Xenon Pharmaceuticals Inc.
Senior Manager, Clinical Supplies
Xenon Pharmaceuticals Inc., Boston, Massachusetts, us, 02298
Who We Are:Xenon Pharmaceuticals (NASDAQ:
XENE) is a neuroscience-focused biopharmaceutical company committed to discovering, developing, and commercializing innovative therapeutics to improve the lives of people living with neurological and psychiatric disorders. 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 and depression. Our flagship azetukalner program represents the most advanced potassium channel modulator in clinical development for multiple indications. Building upon the positive results and compelling data from our Phase 2b “X-TOLE” study in adult patients with focal epilepsy, our Phase 3 epilepsy program includes multiple clinical trials evaluating azetukalner in patients with focal onset seizures and primary generalized tonic-clonic seizures. In 2024, we are planning to initiate a Phase 3 azetukalner program in major depressive disorder, based on topline data from our Phase 2 “X-NOVA” clinical trial. In addition, we are proud of the leading-edge science coming out of our discovery labs, including early-stage research programs that leverage our extensive ion channel expertise and drug discovery capabilities to identify validated drug targets and develop new product candidates. 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 Senior Manager, Clinical Supplies to join our team. The Senior Manager, Clinical Supplies is responsible for ensuring that 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 the planning, forecasting, packaging, labeling, distribution and return of clinical supplies for assigned clinical trials and collaborates closely with the broader CMC and Supply Chain Management team, 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 in Boston, MA, USA. We will consider other jurisdictions for exceptional candidates. This role is a hybrid position, requiring a minimum of 2 days per week in the office.
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 ensure the proper distribution of supplies to study sites.Coordinate procurement, temperature excursions and product complaints. Ensure expiry date extensions are performed at depot/sites as needed in order to support continued use.Manage the return and destruction of clinical supplies, with proper documentation of all steps.Serve as the primary point of contact for third party packaging, distribution, and storage vendors, including the issuance of Requests for Information and review of vendor proposals. Assist in preparing the associated budget.Design, review and coordinate the approval of investigational supply label text and proofs to meet country-specific language(s), translation, and regulatory requirements.Liaise with appropriate internal and external parties to ensure adequate clinical study supply releases are obtained per the applicable regulations (e.g., EU Qualified Person (QP) 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 (KPI) reports, perform root-cause analyses, and implement continuous improvement actions, as needed.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.Other duties as assigned.QUALIFICATIONS:A university degree in health sciences, life sciences or physical sciences (or equivalent) with 7+ years’ experience in the pharmaceutical/biotechnology industry and 5+ years of international clinical supply experience.A minimum of 5 years’ management level experience in a pharma or biotech environment. Job level commensurate with years of 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, as pertinent to clinical supplies.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.The base salary range for this role is $140,300 to $177,400 USD; we will consider above this range for exceptional candidates. Base salary is determined by a combination of factors including, but not limited to, education and other qualifications, years of relevant experience, and internal equity.
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.
US positions only:
Xenon Pharmaceuticals USA Inc. participates in the E-Verify program in all states in which we hire. Learn more about the E-Verify program here.To apply for this position, click Apply Now to complete the application. We thank all applicants for their interest; however, due to the volume of applicants, only those chosen for interview will be contacted.#J-18808-Ljbffr
XENE) is a neuroscience-focused biopharmaceutical company committed to discovering, developing, and commercializing innovative therapeutics to improve the lives of people living with neurological and psychiatric disorders. 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 and depression. Our flagship azetukalner program represents the most advanced potassium channel modulator in clinical development for multiple indications. Building upon the positive results and compelling data from our Phase 2b “X-TOLE” study in adult patients with focal epilepsy, our Phase 3 epilepsy program includes multiple clinical trials evaluating azetukalner in patients with focal onset seizures and primary generalized tonic-clonic seizures. In 2024, we are planning to initiate a Phase 3 azetukalner program in major depressive disorder, based on topline data from our Phase 2 “X-NOVA” clinical trial. In addition, we are proud of the leading-edge science coming out of our discovery labs, including early-stage research programs that leverage our extensive ion channel expertise and drug discovery capabilities to identify validated drug targets and develop new product candidates. 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 Senior Manager, Clinical Supplies to join our team. The Senior Manager, Clinical Supplies is responsible for ensuring that 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 the planning, forecasting, packaging, labeling, distribution and return of clinical supplies for assigned clinical trials and collaborates closely with the broader CMC and Supply Chain Management team, 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 in Boston, MA, USA. We will consider other jurisdictions for exceptional candidates. This role is a hybrid position, requiring a minimum of 2 days per week in the office.
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 ensure the proper distribution of supplies to study sites.Coordinate procurement, temperature excursions and product complaints. Ensure expiry date extensions are performed at depot/sites as needed in order to support continued use.Manage the return and destruction of clinical supplies, with proper documentation of all steps.Serve as the primary point of contact for third party packaging, distribution, and storage vendors, including the issuance of Requests for Information and review of vendor proposals. Assist in preparing the associated budget.Design, review and coordinate the approval of investigational supply label text and proofs to meet country-specific language(s), translation, and regulatory requirements.Liaise with appropriate internal and external parties to ensure adequate clinical study supply releases are obtained per the applicable regulations (e.g., EU Qualified Person (QP) 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 (KPI) reports, perform root-cause analyses, and implement continuous improvement actions, as needed.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.Other duties as assigned.QUALIFICATIONS:A university degree in health sciences, life sciences or physical sciences (or equivalent) with 7+ years’ experience in the pharmaceutical/biotechnology industry and 5+ years of international clinical supply experience.A minimum of 5 years’ management level experience in a pharma or biotech environment. Job level commensurate with years of 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, as pertinent to clinical supplies.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.The base salary range for this role is $140,300 to $177,400 USD; we will consider above this range for exceptional candidates. Base salary is determined by a combination of factors including, but not limited to, education and other qualifications, years of relevant experience, and internal equity.
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.
US positions only:
Xenon Pharmaceuticals USA Inc. participates in the E-Verify program in all states in which we hire. Learn more about the E-Verify program here.To apply for this position, click Apply Now to complete the application. We thank all applicants for their interest; however, due to the volume of applicants, only those chosen for interview will be contacted.#J-18808-Ljbffr