Vice President, Regulatory Affairs
Company: Trillium Therapeutics Inc.
Posted on: February 20, 2021
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. The Company 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. Accountabilities
- 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
- Develop internal processes for regulatory review of various
documents such as clinical protocols, manufacturing changes,
- Oversee preparation, submission, application, and routine
reports, including preparation of amendments and supplements, as
- 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
- Implement, and review current policies and practices issued by
Federal and international regulatory agencies.
- Stay abreast with changes to global regulations and
- Supervise additional regulatory affairs personnel
(directors/managers) and contractor and/or CRO resources as the
organizations grows. Qualifications
- 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
- 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
- Experience with programs leading to accelerated approval.
- Successful completion of BLA and MAA application(s).
- Experience with CMC-related regulatory topics. Personal
- Able to work across many interfaces (clinical/clinical
operations, project management, non-clinical, 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),
with excellent scientific writing skills.
- Strong integrity and a commitment to improving patient
- 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 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. Cambridge Office 2488
Mississauga, ON L5L 1J9
Tel: +1 416.595.0627
Keywords: Trillium Therapeutics Inc., Cambridge , Vice President, Regulatory Affairs, Executive , Cambridge, Massachusetts
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