Manager/Senior Manager, Clinical Supplies

Xenon Pharmaceuticals•Needham, MA

12d•Hybrid

About The Position

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.

Requirements

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.

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