Sr. Director (Head), Clinical Operations – Late-Stage Biotech – report to CMO:
RTP, NC Area: RETAINED SEARCH
Summary: Cornerstone Search Group has been retained by the CEO of a late-stage, cutting-edge biotech company whose first-in-class, lead clinical candidate is in late-stage clinical development for its initial indication, which has achieved the FDA’s “Fast Tracked” designation. In this critical and highly-visible role that is based in the RTP, North Carolina Metro Area, you will oversee all Clinical Operations (strategy, people management, vendor management, budget, etc. for project management, data management, and clinical monitoring), report to a personable and respected CMO, and work closely with the executive leadership team. Our client is backed by several well-known biotech venture capital companies. Given the smaller biotech environment, our client is seeking a Clin Ops professional who wants to “roll up their sleeves” and can positively collaborate cross-functionally within the organization.
Company: This well-funded, innovative, pre-IPO biotech has a well-proven leadership team with demonstrated success leading pre- & post-IPO companies.
Title: Senior Director, Clinical Operations
Location: Research Triangle Park, NC metro area. Our client is seeking someone who currently lives in the area or has ties to the area.
Attractive Features about this Position and Company:
- Complete ownership of the Clinical Operations department: You will be the highest ranking Clin Ops professional within the organization and will report directly to the CMO. Responsibilities will include team, people, trial and resource/timeline/budget management while also having the ability to develop and implement the strategic vision for the department. The functions under the Clinical Operations department include Clinical Project Management, Data Management, CRA Monitors, etc.
- Gain Valuable Phase III & Regulatory Submissions Experience: You will have the opportunity to step in and gain experience (Ph. III and NDA) that is highly coveted within the industry.
- Visibility: You will work alongside the entire executive leadership team, getting to know and interacting meaningfully with the C-level executives.
- Innovative Company: This company is focused on innovative therapeutic approaches. Their lead compound in development is a first-in-class, internally developed candidate that has gained FDA “Fast Track Status” for its initial indication.
- Small Company Culture: You will be working in a collegial, fast-paced environment where you’ll have the opportunity to put strategy and plans more quickly into motion due to their being less “red tape” than is typically found in mid-sized to larger companies.
- Accountable for the leadership of daily operations and oversight for all clinical operations department activities (clinical project management / data management / clinical monitoring, etc.).
- Ownership and oversight of study/program timelines, budgets, resources, reporting and key project deliverables.
- Provide line management (hiring, training, coaching/mentoring, performance reviews) to Clinical Trial Managers, Sr. CRAs/Site Relation Managers, and other clinical staff.
- Collaborate with MDs (including the CMO who is the hiring manager) to ensure successful initiation and execution of clinical studies.
- Contributes to organizational operations and supports the mission by encouraging interdepartmental and communication/collaboration.
- Effectively work cross-functionally with other related functions within the organization.
- Provide clinical input into the management of Clinical Trial Material by coordinating with CMC personnel regarding drug supply.
- Provide clinical input into on-going SOP development.
- Participate in executive-level meetings and conference calls with Senior/Executive-level leadership, the CMO, Medical Director, etc.
- Bachelor’s degree is required.
- 7 to 10+ years of relevant Clinical Operations experience. Experience should include some time spent in Biotech/Pharma rather than solely in a CRO.
- People management/leadership experience. Prior Clin Ops Department leadership is not required, but prior people management is.
- Ability to interact and collaborate cross-functionally.
- Passion and desire to bring an innovative, life-saving clinical candidate to market.
- Ability to work in a hands-on setting.
- Ability to travel 10-15% domestically (primarily) and globally (just 1 or 2 weeks).
Thomas J. Fascia | Partner
CORNERSTONE SEARCH GROUP - Life Sciences Executive Search
Six Campus Drive | Suite 301 | Parsippany, New Jersey 07054 USA
CH: 41 61 508 7010
Recently Completed / Current Search Assignments:
- VP, Head of Clinical Operations – Oncology Biotech
- Global Head of Clinical Operations/Regional Monitoring – Oncology Biotech
- VP, Global Program Leader, Immuno-Oncology – Mid-sized Pharma
- CMO, Oncology Biotech – Boston
- VP, Head of Real-World Evidence – Top 5 Pharma