Executive Director, Clinical Compliance
Confidential
Executive Director, Clinical Compliance
About the Company
Innovative biotechnology (BioTech) company
Industry
Pharmaceuticals
Type
Public Company
Founded
2017
Employees
51-200
Categories
- Pharmaceuticals
- Medicine
- Manufacturing
- Chemical Products
- Biotechnology
Specialties
- metabolic diseases
- cardiovascular diseases
- pulmonary
- diabetes
- computational chemistry
- and obesity
About the Role
The Company is in search of an Executive Director for Clinical Compliance. The successful candidate will be a strategic leader with a strong background in clinical compliance, quality assurance, and operational excellence within the biotechnology, pharmaceutical, or CRO industry. This role is pivotal in ensuring the company's clinical development programs are in full compliance with regulatory standards and are prepared for inspections and submissions. The Executive Director will be responsible for leading the clinical compliance strategy, strengthening oversight of CROs and vendors, and developing and maintaining processes that support consistent execution and inspection readiness. Applicants must have a BA/BS in a technical discipline, with an advanced degree preferred, and at least 15 years of experience in the field, including a minimum of 7 years in a Director or Senior Director role. The role requires extensive experience in global clinical trials, particularly in Phase 3, and a deep understanding of GCP standards and regulatory requirements. The ideal candidate will have a proven track record of building and leading high-performing teams, be adept at risk management, and have exceptional communication and influencing skills. They should be results-oriented, with a strong sense of integrity, and be able to demonstrate a proactive, solutions-oriented approach to compliance and operational challenges.
Hiring Manager Title
Senior Vice President, Clinical Development Operations
Functions
- Operations
$283k - $325k
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