Associate Director/Director, Trial Operations
Boston, MA, United States
Associate Director/Director, Trial Operations Boston, MA, USA Req #233
Friday, March 8, 2024
Who We Are:
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 an Associate Director/Director, Trial Operations , to join our team. The Associate Director/Director, Trial Operations will be a key member of a highly collaborative Clinical Development team responsible for developing strategies and plans for our portfolio of clinical stage assets, with particular focus on global phase 3 and phase 1 programs. The Associate Director/Director is responsible for ensuring studies within a program are initiated, recruited, managed, and closed in accordance with Xenon’s overall program goals and timelines and in compliance with Xenon’s procedures, FDA regulations, GCP ICH requirements and other applicable regulations. This incumbent will also lead a team of Trial Managers and Associates.
The Associate Director/Director, Trial Operations will have proven leadership ability in a fast paced, multi-location environment and interact with all levels of internal staff, as well as external stakeholders, including, but not limited to CRO’s, Key Opinion Leaders and Advisory Boards and Committees. This is an excellent opportunity for someone with the ability to plan and execute at the program level and to lead, coach and mentor a growing team.
This position reports to the Vice President, Trial Operations and will be in Boston, MA, USA. The level of the position will be commensurate with the candidate’s education and industry experience.
RESPONSIBILITIES:
Provide Trial Operations leadership across multiple studies to support the design, development, execution, and delivery of clinical programs in accordance with Clinical Development Plans and timelines for assigned program area; closely collaborate with Clinical Development, Biostatistics, Data Management, Regulatory, Medical Writing, Medical Affairs, Supply Chain, and Development Program Management to ensure highly integrated cross functional project plans for programs and trials.
Oversee and/or assist in all aspects of trial planning and execution, including, for example, the development of clinical trial protocols, consent forms, case report forms, study plans, and other essential regulatory documents, the selection of qualified investigators and study sites, and conduct and close-out of the trial
Collaborate with cross-functional team members to ensure highly integrated plans and documents for clinical trials.
Oversee adherence to applicable regulations, recognized guidelines, clinical trial protocol, and standards of clinical practice.
Develop and propose short- and long-term goals for the program(s) in accordance with overall Company and Development and Commercial strategies.
Lead in the selection and oversight of CRO and/or functional service provider activities and other clinical vendors to ensure study quality meets the Company’s and regulatory requirements including contributing to the preparation of Requests for Proposals, facilitating the evaluation of the proposals and the selection and management of clinical service providers.
Lead, plan and manage budget proposals and approved budgets in accordance with the Company’s strategic and operating plans and Finance policies
Lead and contribute to the development of department initiatives including developing and maintaining relevant Standard Operating Procedures and other policies, procedures, and systems relevant to the department; collaborating with Quality to plan and execute compliant activities and other continuous improvement initiatives.
Recruit, lead, direct, develop, coach, and evaluate direct reports, if any, in accordance with the Company’s Human Resource policies and practices.
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:
Associate Director will have a minimum of bachelor’s degree with a minimum of 8+ years management experience in a pharma or biotech environment, ideally additional experience in neuroscience.
Director will have a minimum of bachelor’s degree with a minimum of 10+ years management experience in a pharma or biotech environment, ideally additional experience in neuroscience.
A minimum of 3-5 years clinical project/study lead experience within the pharmaceutical and or biotechnology/biopharmaceutical industry or at a CRO. Job level will be commensurate with experience.
Ability to lead cross-functional team through all activities in the full clinical study life cycle.
Strong vendor management skills and experience managing outsourced work.
A good understanding of all phases of the drug development process and the interdependencies between Clinical and other functional areas (e.g., CMC, nonclinical/toxicology, Regulatory Affairs etc.).
Demonstrated ability to successfully work across a variety of teams and manage multiple conflicting priorities.
Demonstrated ability to successfully manage and deliver on critical milestones in the successful completion of clinical trials on time and within budget.
Strong knowledge and understanding of ICH/GCP and US and Canadian regulatory environments; a comprehensive understanding of clinical trial regulations across multiple jurisdictions with previous experience with CTA and IND submissions preferred.
Excellent oral and written communication skills.
Strong interpersonal skills and ability to foster strong collaborative relationships with internal and external team members.
Ability to work both independently and collaboratively as part of a multidisciplinary team.
Exceptional attention to detail and excellent organizational skills.
Ability to thrive in a dynamic and fast-paced environment.
Ability to prioritize duties and manage multiple matters from start to finish with minimal supervision and with a demonstrated ability to lead change and make independent decisions.
Ability to handle highly confidential and sensitive materials and information with complete discretion.
Ability to travel up to 15%, both domestically and internationally.
The base salary range for this role is $166,500 to $233,500 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.
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