We’re always looking for innovative and passionate individuals to join our team! To apply to one of our open positions, send us your CV and tell us about yourself by emailing us today.

The Role

Maintain oversight of the Pharmacovigilance System and to maintain an overview of the safety profiles and any emerging safety concerns in relation to Mineralys Investigational Products. Lead all pharmacovigilance risk management issues for the company

What you will do:

  • Build and maintain a compliant global pharmacovigilance system.
  • Develop and execute clinical safety educational training programs for personnel.
  • Having an oversight on Individual case reports (ICRs), Standards Operating Procedures (SOPs), Risk Management Plans (RMP), Risk Minimization Strategies, effectiveness of follow-up measures, on safety data base, on e-transmission and on important observations from QA audits of PV activities
  • Ongoing monitoring of the safety profile of Mineralys investigational product and continuous overall Pharmacovigilance evaluation during the post-authorization period.
  • Ensure that any request from the Regulatory Authorities for the provision of additional information necessary for the evaluation of the benefits and risks afforded by an investigational product is answered fully and promptly.
  • Responsibility for oversight of any post-authorization Pharmacovigilance commitments and risk management activities for medicinal products
  • Review and sign off documents such as Development Safety Updates Reports (DSURs), Risk Management Plan, clinical expert reports, literature review, and product information, particularly asthey relate to drug safety, to assure that quality is maintained, and that benefit/risk information is accurate and not misleading.
  • Ensure compliance with EU & Global Pharmacovigilance regulations.
  • Act as the internal safety resource in connection with safety issues.
  • Support other departments in safety issues, i.e. participate in the preparation of local informed consent and ‘safety-sections’ of development protocols, investigator’s brochure, and other relevant regulatory filing documents.
  • Active involvement in internal and external developments through close internal interactions and through participation in external safety meetings and assessment of external national safety information.
  • Obtain and verify new information concerning Pharmacovigilance legislation.
  • Proactively manage outsourced activities.

What you will bring:

  • A medical, nursing or Life Science Degree
  • Physician preferred, but not required
  • Substantial experience in the pharmaceutical industry, with solid experience in pharmacovigilance
  • A good understanding of normal and pathological physiological function and excellent knowledge of pharmacology.
  • Must have experience with previous NDA filings and direct interaction with the FDA
  • Extensive clinical trial experience required
  • Experience with product-oriented contact with doctors and patients.
  • Experience of managing outsourced activities.
  • Proficient in developing and implementing programs and policies.
  • Experience in hypertension, cardiovascular or nephrology would be a huge plus!
  • Strong written, verbal and interpersonal communication skills.
  • Proven ability to work as an independent, self-sufficient, solutions oriented professional with swift problem solving and decision-making abilities.
  • Skilled in organization and prioritization with a strong attention to detail. Work precisely according to procedures, rules, and regulations.
  • Ability to deliver accuracy and high quality of work under pressure of tight deadlines and heavy workload.
  • Effective computer skills, and experience with or knowledge of different safety databases.
  • Proven ability to think creatively, meet deadlines, successfully prioritize, and work on multiple tasks simultaneously.
  • Ability to recognize potential obstacles and work to resolve them within set timelines.
  • Approach issues from several perspectives, summarizing data to draw a conclusion.

What we offer:

Mineralys Therapeutics offers a collaborative company culture. In addition to working with a team of highly competent professionals in a growing company, benefits include: 

  • Professional flexibility and remote workforce
  • Competitive Compensation
  • Generous Health Benefits
  • Paid Holidays
  • Flexible Vacation Policy
  • 401(k) match
  • Home office stipend


How to apply:

Send your CV to and feel free to include a note that tells us more about you!  

About Mineralys Therapeutics
Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target diseases driven by abnormally elevated aldosterone. Its initial product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor that Mineralys Therapeutics is initially developing for the treatment of patients with uncontrolled hypertension. Mineralys Therapeutics is based in Radnor, PA. Follow Mineralys on LinkedIn and Twitter.

Broad Function     

The Director of Analytical Development will be responsible for executing product development activities related to analytical development/ transfer with external partners including CMOs and CDMOs) and lead alignment with the CMC team.

Principal Responsibilities

  1. The position will be responsible for technical leadership of analytical development within the CMC function.
  2. The position will ensure success on all drug substance and drug product deliverables by leveraging internal and external resources
  3. The position will be responsible for strategic and scientific alignment of analytical development activities with the overall program needs
  4. The position owns the delivery of product development initiatives/projects with emphasis on analytics for the development of NDAs through various milestones of product development.
  5. Apply high quality standards/ principles during the different stages of product development, including review of drug product & API characterization, raw material quality attributes, design of experiments, stability testing, analytical methods development & validation/optimization, and statistical evaluation of data.
  6. Evaluate the characterization and comparability plans and reports for complex dosage forms and propose techniques as needed.
  7. Proactive management of project risks, opportunities and establishing comprehensive mitigation plans when it comes to product development/analytical challenges
  8. Establish project plan baselines and document assumptions
  9. Compile and challenge project schedules with the project team, manage timelines through critical path analysis, monitor completion of key development tasks through milestone completion, quality gates, and stage gating processes
  10. Manage project Budgets, Contract Milestones and Spend and provide updates on a monthly basis to the SVP of CMC.
  11. Provide oversight and review of all relevant Analytical Development source documents for regulatory submission.
  12. Develop and maintain project plans for internal and external analytical resources, timelines, and budgets
  13. Build and maintain strong collaborations and relationships with external CDMOs, internal technical leads and project teams

Skills and Attributes

1.            Communication Proficiency

2.            Problem Solving/Analysis

3.            Project Management

4.            Strategic Thinking

Supervisory Responsibility

Responsible for the management of personnel who are involved in Analytical Development activities.

Physical Demands

While performing the duties of this job, the employee is regularly required to talk or hear. This is largely a sedentary role with a requirement to keyboard and visually work with a monitor and/or laptop screen for long periods of time. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.


This position requires up to <10% travel. Travel may be outside the local area and overnight. Some of the travel may be international.

Education and Experience

  • PhD in chemistry, chemical technologies, or related area with 15+ years relevant experience in analytical development roles within the pharmaceutical industry
  • Expertise in phase-appropriate small molecule analytical method development and validation
  • Extensive knowledge of advanced analytical principles and theories; expertise in analytical laboratory techniques for drug substance and drug product and application of control strategies through all stages of development
  • Expertise in all relevant Quality and Regulatory guidelines.
  • Knowledge and experience of pre-development activities – pre-formulation, solid state, formulations for animal studies
  • Demonstrated ability to set clear and measurable goals, managing tasks and resources
  • Excellent written and verbal communication skills, organization, and planning skills and a high level of technical aptitude and creativity
  • Ability to implement new technologies for development programs

Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.