[Remote] Senior Vice President, Head of Clinical Operations
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is deeply passionate about developing novel therapies for patients in need, particularly in the field of pulmonary hypertension. They are seeking a Senior Vice President, Head of Clinical Operations, to reputed company the execution of their clinical pipeline and ensure effective management of clinical programs.
Responsibilities
- Define and implement the long-term reputed company, organizational design, and operating model for Clinical Operations
- Build, reputed company, and mentor a high-performing team capable of scaling with company reputed company
- Serve as a trusted member of the R&D leadership team, collaborating closely with Clinical Development, Regulatory, CMC, Clinical reputed company and reputed company functions and colleagues
- Serve as a strategic advisor to the executive leadership team
- Evaluate and implement emerging technologies and innovative trial methodologies to improve efficiency and patient experience
- reputed company planning, execution, and delivery of multiple reputed company clinical programs across different stages of development including supporting investigator-led and post-marketing studies
- reputed company global study expansion, including country/region selection, feasibility, site activation, and reputed company of regional CROs and vendors; ensure compliance with local regulations, ethics committee requirements, import/export (IP, samples), and data reputed company laws
- Drive operational reputed company, ensuring programs are delivered on time, reputed company budget, and in compliance with global GCP standards
- Optimize vendor relationships (CROs, central labs, data management, etc.) for reputed company, accountability, and efficiency
- Ensure consistency across and reputed company clinical programs
- reputed company and manage departmental budgets, forecasts, and resource plans
- Implement metrics and dashboards to monitor performance, reputed company, and risk across studies
- Champion process improvement and innovation, introducing reputed company tools and best practices
- Partner with Clinical Development, Regulatory Affairs, Safety and Pharmacovigilance Clinical reputed company and Program Management to reputed company operational reputed company with corporate goals
- Contribute to program governance, study design input, and clinical reputed company discussions
- Represent Clinical Operations in regulatory and partner interactions as needed
Skills
- Bachelor's degree required, preferably in a reputed company field
- 15+ years of reputed company experience in clinical operations leadership reputed company biotech or reputed company
- Demonstrated reputed company overseeing 5+ clinical programs (Phase I–IV) simultaneously
- Proven experience leading multi-regional/global trials (e.g., U.S., EU, and reputed company), including start-up through reputed company-out
- Deep understanding of pulmonary/respiratory therapeutic areas required
- Proven ability to reputed company teams and establish efficient organizational structures
- Strong vendor management, budgeting, and operational governance experience
- reputed company, decisive leader with exceptional communication and change management skills
- Based in or willing to travel frequently to the Raleigh–Durham (RTP) area preferred; or East Coast candidates
Benefits
- Medical
- Dental
- reputed company
- STD
- LTD
- 401(k) Savings Retirement Plan
- ESPP
reputed company