Associate Director, Regulatory Submissions

We are seeking a key manager to support the Medpace Study Start-up group in APAC Region while being office-based in Melbourne, Australia. This position will be an integral part of the Medpace clinical operations management team. This role will be responsible for the strategic development of the group, and continuous improvement of processes. As a leader of the Study Start-up team you will be responsible for providing input on new business development opportunities and developing and maintaining relationships with clients. You will also be responsible for providing guidance and expertise to the Regulatory Submissions team in terms of competent authority and all applicable submissions. Additional / alternative expertise in other facets of Study Start-up are welcome.

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;Project lead responsibilities: Lead and oversee Study Start-Up/Regulatory Submission activities and timelines to ensure they are in accordance with Medpace standard operating procedures and study protocols;Provide input on new business development opportunities;Develop and maintain relationship with clients; andSupport the local Australian team development.

Qualifications

Bachelor's degree in life sciences or a related field - an advanced degreed is preferred;+10 years of Study Start-Up leadership experience within a CRO or pharmaceutical company;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 skills; andRegional experienceThis role offers potential hybrid working arrangements.

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 mentorsDefined career paths with clear advancement opportunitiesIndustry renowned onboarding and training programs designed to accelerate professional developmentOngoing training and continuous learning opportunities throughout your careerAn environment that encourages employees to influence change, contribute ideas, and grow quickly

Other Employee Benefits

Competitive compensation programs that recognize and reward performanceComprehensive health, wellness, retirement, and PTO benefitsOffice based culture with occasional WFH that provides flexibility for eligible positions after trainingCompany-sponsored social events
Please note benefits may vary based on country.

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.