RETAINED SEARCH: Lead Clinical QA: Late-Phase Biotech (RTP, NC area)
Cornerstone Search Group has been retained by the Global Head of Quality of a late-stage, well-funded, pre-IPO biotech company to identify an experienced Clinical GCP Quality Assurance professional to serve as their first Clinical QA Head. Our client’s lead clinical candidate is a first-in-class, “Fast Tracked” immunotherapy treatment that is in Phase III development for an FDA/EMA designated orphan indication for a life-threatening condition. In this newly-created role, you will establish/revise their GCP QA processes, SOPs, and systems. Given the smaller biotech environment, our client is seeking a candidate that is hands-on, innovative, can positively collaborate cross-functionally across all levels within the organization, and would welcome the opportunity to wear multiple hats, including CMC QA experience.
Company: This well-funded pre-IPO biotech has a well-proven leadership team with proven success leading pre-IPO companies and prior success in this therapeutic area.
Title: Clinical Quality Assurance Lead (title depends upon experience)
Location: Research Triangle Park, NC metro area
Attractive Features about this Position and Company:
- Visibility: A challenging, highly-visible, newly-created role where you will lead Clinical QA and serve as this biotech’s GCP SME.
- Biotech Culture: Work in a collegial, fast-paced environment where you will wear multiple hats, such as having the opportunity to also gain CMC QA experience as well.
- Innovative Science: This company’s Phase III candidate is a first-in-class, novel immunotherapy product that has been “fast-tracked” by the FDA and is aimed at a life-threating condition for which there is no drug therapy available.
- Well-Funded: This company is backed by several highly-regarded, large and successful healthcare investment funds.
Responsibilities in a Nutshell:
This newly-created Clinical QA leadership role will report to the Global Head of Quality and will serve as the company’s first dedicated Clinical QA leader, and will be this biotech’s SME for GCP. Working with Clinical Operations (and their CROs) and CMC (and their CMO), this leader’s responsibilities will include the following:
- Establishing, implementing, and maintaining GCP QA processes.
- Performing GCP gap analysis and reporting on GCP-related deficiencies.
- Writing / revising GCP-related quality system SOPs.
- Ensuring that the clinical trials are performed in accordance with study protocols and are in compliance with all applicable regulatory requirements.
- Conducting quality audits of investigator sites and various clinical vendors (travel is anticipated to be 10%).
- Reviewing and approving corrective/preventive actions to reported audit observations, and ensure proper follow-up documentation is created.
- Conducting quality reviews or audits of clinical study documents, such as IBs, clinical protocols/amendments, CSRs, CRFs, ICFs, etc.
- Conducting targeted training of investigators/site staff when required.
- Support various CMC QA activities as well.
Qualifications Sought / Desired:
- 5 to 10+ years of overall experience, with 3+ years of clinical quality assurance auditing experience preferred. Title awarded will depend upon depth and quality of experience.
- Pharma / Biotech experience is a plus, but not required.
- Scientific education is a plus, but not required.
- Strong knowledge of applicable US CFR, ICH guidelines, and local government requirements governing clinical research.
- Demonstrated ability to multitask and independently prioritize work, manage multiple projects.
- Strong verbal and written communication skills.
- Ability to travel up to 10%.
Cornerstone Search Group considers all inquiries, resume submissions, and any other personal information submitted/shared with us as confidential information. Any information provided/shared with us will not to be shared with any parties outside of Cornerstone Search Group without your prior permission.
Lavinia C. Rodriguez
CORNERSTONE SEARCH GROUP - Life Sciences Executive Search
Six Campus Drive | Parsippany, NJ 07054 USA
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