Manager, Clinical Asset Planning
Posted on: 9 Jan 2021
Cambridge, MA
Job Description
Job Description
The Manager, Clinical Asset Planning plays a critical role in Biogens Clinical Drug Supply (CDS) organization, responsible for ensuring continuous product supply for our global clinical trials by collaborating closely and working strategically with our Asset, Clinical Development, Quality, Regulatory and Manufacturing teams. The successful candidate will oversee the end-to-end clinical supply chain and manage the forecasting, manufacturing, risk management and expiry management plans for multiple clinical assets. This role will report to the Associate Director of CDS.
Primary Responsibilities:
* Maintaining supply continuity for Biogen assets across multiple global trials:
* Accountable for the availability of API/DS/DP and FGI across all protocols.
* Completing and maintaining Rough Cut Capacity Plans for API/DS/DP and FGI
* Execute API/DS/DP and FGI clinical product lifecycle maintenance
* Develop and maintain API/DS/DP and FGI demand and update relevant systems
* Act as a key liaison between the Asset Teams and Clinical Development teams, ensuring that clinical supply and demand is aligned with the Clinical Development Plans
* Collaborate closely with the Clinical Supply Managers to ensure alignment of APD/DS/DP production individual protocol-level Finished Goods forecasts and develop strategies for delivering the product globally
* Provide guidance and support to the Clinical Development Team in understanding the impact of Study Design on the clinical supply chain
* Support supply chain process improvement and technology implementation initiatives
Qualifications
Applicants will be highly detail oriented with excellent communication and presentation skills. Applicants should have a minimum of 5-7 years of supply chain planning/management experience in the pharmaceutical or biotech area. We require a minimum of a Bachelors Degree in Supply Chain Management or Science-based Discipline.
We are interested in hearing from candidates with a proven track record of success in the following areas:
* Effective collaboration across multiple stakeholders in developing and implementing effective supply chain management strategies.
* Developing forecasts and supply plans for IMPs incorporating expiry management and accounting for complex regulatory requirements.
* A solid understanding of drug and process development across modalities (large molecule, small molecule, ASOs, gene therapy) or a solid understanding of clinical trial development across all phases (R-to-D transition, phase 1, 2, 3 studies), and the implications for either on supply chain planning and execution.
* Leveraging tools and systems to manage demand and inventory.
* Proven ability to develop and train more junior team members.
* Ability to work with diverse learning and working styles to leverage strengths.
* Preferred: APICS certification and clinical supplies planning and forecasting experience
Additional Information
All your information will be kept confidential according to EEO guidelines.
Biogen
Cambridge, MA
Biogen Inc. discovers, develops, manufactures, and delivers therapies for treating neurological and neurodegenerative diseases worldwide. The company offers TECFIDERA, AVONEX, PLEGRIDY, TYSABRI, and FAMPYRA for the treatment of multiple sclerosis (MS); SPINRAZA for the treatment of spinal muscular atrophy; and FUMADERM for the treatment of plaque psoriasis. It also provides BENEPALI, an etanercept biosimilar referencing ENBREL; FLIXABI, an infliximab biosimilar referencing REMICADE; and IMRALDI, an adalimumab biosimilar referencing HUMIRA. In addition, the company offers RITUXAN for the treatment of non-Hodgkin's lymphoma, chronic lymphocytic leukemia (CLL), rheumatoid arthritis, two forms of ANCA-associated vasculitis, and pemphigus vulgaris; RITUXAN HYCELA for non-Hodgkin's lymphoma and CLL; GAZYVA to treat CLL and follicular lymphoma; and OCREVUS for the treatment of primary progressive MS and relapsing MS, and other anti-CD20 therapies.
Further, it is involved in developing BIIB098, Opicinumab, and BIIB061 for MS and neuroimmunology; Aducanumab, Elenbecestat, BAN2401, BIIB092, BIIB076, and BIIB080 to treat Alzheimer's disease and dementia; BIIB092 and BIIB054 for treating Parkinson's disease and movement disorders; BIIB067, BIIB078, and BIIB110 to treat neuromuscular disorders; BIIB093, TMS-007, and Natalizumab to treat acute neurology; BIIB104 for treating neurocognitive disorders; BIIB074 and BIIB095 for pain; and Dapirolzumab pegol, BG00011, and BIIB059 for treating other diseases, which are under various stages of development.
The company offers products through its sales force and marketing groups. Biogen Inc. has collaboration agreements with Genentech, Inc., Eisai Co., Ltd., Alkermes Pharma Ireland Limited, Bristol-Myers Squibb Company, Acorda Therapeutics, Inc., AbbVie Inc., C4 Therapeutics, University of Pennsylvania, Applied Genetic Technologies Corporation, and others. The company was founded in 1978 and is headquartered in Cambridge, Massachusetts.
-
IndustryBiotechnology
-
No. of Employees7,800
-
Website
-
Jobs Posted445
