Associate Director Clinical Supply Integrator

Contenido de trabajo

This matrix 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 optimal supply overage for API, DP and Packaged materials. Manages budgets at a compound or trial level and influences key stakeholders (Therapeutic Area (TA), Clinical Team, CMC Team) on the trial design and its operational impact. May act as a matrix team leader or people manager, 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. Description of the Role: Sets direction as the clinical supply chain project and team leader for one or more complex/accelerated compounds, from NME to Life Cycle Management. Leads the Clinical Supplies sub team, and through the team orchestrates all clinical supply activities to successfully deliver a clinical program. Drives a global team in defining and managing change, challenging the status quo, and problem solving. Provides coaching to team members. Independently manages issue escalation and resolves compound issues with limited guidance. 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. Ensures there is a well-designed integrated demand and supply plan from API to Kit. Leads cS&OP escalation topics with little to no guidance from the supervisor. Represents Clinical Supply Chain at the CMC team and the Clinical team leading the product strategy. Communicates and executes the strategy and development plan with high level of autonomy and accountability. 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 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 the compound activities required to meet key CSC/CMC/CT milestones. This includes long range 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. May set direction on promotions, recruitment strategy, and team structure. Mostly interacts with internal stakeholders, occasionally with external. Manages limited number of complex projects with potentially accelerated priority. Qualifications Critical Experiences Required: University/Bachelors Degree plus 8-12 years related experience. Or Masters Degree plus 6+ years related experience. Technical degree and/or experience a plus. 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 communicating and executing strategy / product development plan with high level of autonomy and accountability. 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. Experience working independently on day to day basis, without regularly checking in with supervisor. Advanced understanding and management of the E2E clinical supply budget, GXP, estimates and reporting. Critical Competencies: Influencing – effectively influences CSC internal and key external stakeholders to achieve strategic goals. Uses his/her understanding of team dynamics, cohesiveness and productivity. Problem Solving / Decision Making - Creates a culture and empowers others in the analysis of strategic problems and issues; identifies and manages the impact across the business. No support from a supervisor. Project Management - Leads multi-dimensional projects across the business; manages the inter-relationships among projects for optimal outcomes, processes, and people. CMC Drug Product Development - Demonstrates in-depth knowledge of E2E CSC activities and the broader development process/organization in order to support the development G&O’s with impact on departmental strategy. E2E CSC accountability for portfolio projects at the CMC and clinical teams, managing internal and external stakeholders. Understands and helps shape strategic objectives of the organization and finds ways to implement these strategies in daily activities. Matrix Team Leader – Leads the CSC sub- team applying innovative approaches and out of the box thinking while providing coaching to help develop the team members. Quality – Ensures project activity which is safe, effective and otherwise compliant with global health authority expectations. Communication - Creates forums, systems, and processes that result in information sharing, internal and external to the organization. Confidently presents controversial and/or complex information to all levels of the organization. Strategic Thinking - Understands and shapes strategic objectives of the CPDS organization and finds ways to implement these strategies in daily activities. Helps others understand and apply organizational objectives. Cross functional Coordination - Is viewed as a trusted partner across the business and with internal and external therapeutic area experts; anticipates additional needed relationships and proactively takes actions; leverages relationships; develops strategic alliances. Primary Location Belgium-Antwerp-Beerse- Other Locations North America-United States-Pennsylvania-Malvern, North America-United States-New Jersey-Titusville Organization Janssen Pharmaceutica N.V. (7555) Job Function R&D Requisition ID 2105972545W