Remote Executive Director, Clinical Development

Regulatory Jobs; United States; À distance; USD 340 000 - 370 000; Plein temps

Avantages offerts par ce poste

Medical benefits

Flexible remote work

Résumé du poste

Mineralys Therapeutics is seeking an Executive Director, Clinical Development to lead one or more late-stage programs, designing trials, overseeing execution, and delivering milestones.

You will provide medical oversight for Phase 2/3 and registrational studies, ensure patient safety, data integrity, and collaborate with Regulatory, Safety, Biostatistics, and Clinical Operations to drive study start-up, enrollment, and topline results.

Qualifications

• MD or equivalent medical degree required; board certification preferred in Internal Medicine, Cardiology, Nephrology, Endocrinology, or related field.
• 10+ years of industry clinical development experience, including significant late-stage / registrational trial leadership.
• Prior experience serving as medical monitor and clinical lead for Phase 2/3 studies.
• Proven experience with NDA / BLA submission support and health authority interactions.
• Strong understanding of GCP, ICH guidelines, safety reporting, and global clinical development processes.
• Demonstrated ability to lead cross-functional teams and influence without direct authority.
• Strong scientific communication and presentation skills.
• Experience in hypertension, cardiovascular, renal, or metabolic disease strongly preferred.

Responsabilités

• Lead clinical development leadership for one or more programs, overseeing trial design, execution, and milestones.
• Develop clinical plans, protocols, amendments, and related study documents.
• Provide medical oversight for Phase 2/3 and/or registrational studies, ensuring patient safety and data integrity.
• Partner with Clinical Operations, Biostatistics, Data Management, Regulatory, and Safety to ensure efficient study execution.
• Drive study start-up, enrollment, interim analyses, database locks, topline results, and CSR delivery.
• Serve as medical monitor for assigned studies, reviewing eligibility, safety signals, and SAEs/AEs.
• Collaborate with Pharmacovigilance on safety surveillance and aggregate reporting.
• Support development of risk mitigation strategies and ensure patient safety is central.

Connaissances

Leadership

Cross-functional collaboration

Medical monitoring

Regulatory strategy

Clinical trial design

Communication skills

GCP/ICH knowledge

Formation

MD or equivalent medical degree

Board certification in Internal Medicine/Cardiology/Nephrology/Endocrinology or related field

Outils

Regulatory submission experience

FDA/Health Authority interactions

Description du poste

Mineralys Therapeutics is seeking an Executive Director, Clinical Development to lead one or more late-stage programs, designing trials, overseeing execution, and delivering milestones.

You will provide medical oversight for Phase 2/3 and registrational studies, ensure patient safety, data integrity, and collaborate with Regulatory, Safety, Biostatistics, and Clinical Operations to drive study start-up, enrollment, and topline results.