Director, Clinical Supply Chain

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Join to apply for the Director, Clinical Supply Chain role at Aligos Therapeutics

Ready to make a difference in the lives of patients all around the world? As an innovative clinical-stage biotechnology company, that’s our top priority. Founded in 2018 and headquartered in South San Francisco, California, Aligos was founded with the mission to become a leader in the treatment of liver and viral diseases. Our employees thrive in a science-first culture with many critical domains represented on staff. Our team of respected scientists use their decades of experience to build a cutting-edge pipeline of transformative treatment options that have the potential to change lives. At Aligos, you’ll have an opportunity to pursue your passion among the best in the industry. It’s a place where you’ll be challenged, supported, and inspired. A highly-collaborative, fast-paced work environment where we honor accountability, transparency, and diversity.

About the Role

Director, Clinical Supply Chain will report directly to the CMC Department Head and will be responsible for all aspects of technical operations related to clinical supply chain including but not limited to packaging, labelling, facilitation of QA/QP release and distribution of clinical trial materials to investigational sites. He/she will work closely with clinical operations and quality to assure timely supply of clinical material. Key responsibility will also include managing the CDMO, budget and timelines for Supply Chain activities including drug substance and drug product.

Responsibilities

• Management of clinical supply chain to meet the needs of Aligos’ clinical programs by working with key internal stakeholders such as Clinical Development, Clinical Operations, Quality, Regulatory Affairs, CMC team members, and external vendors responsible for drug product manufacturing, packaging, labeling and distribution of clinical trial materials to investigational sites.
• Forecasting and planning for future clinical trial needs, inventory management, IRT implementation and management, distribution, selection, and oversight of CDMOs and other vendors, expiry date management, returns and destruction with corresponding and detailed supporting documentation. This includes ensuring availability of all CMC elements required for QA/QP review and release.
• Serves as a single point of contact for clinical trial supply management with all internal and external stakeholders to assure that project issues are addressed in a timely and consistent manner to meet all requirements and business needs.
• Assures all outcomes are in compliance with established worldwide regulatory and corporate requirements.
• Assure/secures appropriate resources and systems for effective coordination within the Supply Chain to demonstrate excellence in Quality. For example, in collaboration with Clinical Operations to ensure adequacy and implementation of IRTs that supports the needs of the study/studies.
• Manage supply chain contractor audits via partnerships with the Quality organization.
• In collaboration with CMC team members, provides oversight and management of Aligos related timelines and budget for CMC related activities.
• Ensures contractors and suppliers understanding Aligos’ timelines and needs.
• Ensures on-going performance dialogue, relationship building and contractor monitoring.
• Builds constructive, trusting, and respectful relationships with people at all levels within and outside the organization.

Qualifications

• MS or BS in chemistry, pharmaceutics, or a related discipline; advanced degree preferred.
• ASCM CPIM certification preferred a plus.
• 10+ years manufacturing/clinical supply chain experience in biotech/pharmaceutical industry.
• 10+ years Operations Management experience.
• Demonstrated experience managing the clinical supply chain process, including packaging and labeling and expiry update/stability program functions for worldwide distribution of clinical supply to support clinical trials.
• Experience with clinical supply IRT systems, including their development, testing, and management.
• Expertise in various aspects and workflows of pharmaceutical development operations e.g., CMC, QA/QC, IRT, validation, logistics, drug process development, submission docs, IND, API, product specs, drug product manufacturing.
• Experience working in a small company environment desirable.
• Experience working with CDMOs throughout the globe required.
• Demonstrated working knowledge of GMP and applicable US and ex-US regulatory requirements.
• Demonstrated organizational and leadership skills, advanced computer knowledge and skills, excellent written and oral communication skills.
• Demonstrated expertise managing cross-functional teams that include Clinical Operations, QA, Regulatory, and CMC.
• Demonstrated ability to manage timelines and budgets.
• Ability to analyze resource commitments, project success criteria and other key indicators to provide interventions/adjustments as needed.

Required Skills

• Experience in supply chain management for APAC countries.
• Experience in supply chain management for commercial supplies, nice to have.

Pay range and compensation package

Aligos Therapeutics provides a competitive benefits package that includes access to Medical, Dental, and Vision Insurance, Life Insurance, Short- and Long-Term Disability, Health Savings Account (HSA), Flexible Spending Accounts (FSA), Critical Illness, Accident, Legal and ID Theft, 401k plan, PTO, and ESPP (Employee Stock Purchase Plan). The anticipated salary range for fully qualified candidates applying for this role will be $245,000 – $286,000 (not including discretionary bonus, equity, and benefits). The final salary offered will be dependent on several factors that include but are not limited to relevant previous experience including duration and type of experience within the industry, education, and internal equity.

Equal Opportunity Statement

Aligos Therapeutics, Inc. is an Equal Opportunity Employer. We do not discriminate against qualified applicants based upon any protected group status, including but not limited to race, religion, color, creed, sex (including breastfeeding and related conditions), gender identity/gender expression, pregnancy (including childbirth and related conditions), national origin, ancestry, age, marital status, military or veteran status, sexual orientation, genetic information, physical or mental disability or medical condition as defined by applicable equal opportunity laws. Any request for accommodation can be directed to People Operations.

Seniority level

• Seniority level

  Director

Employment type

• Employment type

  Full-time

Job function

• Job function

  Research

• Industries

  Biotechnology

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