Associate Director, Global Clinical Supply - United States
The Associate Director, Global Clinical Supply is responsible for leading and the planning and execution of Clinical Supply Chain activities globally. The Associate Director is responsible for developing and formalizing robust processes/procedures related to Clinical Supply Chain activities in compliance with global regulations. The Associate Director will face complex problems related to clinical trial supply and will be required to negotiate on timelines and activities with external and internal entities to ensure supply is available for patients. This position will closely interface with Clinical Operations, Quality, Product Development, Regulatory Affairs, Contract Manufacturing Operations (CMO’s), and Contract Research Operations (CRO’s) to ensure Clinical material is available as required and support clinical trial strategy and timelines. The Associate Director will continuously track progress towards objectives and advise management of any issues impacting project timelines and provide solutions to the problems. This position will be expected to lead Clinical Supply Chain Execution teams and actively participate and support clinical study teams in all matters related to drug supply. Responsible for actively managing all Quality Systems related to the Clinical Supply Chain including deviations, investigations, CAPA’s, and Change Control. The Associate Director will be the subject matter expert related to clinical drug supply during regulatory inspections. The Associate Director will support activities leading to the implementation of global clinical inventory management, supply planning and distribution systems consistent with meeting cGMP, clinical development programs, corporate objectives and is responsible for contractor management including performance metrics and contractual agreements. This position will also have some accountability for supporting complex trial planning and supply management requiring subject matter expertise in clinical pharmacy, project management, protocol and pharmacy manual development and oversight of supply logistics either internally or interfacing with external contractors for this service.
- Leads the planning, creation and maintenance of IMP supply project plans, including creating complex study forecasts with input from Clinical, Manufacturing and Medical project managers as well as contract providers
- Lead Clinical Supply Chain Execution teams and actively participate and support clinical study teams in all matters related to drug supply as needed to support the portfolio demands for programs progressing toward critical milestones where end to end supply chain execution is required for world class clinical supply delivery.
- Act as liaison with contractor(s) (CMO’s). Complete quarterly business and performance metrics. Negotiate quotes and work orders for new trials.
- Work with Clinical Operations, QA and Regulatory to develop kits and label text for multiple countries/regions and provide support for IND filings as required.
- Establish SOPs, protocols, and procedures for clinical trial material packaging, labeling and distribution to ensure compliance with cGxP requirements.
- Manage development of pharmacy manuals with appropriate internal subject matter experts and as needed interface with external contractors to provide pharmacy manual writing services.
- Manage vendor selection for clinical study support, including Clinical Packaging and Labeling facilities as required. Work with Regulatory Compliance and QA in selection/qualification of CMO's.
- Manage Quality Systems required documentation, including Deviations, Investigations, CAPA’s, Change Controls, Label and Product Specifications, and others as required.
- Subject matter expert for clinical trial supply during regulatory inspections.
- Develop and apply Project Plans and Schedules that represent the appropriate level of detail and task independency. Ensure timely follow-up to all commitments in a project plan.
- Proactively address risk management issues and implement business continuity plans.
- Prepare supply and cost forecasts as required. Identify cost reduction opportunities and develop and manage clinical supply budget
- This position will also provide technical expertise for the development of clinical study protocols and manuals for phase I-III compounds and will be required to develop admixture, dosing and administration strategies for complex biologic products in early phases of development.
- Minimum of 8 years of related experience in the pharmaceutical industry with at least 5 years of direct experience in Global Clinical Supply Management and 3 years management experience.
- Recent industry experience with clinical supplies or clinical operations, PharmD with prior hospital or investigational drug service experience is preferred.
- Ability to communicate and maintain collaborative relationships effectively with key internal and external stakeholders.
- Proven ability to select, secure and manage external vendors at a senior leadership level to achieve results and control expenditures
- Experience with financial management of supply chain activities including departmental budgeting and oversight of external contracts
- Demonstrated experience with global clinical supply forecasting, planning, packaging, labeling, inventory management, IVRS systems, clinical trial designs (randomized, double, blind, placebo controlled)
- Thorough knowledge and understanding of cGMP, ICH/cGXP guidelines and global Health Authority requirements.
- Proficiency in computer software applicable to IVRS/IWRS, Excel, Power point and MS Project.
- Good organizational, communication and presentation ski9lls, effective project and time management skills and the ability to work under pressure.
- Experience with regulatory submissions a plus.
- Minimum of a Bachelor’s degree in Pharmacy or related Science degree required; advanced degree preferred (PHARM D)
New Haven, CT, United States
Alexion is a global biopharmaceutical company focused on developing and delivering life-transforming therapies for patients with devastating and rare disorders. Alexion developed and commercializes Soliris® (eculizumab), the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), two life-threatening ultra-rare disorders. As the global leader in complement inhibition, Alexion is strengthening and broadening its portfolio of complement inhibitors, including evaluating potential indications for eculizumab in additional severe and ultra-rare disorders. Alexion’s metabolic franchise includes two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare disorders, Strensiq® (asfotase alfa) to treat patients with hypophosphatasia (HPP) and Kanuma™ (sebelipase alfa) to treat patients with lysosomal acid lipase deficiency (LAL-D). In addition, Alexion is advancing the most robust rare disease pipeline in the biotech industry, with highly innovative product candidates in multiple therapeutic areas.
As a leading employer in our industry, Alexion is proud to offer a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Alexion, please visit www.alexionpharma.com or download our App for iPhones and Blackberries.
Alexion is an Equal Opportunity /Affirmative action employer