Associate Director or Director – Clinical Operations
| Company | Kymera Therapeutics |
|---|---|
| Location | Belmont, MA, USA |
| Salary | $Not Provided – $Not Provided |
| Type | Full-Time |
| Degrees | Bachelor’s |
| Experience Level | Senior, Expert or higher |
Requirements
- BA/BS in a scientific field of study with 8+ years of relevant experience working in the pharmaceutical/biotech industry; Immunology & Inflammation experience strongly preferred
- Experience as a clinical operations lead on complex, global phase 2 clinical trials
- In-depth understanding of industry standards and applicable guidelines; FDA regulations and ICH GCP knowledge
- Experience in developing Clinical Operations SOPs and metrics
- Proven leadership experience with the desire and ability to work in a fast-paced, matrixed, start-up environment
- Strong collaboration and team-working, communication and organizational skills required
- Strong problem solving and analytical skills necessary
- Ability to prioritize and manage time demand, incomplete information, and unexpected events
- Willing to travel domestically and internationally
Responsibilities
- Clinical study lead for clinical development trial(s) ensuring successful planning, implementation and conduct of the assigned clinical trial(s)
- Oversee and manage the CRO(s) to ensure timelines of clinical development plans are met
- Work with the clinical trial team to identify and evaluate issues in the study, and suggest and implement solutions
- Participate in design and development of clinical trial protocols
- Provide oversight for development of specific study documents (informed consent forms, study guidelines, operation manuals & training materials)
- Oversee and assist with the development of the clinical components of regulatory submissions
- Analyze and develop action plans to address protocol compliance, safety, data and administrative issues with investigational sites
- Oversee and manage clinical trial budget
- Evaluate site and study performance metrics against agreed upon budget, deliverables and timelines
- Write and review clinical documents such as protocols, trial reports and SOPs consistent with GCPs and other applicable government and regulatory standards
- Lead and mentor others in Clinical Operations
Preferred Qualifications
- Immunology & Inflammation experience strongly preferred