Senior Director, Clinical Operations (Detroit)

Senior Director, Clinical Operations

About the Company

Pioneering biotechnology (BioTech) company developing innovative treatments

Industry

Biotechnology

Type

Privately Held

About the Role

The Company is in search of a Senior Director for Clinical Operations to provide both strategic and operational leadership for multiple global clinical studies. The successful candidate will be responsible for ensuring that these studies are conducted within aggressive timelines, on budget, and in full compliance with all relevant regulatory guidelines. This role involves leading a team of internal and external clinical operations professionals, as well as directly managing program-level responsibilities such as budget, timeline, and drug supply management. The Senior Director will also be tasked with leading all operational aspects of cross-functional clinical programs, including strategic planning, communication, and coordination, and will be the primary lead for vendor management, particularly with Contract Research Organizations (CROs).

Applicants for this role at the company should have a Bachelors degree or higher in life sciences or project management, with a minimum of 10-12 years' of clinical operations management experience. A strong background in Phase 2 and 3 global clinical trial management, particularly with a focus on trials for rare and common diseases, is preferred. The ideal candidate will have an excellent understanding of FDA guidelines, GCP, ICH, and applicable SOPs, and a proven track record in recruiting, managing, and training operations team members. The role requires the ability to manage CROs to meet or exceed KPIs, lead a clinical operations team, and collaborate with internal colleagues to achieve program goals. Strong communication skills and the ability to influence senior stakeholders are also essential.

Travel Percent

Less than 10%

Functions

• Operations
• Medical Care / Hospital Administration