Senior Director, Clinical Research
Clinical/ Regulatory Services Professional
Immunovaccine is looking for a Senior Director of Clinical Research to join their team. The successful candidate will lead the clinical research team, designing and executing clinical trials. Responsibilities include oversight and contribution to the strategy, planning, conduct, and analysis of data from clinical studies, with emphasis on overall clinical study leadership. This person also ensures quality, timely and coordinated clinical study activities and ensures compliance with the appropriate GCP/ICH and health authority guidelines. Along with the Chief Medical Officer, this individual provides clinical development expertise on behalf of the company and represents the company at appropriate academic, industry, medical and regulatory meetings.
We like to set big goals for ourselves and grow every year, we also like to have fun and enjoy regular team events throughout the year.
- Provide leadership to the Clinical Research team involved in the execution of all clinical studies. Responsible for the strategic planning, design, conduct, analysis, and reporting of multiple and simultaneous clinical trials that meet the standards of excellence for ethics, scientific merit, and regulatory compliance, as well as satisfy corporate goals.
- Provide scientific and clinical expertise to a clinical development program and evaluate scientific and clinical strategies for a product.
- Designing Clinical trial strategies to obtain regulatory approval.
- Oversee quality, coordination and timeliness of INDs, Investigator Brochures, CTAs, and clinical reports.
- Support and provide input into the planning, design, preparation, initiation, and execution of study protocols and other required study documentation in compliance with project plans, federal regulations, GCP, and good medical practice.
- Manage the development and execution of high-quality, cross-functional, clinical trial plans, to apply trial management practices in the development, initiation, planning, execution, control, and closing of trials, and to serve as training and a support resource to the Clinical Research team.
- Ensure clinical projects/programs are defined, tracked and communicated to the clinical team, Senior Management team and the Board of Directors (when applicable) in a consistent, timely and effective manner
- Work with Drug Safety leaders and IRB’s to troubleshoot any relevant issues, and keep team members advised of progress, issues and results.
- Identify realizable solutions and alleviate potential hurdles in unique clinical trial situations to ensure trial success.
- Generate clinical trial budgets and estimated duration in collaboration with CROs, investigators, and study sites, and ensures the delivery of study results according to established budgetary guidelines, quality standards and timelines.
- Establish contracts with clinical sites, CROs and other vendors and maintain the necessary clinical trial insurance.
- Hire and motivate an efficient internal team to shape clinical development. Provide both day-to-day management of the members of the Clinical Research team, as well as developing their career paths and assist in setting performance objectives.
- Define and develop governance standards specifically for conducting clinical trials including: Project Planning/Tracking; Status Reporting; Issues Management/Escalation/Resolution; Risk Management; CRO/Vendor Management; Financial Management and Resource Management.
- Ensures continued utilization and maturation of best practice trial management standards and methodologies, risk analysis, decision analysis and contingency planning.
- Proactively communicates with internal colleagues, and collaborates with peers in other functional areas, and develops and maintains effective relationships with KOLs, medical experts, consultants and other external individuals/organizations (ie investigators, CRO’s, business partners, etc).
- Ensures the establishment of Processes, Workflows and SOPs as appropriate to ensure GCP compliance according to national and international standards, (e.g. FDA, Health Canada). Responsible for working with the Sr. Director of Quality to oversee Clinical Quality Control review and management of internal study databases, documents and reports
- Participate in the analysis and interpretation of clinical trial data and the reporting of the clinical trial results and help in the development and preparation of study manuscripts for intended publication.
- Represents the company at academic, scientific conferences, medical, industry, advisory boards and regulatory meetings.
- Provides expertise and guidance on potential business development opportunities.
- M.Sc. required, Doctorate/PhD preferred
- 10+ years of current pharma / biotech industry experience, including leading a Clinical Research team
- Advanced understanding of other functions; including but not limited to: Research, Non-Clinical, Manufacturing / Supply Chain, Commercial, Regulatory and Medical Affairs
- Knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and applicable international regulatory requirements
- Experience with, or strong knowledge of oncology drug development and infectious clinical research preferred
- A proven success record in oncology clinical research studies and trial design, as well as the successful submission of IND’s
- Ability and interest to coordinate multiple studies at a time, across a range of clinical indications
We are open to a telecommute/ travel solution for this position from a Canadian based site.
Our Head office is on Summer Street in Halifax. Hours will be primarily 9 am – 5 pm Monday through Friday but as the role grows, there may periodically be some tasks that are required outside of these hours. You will work in an office environment at a desk. Travel is expected for this position; approximately 25- 30%.
Salary and Benefits:
This will be a salaried position. Please indicate clearly on your application your desired salary for this role.
Compensation will be determined based upon skill set and experience of the selected candidate. Immunovaccine offers paid vacation, health/ dental plan, employee assistance program, stock options, annual bonuses and cost of living increases to eligible employees.
If you feel that you are the best candidate for this position, please apply through the “Apply Now” button or by emailing firstname.lastname@example.org.
Please clearly indicate in your application how you meet the requirements for this role and why you think you would be the best candidate for the role. There will be a small testing requirement as part of the interview process.
Applications will be considered immediately upon receipt until the position has been filled.
*We appreciate your application but only candidates selected for interviews will be contacted. We reserve the right to request interview candidates to complete skill/ behavior based assessments as part of the interview process.
** The successful candidate will be required to provide a Criminal Record Check before their start date.