Director - Study Start-Up Project Management

We are seeking an office-based Director of Study Start-Up to support our growing Study Start-Up/Regulatory Submissions team at Medpace! This position will be an integral part of the Clinical Operations leadership team and requires a strong understanding of how study start-up and regulatory submissions are integrated with other clinical operations functions throughout Medpace. Study Start-Up/Regulatory Submissions experience within a CRO is required.

Incentives can include: Competitive bonus program, sign-on/relocation bonus, and equity awards.

Location: Position can be office based in Cincinnati, Dallas or Denver.

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 they are in accordance with Medpace standard operating procedures and study protocols;

Provide input on new business development opportunities; and

Develop and maintain relationships with clients.

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, team-orientation, and interpersonal skills;

Strong customer focus with ability to manage challenging priorities and remain flexible and adaptive in stressful situations;

Excellent written and oral communication; and

Experience managing and developing a team.

Medpace Overview

Medpace is a full-service clinical contract research organization (CRO) providing phase l-lV clinical development services to the biotechnology, pharmaceutical, and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through the advancement of clinical research. We leverage in-country regulatory and therapeutic expertise across all major therapeutic areas including oncology, cardiology, metabolic, endocrinology, central nervous system, and anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, we employ more than 6,500 people across 40+ countries.

Why Medpace?

When you join Medpace, you become part of an innovative team that brings cutting-edge therapies to market while building a meaningful and rewarding career focused on scientific excellence and improving patient outcomes around the world through continuous learning and cross-functional collaboration.

Purpose-Driven Work

Work alongside physicians, scientists, and industry-leading experts committed to advancing the global development of medical therapeutics through clinical research excellence

Collaborative Culture

Contribute to an interactive team environment that empowers decision making, creative thinking, and continuous learning through open communication and mutual trust.

Leadership throughout Medpace is both accessible and approachable

Continuous Growth & Development

Office based environment with on-site mentors

Defined career paths with clear advancement opportunities

Industry renowned onboarding and training programs designed to accelerate professional development

Ongoing training and continuous learning opportunities throughout your career

An environment that encourages employees to influence change, contribute ideas, and grow quickly

Other Employee Benefits

Competitive compensation programs that recognize and reward performance

Comprehensive health, wellness, retirement, and PTO benefits

Office based culture with occasional WFH that provides flexibility for eligible positions after training

Company-sponsored social events and intramural sports

Cincinnati Headquarters Experience

A modern corporate campus designed to support collaboration and productivity

Multiple on-site dining options in the heart of Madison Square

Free on-site parking

Convenient access to on-site 24-7 fitness and wellness facilities

What to Expect Next

A Medpace team member will review your application and if your profile matches our current needs, you will be contacted for an interview. While we review all applications carefully, we are unable to respond to every applicant, and only candidates selected for interviews will be contacted.

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 they are in accordance with Medpace standard operating procedures and study protocols;

Provide input on new business development opportunities; and

Develop and maintain relationships with clients.

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, team-orientation, and interpersonal skills;

Strong customer focus with ability to manage challenging priorities and remain flexible and adaptive in stressful situations;

Excellent written and oral communication; and

Experience managing and developing a team.