Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. The company’s patient-centric products span the cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, and have benefited millions of patients. For more information, visit www.azurity.com.
Azurity Pharmaceuticals is proud to be an inclusive workplace and an Equal Opportunity Employer. Azurity's success is attributable to our incredibly talented, dedicated team that focuses on benefiting the lives of patients by bringing the best science and commitment to quality into everything that we do. We seek highly motivated individuals with the dedication, integrity, and creative spirit needed to thrive in our organization.
About the Role:
This role encompasses both managerial leadership of team responsible for clinical operational activities and a scientific/strategic role as a subject matter expert in scientific and clinical development for both internal (PLM) and external (Corp. Dev.) development product candidates.
Key Responsibilities:
- 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).
Required Skills and Experience:
- 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.
Preferred Qualifications:
- 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.
- Strong understanding of Clinical Regulatory (FDA, MHRA, ICH) guidelines and requirements, Clinical Quality and GCP regulations.
Physical & Mental Requirements:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Must be able to sit for long periods of time
- While performing the duties of this job, the employee is frequently required to stand; walk; sit; talk and/or hear
- May occasionally climb stairs and/or ride elevators
- The employee must occasionally lift and/or move up to 25 pounds
- Employee must be able to manipulate keyboard, operate a telephone and hand-held devices
- Other miscellaneous job duties as required
Benefits We Offer: - 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.
- Sales - In lieu of annual bonuses, we offer an Incentive compensation program that allows you to earn more - even over plan.
- Fuel Your Success: *Sales Only* - We understand the value of your hard work and provide a car reimbursement program and gas card for both business and personal use as part of our commitment to supporting you.
- 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. *Excludes Sales, Manufacturing, and some Operations positions*
- 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.
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