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 new Vice President, Regulatory Affairs, who will play a key role in developing and implementing the corporate regulatory affairs function. The position will report into the CMO and 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 has been among the top performers on NASDAQ. Nearing completion of ongoing dose escalation studies, Trillium is now scaling up its organization to initiate a phase 2 program across several cancer indications.
- Develop and implement corporate regulatory strategy to ensure competitive advantage and regulatory compliance.
- Develop content and format for regulatory submissions, such as Investigational New Drug (IND) Applications, Clinical Trial Applications (CTAs), Biologics License Applications (BLAs), Market Authorization Applications (MAAs), related supplements and amendments as well as clinical protocols.
- Identify external regulatory consultants as needed and manage communications and deliverables on a project basis.
- Develop and implement registration paths for early clinical development stage programs.
- Advise internal personnel regarding the development and implementation of regulatory strategy through non-clinical, clinical, manufacturing, and other processes. Identify potential regulatory concerns.
- Develop internal processes for regulatory review of various documents such as clinical protocols, manufacturing changes, etc.
- Oversee preparation, submission, application, and routine reports, including preparation of amendments and supplements, as required.
- Sustain excellent relationships with regulatory agency personnel including FDA and EMA. Respond to requests for additional data, and organize and manage participation in meetings. Negotiate directly with regulatory authorities regarding company’s filings.
- Implement, and review current policies and practices issued by Federal and international regulatory agencies.
- Stay abreast with changes to global regulations and guidelines.
- Supervise additional regulatory affairs personnel (directors/managers) and contractor and/or CRO resources as the organizations grows.
- Master’s degree.
- At least 10 years related experience within the biotechnology/pharmaceutical industry along with significant clinical regulatory experience.
- Experience building and leading a regulatory affairs function in an oncology-focused biotech company.
- Experience with oncology products.
- Experience with biologics.
- Experience leading communications with the FDA.
- Working knowledge of eCTD submissions and supportive technologies.
- PhD, PharmD or MD.
- Strong background in other related functions in industry such as discovery/translational science, toxicology.
- Experience and solid understanding of drug development strategy and process.
- Experience with programs leading to accelerated approval.
- Successful completion of BLA and MAA application(s).
- Experience with CMC-related regulatory topics.
- Able to work across many interfaces (clinical/clinical operations, project management, non-clinical, CMC, commercial).
- 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), with excellent scientific writing skills.
- 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 up to 20% of time.
How to Apply
Please send your resume and cover letter to email@example.com 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.