Medical Director/Senior Medical Director

Ribon Therapeutics is a biotechnology company pioneering the discovery of new cancer medicines that target monoPARP proteins, critical regulators of cancer survival mechanisms. Ribon offers a fast-paced, team-oriented work environment and a comprehensive benefits package, including health, dental, 401(k), paid vacation, and much more. Ribon is located in Cambridge, Massachusetts, which is easily accessible by car and public transportation.

Job Description

Responsible for developing and implementing the global clinical strategy and tactical plans for assigned programs, coordinate and monitor the clinical studies ensuring compliance with ICH/GCP and federal regulations, and collaborating with other functions to advance the portfolio. This position reports to the Chief Medical Officer.

Primary Responsibilities

  • Serve as primary Medical leader for all the clinical stage programs
  • Provide medical and scientific expertise to preclinical discovery programs
  • Engage with academic thought leaders to develop and optimize clinical protocol and strategies
  • Ensure the successful conduct of on-going trials. Lead, develop and implement new trial(s)
  • Handle day-to-day clinical, medical, and scientific questions from internal and external sources
  • Proactively identify program risks, and create and implement mitigation strategies
  • Work closely with Pharmacovigilance in development of Risk Management Plans
  • Responsible for review, interpretation, and analysis of clinical trial results including human pharmacokinetics, pharmacodynamics, laboratory, and biomarker data
  • Work with CRO medical monitor to clean and review data and approve clinical trial coding
  • Collaborate cross-functionally in the preparation of the CDP, briefing books for health authority interactions, clinical protocols, investigator brochures, target product profiles, annual IND (DSUR) reports, severe adverse advent reports, and clinical study reports
  • Participate as medical lead in meetings with the EMA and FDA, or other Regulatory bodies
  • Continual review and analysis of the pertinent medical literature and competitive landscape
  • Preparation and/or delivery of abstracts, posters, and slide presentation at external Conference Symposia, and manuscripts for peer-reviewed journals
  • Ensure consistent practices with the highest ethical standards in compliance with internal SOPs, local regulations and laws
  • Serve as the clinical face of the company both internally and externally, including the scientific community and key opinion leaders

Knowledge and Skill Requirements

  • MD required, subspecialty training in Oncology is preferred; RN, MS, PhD or PharmD, with extensive clinical research and drug development experience may also be considered
  • 5+ years of hands on pharmaceutical/biotechnology industry experience in clinical development
  • In depth knowledge of drug development process and oversight of clinical trials
  • Demonstrated ability to meaningfully contribute to development strategy. Own and deliver on tactical implementation of strategy
  • Working knowledge of biostatistics, regulatory, clinical pharmacology, pharmacokinetics, and biomarkers
  • Experience in working effectively with FDA and other global regulatory agencies for filing INDs and/or NDAs
  • Ability to manage multiple tasks and prioritization skills
  • Excellent interpersonal and communication skills (written and verbal)
  • Proven success working with and effectively supporting cross-functional teams
  • Reputation for a collaborative and transparent leadership style

If you are interested in joining Ribon’s team, please email your resume to [email protected].

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