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
The Senior Clinical Project Manager, Clinical Development is responsible for leading the planning, execution, oversight, and delivery of domestic and/or global postmarketing required clinical trials. The Sr. CPM serves as the operational leader for assigned studies, partnering cross-functionally with Medical/Drug Safety, Regulatory, Data Management, Quality, and external vendors to ensure clinical trials are delivered on time, within budget, and in compliance with applicable regulations and quality standards.
Key Responsibilities
- Lead the operational execution of assigned domestic or global, multi-center late phase clinical trial(s) including oversight of selected vendor(s)/CRO to ensure accountability, quality, and on time delivery of key project deliverables.
- Develop and manage study timelines, contract/budget negotiations, and risk mitigation plans to ensure delivery on timeline and financial goals are met.
- Initiate and manage request for proposal activities for assigned clinical studies or clinical development vendors, including CROs, specialty lab vendors, bioanalytical vendors, etc.
- Lead study execution team comprised of cross-functional representatives from Regulatory, Drug Safety, Medical, Drug Supply, Data Management, Biostatistics, and Quality to oversee CRO vendors and ensure study excellence.
- Manage clinical development vendors according to vendor oversight plans.
- Oversee all study-level data monitoring activities, reviews monitoring visit reports, and conducts Sponsor oversight monitoring visits as required.
- Responsible for monthly Protocol Deviation (PD) review, including oversight of CRA documentation and collaboration with Medical Monitor for medical review.
- Prepares and/or reviews study-related study plans/documents; reviews site study documents.
- Assist in strategic trial design and protocol writing.
- Strategic country/site selection with program input and ensuring consistency across all clinical projects for therapeutic area.
- Ensures all clinical trials are executed in compliance with ICH/GCP guidelines/regulations and applicable SOPs: participates in the planning of quality assurance activities and coordinates resolution of audit findings; ensures audit-ready condition of clinical trial documentation including central clinical files, Trial Master File (TMF), and clinical trial registry submissions.
- Ensure inspection readiness and compliance with ICH-GCP, FDA, EMA, and applicable regulatory requirements.
Required Skills and Experience
- Bachelor's degree in Life Sciences or a related scientific discipline (advanced degree preferred).
- 8+ years of Clinical Trial / Project Management experience within CRO, biotechnology or pharmaceutical organizations.
- Demonstrated experience operating at a Senior Clinical Trial Lead or Associate Director level.
- Proven leadership of global clinical studies and cross-functional project teams.
- Strong experience managing CROs, vendors, and external partners.
- Extensive knowledge of ICH-GCP, FDA, EMA, and global clinical trial regulations.
- Excellent communication, leadership, and project management skills.
Preferred Qualifications
- 5+ years' experience of clinical trial management for late phase studies
- Experience with IMP/clinical drug supply logistics, planning, and labeling activities in late phase studies
- Effective communicator who can manage multiple priorities while building strong internal relationships across multiple departments
#LI-Hybrid
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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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