At Recursion, we combine experimental biology, automation, and artificial intelligence to quickly and efficiently identify treatments for human diseases. The Director of Clinical Operations will lead all clinical operations functions for Recursion’s development programs.
THE PROBLEMS YOU’LL SOLVE
You’ll work to collaborate with multidisciplinary groups to advance clinical stage assets to achieve data and regulatory milestones. In a highly virtual environment, initially this role will have oversight of clinical operations, biometrics (data management, statistical programming, and statistics), medical writing, and pharmacovigilance.
The Director of Clinical Operations will report to the Senior Vice President, Strategic Development and will be a key contributor in building out a GxP compliant early development organization.
Success in this role consists of running ethical, patient-focused, clinical studies that meet the regulatory and business needs of the organization.
This means that we need someone inspired by the needs of underserved patient populations, motivated to create a new type of early development organization, and excited to take build a rapidly growing and dynamic team. If this describes you, let’s talk!
In this role you will:
- Provide executive oversight of current and future global clinical programs for all indications from Phase 1 onward
- Provide direct oversight and management of operations and personnel involved in clinical operations, biometrics, medical writing, pharmacovigilance, clinical supplies management, and other functional groups as assigned
- Provide operational and clinical expertise and strategic insights to develop a life-cycle strategy and evaluation of new programs to be prioritized or advanced into clinical development
- Develop clinical timelines and budget forecasts and be accountable for tracking and delivering accordingly
- Review master service agreements, statements of work, and quality agreements relating to outsourced functions
- Provide oversight of global CROs and vendors from identification to selection to close of contracts
- Participate in developing and providing input to protocols, annual safety reports, Investigator Brochures, clinical study reports, publications/presentations and regulatory submissions
- Ensure that clinical trials are properly resourced, managed and executed in accordance with timelines and good quality practices
- Plan clinical headcount and hiring needs to meet program workload demands
- Implement best practices and standards for trial management in collaboration with other members of the clinical operations team, including establishment of SOPs
- Lead initiatives to build clinical department infrastructure
- In collaboration with QA, ensure that clinical trials are conducted in compliance with applicable regulatory requirements and inspection-ready
- Represent/advocate for clinical operations needs/resources at a senior management level
- Other duties as assigned
THE EXPERIENCE YOU’LL NEED
- Degree in the life sciences or related field
- At least 15 years of clinical operations experience in a pharmaceutical/biotech environment, including global experience. At least 3 years within a similar role as listed in this job description.
- Global clinical trial management experience with rare disease experience highly preferred
- Experience managing CROs and vendors throughout entire clinical operations life cycle
- Proven success participating in cross-departmental (senior management, regulatory, QA, CMC, program management, finance, business development, pharmacovigilance, medical affairs, clinical development, medical writing) clinical strategy, planning and implementation activities
- Proven success in leading and coordinating cross-functional clinical operations teams (e.g., clinical operations, data management, biostats, clinical supply chain)
- Direct experience with sponsor, site, and/or vendor preparation for and participation in regulatory inspections, with global experience preferred
- Excellent working knowledge of FDA, EMA, PMDA regulations and expectations, Good Clinical Practice, ICH guidelines, and clinical operations best practices
- Collaborative and team-oriented
- Demonstrates strong problem-solving, communication, and leadership skills
- Demonstrates strong organizational, project management, and soft skills
- Willing to travel to support clinical and corporate activities
THE PERKS YOU’LL ENJOY
- Coverage of health, vision, and dental insurance premiums (in most cases 100%)
- 401(k) with generous matching (immediate vesting)
- Stock option grants
- Two one-week paid company closures (summer and winter) in addition to flexible, generous vacation/sick leave
- Commuter benefit and vehicle parking to ease your commute
- Complimentary chef-prepared lunches and well-stocked snack bars
- Generous paid parental leave (including adoptive)
- Fully-paid gym membership to Metro Fitness, located just feet away from our new headquarters
- Gleaming new 100,000 square foot headquarters complete with a 70-foot climbing wall, showers, lockers, and bike parking
WHAT WE DO
Poised at the crossroads of biology and computation, Recursion is revolutionizing the pharmaceutical industry’s approach to drug discovery and development. Our unique platform leverages the most advanced biology, high-throughput automation, and artificial intelligence to rapidly discover treatments for rare diseases, diverse immune and inflammatory diseases and new indications in the future.
Recursion is an equal opportunity employer and complies with all applicable federal, state, and local fair employment practices laws. Recursion strictly prohibits and does not tolerate discrimination against applicants because of race, color, religion, creed, national origin or ancestry, ethnicity, sex, pregnancy, gender (including gender nonconformity and status as a transgender individual), age, physical or mental disability, citizenship, past, current, or prospective service in the uniformed services, or any other characteristic protected under applicable federal, state, or local law.