Position Description

Chief Medical Officer
Location Lexington, MA
Employment duration Full time
ID 375
Apply Now

AgenTus Therapeutics is a dynamic new start-up subsidiary developing T cell receptors (TCRs) and chimeric antigen receptors (CARs) designed to supercharge human immune effector cells to seek and destroy cancer. We aim to deliver cures to cancer patients around the world by leveraging our proprietary platforms for TCR discovery, targeting novel phosphopeptide neo-epitopes and developing unique allogeneic cell therapies. Together with our parent company, Agenus, we have a deep and diverse repertoire of immunotherapy treatments that can be used in combinations that will synergize to help the body’s immune system fight cancer.

 

The CMO will be AgenTus’ medical expert and responsible for strategic development and tactical implementation of the clinical studies for our research programs. This will include providing direct medical/physician oversight for phase I/II and proof of concept clinical trials, and clinician input into all aspects of discovery, preclinical development, and clinical development, from target selection to preclinical and regulatory strategy, clinical development and tactics. The ideal candidate will have a thorough understanding of the principles of oncology, pharmacology, nonclinical (toxicology), clinical and regulatory requirements for testing new therapies in humans, and experience working closely with clinical studies.  Prior experience in immune-oncology and/or cell therapy would be an asset.

 

AgenTus is looking for an ambitious, self-motivated physician with high energy and the ability and drive to develop, accomplish and follow up on different medical projects and tasks. The successful candidate should have clinical experience as practicing physician with strong scientific research or clinical background in oncology in general, and immune-oncology and/or cell therapy if possible. Experience about inflammation/autoimmunity is an advantage. The scope for the role is broad and requires an interest for working with many different tasks and duties, as well as being a productive member of AgenTus’ senior team. AgenTus values solid relation building skills, collaboration skills, project management skills as well as excellent presentation skills.

 

Responsibilities: About the Role

• Provide medical and scientific expertise regarding AgenTus’ disease areas and products. Support the management team and research team with medical expertise and contribute to the overall product development and corporate strategy.

• Develop and update the strategy for the clinical development plan (CDP) according to corporate strategy

• Provide clinical and scientific input into Discovery Research and Early Development activities

• Contribute to the development of robust clinical development plans for each program, including providing content for clinical development and other sections, as needed

• Identify and establish relationships with leading KOL’s and principal investigators, including organizing and running investigator meetings, KOL meetings and Advisory Boards, as needed

• Write and/or review clinical sections of clinical/statistical reports, including investigator’s brochures, IMPD, INDs, Briefing Packages, BLA, and other regulatory submissions.

  • Review and interpret clinical study results for strategic decisions, publications, and international regulatory filings.
  • Ensure clinical trial data integrity.
  • Communicate internally and externally on clinical trial design and results.

• Oversee clinical trials as medical expert including oversight of study patients’ safety and wellbeing.

  • Provide input in medico-scientific communication.

• Oversee, review and approve clinical study reports, as needed

 

Qualifications: About You

  • MD or MD/PhD with board certification in medical oncology.
  • [8]+ years industry experience in designing and executing oncology clinical trials from Phase 1 through Phase 3, with experience in immuno-oncology and/or cell therapy trials preferred.
  • Knowledge of pharmaceutical business, worldwide drug development and regulatory process, expertise of GCP and applicable guidelines is essential.
  • Prior experience in managing clinical trials for cell therapy is a plus.
  • Experience in leading teams in a fast-paced, cross-functional environment.
  • Experience in protocol development and design, including understanding of the strengths and weaknesses of study design, development of case report forms and statistical analysis plans.
  • Experience in working with and managing CROs and other vendors as required.
  • Experience in working closely with investigative sites, including principal investigators, sub-investigators, study coordinators and other site personnel involved in clinical trials.
  • Motivated to work in a fast-paced, high accountability, small company environment. A “can do” and collegial professional who leads through influence and interpersonal skills.
  • Demonstrated record of accomplishment in a compressed time frame; capable of prioritizing tasks and delivering on deadlines with high performance standards and attention to detail.
  • Demonstrated ability to collaborate successfully with multiple functions in a team environment.
  • Strong written and oral communication skills, including presentation skills.
  • Ability to analyze and interpret clinical efficacy and safety data and develop written reports and presentations.
  • Ability and desire to grow with the company, assume increasing responsibility and build and lead a medical team.
  • Prior experience in managing US and worldwide clinical development and clinical operations teams.
Back Apply Now