Senior Director, Clinical Operations
Sumitomo Pharma America, Inc.
Google Cloud Platform
Vice President, Clinical Operations
Avalyn Pharma
full-time
Posted on:
Location Type: Remote
Location: Remote • Massachusetts • 🇺🇸 United States
Visit company websiteJob Level
Lead
Tech Stack
Google Cloud Platform
About the role
- Develop and execute a comprehensive strategic vision for the clinical operations department, ensuring alignment with Avalyn’s broader organizational objectives.
- Lead the planning, initiation, execution, and closure of all clinical trials globally, including complex, early-phase, and late-phase studies.
- Oversee departmental resource planning, including budget allocation, staffing, and infrastructure.
- Ensure all clinical operations adhere to relevant regulations (FDA, EMA, ICH-GCP) and internal quality standards.
- Establish and maintain strategic relationships with external vendors, CROs, laboratories, and other service providers.
- Identify potential risks in clinical trial execution, including data integrity, patient safety, and protocol adherence.
- Build and lead a robust, motivated clinical operations team.
- Collaborate closely with internal stakeholders (Senior Leadership, Clinical Development, Medical Affairs, Regulatory) and external partners to align clinical operations with organizational strategy.
- Oversee the use of data, KPIs, and metrics to monitor trial progress, quality, and operational performance.
Requirements
- Advanced degree in life sciences, medicine, pharmacy, or a related field; Ph.D., M.D., or equivalent preferred.
- 15+ years of progressive leadership experience in clinical operations within the pharmaceutical, biotech, or healthcare industry, with a proven track record in managing large, global clinical trial programs.
- Extensive experience managing a department or function, including leading large teams and cross-functional groups.
- Deep knowledge of regulatory requirements (FDA, EMA, ICH-GCP), clinical trial conduct, and GXP standards.
- Demonstrated success in vendor management, contract negotiations, and strategic partnering.
- Strong financial acumen, with experience managing departmental budgets and resource planning.
- Excellent leadership, strategic thinking, and decision-making skills, with the ability to influence and motivate at all levels.
- Exceptional communication, interpersonal, and stakeholder management capabilities.
- Experience with clinical trial technology and data systems is advantageous.
- Previous experience in rare diseases or respiratory therapeutics is preferred but not mandatory.
Benefits
- Health insurance
- 401(k) matching
- Flexible work hours
- Paid time off
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical trial managementregulatory compliancebudget managementresource planningdata integrityprotocol adherencevendor managementcontract negotiationsstrategic partneringGXP standards
Soft skills
leadershipstrategic thinkingdecision-makinginfluencemotivationcommunicationinterpersonal skillsstakeholder management
Certifications
Ph.D.M.D.
