Manager/Senior Manager, Clinical Supply

Alkeus Pharmaceuticals, Inc. is a clinical-stage biotech company focused on the development of innovative therapies to treat serious diseases of the eye with high unmet need. Based in Cambridge, Mass., Alkeus was founded in 2010, and since that time has been developing its lead compound, gildeuretinol acetate (ALK-001). Designated as a breakthrough therapy and granted orphan drug status by the U.S. Food and Drug Administration, gildeuretinol is being evaluated in multiple clinical trials for the treatment of Stargardt disease and geographic atrophy (GA) secondary to age-related macular degeneration (AMD), a leading cause of blindness in the U.S.

Position Summary:

The Manager / Senior Manager of Clinical Supply oversees trial supply activities, including budgeting, logistics, compliance with multinational regulations and GxP requirements for drug development. This role will help create and improve Alkeus' Clinical Supply processes. These processes involve managing IMP supplies, project management, IVRS/IRT functionality, labeling and global distribution. The role collaborates with internal teams (Tech Ops, Clinical Ops, Quality, Regulatory Affairs, etc.) and external partners (CMOs, CROs) to ensure timely material availability. The position requires proactive problem-solving and quality system management (deviations, investigations, CAPAs, and Change Control) to enable clinical trial strategies and timelines.

Primary Responsibilities:

• Provide technical expertise for the development of clinical study protocols and pharmacy manuals for phase 1-4 compounds.
• Lead the planning, creation and maintenance of IMP supply project plans, based on study forecasts with Clinical Operations, Clinical Development and contracted vendors.
• Drive the clinical label text creation, translation, label proof, approval process and printing activities for global clinical trials.
• Review and approve specifications, batch records, packaging, and distribution instructions for clinical products.
• Set-up, schedule, and oversee third party packaging, labeling, QP release and international cold chain distribution operations for Investigational Medicinal Product (IMP) and Placebos.
• Identify, recommend and implement process and system improvement opportunities.
• Set-up, test, and manage IRT system.
• Manage Clinical Supplies inventory for assigned projects to ensure that inventory systems are kept up-to-date and that final product reconciliation is accurately completed.
• Develop Standard Operating Procedures (SOPs) and guidelines related to inventory management, distribution, transportation, disposition of returned/unused materials.
• Participate as SME for clinical regulatory audits related to supply.
• Represent Clinical Supply on global clinical project teams.
• Oversee and adapt processes as supply chain evolves from clinical to commercial partners.
• Deliver on other related projects as assigned.

Qualifications:

• Education and Certification:
  • Bachelors degree in Business Administration, Supply Chain, or Pharmaceutical Science preferred
• Work Experience:
  • 5-8 years of related experience in the pharmaceutical industry with at least 5 years of direct experience in Global Clinical Supply Management
  • Experience managing a contract manufacturing organization required
  • Experience utilizing IRT (Interactive Response Technology), electronic Trial Master File (eTMF), and other clinical study related systems required
  • Self-directed individual who can work effectively with limited direction in a complex, fast-paced environment
  • Experience in rare disease a plus
  • Knowledge of GMPs and GDPs of clinical and commercial products
  • Knowledge of import/export requirements and significant experience with international clinical supply
  • Strong knowledge of Microsoft Office, including Excel and PowerPoint, and Smart Sheet

Skills and Key Success Factors:

• Entrepreneurship spirit with a passion to build, learn and evolve with the team
• Highly organized and detail oriented with a passion to deliver quality results
• Excellent verbal and written communication skills, with experience translating complex concepts for various audiences
• Demonstrated record of intellectual curiosity, innovation and creative problem solving with an entrepreneurial spirit
• Ability to lead fast-paced projects with a keen sense of urgency to get the job done well
• Evidence of "hands-on" experience and expertise
• Proven and successful track record as a team-player and collaborator in small working environments
• Highest levels of professionalism, confidence, personal values and ethical standards

Other Relevant Information:

• Travel: able to travel up to 20% of time

Alkeus Pharmaceuticals, Inc., is an equal opportunity employer and considers all qualified applicants for employment without regard to any characteristic protected by applicable law. We celebrate diversity and are committed to creating an inclusive environment for all employees.