Senior Director, Clinical Affairs
Our client, a leading pharmaceutical company is looking for a Senior Director, Clinical Affairs to join their team. Reporting to the Senior Vice-President, Medical Affairs and Chief Medical Officer, the Director will be responsible for the design of clinical trials including protocol development, clinical trial discussions with regulatory authorities, and development of the timeline and budget.
- Manage the process of screening, qualifying, and selecting, and contracting with investigators, sites and vendors required for conduct of clinical trial.
- Develop and manage departmental budgets.
- Obtain necessary clinical trial approvals from IRBs/EC’s and regulatory bodies such as the FDA, Health Canada, and other Competent Authorities.
- Ensure studies are on track for site initiation, patient recruitment, and enrollment, and take corrective actions where necessary to address issues and honour timelines.
- Ensure clinical results are interpreted and documented clearly and concisely for regulatory submissions and publications. Write and develop clinical trial reports and risk assessments.
- Develop SOPs and work instructions to assure internal files and clinical study files conform to Good Clinical Practice regulations and standards.
- Provide oversight and improve processes for investigator-sponsored studies.
- Maintain surveillance and analysis of published literature/clinical results and competitive products across all pertinent indications to guide Marketing & sales and strategic purposes and use in regulatory submissions.
- Develops budgets for all clinical projects and adheres to company financial goals.
- Undergraduate University degree in life sciences (BSc.)
- Advanced professional degree or a PhD in life sciences, a major asset.
- Minimum of 10 years of relevant clinical research and industry experience
- Experience in successful pharmaceutical development and Regulatory product approval.
- Established capabilities with global regulatory and compliance requirements for clinical research including but not limited to US CFR, EU CTD, and ICH GCP.
- Leadership and team spirit
- Excellent adaptability and flexibility.
- Excellent capacity for analysis, good judgment, and critical skills
- Capacity to prioritize and execute several projects at the same time and with a minimal supervision.
- Strong leadership and team spirit
- Ability to work in a fast-paced environment.
- Effective communication skills, both verbal and written.
Please submit your resume directly to Céline Chabée at email@example.com, indicating “Senior Director, Clinical Affairs” in the title of the email.
Only selected candidates will be contacted.