Clinical Operations, Sr. Director/Director/ Associate Director
1 month ago
Anavex Life Sciences Corp. is seeking talented and highly motivated Clinical Operations leaders to join our team. This role will provide the expertise necessary for the conduct, oversight, and management of clinical trials and operations processes to support the efficient and quality delivery of our clinical programs and our portfolio. The successful candidate will be a hands-on clinical operations leader who can think both strategically and tactically and anticipate future trends in clinical trial execution.
Key Responsibilities
* Accountable for the oversight and efficient delivery of assigned clinical studies in compliance with ICH/GCP, internal SOPs, procedures and policies, and local regulations, and in accordance with established program timelines, within budget, and of high quality.
* Lead strategic planning and oversight for the implementation of study start-up and execution of clinical trials, including oversight of CRO activities and clinical vendors to ensure study delivery at the highest quality standards.
* Develop operational strategy and clinical operations plans to support the execution of the Clinical Development Plan.
* Collaborate with clinical teams to support the design, development, execution, and delivery of clinical studies in accordance with the clinical development plan.
* Collaborate with cross-functional stakeholders including Clinical Development, Regulatory, Statistics, Data Management, Project Management, Drug Safety and Supply, and other relevant stakeholders to ensure harmonization of efforts necessary for on-time, on-budget quality delivery of clinical studies.
* Support the selection, oversight, and management of CROs and other vendors.
* Oversee and facilitate site feasibility/capability assessments in collaboration with the CRO and other key cross-functional team members.
* Manage and provide oversight to the cross-functional team, CRO, and vendors in relation to all aspects of clinical trial operations.
* Review and provide clinical operations input into relevant clinical documents including study protocol, investigator brochure, regulatory documents, clinical study reports, and other documents and plans as appropriate.
* Responsible for managing effective relationships with CROs and other vendors for all clinical trial activities, including study start-up, trial maintenance close-out phases, and completion of Trial Master File (TMF), with quality.
* Responsible for representing Clinical Operations on all cross-functional project teams and CRO/vendor operational meetings and ensuring compliance with internal operational standards and procedures.
* Perform and document study-level Sponsor Oversight of outsourced clinical activities.
* Communicate study status, budget, and other issues to ensure timely decision-making by senior management.
* Accountable for TMF - completeness, timeliness, and quality on assigned programs. Ensure and conduct routine quality/completeness checks of the TMF to ensure full compliance with CRO and Sponsor files.
* Oversee/collaborate on and contribute to inspection readiness activities that support audits and regulatory inspections related to clinical trial conduct.
* Maintain oversight and participate in the creation, review, training, and maintenance of departmental and organizational SOPs to ensure compliance.
* Lead and/or participate in clinical operations workstreams related to departmental and operating model related initiatives.
* Maintain knowledge of the therapeutic area, current medical practice, and pharmaceutical regulations to ensure best practice across all activities and with a mindset of continuous improvement to develop more efficient ways of working in clinical development.
The position will be filled at a level commensurate with experience.
Requirements
* Bachelor's degree required; Life Sciences preferred.
* An advanced scientific or business degree or clinical degree is highly desirable.
* 8+ years' experience in the pharmaceutical industry and/or clinical research organization leading and managing clinical operations or related activities.
* Expert knowledge of global regulatory and compliance requirements for clinical research, local country requirements, and ICH GCP, including experience with global regulations and global regulatory inspections is required.
* Experience developing all Clinical trial plans, including but not limited to; site management, risk assessment and mitigation strategies, recruitment, and retention plans, etc.
* Global/international experience required, including the ability to collaborate with colleagues and partners in other locations.
* Experience building and leading teams, managing global teams, and coordinating collaboration with cross-functional teams in a dynamic environment is preferred.
* Record of successful implementation and completion of clinical trial programs with adherence to timelines and budgets.
* Demonstrated ability to lead under pressure, manage and resolve conflicts, and successfully implement new initiatives.
* Demonstrated ability to collaborate successfully with multiple functions in a matrixed team environment.
* Demonstrated ability to achieve high-performance goals and meet deadlines in a fast-paced environment; a collaborative team player with a can-do attitude and the ability to identify and implement creative solutions to complex problems.
* A leader with a growth mindset, willing to learn from others, committed to mentoring others, and dedicated to promoting psychological safety.
* Ability to build and lead high-functioning teams, both within clinical operations and cross-functionally.
* Proficient working knowledge of FDA and EMA regulations, GCPs, ICH guidelines, and all phases of clinical drug development.
* Experience with vendor and site selection, contracts and budgeting, and vendor and site oversight.
* Extensive knowledge of clinical trial methodology and regulatory/compliance requirements governing clinical trials.
* Ability to proactively identify challenges and implement mitigation measures.
* Work comfortably in a fast-paced, dynamic work environment. Must be able to organize, prioritize, and work effectively in a constantly changing environment.
* Strong negotiation and conflict resolution skills
* Strong financial acumen with experience in budgeting models and spreadsheets.
* Strong learning orientation, curiosity, passion for science, and patients.
* Embrace and demonstrate a diversity and inclusion mindset and models these behaviors for the organization.
* Effective team player, strategic thinker, and with good communication skills.
* Ability and willingness to travel, 15%
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