Work Location
Corporate Headquarters (South San Francisco, CA) - Hybrid Non-Local Candidates will be considered
Position Summary
This position reports into the Vice President of Global Clinical Operations. The Clinical Supply Chain Manager/ Sr. Manager will contribute to the development and implementation of clinical studies.
Responsibilities
- Serve as the primary clinical supply chain contact, working collaboratively with internal stakeholders (ie. Clinical Operations, CMC, etc.) and external partners
- Manage clinical supply planning and forecasting for study protocols
- Support financial planning for global clinical supplies (including budgeting, forecasting, and strategic planning activities for clinical trials)
- Interpret relevant protocol information to develop packaging/labeling design and/or global distribution strategies
- Monitor global clinical supply inventory at the clinical site level for both IXRS and studies by tracking of specific milestone dates and adjusting drug distribution accordingly
- Coordinate the origination, proofing and translation of clinical study labels, as required
- Coordinate drug supply delivery timelines with Clinical, packaging suppliers, drug depots, etc.
- Maintain close communication with team members (ie. clinical, regulatory) to ensure the adequate supply of clinical supplies throughout the duration of all clinical trials
- Monitor IXRS portal processes including high and low enrolling site settings, drug acknowledgement, depot and site supply levels, and IMP status of released lots or expired drug
- Recommend appropriate method of packaging, labeling, and distribution
- Manage third party packaging/labeling, and logistics suppliers
- Provide reports on available inventory, and updates expiry date/shelf life extensions at the depot
- Procure ancillary supplies with attention to local sourcing vs bulk sourcing strategies, lead-time, and expiry dating
- Coordinate the assessment of temperature excursions during storage, receipt, or transit to study sites or depots
- Coordinates timely material release with Regulatory and QA functions
- Analyzes and interprets US and foreign countries’ import and export regulations to facilitate compliance efforts by applying for and coordinating import permits and export permits
- Designs labels to ensure regulatory compliance with US, Canada, EU, APAC regulations, as appropriate.
Qualifications
- BS/BA or MS/MA degree in related discipline or equivalent combination of education and experience
- A minimum of 8+ years related clinical supply management experience in cGMP and GCP Ph 1-III studies (Supply Chain Management Association accreditation as a Supply Chain Management Professional (SCMP) a plus)
- Has a thorough knowledge of the clinical development process, FDA, EMA and other regulatory requirements that may impact global clinical studies as well as ICH and GCP guidelines
- Experience with financial budgeting or reporting
What Annexon offers
- Diversity, Equity, Inclusion, and Belonging are important to us. We believe that diversity, equity, inclusion and belonging are essential for the strength of our business and the vitality of the communities we serve. To learn more about our diversity commitment, culture and values, visit https://annexonbio.com/careers/
- A stimulating and rewarding workplace includes flexible work schedules, remote opportunities and the ability to achieve a work-life balance.
- We are located in Brisbane, CA, with shuttle service from BART, CalTrain and the Ferry.
- Annexon offers a competitive base salary and equity participation, employee stock purchase plan, as well as a comprehensive health benefit package that includes medical, dental, vision, 401(k), flexible spending plans, as well as other benefits.
Company Summary
Annexon Biosciences (Nasdaq: ANNX) is a biopharmaceutical company advancing a late-stage clinical platform of novel therapies for people living with devastating classical complement-mediated neuroinflammatory diseases of the body, brain, and eye. Annexon’s novel scientific approach targets upstream C1q to block the classical complement inflammatory cascade before it starts, and its therapeutic candidates are designed to provide meaningful benefits across multiple autoimmune, neurodegenerative and ophthalmic diseases.
With proof-of concept data in Guillain-Barré syndrome, Huntington’s disease and geographic atrophy, Annexon is rigorously advancing its mid-to late-stage clinical trials to bring new potential treatments to patients as quickly as possible. To learn more visit annexonbio.com.
EEO Employer – Annexon highly values Diversity, Equity, Inclusion and Belonging
Annexon Biosciences is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment based on race, color, religion, national origin, age, gender, sex, ancestry, citizenship status, mental or physical disability, genetic information, sexual orientation, veteran status, or military status. We are proud to promote a work environment where everyone, from any background, can do their best work.Staffing AgenciesAnnexon Biosciences does not accept unsolicited agency resumes and will not pay fees to any third-party agency or firm that doesn’t have a signed agreement with Annexon Biosciences.
Please do not send agency CVs/resumes through Annexon’s website or Annexon Employees. Inquiries must be sent to talentacquisition@annexonbio.com with the Subject Heading: Staffing Agency Request.
