Associate Director, Clinical Supply Integrator Job

Job description

Associate Director, Clinical Supply Integrator-6952151202DescriptionJanssen Pharmaceuticals, Inc., a pharmaceutical company of Johnson & Johnson, provides medicines for an array of health concerns in several therapeutic areas, including: attention deficit hyperactivity disorder (ADHD), cardiovascular disease, general medicine (acid reflux disease, infectious diseases), mental health (bipolar I disorder, schizophrenia), neurologics (Alzheimer’s disease, epilepsy, migraine prevention and treatment), pain management, and women’s health. Our ultimate goal is to help people live healthy lives. We have produced and marketed many first-in-class prescription medications and are poised to serve the broad needs of the healthcare market – from patients to practitioners, from clinics to hospitals. For more about Janssen Pharmaceuticals, Inc., one of the Pharmaceutical Companies of Johnson & Johnson, visit www.janssenpharmaceuticalsinc.comAssociate Director, Clinical Supply Chain IntegratorThis matrix team leader is responsible for end-to-end supply chain management of clinical supplies aligned per Therapeutic Area. Through the CSC Technical 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 the right trial design and its operational impact.
Responsibilities:Acts as the clinical supply chain project and team leader for one or more compounds. Leads the Clinical Supplies subteam, and through the team orchestrates all clinical supply activities to successfully deliver a clinical program. Drives team problem solving and acts as a coach to team members to drive their technical and personal development.
For each compound, leads the monthly cS&OP cycle and takes leadership over the escalation and (as appropriate) resolution of critical risks and issues. Ensures there is a well-designed integrated demand and supply plan from API to Kit. Leads S&OP escalation topics with limited or no guidance.
Represents the Clinical Supply Chain at the CMC team and drives the CMC planning, coordination, and decision related to clinical supply activities (API, DP, Kit) to ensure uninterrupted supply for clinical programs and trials. Represents PDMS at the Clinical team. Influences 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.
Manages the activities required to meet First-Patient-In date of clinical trials. This includes initial demand forecasting, configuration of the distribution network, IVR / RTSM specifications, kit and label design, and developing supply strategies to meet clinical plans while optimizing drug overage. Influences decisions in therapeutic areas from a clinical supply chain perspective.
Manages the activities required to meet First-Patient-In date of clinical trials. This includes initial demand forecasting, configuration of the distribution network, IVR / RTSM specifications, kit and label design, and developing supply strategies to meet clinical plans while optimizing drug overage. Ensures seamless transition to the Trial Supply Manager and provides oversight and support through execution phase of trial.
Develops and manages the clinical supply budget for trials and programs (internal FTEs as well as OOPs, excluding API and DP)Act as Clinical Supply Chain champion in collaborative efforts with external companies (e.g., due diligence efforts, clinical development parterships). Partners with CMC Lead in leading effort to clarify processes and roles/responsibilities across two companies to ensure timely delivery of supplies.
Develops strong collaborations with the TAs, GCO, and PDMS to ensure customer satisfaction.
Represents Clinical Supply Chain for a particular compound and for various processes during GCP and GMP health authority inspections.
Identifies and leads innovative projects to significantly improve functional and cross functional processes and tools.
Exemplifies and drives the use of core processes and tools in the department and the teams, and serves as a mentor to others to drive adoption. Creates clarity in roles and responsibilities and holds teams strongly accountable to them.
Focus and Scope:Large molecules, Small molecules, Vaccines programs, able to lead the most complex and accelerated clinical programs.
J2W: LI NAQualificationsMinimum Requirements:University/Bachelors Degree plus 8+ years related experience Or Masters Degree plus 4+ years related experience. S/he must possess very strong clinical supply design expertise (e.g., influencing clinical protocols, designing patient kits, developing distribution strategy). S/he must demonstrate a deep understanding of the E2E supply network and process and uses the knowledge in the job. strong knowledge of pharma/ bio research and development, end-to-end supply chain management, clinical supply logistics and distribution and good knowledge of clinical research and operations and ability to consolidate and manage overall clinical supply demand. Excellent knowledge of CMC drug development process and roles, strong knowledge of GXP, excellent knowledge of RTSM (IVRS) functionality and good knowledge of project management and demand tools are required. Good use of clinical supply demand simulation tools required (e.g. Optimizer), proven financial expertise including knowledge of financial systems, strong project management skills and communication and influencing skills are required. S/he must possess very strong matrix team leadership skills, big picture orientation with attention to detail, ability to collaborate internally and have seamless partnerships, ability to work in cross cultural environment, strong strategic thinking skills and be results oriented.
This role may be located in Malvern, PA or Titusville, NJ and requires minimal travel.
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Primary Location:North America-United States-New Jersey-TitusvilleOther Locations:North America-United States-Pennsylvania-MalvernOrganization: Janssen Research & Development, LLC. (6084)Job Function: Clinical SuppliesCertain sites within the Johnson & Johnson Family of Companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
Johnson and Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law. EEO is the Law EEO is the Law GINA Supplement