Senior Manager, Trial Operations

Xenon Pharmaceuticals•Needham, MA

2d•Hybrid

About The Position

We are seeking a Senior Manager, Trial Operations to join our team. This is a strategic yet hands-on clinical operations role that is responsible for the successful delivery of Phase 3 clinical trials, overseeing activities from study start-up through closeout. The Senior Manager will partner closely with Clinical Development, Clinical Science, CMC, Regulatory Affairs, and external vendors, to drive trial strategy and execution to ensure high-quality study delivery against the plan. The role is instrumental in overall vendor selection and management, site feasibility and start-up planning, budget and timeline management, and proactive risk identification and mitigation. The successful candidate will bring deep clinical operations expertise, strong project management and organization capabilities, and a proven ability to lead cross-functional teams and external partners in achieving critical program objectives. This position reports to the Director, Trial Operations, and will be based out of Boston, MA, USA in our Needham office. We may consider remote locations for exceptional candidates. This is a Hybrid position requiring a minimum of two onsite days per week.

Requirements

A minimum bachelor’s degree in a scientific discipline and/or other healthcare designation (e.g., RN).
A minimum of 5-8 years clinical project/study management experience within the pharmaceutical and/or biotechnology/biopharmaceutical industry or at a CRO.
Job level will be commensurate with experience.
Strong proven experience in trial operations oversight, rollout for Phase 3 studies in related therapeutic areas
Ability to lead cross-functional team through all activities in the full clinical study life cycle.
Strong vendor management skills (including CRO) 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.), with specific experience in phase 3 clinical trials.
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.

Nice To Haves

Ability and willingness to travel 5-10% of the time (internationally and domestic)

Responsibilities

Provide clinical trial management leadership for multiple Phase 3 clinical trials, across therapeutic areas.
Collaborate with cross-functional team members to ensure highly integrated plans and documents for clinical trials.
Develop, propose, review and manage plans for assigned studies and activities.
Lead the preparation of Requests for Proposals (RFPs) in collaboration with other internal team members, coordinate the evaluation of proposals and provide input into the selection and contracting of Contract Research Organizations (CRO) and other clinical service providers.
Manage contracted service providers to deliver against the contracts.
Lead the selection of qualified investigators and study sites in collaboration with the Clinical Development team.
Review and oversee study budgets and invoices to ensure vendors are invoicing in accordance with their contracts.
Develop and manage study timeline and study metrics cross-functionally.
Conduct risk assessments, mitigation strategies and contingency planning.
Communicate with internal/external teams to proactively recognize challenges and risks and work cross-functionally on strategies to mitigate/resolve.
Actively participate and lead activities in all aspects of clinical trial operations, including the coordination, writing, review and/or finalization of clinical trial protocols, consent forms, case report forms, study plans, safety reviews and other essential regulatory documents.
Train and mentor new staff or peer mentorship of new hires.
Actively participates in documentation, sharing and implementation of trial conduct best practices and lessons learned with junior staff.
Oversee adherence to applicable regulations, recognized guidelines, clinical trial protocol, and standards of clinical practice.
Participate in the development and updating of standard operating procedures as required.
Act in accordance with Company policies, including, for example, the Code of Business Conduct and Ethics.
Other duties as assigned.