Vice President, Clinical Development

Role Overview

• Development of Clinical Development strategy for all internal and external (partnered through licensing) programs including timeline and cost estimates, inclusive of pre-approval and post-approval label-expansion studies.
• Personnel management of full-time employees who fill the roles of: Clinical Trial Manager, Data Manager, Clinical Project Manager and Clinical Program Manager.
• Personnel management of part time contractors who fill the roles of: biostatistician, Clinical Quality Manager, Medical Writing, Bioassay development, preclinical development, pharmacokinetics, clinical monitor / medical director (MD).

Requirements

• Strong scientifical and clinical development background spanning small molecules and biologic development in a broad range of therapeutic areas including CNS, oncology, cardiovascular, anti-infectives, GI, obesity, respiratory, and rare diseases.
• Strong understanding of 505(b)(2) and hybrid medicine approval pathways and the strategies to minimize approval requirements for clinical studies.
• Strong operational background in leading and managing the timelines and Phase I-IV clinical trials globally.
• Strong communications skills and ability to lead and contribute to cross functional teams.
• Strong interpersonal skills to support, mentor and manage high performing team of experienced clinical development professionals and related part-time contractors.
• MD or Ph.D. in a basic or health related scientific discipline with related research and drug development experience, with an emphasis in late-stage clinical development expertise (Preferred).
• Strong understanding of Clinical Regulatory (FDA, MHRA, ICH) guidelines and requirements, Clinical Quality and GCP regulations (Preferred).

Tech Stack

• Google Cloud Platform

Benefits

• Unlock Your Earning Potential: Join our team and be rewarded with a competitive compensation package, including an annual bonus based on company performance, that recognizes your exceptional talent.
• Comprehensive Health Coverage: We value your well-being and offer excellent medical, dental, vision, and prescription coverage to ensure you and your family are always taken care of.
• Flexibility for Your Lifestyle: Achieve work-life balance with our hybrid work model, allowing you to work two days from home and three days in the office. *Sales, Manufacturing, and some Operations positions excluded.
• Invest in Your Future: Our Retirement Savings Plan (401K) is designed to help you secure a comfortable retirement by matching dollar for dollar up to 5%.
• Time Off That Counts: Take advantage of our generous time off policy, which offers up to 15 vacation days annually + rollover (up to 40 hours) as well as five sick/wellness days. For new employees, vacation accrual will be prorated based on your start date.
• Meaningful Time with Your Loved Ones: We close between Christmas and New Year’s to give you an extra week off to spend quality time with your family and recharge.
• Enjoy the Holidays: Over the course of the year, Azurity recognizes 13 holidays.
• Invest in Your Education: We support your professional growth with tuition reimbursement for undergraduate and graduate level courses or certifications.
• Recognize and Be Recognized: Our Azurity High Five peer recognition platform allows you to celebrate your colleagues' accomplishments and receive recognition for your own outstanding work.