Qureos Mentor

Travere Therapeutics

<div><div>Department:</div>
106750 Clinical Development<div></div><div>
Location:</div>
San Diego, USA- Remote<div></div><div>
Be a part of a global team that is inspired to make a difference in the lives of people living with rare disease.</div><div></div><div>
At Travere Therapeutics, we recognize that our exceptional employees are vital to our success. We are a dedicated team focused on meeting the unique needs of rare patients. Our work is rewarding &ndash; both professionally and personally &ndash; because we are making a difference. We are passionate about what we do.</div><div></div><div>
We are seeking talented individuals who will thrive in our collaborative, diverse, fast-paced environment and share in our mission &ndash; to identify, develop and deliver life-changing therapies to people living with rare disease. We stick by our values centered on patients, courage, community, and collaboration to pursue our vision of becoming a leading biopharmaceutical company dedicated to the delivery of innovation and hope to patients in the global rare disease community.</div><div></div><div>
At Travere Therapeutics, we are in rare for life. We continue to courageously forge new paths as we move toward a common goal of elevating science and service for rare patients<i>.</i></div><div></div><div>
Role Summary</div><div>
The Executive Director, Medical Monitor &amp; Safety Physician is a senior clinical and safety leader responsible for medical monitoring and end-to-end safety oversight across one or more development programs and/or therapeutic areas. This role serves as the accountable safety physician for clinical trials and senior medical authority for safety across programs, with responsibility for benefit&ndash;risk positioning and safety-related decision-making.</div><div></div><div>
The incumbent will partner closely with Clinical Development, Pharmacovigilance, Clinical Operations, Regulatory, Biostatistics, Medical Affairs, and Quality to ensure patient safety, regulatory compliance, and scientifically sound benefit-risk evaluation throughout the product lifecycle. This role holds delegated authority to escalate and resolve significant safety issues impacting program development and regulatory strategy.</div><div></div><div>
This position is hands-on and strategic: you will provide real-time medical monitoring support and be a key contributor to safety deliverables (e.g., DSUR, PBRER/PSUR, RMP) as well as represent projects and programs in internal and external forums, including interactions with regulators, DSMBs, investigators, and partners.</div><div></div><div>
Key Responsibilities</div><div>
Medical Monitoring &amp; Clinical Trial Safety Oversight (Clinical Development)</div><ul><li><div>
Serve as the lead Medical Monitor for assigned clinical studies (Phase 1&ndash;3 and/or post-marketing), ensuring subject safety and protocol compliance.</div></li><li><div>
Provide timely medical review of critical eligibility questions, protocol deviations impacting safety, dosing decisions, stopping rules, and emergent safety issues.</div></li><li><div>
Support site and investigator engagement, including medical support for safety-related questions and training on risk mitigation measures.</div></li><li><div>
Lead and/or oversee clinical event review (AEs, SAEs, AESIs), including assessment of seriousness, expectedness, relatedness, and follow-up requirements.</div></li><li><div>
Ensure medical input into informed consent language, safety sections of protocols/IBs, and trial-level safety management plans.</div></li></ul><div></div><div>
Safety Strategy &amp; Medical Oversight (Drug Safety &amp; Pharmacovigilance)</div><ul><li><div>
Lead ongoing benefit&ndash;risk assessment for assigned products, integrating clinical, nonclinical, and real-world safety information and serve as the accountable medical authority for benefit&ndash;risk determinations within assigned programs.</div></li><li><div>
Participate in safety review meetings and provide medical oversight as needed and drive decision-making on risk controls and communications. Serve as a core decision-making member of safety governance forums with authority to recommend escalation and risk mitigation actions.</div></li><li><div>
Participate in the development and maintenance of Risk Management Plans (RMPs), Safety Surveillance Plans (including AESIs, thresholds, and escalation pathways). Provide final medical review and approval of program-level safety surveillance strategies.</div></li><li><div>
Provide Medical oversight of signal detection activities from clinical trials, literature, spontaneous reports, and partner data.</div></li><li><div>
Provide medical reviews of case series targeted analyses, aggregate safety data reports (e.g., DSUR, PBRER/PSUR) and other periodic safety deliverables and serve as accountable medical signatory for such reports as applicable.</div></li><li><div>
Support SUSAR/expedited reporting oversight, ensuring alignment with global reporting requirements and company SOPs.</div></li><li><div>
Prepare and participate in regulatory interactions (briefing documents, meeting participation, inspection readiness support). Represent the organization as the senior medical safety authority in health authority interactions.</div></li></ul><div></div><div>
Data Review, Committees, and External Engagement</div><ul><li><div>
Serve as the safety physician representative for DSMB/DMC interactions, including charter input, closed/open session preparation, and action follow-up.</div></li><li><div>
Provide medical leadership for endpoint adjudication committees and safety adjudication processes when applicable.</div></li><li><div>
Contribute to investigator meetings, advisory boards, partner governance committees, and alliance management activities (where relevant).</div></li></ul><div></div><div>
Leadership, People, and Matrix Management</div><ul><li><div>
Mentor and develop medical monitors, safety scientists, and cross-functional colleagues; establish best practices for medical monitoring. Provide senior medical oversight and direction across cross-functional safety contributors.</div></li><li><div>
