Director, Clinical Science

Role Summary

Director, Clinical Science – The Director, Clinical Science, will provide management and support for Travere’s on-going and future nephrology development and life-cycle activities for clinical programs. The position will work with cross-functional multidisciplinary study teams on clinical trial design and execution as well as related translational and clinical data analyses, interpretation, and presentation of data while ensuring that Good Clinical Practices (GCPs) are followed.

Responsibilities

• Assist in design and implementation of clinical studies (including human pharmacology studies) and data analyses.
• Assist in reporting clinical trial data for safety and efficacy.
• Collaborate with team members to ensure Good Clinical Practices (GCPs) are followed.
• Leadership position for writing clinical and data analysis reports, slide presentations, clinicaltrial.gov summaries, etc. with other clinical development and clinical pharmacology team members, internal and external collaborators, and statistical staff.
• Contribute to clinical, scientific, and mechanism of action portions of INDs, New Drug Applications (NDAs) and Biological License Applications (BLAs), including protocols, SAPs, mock TFLs, investigator brochures, medical reports, efficacy and safety summaries, scientific rationales, benefit/risk ratios, regulatory briefing books, and responding to information requests from regulators.
• Establish and maintain relationships with alliance partners, external companies, investigators, and key opinion leaders to optimize performance on clinical activities and collaborations.
• Prepare manuscripts for scientific and medical journals as well as prepare and present at scientific meetings.

Qualifications

• PhD, PharmD, and/or MD in related Life Science discipline required; experience in rare disease and/or nephrology preferred.
• 6 years of experience in the pharmaceutical industry; equivalent combination of education and applicable job experience in academic or other setting may be considered.
• Experience working on clinical trials and clinical studies required; experience with human pharmacology studies preferred.
• Experience contributing to INDs, NDAs, BLAs, and regulatory information requests strongly preferred.

Skills

• Strong organizational abilities, high attention to detail, and excellent presentation skills.
• 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.
• Demonstrated ability to review, interpret and present complex scientific data.
• Well organized with the ability to multitask, prioritize, and manage shifting responsibilities in a dynamic, cross-functional teamwork environment.
• Excellent collaboration skills with strong attention to detail and the ability to multi-task and manage complexity.
• Strong interpersonal and outstanding verbal and written communication skills.
• Ability to adapt to modification and changes to project plans, demonstrating flexibility to implement new strategies and tactics to accommodate these changes.
• Ability to travel domestically and internationally as needed (up to 15%).

Education

• PhD, PharmD, and/or MD in related Life Science discipline required; experience in rare disease and/or nephrology preferred.

Additional Requirements

• None beyond travel expectations noted above.