Head of Clinical Operations
Trillium Therapeutics Inc. is a clinical stage immuno-oncology company developing innovative therapies for the treatment of cancer. We employ biologic and small molecule-based approaches that enhance the ability of the patient’s own immune system to detect and destroy cancer cells. Headquartered in Mississauga, Canada, Trillium offers a flexible, diverse and inclusive workplace and market leading employee benefits. This role is based in Trillium’s US Office in Cambridge, MA.
The Head of Clinical Operations provides strategic and operational leadership to the success and operational excellence of Trillium’s clinical stage programs. This involves ensuring that clinical stage programs achieve program objectives within established timelines, budgets, and regulatory and quality expectations. Providing strategic direction, s/he will oversee and manage the maintenance of a high performing Clinical Operations Team; work collaboratively with other internal Teams to ensure resources are in alignment with the organizational goals; participate in the planning of quality, operational improvements, and budget management. The Head of Clinical Operations will contribute to strategic planning to ensure optimized clinical development plans for the clinical assets, represent Clinical Development on cross-functional project teams, and closely coordinate with other functional areas including non-clinical, CMC and expert consultants. S/He will ensure the clinical data is collated and critically evaluated at appropriate intervals. S/He will provide feedback and updates on project progress and identify and address issues in a timely manner for the project team(s) and Executive Management. S/He will ensure the successful delivery of these activities through adherence to Trillium Therapeutics SOPs (and Work Instruction documents), ICH-GCP and CRO oversight SOPs.
This role oversees and manages all aspects of assigned clinical trials. S/he:
- Provides strategic and technical guidance and leadership to the Clinical Operations Team responsible for the management and execution of the clinical trials. This includes, but is not limited to ensuring the delivery of the program within scope, budget and quality standards.
- Leads and directs recruitment, development, and retention of the Clinical Operations Team; ensures appropriate prioritization of activities and resourcing for all clinical programs; drives operational excellence; fosters a collaborative and integrated culture across the US and Canadian teams.
- Collaborates with internal and external medical, scientific, and operational experts and presents the Clinical Operations Team’s strategic and technical perspective; builds and maintains relationships with KOLs, clinical sites, cooperative groups, CROs and all other clinical partners and stakeholders.
- Provides direction and leadership in CRO selection and management to ensure that external vendors deliver within established timelines, budget, and quality expectations.
- Defines operational strategic plans, provides primary leadership and oversight in the implementation of Clinical Development Plans.
- Prepares, manages and circulates study specific metrics and updates required for the Executive Management and Board of Directors’ (BOD) meetings.
- Attends where possible, major scientific conferences were Trillium studies are presented.
- Analyzes and develops action plans to address issues with investigational sites, CROs and vendors.
- Develops and manages clinical research budgets and cross-functional timelines.
- Manages and motivates the Clinical Operations Team which includes Study Managers, Associates and contractors.
- Provides direction, coaching and mentoring to junior colleagues to work strategically and drive results.
- Provides project management oversight and training on issues related to design and conduct of clinical trials.
- Provides technical expertise for the development of clinical documents such as Clinical Monitoring Plan, Safety Plan, Sample Management Plan, etc.
- Provides technical expertise for review of relevant documents including protocols, informed consents, case report forms, monitoring plans, investigator brochures and clinical study reports.
- B.Sc. in a scientific discipline
- Minimum of 10 years of progressive clinical operations industry experience
- Strong background in oncology and hematology; global clinical trial experience is strongly preferred
- Extensive clinical development experience with biologic drug development in all clinical phases
- Comprehensive understanding of clinical regulatory requirements and knowledge of relevant guidelines
- Demonstrated ability to work in a small biotechnology company environment, interact across multiple disciplines and geographies, and manage outside consultants, vendors and contractors
- Excellent organizational and communication skills
- Leadership and supervisory experience
- Key competencies: Functional/Technical Skills, Planning, Developing direct reports and others, Conflict management, Drive for results, Communications (written, verbal, presentation skills), Interpersonal savvy, Dealing with ambiguity, Composure
How to Apply:
Please send your resume and cover letter to firstname.lastname@example.org with the title of the role in the subject line. Kindly note that phone calls and third parties are not accepted. Candidates must be authorized to work in the U.S.