Position Summary:
The Senior Director, Medical Monitor & Safety Physician is a clinical and safety leader responsible for providing medical monitoring and operational safety oversight of Nephrology and/or Metabolic clinical programs. This role delivers hands on medical monitoring, supports benefit risk evaluation, and contributes to safety strategy execution in close partnership with Clinical Development, Pharmacovigilance, Clinical Operations, Regulatory, Biostatistics, and other cross functional teams.
This position functions as a key contributor to the Executive Director, ensuring high quality medical review, timely safety assessments, and consistent implementation of safety processes. The Sr. Director plays a critical role in safety decision support and program execution.
Responsibilities:
Medical Monitoring & Clinical Trial Safety Oversight
- Serve as Medical Monitor for assigned clinical studies (Phase 1–3 and post marketing), ensuring subject safety and protocol adherence.
- Conduct timely medical review of eligibility questions, protocol deviations, dosing decisions, stopping rules, and emergent safety issues.
- Support investigator engagement, including safety related medical guidance and training on risk mitigation measures.
- Lead or support clinical event review (AEs, SAEs, AESIs), including assessment of seriousness, expectedness, relatedness, and follow up requirements.
- Provide medical input into informed consent forms, safety sections of protocols/IBs, and study level safety management plans.
Safety Strategy & Pharmacovigilance Support
- Contribute to ongoing benefit risk assessments by integrating clinical, nonclinical, and real world safety information.
- Participate in safety review meetings and provide medical input into risk mitigation and communication strategies.
- Support development and maintenance of Risk Management Plans (RMPs), Safety Surveillance Plans, AESI definitions, and escalation pathways.
- Conduct medical review of case series, targeted analyses, and aggregate safety reports (e.g., DSUR, PBRER/PSUR).
- Support SUSAR/expedited reporting oversight in alignment with global reporting requirements and internal SOPs.
- Contribute to regulatory interactions, briefing documents, and inspection readiness activities.
Data Review, Committees, and External Engagement
- Participate in DSMB/DMC interactions, including preparation of closed/open session materials and follow up actions.
- Support endpoint adjudication committees and safety adjudication processes.
- Contribute to investigator meetings, advisory boards, partner governance committees, and alliance management activities.
Leadership & Cross‑Functional Collaboration
- Provide drug safety leadership within matrix teams, influencing alignment and execution across functions and vendors.
- Support departmental strategy implementation, operational improvements, and process enhancements.
Quality, Compliance, and Inspection Readiness
- Ensure safety activities adhere to GxP, ICH guidelines, and applicable global regulations.
- Support SOP development, deviation investigations, CAPAs, and continuous improvement initiatives.
- Participate in audit/inspection preparation and serve as a knowledgeable medical safety representative.
Education/Experience Requirements:
- MD or DO (or equivalent international medical degree).
- 8 years of experience in clinical development and/or pharmacovigilance, including medical monitoring responsibilities.
- Experience supporting interventional clinical trials (Phase 1–3 preferred).
- Strong understanding of global PV regulations and ICH guidelines.
- Demonstrated experience contributing to aggregate safety reporting (e.g., DSUR, PBRER/PSUR) and risk management planning (e.g., RMP).
- Ability to collaborate effectively in a fast paced environment and work with CROs/partners.
Additional Skills/Experience:
- Experience in early development, first in human studies, and dose escalation (including DLT review).
- Experience supporting labeling, CCDS development, and post marketing safety activities.
- Experience with global filings and interactions with FDA/EMA and other health authorities.
- Strong clinical judgment and patient safety mindset.
- Ability to translate complex safety data into clear, actionable recommendations.
- Effective written and verbal communication, including medical storytelling.
- High standards for compliance, quality, and inspection readiness.
- Ability to influence in a matrix environment and collaborate across functions.
- Strong organizational skills with the ability to manage multiple priorities.
- Embodies Travere’s core values: Courage, Community Spirit, Patient Focus, Teamwork.
- Strong interpersonal and communication skills.
- Ability to work effectively in a multidisciplinary, inclusive environment.
- Ability to adapt to changing project plans and evolving priorities.
- Ability to travel domestically and internationally (up to 20–25%).
- All positions have an essential job function to be able to perform face to face work with colleagues and/or onsite in San Diego. No role is expected to be 100% remote.
_**Travere is an EEO/AA/Veteran/Disability Employer**_
Total Rewards Offerings:
_Travere provides comprehensive total rewards offerings that demonstrate our commitment as a diverse, equitable, people-centric, and pay-for-performance organization. _
_Benefits:_
_Our benefits include premium health, financial, work-life and well-being offerings for eligible employees and dependents, wellness and employee support programs, life insurance, disability, retirement plans with employer match and generous paid time off._
_Compensation_**: _Our competitive compensation package includes a combination of both cash compensation (base pay and short-term incentive) and long-term incentive compensation (company stock), designed to recognize, retain, and reward employees._
Target Base Pay Range:
$233,000.00 - $315,000.00
_*This information is current as of the date of this posting and may be modified in the future. Actual pay offered to a candidate will depend on a variety of factors including the candidate’s experience, education, skills, and location._
Travere will accept applications on an ongoing basis until a candidate is selected for the position.
Travere Therapeutics, Inc. is an EEO/AA/Veteran/Disability Employer.
If you require a reasonable accommodation to complete the application or interview process, please contact us by sending an email to accommodations@travere.com. Please note that this email address is to be used exclusively to request an accommodation with the online application, interview or hiring process only. Travere HR will not reply to emails sent to this address for any other reason.
About Travere Therapeutics
At Travere Therapeutics, we are in rare for life. We are a biopharmaceutical company that comes together every day to help patients, families and caregivers of all backgrounds as they navigate life with a rare disease. On this path, we know the need for treatment options is urgent – that is why our global team works with the rare disease community to identify, develop and deliver life-changing therapies. In pursuit of this mission, we continuously seek to understand the diverse perspectives of rare patients and to courageously forge new paths to make a difference in their lives and provide hope – today and tomorrow. For more information, visit [travere.com](http://travere.com/).
