Key Responsibilities

Lead the planning, execution, and delivery of international Phase I-III clinical studies
Ensure successful study conduct through effective oversight of CROs and external vendors, with accountability for quality, timelines, budgets and study objectives
Establish and drive study governance, including risk management, issue resolution and performance oversight throughout the study lifecycle
Collaborate closely with cross-functional teams to align clinical, scientific, regulatory and operational priorities
Contribute to protocol development, study planning and operational strategies to support efficient trial execution
Ensure compliance with ICH-GCP, applicable regulations and internal standards while maintaining inspection readiness
Support interactions with health authorities and contribute to regulatory submissions, inspections and audits
Promote a culture of collaboration, accountability and continuous improvement

Your Profile

Advanced degree in Life Sciences, Pharmacy, Medicine or a related scientific field
PhD preferred
Proven track record of successfully leading international Phase I-III clinical studies
Strong expertise in CRO and vendor oversight, study governance and operational risk management
Sound understanding of clinical trial design, protocol development and study execution
In-depth knowledge of ICH-GCP and global clinical research regulations
Experience with regulatory submissions, health authority interactions and inspection readiness activities is highly desirable
Strong leadership, communication and stakeholder management skills, coupled with a collaborative and results-driven mindset
Fluency in English is essential
German language skills are beneficial

Our employees are our greatest asset.

And to show our appreciation, we offer attractive benefits:

Benefits

Your work-life balance is important to us.
We offer flexible working hours with the option of working a proportion of those hours remotely, 30 annual vacation days and an excellent cafeteria
Attractive salaries and success-based bonuses for all medac employees
Individual training opportunities: Our medac academy offers a wide range of programmes including leadership training, coaching essentials and language classes
A funded pension scheme and other social benefits
We care for our employees beyond the workplace and provide advice on caring for elderly relatives as well as offering counselling
We promote sports and activities to improve our employees’ health

About Medac

We are a strong community: with more than 2,000 employees worldwide, we are committed to improving human health. Our work is more than just a job. With a career at medac, you can make a real difference in the industry. Look into this job opportunity and become part of an exceptional workforce.

#J-18808-Ljbffr

HQ medac GmbH