Associate Director, Regulatory Submissions

We are seeking a key manager to support the Medpace Study Start-up group in the 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 or 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 relationships with clients;
• Support the local Australian team development.

Qualifications:

• Bachelor's degree in life sciences or a related field - an advanced degree 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 the ability to manage challenging priorities and remain flexible and adaptive in stressful situations;
• Excellent written and oral communication skills;
• Regional experience.

This role offers potential hybrid working arrangements.

Medpace Overview:

Medpace is a full-service clinical contract research organization (CRO) providing phase I-IV 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.

Why Medpace?

• 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.

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.