Director Clinical Supply Chain

Supply Chain Waltham, Massachusetts


Description

Position Summary:

Partnering closely with the cross-functional stakeholders, the leader will apply supply chain management fundamentals to develop a strategic plan for clinical supply chain. The position will oversee activities related to packaging, labeling and global distribution to clinical sites. The leader will develop a strategic plan for procurement, supply planning and distribution of ancillaries, concomitant medications, and comparator products.

Key Responsibilities:

  • Responsible for clinical supply team for on-going and new clinical trials by ensuring on-time delivery, including demand forecasting, trial monitoring & resupply planning, IRT set-up and distribution activities.
  • Oversight for the design and execution of packaging and labeling campaigns with clinical packaging and labeling vendors.
  • Lead the label text, proof and variable text processes from generation through approval for open and blinded clinical labels with a single or multiple languages.
  • Manage the storage, distribution and inventory tracking through the supply chain in accordance to relevant regulations. Develop tracking systems documenting lot usage per clinical trial to ensure proper accountability and genealogy.
  • Manage vendor selection related to packaging, labeling and distribution, and any others as required. Work with stakeholders as required in selection/qualification of CMO’s and to negotiate effective supply and technical agreements.
  • Build and maintain effective business relationships with vendor portfolio, ensuring objectives are being met based on quality, cost and performance.
  • Facilitate and manage productive team communication and collaboration, both internally and externally.

Education, Registration & Certification:

  • The ideal candidate should have a Bachelor’s degree in life sciences /engineering or relevant work experience.
  • You should have a passion for learning, creating, relating, communicating, and leading cross functional teams.

Experience:

  • 8-10 years of progressive experience in biopharma. Clinical Supply chain experience desired.

Physical Demands and Work Environment:

Will work from the Company’s Waltham office, with additional travel as required to oversee the virtual development and manufacturing network (up to 25%).

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

Benefits:

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.