Associate Director, Clinical Supply Chain

Supply Chain Waltham, Massachusetts


Description

Position Summary:

Apellis is looking to hire an experienced Associate Director of Clinical Supply Chain to join the Supply Chain team and to ensure clinical trial supply continuity which will enable Apellis to move our clinical stage programs toward commercialization.  Reporting into Senior Director of Clinical Supply Chain, this role will be focused on ensuring supply continuity for two of Apellis’ on-going Ph3 clinical trials.  Additionally, this role will help drive organizational structure and working standards for Apellis’ growing Clinical Supply Chain capabilities.  A successful candidate will be able to drive operational execution and be able to help set strategic direction.

Key Responsibilities Include:

  • Responsible for clinical trial supply continuity. Including IMP, co/con-meds and ancillary supplies. 
  • Finished goods planning and distribution. Both at the depot level and site level.
  • Represent the supply chain function at departmental meetings (i.e. Study Management Teams).
  • Manage the distribution strategy (i.e. import licenses).
  • Work with the appropriate functions to help generate kits lists
  • Act as an intermediate between Manufacturing, Supply, Distribution and Clinical Operations partners.
  • Create, manage and track POs.
  • Use IRT for inventory management.
  • Work with IRT vendors on IRT set up (UATs and IRT spec integration).
  • Work with Quality and Distribution partners to manage, track and closeout in-transit temperature excursions.
  • Work with appropriate partners to adjudicate distribution issues (i.e. importation issues).
  • Enable and help with GMP and non-GMP sample shipments.
  • Monitor, track and proactively manage IMP expiry.
  • Work with Quality, Regulatory and Clinical partners on study close outs.
  • Ensure consistent, reliable, and complaint supply of clinical products in accordance with the forecast and inventory requirements, the planning assumptions, and supply budget
  • Establish excellent working relationships with Technical Operations, Quality, Clinical Operations, and Finance functions and forge integrated ways of working to efficiently manage and report on the flow of product and information
  • Collaborate with others to conduct supply chain risk management process
  • Develop and manage relationships with key external business partners, suppliers, vendors and consultants to ensure product supply and market needs are met.

Education, Registration & Certification:

  • BS in Science, Business, Supply Chain Management, or related fields
  • MBA preferred
  • APICS certification preferred: CSCP and/or CPIM

Minimum Required Experience

  • At least 10 years of pharmaceutical industry experience
  • At least 8 years of global clinical supply chain experience
  • Demonstrated success in a fast growing company
  • Successful clinical trial supply experience
  • Operational level supplier relationship management experience

Skills, Knowledge & Abilities:

  • Broad knowledge base of supply chain operations in the SCOR operating model disciplines.
  • Strong Leadership skills. Able to represent the company externally and the Supply Chain function internally.
  • Working knowledge of regulated manufacturing, GMP, and quality systems within drug or device.
  • Demonstrated complex problem-solving ability and sound judgement ability.
  • Organizational, communication and interpersonal skills.
  • Excellent written, oral communication, and presentation skills along with the ability to communicate effectively.
  • Demonstrated business acumen and influencing skills
  • Highly organized, committed, results driven, problem solver

 

 

Physical Demands and Work Environment:

This is largely a sedentary role; however, some filing is required. This would require the ability to lift files, open filing cabinets and bend or stand on a stool as necessary.

This job operates in a professional office environment and routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

Travel Requirements:

  • This role is based in Waltham, MA.
  • Some travel of approximately 10% will be required periodically

Benefits and Perks:

Apellis offers a great benefit package which includes: health insurance with full premium coverage, 401K with company match, paid time off (PTO), long- term disability insurance, life insurance and more!  Visit http://apellis.com/careerbenefits.html to learn more.

Company Background:

We are a clinical-stage biopharmaceutical company focused on the development of novel therapeutic compounds to treat disease through the inhibition of the complement system, which is an integral component of the immune system, at the level of C3, the central protein in the complement cascade. We believe that this approach can result in broad inhibition of the principal pathways of the complement system and has the potential to effectively control a broad array of complement-dependent autoimmune and inflammatory diseases.

Visit http://apellis.com/about.html to learn more.

EEO Statement:

Apellis is an equal opportunity employer and complies with all applicable federal, state and local fair employment practices laws. Apellis strictly prohibits and does not tolerate discrimination against employees, applicants or any other covered persons because of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including gender nonconformity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, marital status, AIDS/HIV status, smoker/nonsmoker, and occupational pneumocononiosis or any other characteristic protected under applicable federal, state or local law.

Other Duties:

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. 

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EEO Statement: Apellis is an equal opportunity employer and complies with all applicable federal, state and local fair employment practices laws. Apellis strictly prohibits and does not tolerate discrimination against employees, applicants or any other covered persons because of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including gender nonconformity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, marital status, AIDS/HIV status, smoker/nonsmoker, and occupational pneumocononiosis or any other characteristic protected under applicable federal, state or local law.