Director, Clinical Supply Chain Management

Title: Director, Clinical Supply Chain Management

Location: Brisbane, CA or Remote

About Us:

Vera Therapeutics (Nasdaq: VERA), is a late-stage biotechnology company focused on developing treatments for serious immunological diseases. Vera’s mission is to advance treatments that target the source of immunologic diseases in order to change the standard of care for patients. Vera’s lead product candidate is atacicept, a fusion protein self-administered as a subcutaneous injection once weekly that blocks both B lymphocyte stimulator (BLyS) and a proliferation inducing ligand (APRIL), which stimulate B cells and plasma cells to produce autoantibodies contributing to certain autoimmune diseases, including IgA nephropathy (IgAN), also known as Berger’s disease and lupus nephritis. In addition, Vera is evaluating additional diseases where the reduction of autoantibodies by atacicept may prove medically useful. Vera is also developing MAU868, a monoclonal antibody designed to neutralize infection with BK Virus, a polyomavirus that can have devastating consequences in certain settings such as kidney transplant. For more information please visit: www.veratx.com.

Our values are the cornerstone of our culture. Our values inspire us every day and guide everything we do—from how we hire great people, to advancing our mission together, to achieving our ultimate goal to improve medical treatment for patients suffering from immunological diseases.

Position Summary:

We seek a Director, Clinical Supply Chain Management to join an experienced, fast-paced, and collaborative team. The Director, Clinical Supply Chain Management will report to the SVP, Product Development and Manufacturing and will drive planning, packaging, distribution, and materials management to help support flawless execution of Vera’s clinical studies. The successful candidate will be detail-oriented, self-directed, flexible, and able to manage a team of professionals to meet clinical study goals.

Responsibilities:

• Accountable for ensuring an un-interrupted supply of labeled finished IMP (in the right dosage configuration) to depots and clinical sites supporting global clinical studies
• Oversee distribution and logistics for storage, Import & Export, drug return, reconciliation, destruction, and Depot Management
• Own clinical supply plan; Interface with internal teams (e.g., DP Manufacturing, QA, Regulatory and Clin Ops) for planning and management of manufacturing schedules, inventory, labeling/packaging operations and distribution logistics
• Build strategic relationships with internal and external stakeholders to ensure alignment
• Ensure robust systems and processes (i.e., SOPs) are in place to enable execution of operational and logistical tasks in a cGMP/GCP compliant manner
• Manage and oversee forecast and clinical supply chain budget
• Mentor and work with direct reports and CMC/QA/Clin Ops team members to enable efficiencies
• Serve as an SME regarding import/export aspects and manage global materials logistics, including shipping/delivery and inventory management

Qualifications:

• Bachelor or Master Degree in Science or Business Administration, Operations Management, or similar education required
• 10+ years of progressive experience with 5+ years of people leadership and development experience
• Experience working in a global, complex supply chain organization within the biopharma industry is required
• Experience with biologics (i.e., cold chain) clinical supply chain
• Understands comprehensive global pharmaceutical regulatory requirements (e.g. cGMP, ICH/GDP, GCP, 21 CFR Part 11, and Annex 13, cGCP)
• Experience in deviation investigation and CAPA implementation
• Experience in supplier management and oversight
• Able to deal with frequent change, delays, or unexpected events
• Proficient in Microsoft Office applications, planning applications and models, IRT/IXRS systems, MRP/ERP systems
• Proven ability to manage competing priorities, budgets, and timelines in a fast-paced, rapid-growth environment
• Highly skilled at working collaboratively with cross-functional teams and contractors to drive results and meet company objectives
• Excellent written and verbal communication skills, including a demonstrated ability to effectively communicate in a project team environment, within department, among functional groups and external collaborators
• Must possess high level attention to detail
• Self-directed and proactive with ability to function independently, exercise good judgment and respond quickly and effectively to changing environments
• Travel up to 20%

Vera Therapeutics Inc. is an equal opportunity employer.

Vera Therapeutics is committed to fair and equitable compensation practices, and we strive to provide employees with total compensation packages that are market competitive. For this role, the anticipated base pay range is $220,000 - $250,000. The exact base pay offered for this role will depend on various factors, including but not limited to the candidate’s geography, qualifications, skills, and experience.

At Vera, base pay is only one part of your total compensation package. The successful candidate will be eligible for an annual performance incentive bonus, new hire equity, and ongoing performance-based equity. Vera Therapeutics also offers various benefits offerings, including, but not limited to, medical, dental, and vision insurance, 401k match, flexible time off, and a number of paid holidays.

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We require that all recruiters and staffing agencies have a fully executed, formal written agreement on file.

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