Director, Clinical Science

This is a fully remote position, open to applicants in California.

📋 Description

• Oversee and support ongoing as well as future nephrology development and life-cycle activities for clinical programs.

• Aid in the design and execution of clinical trials, which includes human pharmacology studies and data analysis.

• Assist in the reporting of safety and efficacy data from clinical trials.

• Work collaboratively with cross-functional, multidisciplinary study teams to ensure adherence to Good Clinical Practices.

• Take the lead in drafting clinical and data analysis reports, slide presentations, ClinicalTrials.gov summaries, and associated documents.

• Contribute to the clinical, scientific, and mechanism-of-action sections of INDs, NDAs, and BLAs.

• Develop protocols, SAPs, mock TFLs, investigator brochures, medical reports, efficacy and safety summaries, scientific rationales, benefit/risk assessments, regulatory briefing materials, and responses to regulator inquiries.

• Build and maintain relationships with alliance partners, external organizations, investigators, and key opinion leaders.

• Write manuscripts for publication in scientific and medical journals.

• Prepare and deliver presentations at scientific conferences.

⛳️ Requirements

• A PhD, PharmD, and/or MD in a relevant Life Science field is required.

• A minimum of 6 years of experience in the pharmaceutical industry; an equivalent combination of education and relevant experience in an academic or alternative setting may be considered.

• Required experience in clinical trials and studies.

• Preference for experience in rare diseases and/or nephrology.

• Preferred background in human pharmacology studies.

• Strong preference for experience contributing to INDs, NDAs, BLAs, and regulatory inquiries.

• Exceptional organizational skills and a keen eye for detail.

• Outstanding presentation capabilities.

• Proven ability to work effectively within a multidisciplinary team.

• Demonstrated skill in reviewing, interpreting, and presenting complex scientific data.

• Ability to multitask, prioritize responsibilities, and manage changing demands.

• Strong interpersonal skills and exceptional verbal and written communication abilities.

• Adaptability to modifications and changes in project plans.

• Willingness to travel up to 15% domestically and internationally.

🏝️ Benefits

• Comprehensive health, financial, work-life, and well-being benefits for eligible employees and their dependents.

• Wellness programs and employee support initiatives.

• Life insurance coverage.

• Disability insurance.

• Retirement plans with employer matching contributions.

• Generous paid time off policy.

• Short-term incentive compensation opportunities.

• Long-term incentive compensation through company stock options.