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 Lexington, Massachusetts.
The candidate will be an integral member of a team responsible for discovering and developing transformative cancer medicines that target cellular stress pathways. This position reports to the Vice-President of Molecular Discovery and the individual will be responsible for:
- Leadership in preclinical and early clinical studies, including but not limited to in vitro and in vivo ADME assays, PK/TK support, M&S;
- Representing DMPK function in cross functional project team and provide critical feedbacks to project teams from DMPK point of view;
- Leading regulatory related activities in DMPK areas for R&D and generating and reviewing documents such as investigator’s brochures, INDs & CTAs, and providing scientific support on all licensing activities;
- Managing collaborations with CRO/CMO for outsourcing activities.
- Ensuring reporting timelines for all DMPK related reports. Expected to review, edit, and offer critical feedbacks to the reports generated by CROs.
- Ph.D. degree in relevant discipline with 10+ years of industrial experience, ideally within both large pharma and biotech, with 3+ years of experience as project leader or project representative
- Experience managing DMPK CROs
- Experience with preparation of regulatory documents, such as IND, CTA, NDA, etc.
- Broad background knowledge in DMPK with strong expertise in at least one DMPK area, preferably drug metabolism or modeling & simulation
- Working knowledge of DMPK related regulations and regulatory guidelines from ICH, FDA and EMA
- Track record of contribution to project teams enabling achievement of milestones in a time efficient manner
- Excellent communication, presentation skills, and attention to detail
If you are interested in joining Ribon’s team, please email your resume to email@example.com.