Provide functional leadership in a matrix environment; influence without authority and drive alignment across functions and vendors.</div></li><li><div>
Contribute to departmental strategy, budget planning, and operating model enhancements for a growing biotech.</div></li></ul><div></div><div>
Quality, Compliance, and Inspection Readiness</div><ul><li><div>
Ensure safety activities adhere to GxP, ICH guidelines, and applicable global regulations.</div></li><li><div>
Lead or support SOP development, deviation investigations (as applicable), CAPAs, and continuous improvement initiatives.</div></li><li><div>
Participate in audit/inspection preparation and execution; serve as a subject matter expert during PV and clinical inspections. Represent and defend medical safety decisions directly to regulatory inspectors as required.</div></li></ul><div></div><div>
Required Qualifications</div><ul><li><div>
MD or DO (or equivalent international medical degree) with an active or eligible license (as required by country/region).</div></li><li><div>
10+ years of relevant experience in clinical development and/or pharmacovigilance, including significant medical monitoring responsibilities.</div></li><li><div>
Prior experience serving as a safety physician and/or medical monitor for interventional clinical trials (Phase 1&ndash;3 strongly preferred).</div></li><li><div>
Demonstrated leadership of aggregate safety reporting (e.g., DSUR, PBRER/PSUR) and risk management planning (e.g., RMP).</div></li><li><div>
Strong working knowledge of global PV regulations and standards (e.g., ICH E2A/E2B/E2C/E2D/E2F, GCP).</div></li><li><div>
Experience leading in a matrix environment and collaborating with CROs/partners; ability to operate effectively in a fast-paced biotech setting.</div></li></ul><div></div><div><br>
Preferred Qualifications</div><ul><li><div>
Board certification (or equivalent) in a relevant specialty; experience aligned to the company&rsquo;s therapeutic focus.</div></li><li><div>
Experience in early development (first-in-human) and dose escalation studies, including DLT review and escalation decisions.</div></li><li><div>
Experience supporting labeling, CCDS development, and post-marketing safety activities.</div></li><li><div>
Experience with global filings and direct interactions with FDA/EMA and other health authorities.</div></li><li><div>
Prior people management experience (direct reports) and/or demonstrated ability to build teams and processes at scale.</div></li></ul><div></div><div><br>
Core Competencies</div><ul><li><div>
Clinical judgment &amp; patient safety mindset with strong decision-making under ambiguity.</div></li><li><div>
Strategic benefit&ndash;risk thinking and clear medical storytelling in written and verbal communications.</div></li><li><div>
Influence and leadership across cross-functional teams and external stakeholders.</div></li><li><div>
High standards for compliance, quality, and inspection readiness.</div></li><li><div>
Ability to translate complex safety data into actionable program recommendations.</div></li></ul><div></div><div><br>
Key Interfaces</div><ul><li><div>
Clinical Development, Pharmacovigilance, Clinical Operations, Biometrics, Regulatory Affairs, Medical Writing, Medical Affairs, Quality/Compliance, Nonclinical Safety, CMC, Alliance Management, and external vendors/CROs.</div></li></ul><div></div><div>
Additional Skills/Experience/Requirements:</div><ul><li><div>
The ideal candidate will embody Travere&rsquo;s core values: Courage, Community Spirit, Patient Focus and Teamwork</div></li><li><div>
Driven, intelligent, passionate about making a difference for patients with rare diseases</div></li><li><div>
Strong interpersonal and organizational skills and excellent verbal and written communication skills</div></li><li><div>
Ability to work effectively in a multidisciplinary team to cultivate an inclusive environment of respectful, open, and honest dialogue and to foster a robust sharing of ideas and creative problem solving</div></li><li><div>
Demonstrated ability to review, interpret and present complex scientific data</div></li><li><div>
Well-organized with the ability to multi-task, prioritize, and manage shifting responsibilities in a dynamic, cross-functional teamwork environment</div></li><li><div>
Excellent collaboration skills with strong attention to detail and the ability to manage complexity and challenges</div></li><li><div>
Ability to adapt to modification and changes to project plans, demonstrating flexibility to implement new strategies and tactics to accommodate these changes</div></li><li><div>
Ability to travel domestically and internationally (up to 20 to 25%)</div></li><li><div>
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</div></li></ul><div></div><div>
Total Rewards Offerings:<br>
<i>Travere provides comprehensive total rewards offerings that demonstrate our commitment as a diverse, equitable, people-centric, and pay-for-performance </i><i>organization.</i></div><div></div><div><i>
Benefits:</i><i> 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.</i></div><div></div><div><i>
Compensation</i>: <i>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.</i></div><div></div><div>
Target Base Pay Range:</div>
$285,000.00 - $385,000.00<div></div><ul><li><i>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&rsquo;s experience, education, skills, and location.</i></li></ul><div></div><div>
Travere will accept applications on an ongoing basis until a candidate is selected for the position.</div><div></div><div>
Travere Therapeutics, Inc. is an EEO/AA/Veteran/Disability Employer.</div><div></div><div>
If you require a reasonable accommodation to complete the application or interview process, please contact us by sending an email to <div>accommodations@travere.com</div>. 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.</div></div>

Executive Director, Medical Monitor and Safety Physician

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Travere Therapeutics

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Executive Director, Medical Monitor and Safety Physician