Job Title: Senior Manager, Clinical Supply Chain - Biologics
Location: Hybrid - Waltham, MA. Candidates will be required to be in-office 3 days/week.
Role Overview: We are seeking an experienced and highly motivated Senior Manager, Clinical Supply Chain to lead clinical supply activities supporting early- through late-stage global clinical trials. This individual will be responsible for the planning and execution of clinical supply strategies, including forecasting, labeling, packaging, distribution, inventory management, Interactive Response Technology (IRT) implementation and maintenance, expiry management, and supply reconciliation.
The ideal candidate thrives in a fast-paced, collaborative environment and has demonstrated experience building strong relationships across Clinical Operations, CMC, Program Management, Regulatory Affairs, Quality, and external partners. This individual will work closely with the broader Clinical Supply Chain team to establish scalable processes and best practices while supporting multiple clinical trials across the United States, Canada, and Europe.
The successful candidate will be a proactive and highly effective communicator who anticipates supply risks, develops practical solutions, and delivers results efficiently. Experience supporting global biologics programs involving vials, pre-filled syringes, temperature-controlled products, and active comparators is strongly preferred.
Key Responsibilities:- Develop and execute clinical supply strategies for multiple early- and late-stage clinical programs, including Phase 1, Phase 2, and global Phase 3 studies.
- Lead clinical supply chain activities, including demand forecasting, labeling, packaging, distribution, inventory management, IRT implementation and maintenance, expiry management, returns, reconciliation, and destruction.
- Develop and maintain comprehensive supply plans aligned with clinical enrollment projections, dosing requirements, protocol assumptions, regulatory timelines, and study milestones.
- Author, review, and/or approve clinical label text, packaging specifications, packaging batch records, distribution documentation, pharmacy manuals, and clinical supply sections of study-related documents.
- Provide clinical supply subject-matter expertise for label development, packaging design, distribution strategies, depot networks, kit configurations, and randomization and packaging requirements in accordance with applicable regulations and Good Manufacturing Practices.
- Lead the selection, onboarding, and operational oversight of contract packaging organizations, clinical depots, couriers, IRT vendors, and other external supply partners.
- Support site initiation visits, ongoing clinical trial activities, and open-label extension studies by ensuring the timely availability of clinical supplies, Certificates of Analysis, stability and expiry information, handling instructions, and return or destruction guidance.
- Proactively identify and manage risks related to enrollment changes, protocol amendments, study timelines, supply availability, expiry, inventory levels, and distribution requirements.
- Support clinical supply and logistics planning for global regulatory submissions, health authority responses, and inspection-readiness activities.
- Partner with Quality and other stakeholders to facilitate the timely review, approval, and execution of standard operating procedures, batch records, lot-release documentation, change controls, deviations, investigations, and corrective and preventive actions.
- Collaborate with Quality, Clinical Operations, IRT vendors, and other appropriate functions to confirm product-release status, shipment authorization, IRT configuration, and maintenance of study-blind integrity.
- Identify and implement process improvements through the development of procedures, reports, templates, metrics, and scalable clinical supply practices.
- Manage clinical supply budgets, contracts, purchase orders, timelines, and vendor deliverables in partnership with Finance, Procurement, and Legal, as applicable.
- Serve as the person-in-plant during clinical labeling and packaging campaigns, as needed.
- Travel approximately 20-25% to support vendor due diligence, business reviews, packaging campaigns, and other clinical supply activities.
Qualifications:- Bachelor's or Master's in a scientific discipline with 6+ years of relevant experience in clinical supply chain and logistics
- Demonstrated experience planning and executing clinical supply strategies for complex, global clinical studies, including Phase 3 studies involving active or licensed comparators.
- Hands-on experience managing clinical supply activities, including forecasting, labeling, packaging, distribution, inventory management, IRT implementation and maintenance, expiry management, reconciliation, returns, and destruction.
- Experience supporting temperature-controlled biologic products, including cold-chain storage and distribution.
- Experience supporting clinical supplies presented in vials and/or pre-filled syringes.
- Demonstrated experience managing import and export activities for clinical studies conducted in the United States, Canada, and Europe.
- Strong operational and project-management skills, with experience managing multiple programs, vendors, deliverables, timelines, contracts, and budgets simultaneously.
- Experience working with IRT systems and clinical supply forecasting or inventory-management tools.
- Demonstrated ability to identify supply risks, evaluate alternatives, and communicate recommendations clearly to cross-functional stakeholders and senior leadership.
- A proactive, adaptable, organized, and strategic approach, with the ability to operate effectively in a fast-paced and evolving environment.
Compensation:- An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.
- The anticipated salary range for candidates, who will work in Waltham, MA, is $161,000 to $187,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Oruka is a multi-state employer and this salary range may not reflect positions that work in other states.
We're looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day.
Salary Range for the Role
$161,000-$187,000 USD
What We Offer:- A chance to be part of a vibrant startup culture where your work can directly impact bringing new medicines to patients.
- Competitive salary and benefits package.
- A supportive and inclusive team environment where everyone is encouraged to bring their authentic selves to work.
- Opportunities for professional growth and development.
