Repare Therapeutics is a 2017 “Fierce 15” startup backed by tier-one strategic and institutional biotechnology investors (http://www.reparerx.com/news). Repare develops next generation, precision oncology drugs that target specific vulnerabilities of tumor cells in clearly defined patient populations. Founded by leading experts at the forefront of DNA damage and repair (DDR) cancer biology and genome-scale synthetic lethal screening technologies, Repare has assembled a seasoned team of industry veterans and a world-class Advisory Board.
Repare currently has an outstanding opportunity available for a motivated and accomplished computational scientist. The successful candidate will work closely with biologists, chemists, and translational scientists to impact critical decisions across all stages of drug R&D, from target identification, patient stratification to clinical development. If you are aspired to become an expert of drug discovery and development, experienced in generating novel insights by combining biology and analysis of genome-scale large data, and savvy with computational techniques in statistics and mathematics, you will thrive in our team-oriented, fast-paced, dynamic environment!
Job title will depend on the experience of the candidate.
Summary of Position:
Repare Therapeutics is looking for an experienced and passionate individual to lead clinical operations for our oncology programs. This Clinical development and Operation Lead position reports directly to the CMO and work collaboratively with the broader oncology development team to advance the science into the clinic and to bring medicines to patients who desperately need them. For the right individual this role will not only lead and develop a team of clinical operations professionals but provide an opportunity to work with accomplished drug developers who are passionate about the work and driven to help patients in need.
Position Responsibilities include:
- Develop and implement clinical project plans in accordance with corporate and regulatory objectives
- Oversight of clinical operation activities (vendor selection, trial management, site monitoring, vendor management, TMF, data management, IMP management, project management, etc.) for one or more clinical programs.
- Contribute to key study documents in conjunction with other functional area leads (e.g. protocols, project plans and timelines, statistical analysis plans, final study reports, etc.)
- Manage clinical trial resources and reforecasting projections, including hiring plans and budgets
- Coordinate advisory boards, investigator meetings and CRA trainings
- Ensure clinical trial compliance with all SOPs and GCP/ICH guidelines; maintain an inspection readiness state throughout the lifecycle of the trial
- Proactively identify, resolve and escalate issues that may jeopardize clinical study completion on time or within budget
- Assist in the identification and activation of clinical sites
- Contribute to global clinical / regulatory submissions
- Communicate study updates to senior leadership and in open forum presentations
- Undertake line management responsibilities for assigned team members, serving as coach and mentor
- Develop and maintain oversight of departmental SOPs to ensure compliance
- May require travel, including international travel
- Bachelor’s in a scientific discipline; advanced degree preferred
- Minimum 10 years of experience in a biotech/pharmaceutical/ CRO setting, principally in oncology drug development; minimum 7 years of clinical operations experience; minimum 5 years in a supervisory role
- Proven track record of effectively managing contract research organizations
- Demonstration of effective leadership through vision for her/his team, coaching and mentoring, and organizational development
- Highly organized, outcome oriented, self-motivated performance
- Comfortable in a fast-paced small biotech environment with the ability to adapt to change
- In depth knowledge and understanding of all aspects of clinical operations management, with a track record of successfully managing programs to completion on time and on budget
- Excellent interpersonal skills, ability to develop important relationships with key stakeholders across a variety of disciplines, strong conflict management and negotiation skills
- Ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations
- Excellent working knowledge of federal regulatory requirements and guidelines for Good Clinical Practice
- Outstanding oral and written communication skills including experience authoring clinical protocols and other key trial documents
Repare Therapeutics is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.