VP, Clinical Operations
Description
SUMMARY: Our client is a rapidly growing and well-funded clinical-stage biotech company seeking an accomplished VP, Clinical Operations to build, scale, and lead its Clinical Operations organization during this pivotal period of pipeline advancement and organizational growth. This is a newly-created role that calls for someone who can operate at both ends of the spectrum: an executive capable of setting strategy and building for the future, but also a hands-on, roll-up-your-sleeves leader willing to personally engage in the details.
This company is developing a differentiated pipeline/portfolio of innovative 1st-in-class therapies (across all phases) designed to transform the treatment of serious and underserved rare diseases.
This is a particularly compelling opportunity for an experienced Clinical Operations executive who wants to do more than oversee an established function. Reporting directly to the Chief Medical Officer, this leader will have broad ownership of Clinical Operations and the opportunity to shape the infrastructure, operating model, capabilities, and team required to support an increasingly mature and expanding clinical portfolio.
Location
Greater Boston Area
Features
ATTRACTIVE FEATURES ABOUT THIS POSITION AND COMPANY:
- Unique “Ground-Floor” Opportunity: This is not a traditional “maintain what already exists” Clinical Operations leadership position. You will be looked upon to build and shape the function for the company's next phase in its evolution/maturation, while remaining close enough to the programs to directly influence how trials are designed and executed. A rare combination of late-stage execution, pipeline breadth, company-building, and meaningful executive-level influence.
- Perfect Time to Join: Join at an exciting inflection point where the organization has meaningful clinical validation, an increasingly mature portfolio, financial strength and program runway—but remains small and agile enough for one exceptional leader to have an outsized impact on how the company operates and what Clinical Operations ultimately becomes
- Build and Scale Leadership Opportunity: This leader will have broad ownership of Clinical Operations and the opportunity to shape the infrastructure, operating model, capabilities, and team required to support an increasingly mature and expanding clinical portfolio.
- Best of Both Worlds: Join a company which offers a rare combination of biotech upside / high-impact/ entrepreneurial feel, as well as pipeline breadth / strong financing / financial runway.
Responsibilities
The VP, Clinical Operations will report to the Chief Medical Officer and have overall responsibility for the management of all aspects within the Clinical Operations department to include operational oversight and strategy of the clinical programs. This VP will build, scale, and lead a high-performing Clinical Operations organization, and will be responsible for people management (direct reports), cross-functional management, executive-level collaboration, strategy, vendor relationships, compliance, and budgets/resources.
The ideal candidate is both a builder and a doer: someone who has stood up clinical operations infrastructure before and is equally comfortable setting strategy and personally managing critical study details; combines strategic leadership, early-to-late phase trial execution experience, organizational building capabilities, and a willingness to remain hands-on.
- Provide overall leadership and strategic direction for the Clinical Operations function and ensure the successful operational delivery of the company's clinical development portfolio.
- Provide expertise for all aspects of clinical operations, including program strategy, vendor oversight, budget management, protocol development, and providing strategic and tactical guidance in the planning, execution, and reporting of all operational aspects of the clinical trials.
- Provide innovative strategies and tactics designed to help the company achieve its goals.
- Establish and maintain functional excellence in all scientific and operational aspects.
- Define and execute the clinical operations strategy in alignment with corporate goals, development timelines, and portfolio priorities.
- Perform gap analysis and develop processes and procedures for clinical trial conduct.
- Set clear goals, objectives, and milestones for Clinical Operations with the Chief Medical Officer that are consistent with departmental and corporate objectives and priorities.
- Drive innovation into the Clinical Operations function and advance the company’s systems and processes.
- Establish meaningful operational metrics, dashboards, and reporting that provide senior leadership with clear visibility into study and portfolio performance.
- Effectively lead the management of CROs/external vendors, considering appropriate KPIs and metrics, through both hands-on oversight as well as through delegating tasks internally.
- Develop long-range operational, resource, and budget plans that anticipate the company's growth and the needs of a maturing pipeline.
- Provide operational input to protocols, development plans, and regulatory submissions.
- Implement and incorporate performance metrics into development planning to ensure optimal operational strategies.
- Help shape a culture of quality, accountability, speed, and collaboration during a period of rapid growth.
- Represent the company externally and travel to investigative sites as needed.
Qualifications / Requirements
DESIRED BACKGROUND & EXPERIENCE:
- Bachelor’s degree is required. An advanced degree in life sciences or related field is preferred.
- 15+ years of relevant and progressive clinical operations experience gained working in the industry for a pharmaceutical and/or biotech company, preferably a mix of both.
- A proven track record of building, scaling, hiring, developing, and leading Clinical Operations teams and functions.
- Proven ability to work effectively in a fast-paced and hands-on environment, and the ability to move seamlessly between executive-level strategy and study-level execution.
- Experience in hematology, blood disorders, rare disease or other complex specialty development areas is desirable.
- Ability to prioritize, adapt quickly, and make sound decisions amid ambiguity and shifting priorities.
- Proven track record of successfully delivering global clinical trials across multiple phases, ideally including pivotal studies supporting regulatory approval.
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