What are the responsibilities and job description for the Associate Director Clinical Operations position at Curve Biosciences?
Associate Director, Clinical Operations
About the Company
Curve Biosciences™ (“Curve”) is creating AI-driven insights into biology for ~130 million patients with chronic disease. Our Whole Body Atlas, the largest tissue database in the world, uniquely enables the company to deliver these precise biological insights and complement other clinical tools. Led by a team with decades of biotech experience and multiple successful exits, Curve is focusing on chronic liver care with the vision to rapidly expand to other chronic diseases.
At Curve, we are committed to transforming chronic care by monitoring disease progression, enhancing patient compliance, lowering healthcare costs, and improving health outcomes. Our potential to transform chronic care relies on generating strong evidence in thoughtful clinical studies. We are seeking a skilled clinical operations professional to help lead our clinical studies who is passionate about impacting the lives of individuals facing chronic health challenges.
The Associate Director of Clinical Operations will work with the Head of Clinical Operations and COO in achieving these goals. To excel in the role, we anticipate candidates to have technical expertise, exceptional communication skills, and a cultural fit to embrace teamwork, adaptability and innovative thinking from their 8 years of previous work experience. Study experience with blood-based tests and / or medical imaging is a plus. If you are passionate about making a real difference in people’s lives and eager to be in a team that is developing innovations compatible with efficient healthcare delivery, we encourage you to apply.
Responsibilities
The Associate Director of Clinical Operations will be responsible for study set up and execution, as well as all vendor management and sponsor oversight activities. Activities will include vendor selection / management, protocol / study document development and study start-up, maintenance, and closure in collaboration with the technical team to execute central laboratory activities. Key responsibilities are included below.
- Lead overall operation of the entire clinical study / program including project planning, budget, resource management and contract research organization (CRO) management, in collaboration with the Head of Clinical Operations and COO
- Handle clinical operational plans and incorporate the study and scientific plan
- Oversee development of study related documents and overall direction for the CRO and clinical sites to adhere to study and protocol requirements
- Ensure compliance with good clinical practices and regulatory guidelines
- Ensure issues are escalated, managed, and documented with high quality standards through resolution
- Recommend and implement innovative process ideas to impact clinical trials management
- Oversee study budget, including close oversight of CRO and vendor activities according to relevant statements of work and budgets
- Oversee and document CRO and vendor oversight through the life of the study with inspection readiness in mind, covering all cross-functional development activities outsourced to the CRO or vendor, including third-party vendors contracted by the CRO
- Oversee development and execution of in-house central laboratory activities required for the conduct of the study
- Implement inspection readiness through the life of the study, and support quality documentation and (if needed) preparations for regulatory inspections
- Prepare and present regular project reviews for Head of Clinical Operations, leadership team and other internal or external stakeholders
- Drive and support a collaborative, respectful, quality and results-driven culture with colleagues, consultants, and CRO partners
- Support Head of Clinical Operations, COO and Executive Team in overall clinical strategy and operations, study design, protocol development, operational infrastructure and more, as additional growth opportunities in this role
Job Skills and Qualifications
Preferred
Employee Benefits
Curve Biosciences is dedicated to improving our patients’ lives and supporting our employees’ dreams. Some of our employee benefits include :
Curve Biosciences is an equal opportunity employer. We highly value diversity at our company and do not discriminate on the basis of race, religion, color, national origin, gender, age, sexual orientation, marital status, veteran status or disability status.
Salary : $140,000 - $170,000