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 a Senior Director, Regulatory Affairs, CMC. The successful candidate will be responsible for formulating and implementing CMC regulatory strategies, submissions and compliance activities required to achieve regulatory approvals, engaging with regulatory experts, and collaborating with internal and external stakeholders to advance clinical-stage assets of Trillium Therapeutics Inc. The candidate will possess a deep knowledge, understanding, interpretation and utilization of regulatory guidances and regulations focused on biologics (specifically therapeutic protein products), as well as industry standards and best practices.
This role will report into the VP, Regulatory Affairs, with a dotted line to the Chief Development Officer, and is based in our Cambridge, MA office.
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 has been among the top performers on Nasdaq. 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 ensure strong execution of the program.
- Proactively manage regulatory CMC aspects of programs, including overseeing preparation and submission of CMC submissions, supporting clinical trial applications and marketing applications appropriate to phase of development.
- Write CMC regulatory documents and act as in-house expert to internal and external parties.
- Ensure timely delivery of high-quality CMC documents, including regulatory authority requests for information, meeting briefing books, meeting minutes, IND/IMPD/CTA submissions, NDA/BLA submissions, and DMFs while assuring all documents meet regulatory requirements and quality compliance.
- Support and comply with procedures for electronic submissions and document archiving to ensure efficiency and traceability of all CMC regulatory documents.
- Facilitate the development of, review and comments on all technically complex CMC documentation for submission to regulatory authorities, including process development, process validation, analytical method development, and analytical method validation supporting establishment of specifications and in-process, release and stability data and information appropriate to phase of development.
- Articulate complex Regulatory CMC issues to project teams and external stakeholders to support global development of drug candidates.
- Evaluate proposed manufacturing and quality changes for impact to ongoing and existing filings and provide strategic regulate guidance for optimal implementation of changes.
- Manage interactions with FDA and other regulatory authorities for assigned projects to ensure acceptance, rapid review and approval of clinical trial applications, marketing applications, amendments/supplements/variations, and other submissions which present CMC information.
- Develop and maintain excellent relationships with regulatory authorities, internal functional groups especially CMC colleagues, contract manufacturing organizations, and corporate partners.
- Support the Senior Director, Regulatory Compliance and Operations, or equivalent, in preparing and hosting regulatory inspections.
- Support the program teams to ensure the CMC regulatory strategy and initiatives are aligned across all functional areas.
- Maintain in-depth and current understanding of the laws, regulations and guidelines pertaining to CMC/Quality information relevant to Trillium’s development programs.
- BSc in applied science; MSc or PhD preferred.
- 10+ years experience working in Regulatory CMC role in the biotechnology/pharmaceutical sector. Small biotech experience preferred.
- Experience in biopharmaceuticals/biologics development is essential.
- Profound understanding and superior knowledge of cGMP regulations, FDA/EMA/HC/ICH guidelines related to CMC with specific experience in the preparation of CMC regulatory filings for biopharmaceuticals.
- Experience with regulatory authorities’ cGMP inspections and audits at Contract Manufacturing Organizations (CMOs) preferred.
- Effective communicator (both written and verbal), with excellent technical writing skills. Able to distill complex information and communicate regulatory CMC initiatives across functions.
- 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 with a bias for action.
- Once routine travel resumes, willingness and ability to travel up to 20% 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.