Vice President, Clinical Operations
Atomwise is a technology-enabled pharmaceutical company leveraging the power of AI to revolutionize small molecule drug discovery. The Atomwise team invented the use of deep learning for structure-based drug design; this technology underpins Atomwise’s best-in-class AI discovery engine, which is differentiated by its ability to find and optimize novel chemical matter.
Atomwise has extensively validated its discovery engine, delivering hit ID success in over 200 academic and collaboration projects-to-date including a wide-variety of protein types and numerous “hard-to-drug” targets. Atomwise is building a wholly-owned pipeline of small-molecule drug candidates, with two programs in lead-optimization and programs in immunology and oncology in the discovery stage.
The company has raised over $174 million from leading venture capital firms to advance its mission to make better medicines, faster.
About the role
Atomwise is hiring a VP of Clinical Operations, a key member of the clinical development team who will oversee execution of Company’s clinical studies efficiently and with high quality, meeting corporate timelines and following local and global requirements. This individual will be instrumental in hiring and/or managing related positions, e.g., Data Management, Biostats, Stats Programming, CTAs, CTMs, and growing the Clinical Operations organization.
- Responsible for contributing to the drug development strategy, planning, execution, and cost projections for all Clinical Operations development programs
- Provides strategic guidance and direction to cross-functional study teams, consultants, and vendors to ensure successful study execution
- Identifies potential vendors, reviews proposals, and manages the selection process; oversees selection and management of CROs to ensure coordinated execution and high-quality study deliverables
- Acts as primary leader for CRO’s and vendors for assigned clinical studies/programs
- Responsible for strategic development of the clinical strategy and plan for execution of clinical studies/programs (i.e., generation of operational timelines, enrollment models, assessment of availability of the patient population, complexity of trial designs etc.)
- Interacts with and influences all levels of management and cross-functional team members to develop strategies and execute plans to achieve program objectives
- Review and provide expert clinical operations input to and ensure consistency of clinical documents within program and across as needed (study protocols, clinical study reports, study plans, regulatory documents, etc.)Responsible for operational decision making, risk mitigation, and contingency planning as well as operational efficiency and innovation at the study/program level
- Develops, forecasts and monitors study related budgets, contracts and financial updates
- Prepares training materials, SOPs and presentations related to the planning and conduct of the trial
- Responsible for executing clinical programs in compliance with quality standards (ICH/GCP, Global Regulations, and Atomwise policies and all applicable procedures)
- Travels to development partners, CRO’s, vendors, and clinical sites, as needed
- Key person to interface with investigators and study staff
- BS, BA in life science or equivalent
- At least 10+ years of experience pharmaceutical industry/clinical research
- At least 8+ years with direct experience in Clinical Operations/project management of Phase 1-3 global clinical trials and having demonstrated a high level of technical and leadership competencies
- Strong knowledge of FDA regulations and GCP/ICH guidelines, and knowledge of regulatory requirements regarding clinical trial management
- Responsible for maintaining Clinical Operations business standards across studies, including CT.Gov and other regulatory reporting requirements and other clinical trial management systems, including maintenance of the clinical trial master files and other required documentation systems
- Responsible for the Clinical Program(s) always maintaining a state of inspection readiness
- Responsible for operational decision making, risk mitigation, and contingency planning as well as operational efficiency and innovation at the study/program level
- Experience in successful study initiation through study completion/primary data analysis and in multiple phases of clinical trials
- Ability to demonstrate successful coaching/ mentoring and people management (remote management experience preferred)
- Must be able to work in a fast-paced environment with demonstrated ability to juggle multiple competing tasks and demands
- Strong interpersonal skill set to interact with investigators, vendors, and individuals at all levels of the organization
Compensation & Benefits
- Competitive salary, commensurate with experience
- Stock compensation plan – you’ll be an Atomwise co-owner
- Platinum health, dental, and vision benefits for you and your dependents
- 401(k) retirement plan with generous company match (up to 4%)
- Flexible paid time off (PTO), 13 paid holidays, and wellness breaks for employees to spend time with their loved ones and recharge
- Health Savings and Flexible Spending Account options to help save money on healthcare, daycare, and commuting
- Employee Assistance Program (EAP) and Pet Insurance
- Funding for professional development and conference attendance
- Flexible work schedule
- Generous paid parental leave
Atomwise is an equal opportunity employer and strives to foster an inclusive workplace. Our mission is to develop better medicines faster, and we know that we need a diverse team to develop medicines that serve diverse populations. Accordingly, Atomwise does not make any employment decisions (including but not limited to, hiring, compensation, and promotions) on the basis of race, religion, color, national origin, gender, gender identity, sexual orientation, age, veteran status, disability status, or any other characteristics protected by applicable federal, state, and local law.
We strongly encourage people of diverse backgrounds and perspectives to apply.
*Pay range for this role is between $285,000 - $315,000*