Manager/Senior Manager, Clinical Supplies

Xenon Pharmaceuticals Inc.; Needham (MA); Hybrid; USD 120,000 - 190,000; Full time

Job summary

Xenon Pharmaceuticals Inc. is seeking a Manager/Senior Manager, Clinical Supplies for our Needham/Boston, MA team. You will ensure labeled clinical supplies reach sites on time, oversee planning, forecasting, packaging, labeling, distribution, and returns, and collaborate with CMC, Supply Chain, Clinical Operations, Regulatory, and QA teams.

The role reports to the Senior Director, Clinical Supplies. Hybrid work requires at least two days on-site weekly; relocation to Needham area is expected

Qualifications

• Thorough knowledge of GMP, GCP, GDP, and ICH guidelines.
• Experience with IXRS design, implementation, UAT, and monitoring.
• Proficiency with Microsoft applications and inventory management systems.
• Excellent written and oral communication skills with diverse stakeholders.

Responsibilities

• Develop study-specific supply plans and support manuals and training materials.
• Forecast and align supply planning with study activity and timelines.
• Maintain complete Trial Master File documentation for supply activities.
• Monitor site inventory levels and proactively address issues.

Skills

GMP knowledge

GCP knowledge

GDP knowledge

IXRS design

Inventory management

Communication

Project coordination

Education

Bachelor's degree in health sciences or related

Tools

IXRS systems

Job description

Who We Are:

Xenon Pharmaceuticals (NASDAQ:XENE) is a neuroscience-focused biopharmaceutical company dedicated to drug discovery, clinical development, and commercialization of life-changing therapeutics for patients in need. We are looking for great people who thrive in a respectful, collaborative, inclusive, and productive culture to join the Xenon team.

What We Do:

We are advancing an exciting product pipeline to address indications with high unmet medical need, including epilepsy, depression and pain. Our Phase 3 azetukalner program represents the most advanced, clinically validated potassium channel modulator in late-stage clinical development for multiple indications. In March 2026, we announced positive topline data from our Phase 3 X-TOLE2 study of azetukalner in focal onset seizures (FOS), and we anticipate submitting a New Drug Application to the Food and Drug Administration in the third quarter of 2026. Our Phase 3 epilepsy program also includes a second FOS study, X-TOLE3, which would support regulatory submissions outside the U.S., and the X-ACKT study in primary generalized tonic-clonic seizures, which would support regulatory submissions for an additional epilepsy indication. We also have multiple Phase 3 azetukalner clinical trials underway in major depressive disorder (MDD) and bipolar depression (BPD), based on topline data from our Phase 2 X-NOVA clinical trial. In addition, we are proud of our strong heritage in human genetics, deep understanding of ion channel biology, and expertise in novel chemistries to enable potent, selective ion channel targeting. We continue to advance an early-stage pipeline of novel therapeutic candidates, including Phase 1 studies for XEN1701 and XEN1720 (targeting Nav1.7) and XEN1120 (targeting Kv7), which are being developed for pain. Backed by a strong balance sheet to support our growth plans, we continue to build a fully integrated, premier neuroscience company with strong discovery, clinical development, corporate, and commercial operations.

About the Role:

We are seeking a Manager/Senior Manager, Clinical Supplies title to join our team. The Manager/Senior Manager, Clinical Supplies will be responsible for ensuring that the labeled clinical supplies are provided to clinical sites on time and in accordance with clinical trial protocols and applicable regulatory requirements. This role includes the management and oversight of planning, forecasting, packaging, labeling, distribution and return of clinical supplies, and collaborates closely with CMC and Supply Chain teams as well as with key internal stakeholders such as Clinical Operations, Regulatory Affairs and Quality Assurance.

This position reports to the Senior Director, Clinical Supplies and will be based out of Boston, MA, USA in our Needham office. The level of the position will be commensurate with the candidate’s education and industry experience. Hybrid positions require a minimum of two onsite days per week. On-site positions require up to five on-site days per week.

RESPONSIBILITIES:

• Develop study-specific Investigational Product Supply Plans and contribute to Pharmacy Manuals and supply-related training/instructional materials.
• Manage supply planning/forecasting to ensure alignment with study activity and timelines.
• Perform supply accountability tracking and ensure that all Master, Pharmacy and Subject logs are appropriate. Ensure all investigational product supply activities are documented in the Trial Master File.
• Monitor inventory levels at sites throughout the trial in order to proactively avoid potential issues.
• Collaborate with study teams and external vendors to assure proper distribution of supplies to study sites.
• Coordinate procurement, temperature excursions, and product complaints. Ensure expiry extensions are performed at depot/sites as needed to support continued use.
• Manage the return and destruction of clinical supplies, with proper documentation of all steps.
• Serve as primary point of contact for third party packaging, distribution, and storage vendors, including Request for Information (RFI), Quotes, Work Orders. Assist in preparing the associated budget and quarterly budget tracking.
• Design, review and coordinate the approval of investigational supply label text and proofs to meet specific country language(s), translations and regulatory requirements.
• Liaise with appropriate internal and external parties to ensure adequate clinical study supply releases are obtained per the applicable regulations (Qualified Person release, Certificates of Analysis/Compliance, BSE/TSE certifications, etc.).
• Work with Clinical Operations to develop study‑specific IxRS specifications and requirements documents.
• Perform the unblinded monitoring of IxRS/depot inventory to ensure that resupply order generation, etc. occurs within defined Specifications.
• Prepare Key Performance Indicators report, perform root‑cause analysis assessment, and implement continuous improvement actions, as needed. Participate in annual Business Review Meetings with packaging and labeling vendors.
• Act in accordance with Company policies, including, for example, the Code of Business Conduct and Ethics and ensure policies are understood and followed by direct reports, if any.
• Some international travel may be required. [only for travelers]
• Other duties as assigned

QUALIFICATIONS:

• A university degree in health sciences, life sciences or physical sciences (or equivalent) with a minimum of 7+ years’ experience in the pharmaceutical/biotechnology industry and a minimum of 5+ years of international clinical supply experience.
• Thorough knowledge of Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), Good Distribution Practices (GDP), International Conference on Harmonization (ICH) Guidelines and other relevant global pharmaceutical regulations, guidelines and directives.
• Experience with Interactive Voice/Web Response System (IXRS) design, implementation, user acceptance testing and monitoring.
• Proficiency with Microsoft applications, electronic data capture systems and inventory management systems.
• Excellent written and oral communication skills, including the ability to communicate with scientific and non-scientific personnel.
• Excellent attention to detail and commitment to providing accurate, high‑quality work.
• Good organizational skills and the ability to manage multiple competing priorities.
• Strong interpersonal and team skills to work both independently and collaboratively as part of a multidisciplinary team.

Our Total Rewards program includes base salary, target bonus, and stock options, as well as a full range of benefits including medical, dental, vision, short-& long-term disability, accidental death & dismemberment, and life insurance programs, Employee Assistance Program, travel insurance, and retirement savings programs with company matching contributions.

Xenon encourages time to rest and re‑charge through vacation, personal days, sick days, and an end‑of‑year company shutdown. Xenon highly values employee development and has an expanding Training, Learning & Development program, including a Tuition Assistance program for advanced degrees.