Trillium Therapeutics is a clinical stage immuno-oncology company based in Cambridge, MA and Toronto, ON. Following recent promising clinical data updates and after raising over $300 million in 2020, the Company has embarked on a substantial organizational scale-up and initiated an ambitious phase 1b/2 program across a range of cancer indications. The Company is seeking an Associate Director/Director, Clinical Operations, who will report to the VP or SVP of Clinical Operations. This role will be responsible for and play a key role in the operational strategic planning, oversight and delivery for one or more assigned clinical programs to support corporate objectives/milestones.
This position will be based in Cambridge, MA.
Trillium Therapeutics (Nasdaq:TRIL) is a clinical stage biotechnology company developing next generation immunotherapies targeting CD47, a checkpoint of the innate immune system. Immunotherapy is a rapidly evolving field that is redefining cancer care by harnessing a patient’s own immune system to eliminate tumor cells. First generation immunotherapies, targeting the adaptive immune system via T cell checkpoint inhibitors, have been enormously successful scientifically (2018 Nobel prize), clinically (achieving real cure rates), and commercially (soon to be the largest drug class ever). CD47 is now emerging as one of the most promising next generation immuno-oncology targets.
Trillium has two highly differentiated CD47 blockers in development that – unlike other CD47 agents – have shown unique monotherapy activity across a range of hematologic malignancies. Under new leadership, Trillium has undergone a wide-ranging transformation program, including a major strategy reset. In 2020, the company raised over $300M and secured a strategic investment from Pfizer. After initiating an ambitious Phase 1b/2 program across multiple hematologic and solid tumor indications earlier this year, Trillium is now scaling up its organization to ensure strong execution of the program.
- Ensure that clinical trial projects are properly resourced, managed and executed within budget and in accordance with established timelines and quality standards.
- Oversight of clinical study teams, including management of vendors (e.g., CRO) and coordination of activities.
- Prioritize day to day issues and overarching goals with a keen eye to (understanding of) ICH/GCP Guidelines, escalating to Upper Management as appropriate.
- Contribute to and assist in maintaining a quality-focused clinical infrastructure by assisting in development, revision and/or implementation of SOPs consistent with the organization’s day to day execution of trials such that operational processes, systems and standards are consistent with GXP and are adopted, implemented and documented consistently across trials and programs.
- Work closely with Project Leaders and Clinical Development teams for development of protocols, Investigator Brochure’s, abstracts, etc.
- Attend project team meetings and provide updates regarding clinical studies.
- Assist in the identification and management third party vendors, including development of Request for Proposals (RFPs), scope of work (SOW) documents, and vendor specifications.
- Provide real time updates with other departments to ensure communication and good relationships in connection with matters related to clinical trial projects.
- Coordinate activities related to audit findings and/or identification of significant site noncompliance.
- Develop relationships with Key Opinion Leaders.
- Participate in Scientific /Clinical Advisory Board (S/CAB) Meetings and attend therapeutic meetings/conferences, as applicable.
- Mange direct reports, regular meetings and oversight as well as complete all yearly review activities.
- Train and mentor junior staff on Clinical Operations processes and the related execution of GCP and ICH guidelines such that compliance is the top priority, followed closely by excellent execution of all responsibilities.
- Travel to sites when necessary.
- Work in compliance with the Trillium’s Code of Business Conduct and Ethics and all workplace policies, procedures and regulations.
- Other duties as assigned.
- BA/BS degree or equivalent required; advanced degree in health or biologic sciences is preferred.
- A minimum of 12+ years’ experience in the pharmaceutical industry, with minimum 10 years direct experience in planning and managing clinical trials.
- Significant experience with responsible roles in the conduct or management of Phase I – IV clinical trials.
- A good working knowledge of medical terminology, physiology and pharmacology and an excellent knowledge of applicable U.S. and international regulations and guidelines.
- Excellent oral and written communication, organizational and planning skills are required, with a proven ability to manage budgets.
- Be detail-oriented, a self- starter and be comfortable with broad responsibilities in an entrepreneurial, fast-paced, small company environment.
- Able to work across many interfaces (clinical development, project management, non-clinical, CMC).
- Demonstrated strong interpersonal skills, ability to influence, and the ability to function in a global team environment.
- Strong integrity and a commitment to improving patient outcomes.
- Must be willing and able to be “hands-on”, and can thrive in a matrixed, fast-paced business environment.
- Ability to work effectively with other company leaders and develop strong working relationships with them.
- Once routine travel resumes, willingness and ability to travel 25-30% of time, including internationally.
The duties and responsibilities contained in the job description are not exhaustive and may be changed by the Company at any time.
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.
We thank all applicants for their interest. We will be reaching out only to candidates whose backgrounds most closely match our needs.