Sr. Director, Clinical Quality & Compliance | Build/Create/Develop | Fast Growing Biotech | Boston area: RETAINED SEARCH

Cornerstone Search Group
Published
July 15, 2022
Location
Greater Boston Area, United States of America
Category
Job Code
bcsTR1524csg
Contact Email
bskurka@cornerstonesg.com

Description

Sr. Director, Clinical Quality & Compliance | Build/Create/Develop | Fast Growing Biotech | Boston area: RETAINED SEARCH

SUMMARY:  Cornerstone has been retained by an attractive, well-funded and rapidly growing clinical-stage biotech company that focuses on developing first-in-class therapies in the rare disease area.  With quality being at the cornerstone of everything our client does and a key focus as they prepare to progress forward in development, they are expanding their team and looking to hire an industry experienced Quality professional (who has extensive experience in the GCP space) who can provide leadership and direction to and develop the Clinical Quality department, be a true partner/quality representative across the board (i.e. Clinical Ops, etc.), and help mature the organization toward commercial readiness.

This is a unique hands-on leadership opportunity where you will be looked upon to grow and develop the group and help build a Quality culture, as well as systems/procedures/metrics for clinical quality for this fast paced, growing organization, and ensure short term and long term strategies are in place for department success.  This ideal candidate will be a strategic thinker who has experience being part of seeing an application/program through from trial to commercialization, and who enjoys the small biotech space and possesses the right communication style to build rapport/trust with functional leaders.

ATTRACTIVE FEATURES ABOUT THIS POSITION AND COMPANY:

  • Opportunity to Build, Create, Develop: This is an exciting opportunity where you will have the autonomy to grow and develop your own group, and truly help build a quality culture and mature the organization.
  • Visibility & Autonomy: This is a visible role where you will be the “face of Clinical Quality” with a lot of autonomy to make important decisions, and sit at the table with the VP and other senior leaders for key health authority discussions, inspections, etc.
  • Great Time to Join: This is a great time to join this exciting, high-growth biotech company; while they are in the early clinical phase and progressing forward/preparing for later-stage trials, and where you will play a big role in shaping the current/future state of Clinical Quality and truly impact the success and continued evolution/maturity of the organization.
  • “Best of Both Worlds”: Join a well-funded and rapidly-growing company while also getting all the pluses of a smaller early-stage organization (quick decision-making, nimble/agile, high impact/exposure, chance to truly impact/influence, etc.).

ABOUT THE ROLE:

This individual will be responsible for providing leadership, compliance guidance and direction for introduction of investigation products to early-phase clinical trials. This person must have the ability to align, direct and weigh in on clinical quality issues and lead investigations, review and comment on regulatory documents and can author policy and procedure. They will play a leading role in the continued growth of the quality and clinical quality team, including quality strategy, infrastructure, vendor selection/ management, team mentoring, and recruitment, as well as be the quality representative to the clinical operations group. This person will also hire and develop employees within the clinical quality group.

RESPONSIBILITIES:

  • Provide solid technical and organizational leadership to Quality programs and activities and provide leadership and value-added services to the company.
  • Provide consultation in the interpretation of GCP regulations, guidelines, policies, and procedures. Review and advise on the content of protocols, pharmacy manuals, investigators brochures, informed consent, etc.
  • Plan, conduct, and report on independent audits of internal systems/ procedures and vendors. This person shall support, maintain, and review QA systems, clinical training curriculum, and corrective action and preventative actions (CAPAs).
  • Lead the quality oversight for assigned global clinical trials (Phase I-III) in close collaboration with the clinical study team. Produces in close collaboration with clinical study team GCP quality metrics allowing real‐time quality monitoring and reporting; conducts trend analyses of GCP quality system metrics (e.g. audit observations, protocol deviations, CAPAs, GCP QA activities) for quality management reporting.
  • Lead the development and tracking of quality metrics, and lead real‐time quality oversight of the assigned clinical trials.
  • Rational persuasion particularly in discussion with and between product development/IP production, and Clinical Operations departments.
  • Lead and manage the review and approval for supplier/vendor oversight with regard to CRO and CTLs.
  • Strategize about and drive Quality initiatives, author policies and procedures, guide/direct audit programs.

DESIRED EXPERIENCE:

  • 10+ years of relevant experience (with 7+ years of experience in a GCP environment) working at a pharmaceutical and/or biotech company.
  • Bachelor’s degree in a life sciences/scientific or related disciple. An advanced degree is preferred.
  • Extensive knowledge of FDA/EMA regulatory requirements applicable to GCP, clinical trial quality management for biologics.
  • Has ideally been part of seeing an application/program through from trial to commercialization, and has been on the receiving end of a successful FDA inspection.
  • 5+ years of experience leading (direct reports) and developing personnel.
  • Prior orphan drug/rare disease experience is a plus.
  • Ability to travel as necessary up to 20% for potential audits.

CORNERSTONE’S PRIVACY POLICY:

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 be shared with any parties outside of Cornerstone Search Group without your prior permission.

CONTACT:

Brian Skurka | Partner

E: bskurka@cornerstonesg.com

P: 973-656-0220 x738

LinkedIn: https://www.linkedin.com/in/brianskurka1

Cornerstone Search Group, LLC

350 Main Street | Chatham, New Jersey 07054 USA

www.cornerstonesg.com

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