Associate Director, Clinical Supply Integrator

Janssen Research & Development, LLC., a member of the Johnson & Johnson Family of Companies, is recruiting for an Associate Director, Clinical Supply Integrator At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Research & Development, LLC; is part of the Janssen Pharmaceutical Companies. This team leader is responsible for end-to-end supply chain management of clinical supplies. through the Clinical Supply Sub-Team develops supply strategies matching needs of clinical programs and trials to ensure on time delivery and efficient supply overage for API, DP and Packaged materials. Handles budgets at a compound or trial level and influences contributors (Therapeutic Area (TA), Clinical Team, CMC Team) on the trial design and its operational impact. This individual is responsible for overseeing a group focused on end-to-end supply chain management and works with a high degree of autonomy and independence. Key Responsibilities: Sets direction as the clinical supply chain project and team leader for one or more complex/accelerated compounds, from NME to Life Cycle Management. Lead the Clinical Supplies sub team to orchestrates all clinical supply activities to successfully deliver a clinical program. Communicates the strategy and development plans to stakeholders. Drives a distributed team in defining and handling change, challenging the status quo, and problem solving. Provides mentorship to team members. Leads the monthly CS&OP cycle and takes leadership oof issues and (as appropriate) resolution of critical risks, including communication to collaborators. Ensures there is a well-designed coordinated demand and supply plan from API to Kit. Represents Clinical Supply Chain at the CMC team and the Clinical team leading the product strategy. Accountability for CSC planning, project budgets, coordination, and decisions related to clinical supply activities resulting in uninterrupted supply. Develops strong collaborations with the TAs, GCO, and CPDS, BIOTD and Vaccines to ensure translation of customer needs to fit-for-purpose. Potentially act as SPOC (Single Point of Contact) for TA’s & GCDO aligned per Therapeutic Area contributing to due diligence efforts, clinical development partnerships, Medical Affairs, Single Patient Requests, Named Patient Programs/Early Access Programs). Represents CPDS at the Clinical team, ensuring clinical strategy can be executed. 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 including demand forecasting prior to transition to TSM, selection of formulation and comparators used in clinical trials, and developing supply strategies to meet clinical plans while optimizing drug overage. Participates in GCP and GMP health authority inspections. Contributes to some degree to strategy development at the functional level and drives structured improvements of functional processes (quality, cost, time, asset utilization) in line with business or operational strategy. Large Molecules; Small Molecules; Vaccines; Drug Development; Able to lead the most complex programs and accelerated clinical programs. Qualifications Education: Minimum of a Bachelor’s or equivalent University degree required; Master's/MBA Degree preferred. Experience and Skills: Required: Minimum of 8 years relevant work experience 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 Excellent knowledge of CMC drug development process and roles or equivalent experience Experience leading and supervising late stage compound teams or multiple early projects for process development, tech transfer and regulatory filings Experience interfacing directly with CMC/Tech team members, internal operations, Regulatory, JSC, external service providers and internal DPDS customers such as GCO and TA with limited or no guidance Experience influencing or persuading others to accept new ideas, approaches or concepts or gains alignment on divergent issues with limited guidance Experience managing a limited number of complex projects with potentially accelerated priority OR Leads complex Phase 3 clinical programs Advanced understanding and management of the E2E clinical supply budget, GXP, estimates and reporting Influencing - effectively influences CSC internal and key external stakeholders to achieve strategic goal