Director of Clinical Operations
3 weeks ago
The Director of Clinical Operations is a critical role in the organization responsible for overseeing all clinical trial operations and team members. You will provide leadership, management, and oversight to the clinical operations department. You will report directly to the CEO and be responsible for working cross-functionally to build clinical and operational strategies and promote innovation and process excellence.
HOW YOU’LL MAKE AN IMPACT
- Lead and direct all site operations (both day-to-day and long-term) across end-to-end trial services offering (e.g., site qualification through closeout), overseeing administrative, clinical, and operational functions while ensuring compliance with regulatory requirements and superior quality standards.
- Responsible for overseeing all clinical team members, and ensuring cross-functional collaboration with the rest of the organization to complete project milestones within budget, scope, time-frame.
- Manage all levels of internal clinical operations, including internal dashboards with agreed-upon KPIs, clinical and financial reporting to the CEO and leadership team.
- Strategize innovative methods to drive efficient site performance aligned to agreed-upon KPIs, with a core focus on improving patient recruitment and retention, and time to value.
- Develop, implement, and own all standard operating procedures (SOPs) across all trial sites, ensuring standardization of services and quality.
- Develop and routinely iterate on strategic plans for core business expansion into new therapeutic areas, geographies, sites, etc. and own the implementation of expansion efforts, including new site startup.
- In partnership with BD leadership, develop study budgets that are complete and exhaustive of all study and site costs, and negotiate study budgets directly with sponsors.
- Develop, implement, and own rigorous data fidelity standards for clinical documentation across all trial sites and team members, and develop frameworks to ensure quality assurance.
- Direct and execute on all physician network development efforts across trial sites and geographies, through collaboration with existing employees, board members, and principal investigators (PIs) to support, grow and expand the Company’s network of principal and sub investigators across study indications.
- Maintain and grow existing strategic partnerships with patient recruitment and physician network vendors, and develop/recommend additional alliances for consideration.
- Build and maintain long-term professional relationships with clinical investigators, sponsors and monitors.
ON YOUR FIRST DAY WE’D LIKE YOU TO HAVE
- Bachelor's degree in biology, clinical research, project management, or related field
- Minimum of 8 years experience in clinical research, including a minimum of 5 years in a lead clinical operations and/or clinical project management role(s)
- Experience in a clinical or research function in the past (MD, PA, RN, PhD, CRC)
- Exceptional working knowledge of ICH-GCP, US CFR, and HIPAA
- Experience running clinical teams in pharma, CROs, site networks, or similar startups
- Experience with trial contracting, budgeting and invoicing, oversight and implementation of trials
- Ability to write, implement and ensure compliance with company SOPs
- Strong leadership skills with proven ability to lead internal and external teams
- Ability to work independently and make appropriate strategic decisions to operationalize and move clinical projects forward
- Ability to oversee multiple projects concurrently, while maintaining attention to detail
- Ability to prioritize tasks and resources, meet deadlines, and be adaptable to changing priorities
- Excellent written and oral communication and presentation skills
WE OFFER
- Competitive compensation with upside potential, plus meaningful equity
- PTO (vacation, sick leave, and holidays)
- Healthcare (medical, dental, vision) and retirement (401(k)) benefits
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