Director/Senior Director/Executive Director, Clinical Development

Posted on: December 19, 2024

Anavex Life Sciences Corp. is seeking a talented and highly motivated clinician to join our team. This position will have full responsibility for planning, implementation and daily operation of drug development projects. He/She/They will collaborate with key internal and external stakeholders to support company initiatives that improve the quality and content of all clinical programs to deliver our portfolio.

Key Responsibilities

Lead the development and the execution of clinical development projects.
Aid in identification of new targets in addition to advancing projects in the current pipeline.
Develop clinical development plans and strategies for investigational drugs in pipeline that integrate pre-clinical and early clinical findings while working to ensure cross-functional alignment throughout the early phases of clinical development.
Design scientifically rigorous and maximally cost-effective clinical protocols that are aligned with the clinical development plan.
Present and defend protocols and clinical development plans at internal governance forums.
Serve as Medical Monitor responsible for the safety monitoring of clinical trials and as medical expert for Phase I/II/III studies, managing the process from protocol development through study execution to completion of study reports and integrated regulatory documents.
Monitor study progress, ensure proper study conduct, adherence to study protocol, lead data review, evaluation, and analysis with support from Data Management, Statistics and Programming Teams.
Present study updates, interim results, and final headline data to senior management as required.
Summarize the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical study reports, or publications.

Position will be filled at level commensurate with experience.

Requirements

MD or MD/PhD preferred
7+ years’ pharma/biotech industry experience preferred
Neuroscience experience preferred
Experience leading drug discovery project teams from lead optimization to IND-enabling studies is a plus
Knowledge of regulatory requirements, biostatistics and pharmacovigilance relevant to clinical development
Excellent presentation, communication, and coordination skills with internal and external collaborators
Experience working in a matrix team environment including interactions with clinical, commercial, drug safety and regulatory functions
Self-starter and able to anticipate potential challenges and develop a mitigation plan

Location

Flexible work arrangements may be possible