Mineralys Therapeutics
Executive Director, Clinical Development
Remote role where the employee must remain based in a particular country.
United States only
Employer listed it 3 weeks ago · Added yesterday
Been open since 3 weeks ago, still being checked, but it has been live a while.
Salary
$340,000 to $370,000
Location
United States only
Timezone
Not stated
Contract
Full-time
Experience
Lead
Category
Other
Stated by the employer in the job description
Remote flexibility
Work from home
This is a remote role, but the employee must be based in United States. It is work from home rather than work from anywhere.
What the employer says
- Source listing states candidate location: "US Remote, Remote - US"
What Nomaders makes of it
- Residency required in United States
- Payroll and tax are likely handled in that country only
The quotes above are the employer's own words; the reading is ours. Always check the original listing and employment terms before working from another country.
About 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.
Executive Director, Clinical Development
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.
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.
Requirements
- ·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.
Benefits
No benefits package published with this listing. Ask about it at first interview.
How to apply
- 1Check the flexibility label above, work from home, matches where you plan to live and work.
- 2Tailor your CV to the role at Mineralys Therapeutics, mentioning your remote working experience.
- 3Apply directly on the employer's careers page using the button below. Nomaders never handles your application.
Found 1d ago. Last checked 23 Sept. Always confirm the details on the original posting, salary and location can change after publication.
Listing sourced from Company boards.
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