CSC) holds the responsibility of global clinical supplies of the Janssen Research & Development portfolio and the Global Medical Affairs portfolio. Our activities include all in-house and outsourced manufacturing of clinical supplies (API, Drug Product, Packaged and Labeled Clinical Supplies), demand forecasting, supply planning, and global distribution of supplies. Through a global network and organization, we are responsible for the clinical supplies of Synthetics, Molecules and Bio Therapeutics and Advanced Therapies products in development and low volume commercial supply and secure the supply to more than 60,000 patients in more than 330 clinical trials every year.
Key Responsibilities:
- This matrix team leader leads the end-to-end supply chain management of clinical supplies.
- Sets direction as the clinical supply chain project and team leader for one or more complex or accelerated compounds, from NME to Life Cycle Management.
- Through the Clinical Supply Sub-Team, develops supply strategies matching needs of clinical programs and trials to ensure on time delivery and optimal supply for API, DP and Packaged materials.
- For each compound, leads the monthly cS&OP cycle and takes leadership over the escalation and (as appropriate) resolution of critical risks and issues, including communication to key stakeholders.
- Represents Clinical Supply Chain at the CMC team and the Clinical team leading the product strategy. Communicates and implements the strategy and development plan. Collaborates with the TAs, GDO, and DPDS to ensure translation of customer needs to fit-for-purpose.
- Represents DPDS at the Clinical team, ensuring clinical strategy can be implemented. Influences the clinical teams in the trial design and operational aspects thereby ensuring cost efficiency and customer satisfaction, and coordinates, escalates & communicates to the clinical team as needed.
- Manages activities and budgets at a compound or trial level to meet key CSC/CMC/CT milestones.
Education:
- University/Bachelors Degree plus 8-12 years related experience. Or Masters Degree plus 6+ years related experience. Technical degree and/or experience a plus.
Experience and Skills:
Required:
- Clinical supply design expertise (e.g., influencing clinical protocols, designing patient kits, developing distribution strategy) or equivalent (manufacturing, planning, supply chain, drug product development experience a plus) is required.
- Excellent knowledge of CMC drug development process and roles or equivalent experience is required.
- Experience communicating and implementing strategy / product development plan with high level of autonomy and accountability is required.
- Excellent written and verbal communication skills, able to communicate clearly, making the complex clear and compelling to all levels of the organization in both written and oral forms is required.
- Experience leading late stage compound teams or multiple early projects for process development, tech transfer and regulatory filings is required.
- Strong project execution and cross-functional coordination skills, able to build strong collaborative teams and relationships, leading cross functional/ virtual teams where required, contributes to employee engagement is required.
- Experience interfacing directly with CMC/Tech team members, internal operations, Regulatory, JSC, external service providers and internal DPDS customers such as GDO and TA with limited or no guidance is required.
- Experience influencing or persuading others to accept new ideas, approaches or concepts or gains alignment on divergent issues is required.
- Experience managing a limited number of complex projects with potentially accelerated priority OR Leads complex Phase 3 clinical programs is required.
- Advanced understanding and management of the E2E clinical supply budget, GXP principles, estimates and reporting is required.
- Ability to work in a high-pressure environment, act with speed, flexibility, and accountability to achieve goals, solutions oriented, Integrity and Credo Based Actions is required.
Preferred:
- Experience with the following functions: clinical supply chain packaging & distribution, clinical trial operations, project management, pharma/bio research and development, inventory management is preferred.
- Experience with clinical supply demand management tools (e.g., IVRS, SAP, OMP+) is preferred.
- Intermediate to advanced software skills (e.g., Microsoft Excel, OneNote, PowerPoint) is preferred.
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