Summary of Position

Anavex Life Sciences Corp. is seeking a talented and highly motivated Clinical Scientist to join our team. The Clinical Scientist will provide scientific expertise necessary for design, implementation and conduct of clinical studies as part of the development program team. He/She/They will provide technical and scientific leadership necessary for clinical and scientific leadership and support for delivering scientifically robust study protocols, clinical development plans and governance approvals in support of company initiatives that will improve the quality and content of all clinical programs to deliver our portfolio.

Key Responsibilities 

• Provide scientific expertise necessary to design and deliver clinical studies and programs.

• Lead the planning, implementation, execution, maintenance, and close-out of clinical trial activities with minimal to moderate level of supervision.

• Provide scientific and clinical leadership to the cross-functional study team.

• Collaborate in clinical development planning together with early development and clinical development physicians.

• Collaborate and liaise with external partners and scientific community (e.g., KOLs, CROs).

• Maintain a thorough understanding of assigned protocols and protocol requirements and educate team members.

• Serve as Clinical Trial Lead for one or more trials depending on competence and experience.

• Evaluate innovative trial designs in collaboration with the study physician.

• Manage protocol and ICF development process (e.g., documents and amendments) with minimal guidance; includes writing, reviewing, resolution of cross functional comments and ensuring high clinical quality in collaboration with Medical Writing and according to GCP and ICH standards.

• Present to governance committee and early clinical development team meetings as required.

• Serve as primary contact for site-facing activities such as training and support for clinical questions.

• Contribute to development and delivery of face to face or virtual investigator and supervise training.

• Responsible for timely responses to investigational study sites for local ICF changes, protocol & EC/IRB questions or requests.

• Provide information required by Protocol Manager for development of trial budget, CRO scope of work, etc.

• Conduct and oversee activities related to data generation and validation to ensure consistent and quality data including CRF design, clinical data review and query resolution.

• Develop Data Review Plan in collaboration with Data Management.

• Review medical data to identify clinical data trends, interpret data in collaboration with Study Physician.

• Develop and/or review site and CRA training materials and presentation at SIV and Investigator meetings (virtual or face to face) and support on Study committee activities (e.g., safety review).

• Support development of clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., pre-IND, IND, IB, DSUR, regulatory responses).

• Author/review abstracts, presentations, and manuscripts for external publications.

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Position will be filled at level commensurate with experience. 

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Qualifications

• Life Sciences degree (MD, PhD, PharmD, MS, RN or other scientific field preferred) with experience in clinical science, clinical research, or equivalent

• Proficient knowledge of GCP and ICH standards.

• Proficient knowledge and experience in the drug development process including study design, data management, statistics, and clinical operations.

• Proficient knowledge and skills to support program specific data review, trend identification and data interpretation.

• Proficient knowledge of the disease area(s), KOLs, indication(s), compound(s) under study (including MOA, PK/PD, biomarker & safety profile).

• Must be able to effectively communicate and collaborate across functions and job levels.

• Strong sense of teamwork; ability to lead matrix team activities.

• Proficient critical thinking, problem-solving, decision-making, and medical writing skills.

• Detailed oriented, ability to take initiate, proactive and ability to assimilate technical information quickly.

• Good verbal, written, communication and interpersonal skills.

• Adaptable / Flexible - willing and able to adjust to multiple demands and shifting priorities as well as an ability to meet day-to-day challenges with confidence and professionalism.

• Proficient planning/project management skills (ability to develop short to mid-range plans that are realistic and effective in meeting goals).

• Proficient in Microsoft Word, Excel, PowerPoint, Electronic Data Capture, J-Review or similar data reporting tools.