Our client is a biopharmaceutical company focused on innovative therapeutics for life threating diseases. They have asked us to assist them in their search for a Senior Director, Clinical Operations.

Major tasks and responsibilities include:

• Collaborates with executive management to develop appropriate clinical development organization structure, implement hiring plans, and manage the team across functions.
• Develops the overall clinical operations and trial management strategy across the company’s clinical programs.
• Serves as the escalation point for clinical CROs and vendors and holds accountability for vendor performance including project management, data management, safety & pharmacovigilance, medical writing and clinical supplies.
• Interacts with alliance partners including communicating clinical plans, status, risks and mitigations.
• Guides the clinical team to ensure the development of study timelines and ensures operational plans are developed to deliver clinical activities to the defined timelines.
• Supports the clinical team in the design and review of clinical trial documents, regulatory submissions, and reports.
• Ensures the clinical team institutes effective processes with vendors to select and manage clinical sites and the associated vendors.
• Develops strategies to augment vendor activities to support the acceleration of clinical timelines and delivery of high-quality data.
• Mitigates risks and develops action plans to ensure timely completion of clinical trials.
• Ensures quality processes are developed and implemented including vendor and site auditing programs, SOP development and implementation.
• Manages clinical trial budgets and invoicing.

We seek candidates with the following qualifications:

• A Bachelor’s degree in a scientific field is required. An advanced degree such as an MS or PhD is preferred.
• Must have at least 12 years of clinical development experience with biotechnology drug development sponsor companies with substantial early development.
• Experience developing therapeutics for oncology or autoimmune indications is highly preferred.
• Must have a deep understanding of clinical development and the functions needed to support the delivery of clinical studies.
• The ability to manage and coordinate external project teams, consultants, and clinical sites while advancing drug candidates through early-stage clinical trials is required.
• Must have excellent written and oral communication skills.
• Requires the ability to organize and multitask in a highly collaborative and cross-functional environment.

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.