Sr. Manager, Clinical Supplies

6 Month Contract (may extend or convert)

Remote (75%) + 1 week / month in South SF

Looking for West Coast Based Candidates (travel reimbursed)

MUST HAVE

• Pharma/Biotech Clinical Supply Planning & Logistics experience (forecasting (IP) supply requirements, managing packaging, labeling, and distribution through 3rd party vendors)
• Phase 1 & Small Biotech experience
• APAC logistics experience is a plus
• Strong MS Excel skills

Seeking a talented, independent, and highly motivated Senior Manager, Clinical Supplies Planning and Logistics with experience in clinical supply planning and logistics. This role is responsible for forecasting Investigational Product (IP) supply requirements, managing packaging, labeling, and distribution through 3rd party vendors, for one or more clinical trials. Collaborates and interacts internally with Clinical Operations, Medical Monitors, Program Management, Quality, Regulatory, CMC and externally with Clinical Service Providers (e.g., CROs, IP Drug Depot).

Responsibilities

• Manage all aspects of IP supply planning and logistics, to ensure alignment with study plans, timelines, budget, and overall clinical development plan.
• Management of IP vendors (performance, quality, timelines, results, costs): participates in review of RFP, reviews IP services vendors budgets.
• Manages relationships with external partners (CMOs, CROs, shipping and IRT vendors, study sites) and study team members to ensure successful execution of clinical trials
• Collaborates with Clinical Operations and Regulatory Affairs to provide packaging and labeling strategy, including labeling and packaging design in compliance with relevant SOPs, polices, and regulations
• Works closely with QA to ensure compliance around IP documentation, procedures, Lot numbers, managing expiration dates, and coordinating release schedules.
• Manages clinical supply and logistics activities, including but not limited to demand forecasting and supply planning, IRT start-up through study closure, label generation and approval, packaging and labeling operations, release and distribution, temperature excursion, expiry extension, drug return and destruction records, and inventory management.
• Assists the design and review of IP-related study documents (e.g., pharmacy manual, IP section of protocol) and training materials for clinical study teams and investigational site use as needed. Supports inspection team in preparation for and during regulatory agency inspection.
• Ensures appropriate documentation of IP supply activities is provided to clinical trial teams for the Trial Master File. Provides input to drug kit randomization specifications and reviews and master kit lists

Qualifications Required:

• BA/BS required, preferably in a scientific discipline. Other BA/BS degree with clinical supply experience will be considered.
• 6+ years of relevant experience in the biotechnology/pharmaceutical industry, including at least 3 years in clinical supply management in a small biotech-type of environment.
• Experience in small molecules (capsule and tablet) clinical supply planning and logistics for multi-center, blinded global studies required
• Experience in IP logistics in APAC (e.g., IP manufacturing and import from Asia to US) preferred
• Knowledge of global pharmaceutical regulatory requirements: cGMP, GCP, GDP
• Experience in forecasting, labeling, and distribution in clinical environment
• Phase one study experience (FIH, Single Center, etc.) preferred.
• Understanding and proven experience in IRT/RTSM,
• Clinical Supply and similar vendor management experience
• Knowledge of import/export policies

Core competencies and skills

• The ability to prioritize and handle multiple activities on a daily basis while being flexible and responsive to frequently shifting priorities
• Demonstrated ability to integrate into a partially remote team environment (US, APAC) with a positive attitude
• Action-oriented with excellent problem-solving skills
• Strong sense of integrity
• Other qualitative requirements:
• Organizational skills
• Result-driven
• Strategic agility
• Resilience and flexibility dealing with ambiguity