Head of Clinical Operations
- Job Title
- Head of Clinical Operations
- Job ID
- Boulder, CO
- Other Location
OnKure is looking for a Head of Clinical Operations. The Head of Clinical Operations (Level based on Experience) will be responsible for leadership, strategic planning, and oversight/execution of clinical studies in the clinical development portfolio. They will contribute clinical operations expertise in cross functional meetings and initiatives. They will mentor and manage a team of highly motivated clinical operations professionals.
- Strategic Planning:
- Contribute to and implement overall strategy for the clinical operations team and programs in OnKure’s portfolio
- Support strategic and operational development of protocols to enable achievement of key development strategies
- Identify methods, means, and risk mitigations to ensure achieving clinical trial goals
- Provide operational execution strategies and input to clinical study design
- Overall Management of Clinical Trials:
- Responsible for overseeing all clinical trials in OnKure’s portfolio, including mentoring and supporting staff and CROs
- May provide hands on support of studies to ensure clinical trials are conducted in accordance with the protocols, Standard Operations Procedures (SOPs), Good Clinical Practices (GCPs), and other applicable regulatory requirements
- Lead and ensure effective delivery from Clinical Operations teams in the management of contract research organizations (CROs) and other trial vendors
- Understand and account for cost drivers for clinical studies
- Ensure delivery of clinical trial activities on budget and on time
- Manage and reconcile overall study budgets
- Foster Partnership:
- Build strong partnerships across cross functional groups (CMC, Regulatory, Development Operations, legal and finance) and external partners to drive clinical trial success
- Operational Excellence:
- Identify gaps and contribute to process improvements to drive streamlined clinical trial execution, implementing best practices, and developing defined roles and responsibilities within the clinical operations team
- Metrics, Tracking and Reporting:
- Partner with external partners and internal study leads to develop metrics, tracking dashboards, and reporting mechanisms to leadership for real time study updates
- Maintain accountability to clinical study deliverables and timelines
Preferred Experience and Qualifications:
- BS or higher Degree in a scientific discipline, with an advanced or professional degree desirable
- 15+ years clinical development experience, including direct experience in Oncology
- Experience leading cross-functional teams and executing complex clinical studies utilizing CRO partners and in house lead clinical studies
- Experience in design, and execution of early phase through registrational clinical studies
- Strong regulatory knowledge of oncology clinical development regulations in the US and competency in non-US region regulations
OnKure, Inc. is a private biotech company, based in Boulder, Colorado. The company was founded and is led by several scientific leaders from Array BioPharma, another Boulder-based company. Our mission is to create novel, high quality drugs to provide meaningful therapy for cancer patients. Our near-term goals are to advance our clinical stage drug, OKI-179, into several Phase 2 clinical trials, build a state-of-the-art drug discovery group and establish a robust pipeline of projects and development candidates.
Our Boulder facilities feature modern offices, and new laboratories are under construction. With the mountains at our doorstep, great schools, cultural and unparalleled outdoor activities, Boulder is the No. 1 place to live out of the 150 most populous metro areas in the U.S. for the second year in a row!
To attract the very best talent, OnKure offers a generous compensation and benefits package that includes competitive pay, performance-based bonus opportunities, stock options, insurance coverage (health, dental, life, and disability), self-managed paid time off, and a 401(k) plan with company match. We operate on a flexible schedule that allows a combination of both in-office and home-based work.
The annual compensation range for this role, based on experience, is $175,000-$290,000.
OnKure is an equal opportunity employer and welcomes all job applicants. All qualified applicants will receive consideration for employment without discrimination based on race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other protected factors.
- Strategic Planning: