Our client is a biotechnology company. They have asked us to assist them in their search for a Senior Director, Clinical Portfolio Execution.

Major tasks and responsibilities include:

• Builds the clinical operations team responsible for design and delivery of studies for visible clinical programs.
• Contributes to global clinical development program plans and provides in-depth consultation on
• Outlines the goals as well as the main priorities & strategies and forecasts timelines and milestones, clinical program budgets and resources.
• Manages budget responsibility of external spend.
• Manages clinical program-related expenditures in collaboration with R&D Project management and finance staff.
• Assesses, communicates, and manages risks around investments and timelines.
• Evaluates quality trends across all development programs within the therapeutic area.
• Ensures appropriate resources are allocated for timely follow-up for CQA audit and inspection reports within each responsible program.
• Ensures findings related to clinical operations activities are resolved and corrective action plans are implemented.
• Participates in inspection readiness activities.
• Collaborates with clinical outsourcing and cross-functional teams, evaluates adequacy of CROs and other providers, and makes recommendations for CRO selection.
• Influences and contributes to the leadership of the CDO function in key areas of change and continuous

We seek candidates with the following qualifications:

• A minimum of a Bachelor's Degree is required. Other degrees and certifications considered if commensurate with related clinical research experience.
• Must have a minimum of twelve years of relevant clinical research experience in the pharmaceutical industry, including a track record of eight years leading and managing a team of clinical operations professional staff.
• Requires the proven capability to lead multiple development assets and clinical trials across multiple teams.
• Must have a solid understanding of the global drug development process, and specifically, each step within the clinical trial process.
• Requires thorough knowledge of ICH GCP guidelines, quality management principles, and their applicability to all stages of the clinical development process.

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 50 Healthcare & Life Sciences Search Firms and Forbes' list of Top 200 Best Executive Recruiting Firms.