Our client is a dynamic biopharmaceutical company revolutionizing medicine by merging biology, engineering, and chemistry to discover breakthrough treatments that transform the lives of patients battling life-threatening diseases. They have retained us to assist in their search for a Head of Clinical Operations.

Major tasks and responsibilities include:

• Provide leadership to Clinical Study Management: Build a high-performing team, set strategic direction, and achieve exceptional results. This includes optimizing organizational design and resources, enhancing key processes, managing talent and succession planning, overseeing clinical trial budgets, and leading all therapeutic clinical programs and studies.
• Manage Clinical Study Management activities: Ensure on-time, on-budget delivery of protocols with requisite quality to support regulatory approval. Oversee a global and diverse study management team, ensuring compliance, quality, and timeline objectives are met for all trials.
• Work collaboratively in a matrix organization with all internal and external stakeholders to deliver objectives on time, within budget, and with high quality.
• Collaborate with Functional Service Provider (FSP) as needed to ensure adequate and appropriate resourcing for the company’s internal clinical trial portfolio.
• Support the development and management of Sponsor of Choice site investigator relationships in conjunction with Clinical R&D stakeholders (e.g., Site Engagement & Monitoring Excellence). Contribute to program lifecycle management through effective study resource allocation and execution, including prioritizing programs and engaging with key opinion leaders (KOLs).
• Take responsibility for clinical audits, working closely with the Clinical Quality Assurance group to ensure compliance and cultivate a learning culture with a quality-focused mindset.
• Represent Clinical Operations Study Management in strategic initiatives at all organizational levels.
• Build, enhance, and execute strategies for best-in-class patient enrollment and study delivery.
• Solve clinical study-related challenges effectively with a sense of urgency, using sound judgment in relation to global regulations, guidelines, investigator interactions, and timelines.
• Manage resources effectively to ensure appropriately skilled and high-performing staff are assigned to the portfolio, achieving R&D objectives. Ensure scientific and operational training for staff members.
• Contribute to ongoing department infrastructure development efforts, such as SOP development, implementation, and/or innovation of new processes, clinical system capabilities, and workforce adoption to consistently deliver operational excellence.
• Serve as a talent magnet by developing, coaching, and retaining top talent within the team. Set clear performance standards and hold yourself and the organization accountable for achieving results. Embrace metrics and performance standards (KPIs).

 
We seek candidates with the following qualifications:

• Commitment to operational excellence.
• Post graduate degree in life sciences, business, or a related field, with a proven track record of leading and delivering global oncology clinical trials. Experience should demonstrate support for global regulatory submissions, successful regulatory inspections, and product approvals or marketing authorizations. PMP certification is a plus; an MBA is preferred.
• Minimum of 15 years of experience in Clinical Trial Operations, with a background that includes working in hospitals, research institutions, reputable CROs, or sponsor environments. Demonstrated experience managing multi-phase, multi-therapeutic, and diverse clinical trials from initiation to completion, including regulatory submissions and inspection preparation.
• Proven proficiency in leading an in-house clinical operations delivery model.
• Must have extensive management experience in clinical trial settings, with proven ability to collaborate with diverse R&D stakeholders in a matrix organization.
• Demonstrated expertise in managing budgets, resources, and headcount, while overseeing processes, productivity, quality, and project delivery.
• Comprehensive understanding of ICH-GCP and global/regional/local regulatory requirements is essential.
• Exceptional communication skills, with proficiency in written and spoken English. Must be effective in both verbal and written interactions.
• Strategic thinker with high emotional intelligence.
• Proven leadership capabilities to attract, inspire, and develop talent while driving alignment with the company’s goals, purpose, and mission.

If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.

Fairway Consulting Group is included in Hunt Scanlon’s list of Top 40 Life Sciences Search Firms and Forbes' list of Top 150 Best Executive Recruiting Firms.