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Associate Director, Clinical Supply Integrator
Requisition ID: 2402171010
Research & Development, LLC, a member of Johnson & Johnson’s Family of
Companies, is recruiting for an Associate Director, Clinical Supply
Integrator. This position can be based in Malvern, PA or Titusville, NJ.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.
Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.janssenrnd.com for more information. We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it
This role is a matrix team leader or a CSI people leader and is responsible for end-to-end supply chain management of clinical supplies aligned per Therapeutic Area. 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 level and influences key stakeholders (Therapeutic Area, Clinical Team, CMC Team) on the right trial design and its operational impact.
- Act 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, and orchestrate all clinical supply activities to successfully deliver a clinical program
- Drive a global team in problem solving and provides coaching to team members
- For each compound, lead the monthly cS&OP cycle and takes leadership over the escalation and (as appropriate) resolution of critical risks and issues, include communication to key stakeholders
- Ensure there is a well-designed integrated demand and supply plan from API to Kit
- Leads cS&OP escalation topics with no guidance from the supervisor and independently resolve compound issues
- Represent the Clinical Supply Chain at the CMC team and drives the planning, coordination, and decisions related to clinical supply activities (API to Patient Kit) to ensure uninterrupted supply for clinical programs and trials
- Manage issue escalation and resolution at the compound level
- Potentially act as SPOC (Single Point of Contact) for TA & GCDO aligned per Therapeutic Area
- Provide input on promotions, recruitment strategy and team structure
- Represent PDMS at the Clinical team, ensuring clinical strategy can be executed and influence the clinical teams in the trial design and operational aspects thereby ensuring cost efficiency and customer satisfaction, and coordinates escalation & communication to the clinical team
- Manage the E2E clinical supply budget for each compound
- Manage the compound activities required to meet key CSC/CMC/CT milestones
- Act as Clinical Supply Chain champion in collaborative efforts with TA (e.g., due diligence efforts, clinical development parterships, Medical Affairs, Single Patient Requests, Named Patient Programs/Early Access Programs).
- Develop strong collaborations with the TAs, GCO, and PDMS to ensure customer satisfaction
- Participate in GCP and GMP health authority inspections
- Foster team cohesiveness and team productivity to work collaboratively to execute, deliver, and provide results
- A minimum of a Bachelor’s Degree is required, an advanced degree is preferred
- A minimum of eight (8) years of related experience with a Bachelor’s Degree OR six (6) years of related experience with an advanced degree is required
- Ability to influence at any organizational level with the ability to persuade key stakeholders is 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 are preferred
- Expertise in Drug Development processes is preferred
- Excellent knowledge of CMC drug development process and roles is preferred
- Expert in pharma/ bio research and development, end-to-end supply chain management, clinical supply logistics and distribution is preferred
- Robust knowledge of clinical research and operations and ability to consolidate and manage overall clinical supply demand is preferred
- Strong knowledge of GXP is required
- Excellent knowledge of project management and demand tools is preferred
- Proven financial expertise including knowledge of financial systems is preferred
- Ability to travel domestically and/or internationally up to 10% of the time
North America-United States-New Jersey-Titusville
Janssen Research & Development, LLC. (6084)