Executive Director, Clinical Development

Mineralys Therapeutics; United States; Remote; USD 340,000 - 370,000; Full time

Benefits offered by this job

Medical benefits

Flexible remote work

Job summary

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.

Responsibilities

• 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.

Skills

Leadership

Cross-functional collaboration

Medical monitoring

Regulatory strategy

Clinical trial design

Communication skills

GCP/ICH knowledge

Education

MD or equivalent medical degree

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

Tools

Regulatory submission experience

FDA/Health Authority interactions

Job description

Executive Director, Clinical Development

“Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone. Its initial product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor. Mineralys is headquartered in Radnor, Pennsylvania. For more information, please visit https://mineralystx.com. Follow Mineralys on LinkedIn, Twitter and Bluesky”

Mineralys is a fully remote company.

Key Responsibilities:

Clinical Development Leadership

• Serve as the clinical lead for one or more clinical programs, with responsibility for clinical trial design, execution oversight, and delivery of key milestones.
• Lead development of clinical plans, protocols, amendments, , and related study documents.
• Provide medical oversight for Phase 2/3 and/or registrational studies, ensuring patient safety, data integrity, and operational excellence.
• Partner with Clinical Operations, Biostatistics, Data Management, Regulatory, and Safety to ensure efficient study execution and timely issue resolution.
• Drive study start-up, enrollment, interim analyses, database locks, topline results, and CSR delivery.

Medical Monitoring / Safety Oversight

• Serve as medical monitor for assigned studies, including review of eligibility, protocol deviations, safety signals, SAEs/AEs, and benefit-risk assessments.
• Collaborate with Pharmacovigilance on safety surveillance, signal detection, DSMB materials, and aggregate safety reporting.
• Support development of risk mitigation strategies and ensure patient safety remains central throughout program execution.

Regulatory / Submission Support

• Contribute to global regulatory strategy and interactions with health authorities (FDA, EMA, PMDA, etc.).
• Author and review clinical sections of regulatory documents, including briefing books, protocols, CSRs, IBs, and submission modules.
• Present clinical data and strategy to regulators, internal governance committees, and senior leadership.

Scientific / Cross-Functional Leadership

• Serve as the key clinical voice on cross-functional program teams.
• Partner with Translational Medicine, Biomarkers, Medical Affairs and Commercial to align development strategy with future launch needs.
• Support publication planning, congress presentations, and external scientific engagement.
• Build strong relationships with KOLs, investigators, and external experts.

Team / Culture Leadership

• Mentor internal team members and external consultants/CRO partners.
• Foster a culture of collaboration, accountability, urgency, and quality.
• Operate effectively in a lean biotech environment where flexibility and ownership are essential.

Experience and 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.

These positions are eligible for standard Company benefits including medical, dental, vision, time off and 401K, as well as participating in Mineralys incentive plans are contingent on achievement of personal and company performance. Actual compensation may vary from posted hiring range based on geographic location, work experience, education, and/or skill level.

US Salary Range: $340,000 - $370,000

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