Your Path to Endless Opportunities

If you’re looking to push the envelope and join an innovative company where technology meets therapeutic discovery and development and you’re enthusiastic, creative, with a passion for cutting-edge research and development, you should join our team! We are looking for highly motivated, passionate employees to help us drive technology solutions for discovering breakthrough treatments for our portfolio of rare disease and neuroscience programs, as well as for our partners across major therapeutic areas.

Director/Senior Director/
Executive Director, Clinical Operations

Summary of Position

Anavex Life Sciences Corp. is seeking talented and highly motivated Clinical Operations leaders to join our team. This role will provide expertise necessary for conduct, oversight and management of clinical trials and operations processes to support 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 procedures and policies, local regulations, and in accordance with program timelines, within budget and of high quality.

  • Provide oversight for study set-up and execution of clinical trials, including oversight of CRO activities and clinical vendors to ensure study delivery at highest standards.

  • Develop operational strategy and clinical operations plans to support execution of the Clinical Development Plan.

  • Collaborate with clinical teams to support 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 Supply, and other relevant stakeholders to ensure harmonization of efforts necessary for quality delivery of clinical studies.

  • Support the selection, oversight, and management of CROs and other vendors.

  • Oversee site feasibility/capability assessments in collaboration with the CRO and cross-functional team.

  • 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 representing Clinical Operations on 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.

  • 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.

Position will be filled at level commensurate with experience. 

Requirements

  • Bachelor’s degree required; Life Sciences preferred. Advanced scientific, business, or clinical degree highly desirable. 

  • 10+ 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. 

  • Global/international experience required, including 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.

  • 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.

  • Strong financial acumen with experience in budgeting models and spreadsheets.

  • Strong learning orientation, curiosity, and 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.

Your Path to Unique Opportunities
If you’re looking to push the envelope and join an innovative company where technology meets therapeutic discovery and development and you’re enthusiastic, creative, with a passion for cutting-edge research, you should join our team! We are looking for highly motivated, passionate employees to help us drive technology solutions for discovering breakthrough treatments for our portfolio of rare disease and neuroscience programs.

About Anavex Life Sciences Corp.

Anavex Life Sciences Corp. (Nasdaq: AVXL) is a publicly traded biopharmaceutical company dedicated to the development of differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders including Alzheimer’s disease, Parkinson’s disease, Rett syndrome and other central nervous system (CNS) diseases, pain, and various types of cancer. Further information is available at www.anavex.com.


EOE/M/F/V/SO Anavex Life Sciences Corp. is an Equal Opportunity Employer. All qualified candidates will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, gender identity, sexual orientation or protected veteran status. Visit anavex.com/eeo-policy-statement to access our complete Equal Employment Opportunity statement. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

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