Director, Global Study Start-Up & Regulatory Submissions

Medpace; Cincinnati (OH); On-site; USD 150,000 - 230,000; Full time

Benefits offered by this job

Competitive bonus program

Sign-on/relocation bonus

Equity awards

Job summary

Medpace, a full-service CRO, seeks an office-based Director of Study Start-Up to lead our Study Start-Up/Regulatory Submissions team in Cincinnati. The role requires CRO experience and strong leadership to align start-up activities with clinical operations and regulatory timelines.

You will oversee process improvements, mentor a growing team, and develop client relationships while contributing to global study start-up initiatives.

Qualifications

• Bachelor’s degree in Life Sciences or related field.
• Advanced degree is preferred.
• 8+ years as a study start-up senior leader within a CRO.
• Excellent presentation, negotiation, documentation, leadership and interpersonal skills.
• Strong customer focus with ability to manage priorities and remain adaptable.
• Excellent written and oral communication; experience managing and developing a team.

Responsibilities

• Contribute directly to the growth and strategic development of a large, global Study Start-Up team.
• Develop and identify continuous improvement opportunities of internal processes.
• Oversee Study Start-Up/Regulatory Submissions activities and timelines to ensure alignment with SOPs and study protocols.
• Provide input on new business development opportunities; and
• Develop and maintain relationships with clients.

Education

Bachelor’s degree in Life Sciences

Advanced degree

Job description

Medpace, a full-service CRO, seeks an office-based Director of Study Start-Up to lead our Study Start-Up/Regulatory Submissions team in Cincinnati. The role requires CRO experience and strong leadership to align start-up activities with clinical operations and regulatory timelines.

You will oversee process improvements, mentor a growing team, and develop client relationships while contributing to global study start-up initiatives.