[Hiring] Senior Study Manager @Revolution Medicines

Role Description

The preclinical study manager is responsible for the operational activities associated with performing non-GLP and GLP toxicology studies from research to late phases of clinical development. This includes being the primary operational contact and representative for RevMed to the contract research organization (CRO) performing each study. He/she will be responsible for ensuring that each study’s scientific and corporate objectives are achieved, and are compliant with appropriate regulations, policies, standard operating procedures, and all relevant international regulatory guidelines/regulations. Timely resolution of study-related issues, liaising with internal experts and/or consultants, and informing appropriate personnel are pivotal to being successful in this role.

Qualifications

• At least a BS degree in science and 8+ years of experience in biotech, pharmaceutical and/or CRO.
• Current knowledge of ICH and FDA guidelines.
• Strong interpersonal skills and ability to work with cross-functional project teams and CROs.
• Effective communicator, both verbally and in writing, and ability to facilitate open cross-functional collaboration.
• Ability to prioritize responsibilities and meet deadlines.
• Ability to self-motivate and work independently.
• Ability to travel to CRO partners as needed.

Requirements

• Effectively manage day-to-day study related activities and work with Contract Research Organizations (CROs), internal subject matter experts, and toxicologists to help design and develop protocols, and monitor GLP and Non-GLP toxicology studies required for preclinical testing of drug candidates.
• Assisting toxicologists in the review of protocols, study reports, and protocol/report amendments for external studies to ensure high quality deliverables from CROs.
• Coordination of study-related activities with toxicologists and other internal groups supporting nonclinical studies (eg, Project Management, CMC, Bioanalytical, Regulatory, Finance, and Legal), and CROs to ensure program needs and timelines are met.
• Tracking nonclinical study milestones against project goals.
• Participation in regulatory submissions (eg, preparation and/or review applicable nonclinical sections of IBs, NDAs, BLAs, etc.)
• Develop and maintain relationships with study directors, principal investigators, and external collaborators.
• Work with QA to facilitate CRO vendor selection/audit and due diligence activities.
• Negotiating contracts/SOWs and process for approval/full execution.
• Supports development and/or review of SOPs, policies, and guidelines.

Preferred Skills

• BS degree in science and minimum 5+ years of relevant experience in biotech, pharmaceutical and/or CRO industries.
• Knowledge of current GLP regulations, and ICH and FDA guidelines for drug development.
• Strong interpersonal skills and ability to work with cross-functional project teams and CROs.
• Effective communication, both verbally and in writing, and ability to facilitate open cross-functional collaboration.
• Ability to prioritize responsibilities and meet deadlines.
• Self-motivated and independent work ethics.
• Ability to travel to CRO partners as needed.

Benefits

• Competitive cash compensation.
• Robust equity awards.
• Strong benefits.
• Significant learning and development opportunities.

Base Pay Salary Range

$150,000 — $189,000 USD