New · posted Oct 31
Mineralys Therapeutics · Biotechnology
Executive Director, Clinical Development
- Remote, US
- Remote
- Full-time
- Director
The role
“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.
The Executive Director, Clinical Development will serve as the clinical lead for development program(s) and play a critical role in advancing pivotal studies, regulatory strategy, and submission readiness. This physician leader will provide medical and scientific oversight across the program lifecycle, from protocol design and study execution through data interpretation, regulatory interactions, and launch preparation.
This role requires a hands-on clinical development leader who thrives in a fast-paced biotech environment and can partner cross-functionally to drive high-quality execution with urgency.
What you need
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.
What you'll do
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.
Pay and benefits
$340,000 – $370,000 a year
Employer providedMedical
Dental
Vision
Time off
401K
Incentive plans
From the posting
About Mineralys Therapeutics
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.
Job intelligence
The context around this role
Live data · November 3, 2026
Salary intelligence
How the pay compares
This role's midpoint is 18% above the US median for Clinical Development roles at this level.
This roleEmployer provided
Director roles in the US212 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $340,000 | — | $370,000 |
| All US (middle half) | $260,000 | $300,000 | $335,500 |
This role: Mineralys Therapeutics's own published range. Comparisons: the base pay employers published on open Clinical Development roles at the same level on Regulatory Jobs, November 3, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Clinical Development
The general path across 272 open Clinical Development roles on Regulatory Jobs, with the titles they carry most. Not Mineralys Therapeutics's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 28 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership11
- Clinical trial conduct10
- Regulatory submissions4
- Documentation and SOPs2
- Investigations and CAPA2
- Data and digital systems2
- GMP and compliance1
- Quality systems and risk1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and Answers
- ICHICH quality guidelines(official source, opens in a new tab)Q1 stability, Q2(R2) analytical validation, Q7, Q9 risk management, Q10 quality systems
- ICHICH E6 good clinical practice(official source, opens in a new tab)The international standard for the conduct of clinical trials
- FDAFDA NDA(official source, opens in a new tab)New Drug Applications
- FDAFDA BLA(official source, opens in a new tab)Biologics License Applications
Company hiring pulse
Mineralys Therapeutics on Regulatory Jobs
- 2
- Open roles
- 2
- Distinct roles
- 1
- Locations
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Executive Director, Clinical Development at Mineralys Therapeutics
Open until filled. $340K–$370K a year, employer provided.