Lead, Clinical Supply Management

Biogen Idec Cambridge , MA 02138

Posted 1 week ago

Company Description

Job Description

As Biogen's portfolio expands and our Clinical Drug Supply operation continues to grow, we are seeking experienced staff to forecast, direct and manage investigational medicinal supplies for global study protocols. The Lead, Clinical Supply Management, is responsible for study drug supply per assigned protocols serving global patient populations in varied therapeutic areas across Biogen's neurology and rare disease portfolio.

Key job responsibilities are:

  • Overseeing daily supply chain activities in global markets while serving internal and external customers. This position requires a high level of organizational skills, ability to work well independently and balance a diverse workload.

  • Accountable for availability and distribution of finished goods per protocol

  • Drive finished good packaging strategy

  • Develop manufacturing/inventory plan based on demand

  • Routinely identify and communicate supply risks to management and supporting teams

  • Participate in vendor audits

  • Support new hire training and mentor junior staff

  • Lead cross-functional projects such as process improvements and system implementations or enhancement

  • Serve as the single point of contact per protocol to internal and external stakeholders

  • Initiate and maintain import licenses

  • Manage deviations and quality events

  • Co-develop IRT supply strategy

Qualifications

  • Minimum 3-5 years working within biotech/pharmaceutical, medical devices, food or other regulated environment. Experience working within a cGMP supply chain environment and GCP regulations desired. Bachelor of Science or Bachelor of Arts req

  • Supply chain background, clinical science or healthcare background preferred.

  • Analytical/Problem Solving: draws from past experiences to develop solutions to problems that require a high degree of subject matter expertise, ingenuity and creativity. Sets protocol and project priorities and determines objectives within mid- to long-term perspective. Manages links and interdependencies across multiple departments.

  • Relationship Management : demonstrated ability to administer and execute policies, processes, and procedures that affect colleague interactions and workflow of the unit. Routine contact with external 3rd party logistics providers, CMOs, and other internal functional groups.

  • Communication: excellent written and verbal skills, ability to communicate plans, risks and contingencies across various functional groups. Provide routine updates and identifies/communicates issues to managers and customers.

Additional Information

All your information will be kept confidential according to EEO guidelines.

icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Associate Director Clinical Supply Chain

Cogent Biosciences

Posted 7 days ago

VIEW JOBS 10/22/2020 12:00:00 AM 2021-01-20T00:00 Company Description Precision therapeutics for genetically defined diseases. Real solutions for real challenges. Who We Are Cogent Biosciences is a biotechnology company developing real solutions to treat genetically driven diseases. With a focus on rational drug discovery and development, we are leveraging validated biology to advance precision therapies designed to address the true underlying drivers of disease and provide real hope for patients. Cogent's lead therapeutic candidate, PLX9486 (expected to be named CGT9486 in the future), is a precision kinase inhibitor designed to selectively and potently inhibit the KIT D816V mutation. This mutation is responsible for driving a rare and serious condition called Systemic Mastocytosis which can severely impact many different tissues and organs in the body. We are also studying PLX9486 to treat advanced gastrointestinal stromal tumors (GIST), which have a strong dependence on oncogenic KIT signaling. Job Description The Senior Manager/Associate Director Clinical Supply Chain Management position will be responsible for managing multiple investigational drug supplies for world-wide trials. She/he will oversee all aspects of clinical supply management including forecasting, packaging, labeling, distribution, monitoring inventory, and vendor oversight. She/he will have an excellent understanding of the drug development process and be able to independently forecast and manage supply needs and distribution. What You Will Do * Develop strategic clinical supply packaging and labeling designs to fulfill clinical study dosing requirements, patient compliance, and effective study execution by sites. Collaborate with CMC/Manufacturing, Clinical Operations, QA, Regulatory Affairs, vendors, and others, as required, to finalize and implement designs. * Develop and manage forecasts by creating and reviewing clinical supply demand for the clinical trial projections. * Assess labeling, packaging and distribution needs on a study-by-study basis and identify appropriate vendors to conduct this work. Establish agreements with these vendors. * Manage direct outsourcing of labeling, packaging, storage, and distribution of manufactured drug supply and co-administered and/or comparator supplies, as required, to global sites. * Create and manage timelines and budgets to ensure on-time, on-budget delivery of product to sites, raising risks proactively. * Coordinate shipments of in-process GMP materials and released clinical materials between vendors and storage sites, Support country logistics for shipping and importation for the development programs. * Works closely with CMC Manufacturing to ensure that production schedule is sufficient to meet all supply chain requirements * Manage vendors and their respective contracts, invoice review, and budget planning. Establish practices and SOPs as needed, to support industry best practices. Collaborate with Quality to establish and regularly review Quality Agreements with vendors and partners providing packaging, labeling and/or distribution services. Qualifications What You Bring * BS, MS or PharmD degree, Pharmacy degree preferred, and at least 6-8 years of clinical supply chain experience within pharma/biotech. APICS certification or coursework is desired. * Thorough understanding of GXPs governing the manufacture of pharmaceutical drug products and conduct of routine clinical trials distribution. * Extensive experience in clinical supply management including forecasting, logistics (labeling, packaging, distribution, expiries), inventory tracking, and managing IRT systems. * Must be knowledgeable in US, EU, and ROW clinical supply labeling requirements and the QP review/release/certification process for European clinical supplies. * Experience with both ambient and cold chain products. * Must be able to effectively manage multiple activities and problem-solve to achieve business needs. * Strong communication skills, able to work independently and collaborate with key internal and external stakeholders. Additional Information Our Location Cogent is located within walking distance of the Alewife T station in Cambridge, MA. Our space includes an open office layout designed for collaboration. Free access is provided for both on-site parking and gym facilities in the building. We are in close proximity to leading academic institutions like MIT and Harvard and to potential pharmaceutical and biotech partners. This unique location allows for a high level of energy and intellectual exchange within and among fast growing early stage companies. Our Offer To You To attract the very best talent, we offer a generous benefits package that includes competitive pay, performance-based bonus, stock options, insurance coverage (health, dental, life, and disability), unlimited time-off, a 401(k) plan, and commuter/parking benefits. * Cogent is an equal opportunity employer * Note to agencies - we are not accepting unsolicited resumes from agencies and will not be responsible for fees associated with any such submittals Cogent Biosciences Cambridge MA

Lead, Clinical Supply Management

Biogen Idec