Manager, Clinical Supplies

Xenon Pharmaceuticals Inc. - Boston, MA (30+ days ago)


Xenon is a clinical-stage biopharmaceutical company focused on developing innovative therapeutics to improve the lives of patients with neurological disorders. Building upon our extensive knowledge of human genetics and diseases caused by mutations in ion channels, known as channelopathies, we are advancing – both independently and with our pharmaceutical collaborators – a novel product pipeline of ion channel modulators to address therapeutic areas of high unmet medical need, such as pain and epilepsy.

We are seeking a Manager, Clinical Supplies to join our CMC team. This is a permanent full-time, office-based position at either of Xenon’s Burnaby or Boston offices. The incumbent will be required to work flexibly across a number of small molecule drug development programs with an emphasis on managing outsourced cGMP drug product packaging, labeling, logistics and distribution activities in support of Xenon’s clinical trials.

The incumbent will be responsible for ensuring that the 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 the planning, forecasting, packaging, labeling, distribution and return of clinical supplies. The incumbent will collaborate closely with the rest of the CMC department as well as with key internal stakeholders such as Clinical Operations, Regulatory Affairs and Quality Assurance.

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 team and vendors to assure proper distribution of supplies to study sites.
  • Coordinate procurement, temperature excursions and product complaints. Ensure expiry extensions are provided to 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.
  • 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.

QUALIFICATIONS:

  • A university degree in health sciences, life sciences or physical sciences (or equivalent) with 5-7+ years’ experience in the pharmaceutical/biotechnology industry and 3+ 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.

To apply for this position, please e-mail your resume and cover letter directly at to www.xenon-pharma.com and include “Manager, Clinical Supplies” in the subject line. All attachments must be saved as one file and be named: “Your Full Name - Manager, Clinical Supplies”.We thank all applicants for their interest; however, due to the volume of applicants, only those chosen for interview will be contacted.

Job Type: Full-time