Vice President, Clinical Development

Company: Trillium Therapeutics
Location: Cambridge
Posted on: January 8, 2021

Job Description:

SummaryTrillium 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, Clinical Development, who will oversee one or more key clinical development programs. The position will report into the CMO and will be based in Cambridge, MA.The CompanyTrillium 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

• Provide leadership and coordination with key research functions to one or more drug development programs.
• In collaboration with the Clinical Operations lead, lead and coordinate study activities in the program.
• Lead development of the Clinical Strategy/Clinical Development Plan and provide medical oversight of protocol development, study conduct and data generation, as well as reporting.
• Oversee Phase I-III clinical development programs to ensure that regulatory requirements and quality standards are met. Strive to maintain or exceed compliance obligations for Good Clinical Practices guidelines and standard company operating procedures.
• Act as a company representative interacting with external scientific leaders and regulatory authorities for assigned program(s).
• Search and analyze medical literature. Write/review abstracts, manuscripts, etc., for publications and/or presentation at internal/external meetings.
• Lead/participate in investigator meetings and advisory committee meetings as needed.
• Lead/participate in strategic review and input into documents (such as protocols, CRFs, Statistical Analysis Plans, CSRs) to ensure scientific/medical accuracy and consistency with clinical development program.
• Integrate preclinical information (pharmacology, toxicology, pharmacokinetics) and interpret implications for clinical development as articulated in the Investigator's Brochure and first-in-human protocol.
• Co-lead product safety review committees as appropriate.
• Provide consultation on medical subjects to investigators and other company personnel, and apply medical knowledge to guide the safe, ethical, and efficient conduct of trials.
• Participate in due diligence efforts for clinical partnerships and/or in-licensing opportunities.
• Work with specific clinical and research partners to facilitate seamless execution of collaborative efforts.
• May supervise other Medical Directors and/or Clinical Scientists.QualificationsEssential:
  • MD or equivalent.
  • Subspecialty training in a discipline relevant for oncology/hematology therapeutic area.
  • Demonstrated potential or ability to design, initiate, and conduct clinical studies.
  • 4-7 years of proven experience as a study director in the industry, with experience in phase I/II oncology clinical trials required, phase III experience preferred.
  • Proven ability to analyze and interpret efficacy and safety data relating to oncology.Desired:
    • Board-certification in medical oncology/hematology.
    • MD-PhD and strong basic/translational science acumen in a relevant field, demonstrated by the respective publication record.
    • Experience in regulatory interactions throughout the different phases of development.
    • Experience and solid understanding of drug development strategy and process.Personal Attributes
      • Able to work across many interfaces (clinical/clinical operations, clinical/project management, clinical/regulatory, clinical/commercial, etc.).
      • 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 medical/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 30% of time.How to ApplyPlease send your resume and cover letter to careers@trilliumtherapeutics.com with the title of the role in the subject line. Kindly note that phone calls and third parties are not accepted.

Keywords: Trillium Therapeutics, Cambridge , Vice President, Clinical Development, Healthcare , Cambridge, Massachusetts