Director, Clinical Science

Job Description:

• Provide management and support for ongoing and future nephrology development and life-cycle activities for clinical programs
• Assist in the design and implementation of clinical studies, including human pharmacology studies, and data analyses
• Assist in reporting clinical trial safety and efficacy data
• Collaborate with cross-functional multidisciplinary study teams to ensure Good Clinical Practices are followed
• Lead writing of clinical and data analysis reports, slide presentations, ClinicalTrials.gov summaries, and related materials
• Contribute to clinical, scientific, and mechanism-of-action sections of INDs, NDAs, and BLAs
• Prepare protocols, SAPs, mock TFLs, investigator brochures, medical reports, efficacy and safety summaries, scientific rationales, benefit/risk ratios, regulatory briefing books, and responses to regulator information requests
• Establish and maintain relationships with alliance partners, external companies, investigators, and key opinion leaders
• Prepare manuscripts for scientific and medical journals
• Prepare and present at scientific meetings

Requirements:

• PhD, PharmD, and/or MD in a related Life Science discipline required
• 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 in rare disease and/or nephrology preferred
• Experience with human pharmacology studies preferred
• Experience contributing to INDs, NDAs, BLAs, and regulatory information requests strongly preferred
• Strong organizational abilities and high attention to detail
• Excellent presentation skills
• Ability to work effectively in a multidisciplinary team
• Demonstrated ability to review, interpret, and present complex scientific data
• Ability to multitask, prioritize, and manage shifting responsibilities
• Strong interpersonal and outstanding verbal and written communication skills
• Ability to adapt to project plan modifications and changes
• Ability to travel 15% domestically and internationally

Benefits:

• Premium health, financial, work-life and well-being offerings for eligible employees and dependents
• Wellness and employee support programs
• Life insurance
• Disability coverage
• Retirement plans with employer match
• Generous paid time off
• Short-term incentive compensation
• Long-term incentive compensation through company stock