Associate Director, Clinical Pharmacology

Travere Therapeutics; Manchester (NH); Hybrid; USD 150,000 - 195,000; Full time

Benefits offered by this job

Premium health

Life insurance

Disability

Employer 401(k) match

Generous PTO

Job summary

Travere Therapeutics in San Diego, CA seeks an Associate Director, Clinical Pharmacology to design and lead pharmacology strategies across development programs, integrating PK/PD and DDI assessments to support dosing and regulatory submissions.

You will partner with Research, Regulatory, Clinical, and Project Management teams, providing scientific leadership in PK/PD, MIDD, and study design across multiple programs, with up to 10% travel.

Qualifications

• Ph.D. degree or equivalent required.
• 4+ years of experience in a relevant field (or PharmD with 8+ years).
• Leadership in PK/PD, Biopharmaceutics, and Pharmacometric activities.

Responsibilities

• Lead the development and execution of clinical pharmacology strategy across development programs.
• Represent Clinical Pharmacology and provide support to clinical stage project teams.
• Oversee design and implementation of PK/PD studies and dose escalation.
• Provide clinical pharmacology input for regulatory submissions (IND, CTA, NDA).
• Collaborate with Research, Regulatory, Clinical, and other R&D functions.
• Deliver timely clinical pharmacology input at key development milestones.

Skills

PK/PD

Biopharmaceutics

Pharmacometrics

Leadership

MIDD

Regulatory liaison

Education

Ph.D. degree

PharmD with 8+ years

Job description

Department: 107600 Clinical Pharmacology

Location: San Diego, USA- Remote

Be a part of a global team that is inspired to make a difference in the lives of people living with rare disease.

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 - both professionally and personally - because we are making a difference. We are passionate about what we do.

We are seeking talented individuals who will thrive in our collaborative, diverse, fast-paced environment and share in our mission - 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.

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.

Position Summary

The Associate Director, Clinical Pharmacology will be responsible for the design, leadership, and implementation of clinical pharmacology strategies across Travere clinical programs. In this role, you will communicate key Clinical Pharmacology strategies to senior management, regulatory agencies, and external peers. Utilizes scientific expertise to provide appropriate interpretation of data and relates implications of results to management. Serves as liaison to other departments/divisions for any study/project needs. Understands linkages across businesses and understands the impact of business decisions and solutions.

Responsibilities

• Lead the development and execution of clinical pharmacology strategy for assigned development programs, integrating pharmacokinetics (PK), pharmacodynamics (PD), and drug-drug interaction assessments into all stages of clinical trials.
• Represent independently Clinical Pharmacology and provide clinical pharmacology support and guidance to clinical stage project teams.
• Develop and oversee the design and implementation of clinical pharmacology studies (e.g., dose escalation, PK/PD modeling) for early drug candidates, ensuring optimal dosing strategies and evidence generation.
• Provide clinical pharmacology input for regulatory submissions such as briefing documents, IND, CTA and NDA.
• Reviews clinical protocols and scientific reports for regulatory filings and anticipates regulatory questions.
• Prepare and input independently appropriate documents or sections of clinical protocols, Investigator Brochures, Clinical Study Reports with respect to Clinical Pharmacology studies or data.
• Closely partner with Research, Bioanalytical, Clinical, Regulatory, Project Management, and other R&D functions.
• This position will play a key role in delivering strategic and well-timed clinical pharmacology input at key decision points along the development path.

Education/Experience Requirements

• Ph.D. degree or equivalent required. Equivalent combination of education and applicable job experience may be considered.
• 4+ years of experience required or Pharm D with 8+ years of experience in a relevant field.
• Knowledge and experience in multiple therapeutic and/or functional areas.
• Experience across range of development phases.
• Must have demonstrated leadership competencies in PK/PD, Biopharmaceutics, and Pharmacometric activities from planning, implementation through completion across multiple projects.
• Scientific project leadership or related experience.
• Project management skills such as scope management, progress tracking/driving as well as time management.
• Participates in initiatives and advancement of Clinical pharmacology.
• Clinical pharmacology and therapeutic knowledge in one or more disease areas.
• Experience with incorporation of MIDD strategies into drug development across all phases and responding to questions on dose and regimen justification and study design.

Additional Skills/Experience/Requirements

• The ideal candidate will embody Travere's core values: Courage, Community Spirit, Patient Focus and Teamwork.
• Driven, intelligent, passionate about making a difference for patients with rare diseases.
• 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.
• Well organized with the ability to multitask, prioritize and manage shifting responsibilities in a small, fast-moving and entrepreneurial environment.
• Demonstrated ability to review, interpret and present complex scientific data.
• Excellent communication, collaboration, and project leadership skills.
• Ability to manage multiple, complex tasks with competing timelines.
• Self-motivated and can independently manage responsibilities.
• Ability to travel 10% domestically and internationally.
• 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.

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

$150,000.00 - $195,000.00

*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 [e-mail]. 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.