Project Manager, Clinical Development

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.

Brief team/department description:

The Project Manager (PM), Clinical Development is an integrated role within Azurity R&D and specialized to work across projects in Clinical (Phase 1 – 4) in development in the US, India, and globally (i.e., post marking requirements). Reporting into the Vice President, Clinical Development, the (PM) is a support function responsible for management of the business, contractual, program planning, timeline oversight, and budget aspects associated with research across clinical and nonclinical development programs.

The PM functions to drive programs to meet key milestones including project initiation, completion, and financial goals. A key component of the role includes coordination of cross functional R&D resource to reach alignment when troubleshooting and issue resolution are required. Ability to partner with leadership, R&D teams, and stakeholders is critical.

Principle Responsibilities:

• Lead project and program planning across all stages of clinical development, including nonclinical research activities.
• Facilitate optimization of candidate development plans utilizing project management capabilities to identify risks and plan contingencies.
• Development and drive integrated project plans.
• Manage projects within established scope, schedules, and budget.
• Partner with Azurity Finance to maintain accurate oversight of budgets and forecasts.
• Coordinate with Azurity Legal to develop documents including Master Service Agreements, Work Orders, Contracts, and other related documents requiring Legal input.
• Serve as business liaison to vendors including clinical and nonclinical CROs and consultant agencies.

Qualifications and Education Requirements

• Bachelor’s Degree in scientific/life-sciences field. Advanced degree such as Master’s degree is a plus.
• Experience and/or Training: 7+ years of pharmaceutical industry and/or academic experience; 5+ years of project management experience preferred.
• Sound understanding of R&D functions involved in development of medicinal products.
• Ability to partner with leadership to implement initiatives and optimize processes.
• Knowledge and application of project management procedures and tools.
• Strong interpersonal skills, effective communication, and ability to build relationships with a broad spectrum of stakeholders at all organizational levels.
• Ability to prioritize and multi-task to meet objectives in a fast-paced company environment.

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