Job description
Job Title: Senior Manager, Clinical Supplies Planning and Logistics
Reports To: Head of Clinical Supplies Planning and Logistics
Location: SSF (Hybrid)
About Us
We are a clinical-stage biopharmaceutical company developing innovative therapies for patients with serious chronic diseases. Our discovery platform leverages advanced computational technologies and structure-based drug design to develop differentiated small molecule medicines intended to address significant unmet medical needs across multiple therapeutic areas.
The company is led by an experienced team of drug development professionals and is backed by leading life sciences investors. We operate with a global footprint and collaborate across international teams to advance our pipeline.
Position Summary
We are seeking a talented, independent, and highly motivated Senior Manager, Clinical Supplies Planning and Logistics with strong experience in clinical supply planning and Interactive Response Technology (IRT/RTSM) systems.
This individual will serve as the IRT subject matter expert, responsible for vendor management, system design and build oversight, UAT coordination, and system lifecycle management. In addition to IRT oversight, this role will manage core clinical supply activities including forecasting investigational product (IP) requirements, inventory oversight, and management of packaging, labeling, and global distribution through third-party vendors for one or more clinical trials.
This role will collaborate cross-functionally with Clinical Operations, Medical, Program Management, Quality, Regulatory, CMC, and external service providers including IRT vendors, CROs, depots, and CMOs.
Essential Duties and Responsibilities
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Lead IRT vendor management, system planning, execution, and maintenance to ensure alignment with study timelines, budgets, and development plans
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Oversee clinical supply and logistics activities including demand forecasting, supply planning, labeling strategy and approval, packaging operations, release and distribution, temperature excursion management, expiry tracking, drug return/destruction, and inventory reconciliation
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Participate in RFP development and vendor selection; review budgets and scope of work for IP service providers
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Collaborate with external partners (CMOs, CROs, depots, IRT vendors, and study sites) to ensure seamless trial execution
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Partner with Clinical Operations and Regulatory to develop compliant packaging and labeling strategies
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Work closely with Quality Assurance to ensure compliance with documentation, lot tracking, expiration management, and release processes
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Author and review IP-related study documents (e.g., pharmacy manuals, protocol sections) and support regulatory inspection readiness
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Ensure appropriate documentation of IP activities for Trial Master File
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Provide input into randomization specifications and review master kit lists
Qualifications
Education
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Bachelor’s degree required (scientific discipline preferred)
Experience
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Strong experience with IRT/RTSM systems in global clinical trials
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6+ years of relevant biotechnology or pharmaceutical industry experience
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Minimum 3 years in clinical supply management within a small to mid-sized biotech environment
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Experience supporting global, multi-center, blinded studies
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Knowledge of small molecule (oral solid dose) clinical supply planning preferred
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Understanding of global regulatory requirements (cGMP, GCP, GDP)
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Experience in demand forecasting, labeling, packaging, and distribution
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IRT vendor management experience required
Core Competencies
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Ability to manage multiple priorities in a dynamic environment
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Comfortable working within partially remote, global teams
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Strong problem-solving and decision-making skills
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High ethical standards and integrity
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Strong organizational skills and attention to detail
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Results-driven with strategic mindset
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Adaptable and resilient in ambiguous environments
Travel
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Up to 10%
Equal Opportunity Statement
We are an equal opportunity employer committed to fair and equitable compensation practices. The anticipated base salary range for this role will be determined based on geographic location, experience, qualifications, and skills.