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 is now embarking on a substantial organizational scale-up to initiate a phase 2 program across a range of cancer indications. The Company is seeking Clinical Project Manager(s) (CPMs), Clinical Operations reporting to the project leader of the respective project. The Clinical Project Manager(s) will lead the planning and manage the implementation of clinical operational plans in alignment with the company’s strategic objectives, and in accordance with regulatory guidelines and Good Clinical Practice. The position(s) 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, secured a strategic investment from Pfizer, and was among the top performers on Nasdaq in 2020. Nearing completion of ongoing dose escalation studies, Trillium is now scaling up its organization to initiate a phase 2 program across several cancer indications.
The Clinical Project Manager will have ownership and accountability for the operational aspects of one or more clinical trials from protocol development to generation of clinical study reports. They support effective trial reporting and closeout, submission activities and audits/inspections as appropriate; are responsible for effective global management of the study team and relationships with CROs, central labs, IRBs, investigative sites and other external partners; coordinate the activities of all trial conduct partners and team members with a sense of urgency while proactively identifying, managing and communicating risks to key stakeholders. The Clinical Project Manager will liaise with cross-functional team members for technical system and process expertise and malignant hematology/oncology therapeutic area operational knowledge.
- Independently execute effective clinical operational plans with a sense of urgency and aligned with the strategic development plan while ensuring compliance to current regulatory guidance and GCPs.
- Lead the Study Team in setting Study Team goals, and regularly assesses progress against the study goals via team meetings, and analysis of metrics.
- Lead the development and maintenance of integrated study timelines through collaboration with internal and external stakeholders and manage those according to changing requirements.
- Build stakeholder commitment to deliverables and ensures progress toward the completion of trial(s) is in line with agreed study objectives.
- Independently manage activities associated with routine and advanced trial start-up, conduct and closeout activities according to industry and corporate standards and goals.
- Directly interact with clinical site personnel and ensures trial enrollment in line with study timelines and overall corporate plan.
- Regularly meet with manager to discuss overall clinical trial(s) plans, update forecasting, and potential issues or recommendations.
- Prepare and present trial specific updates to management.
- Review Project Specific Request for Proposal, vendor specifications and participate in vendor selection in collaboration with the Clinical Project Manager.
- Develop and manage vendor scope of work as per contract and budget and function as primary liaison between clinical vendors and Trillium Therapeutics to assure understanding of expectations.
- Review vendor invoices and help manage accruals and SOW changes.
- Anticipate, recognize and resolve issues; recognize the need to seek assistance or inform senior management of specific issues.
- Understand when decision making can occur at the study team level versus when there is a need for escalation to the program level, or to senior management.
- Prepare and maintain assigned project files, study documentation and other regulatory documents.
- Contribute to the writing and review of clinical documents such as protocols, informed consents, investigator brochures, DSURs, monitoring plans and reports.
- Regularly provide feedback to Study Team members on individual performance and contribution to the overall team effort.
- Participate in SOP, working instruction and template development.
- Perform necessary administrative functions and additional duties as assigned.
- Bachelor’s degree in a science or health-related field
- Minimum 4 years of experience in biotech/pharma environment; 2-3 years in project management.
- Strong oncology therapeutic experience required.
- Understanding of clinical research principles, drug development process, FDA & ICH, GCP, GCDMP and related regulatory requirements & guidelines.
- Phase I/Ib/II experience required including IND filings, additional phase II or phase III registration experience is a plus.
- Experience in CRO/vendor selection, contracting, oversight and relationship management.
- Demonstrated excellence in clinical trial management including matrix study teams and budgets.
- Strong computer skills including knowledge of Microsoft Excel, Word, PowerPoint, Outlook and MSProject.
- Able to work across many interfaces (clinical development, project management, translational medicine, quality, finance, and CMC).
- Demonstrated strong interpersonal skills, ability to influence, and the ability to function in a global team environment.
- Strong and effective communication skills (written and verbal).
- Strong integrity and a commitment to improving patient outcomes.
- Must be willing and able to be “hands-on” with a strong sense of urgency and accountability, and can thrive in a matrixed, fast-paced business environment.
- Once routine travel resumes, willingness and ability to travel up to 30% of time.
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.