Head Global Clinical Studies

We are seeking an experienced Head Global Clinical Studies (Rare Diseases – Genetics, Parkinson’s & Metabolic Disorders) to lead global interventional clinical studies in rare diseases, with a special focus on genetic studies in Parkinson’s disease and metabolic disorders. This role is pivotal in driving the strategic and operational execution of early- and late-phase clinical trials across multiple regions, ensuring scientific excellence, regulatory compliance, and high-quality data generation.

The ideal candidate must have practical expertise in clinical trial execution, deep scientific knowledge in genetics-driven therapies for rare diseases, and strong leadership skills to collaborate effectively with global stakeholders. Regular travel is required to study sites, engage with investigators, and support regulatory interactions.

Key Responsibilities
• ⁠Lead the design, execution, and oversight of global interventional clinical trials in rare diseases, with a focus on genetic studies in Parkinson’s disease and metabolic disorders.
•⁠  ⁠Develop clinical strategy and study protocols in collaboration with cross-functional teams, including regulatory, medical affairs, and biomarker teams.
•⁠  ⁠Ensure regulatory compliance and engagement with global health authorities, including the FDA, EMA, and other regulatory bodies.
•⁠  ⁠Oversee investigator selection, site engagement, and trial operations, ensuring high-quality patient recruitment and data integrity.
•⁠  ⁠Serve as a key medical and scientific expert, providing insights on trial design, patient populations, and disease-specific endpoints.
•⁠  ⁠Support the interpretation of clinical data and publication strategy, working closely with medical writing and scientific communications teams.
•⁠  ⁠Collaborate with external stakeholders, including academic institutions, patient advocacy groups, and KOLs in Parkinson’s and metabolic diseases.
•⁠  ⁠Represent the company at international scientific meetings, advisory boards, and regulatory discussions.
•⁠  ⁠Mentor and guide clinical development teams, ensuring best practices in trial execution and innovation in study design.

Key Qualifications & Skills
•⁠ MD or PhD with significant experience in clinical development (neurology, metabolic diseases, or genetics preferred).
•⁠  ⁠10+ years of experience in clinical research and global interventional trials.
•⁠  ⁠Expertise in genetics-driven drug development and clinical studies in Parkinson’s disease or metabolic syndromes.
•⁠  ⁠Strong knowledge of GCP, ICH guidelines, and regulatory pathways for rare disease drug development.
•⁠  ⁠Excellent communication skills in English (written and spoken); additional languages are a plus.
•⁠  ⁠Practical experience in trial site engagement and direct involvement in study execution.
•⁠  ⁠Ability to travel regularly (internationally) to oversee studies and meet with investigators, regulators, and collaborators.
•⁠  ⁠Strong leadership, problem-solving, and cross-functional collaboration skills.

Why Join Us?
• ⁠Opportunity to work on cutting-edge therapies in rare diseases with high unmet medical need.
•⁠  ⁠Engage with top scientists, clinicians, and regulators in genetics and precision medicine.
•⁠  ⁠Be part of a fast-paced, innovative, quickly growing and mission-driven organization that values scientific excellence and patient impact.
•⁠  ⁠Competitive compensation, benefits, and professional growth opportunities in a global environment with a highly international team.
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Please send your CV, along with any additional application documents such as a cover letter or qualifications, to doreen.niemann@agyanypharma.com