Azurity Pharmaceuticals

Reformulates established medicines into alternative doses

Senior Clinical Project Manager

Clinical Research OperationsConfirmed live in the last 24 hours

Full-timeRaleigh, NC, USANo salary listedIn-person

About the Job

Requirements

A bachelor's degree in Life Sciences or a related scientific discipline is required; an advanced degree is preferred.
At least 8 years of clinical trial or project management experience within a contract research organization, biotechnology, or pharmaceutical organization.
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 contract research organizations, vendors, and external partners.
Extensive knowledge of International Council for Harmonisation Good Clinical Practice, U.S. Food and Drug Administration, European Medicines Agency, and global clinical trial regulations.
Strong communication, leadership, and project management skills.

Responsibilities

Lead operational execution of assigned domestic or global, multicenter late-phase clinical trials, including oversight of selected vendors or contract research organizations to ensure accountability, quality, and timely delivery of key project deliverables.
Develop and manage study timelines, contract and budget negotiations, and risk mitigation plans to meet delivery timelines and financial goals.
Initiate and manage requests for proposal for assigned clinical studies or clinical development vendors, including contract research organizations, specialty laboratory vendors, and bioanalytical vendors.
Lead a study execution team of cross-functional representatives from Regulatory, Drug Safety, Medical, Drug Supply, Data Management, Biostatistics, and Quality to oversee contract research organization vendors and ensure study excellence.
Manage clinical development vendors according to vendor oversight plans.
Oversee study-level data monitoring activities, review monitoring visit reports, and conduct sponsor oversight monitoring visits as required.
Conduct monthly Protocol Deviation reviews, including oversight of Clinical Research Associate documentation and collaboration with the Medical Monitor for medical review.
Prepare or review study-related plans and documents and review site study documents.
Assist in strategic trial design and protocol writing.
Select countries and sites strategically with program input and ensure consistency across clinical projects for the therapeutic area.
Ensure clinical trials are executed in compliance with International Council for Harmonisation Good Clinical Practice guidelines and regulations and applicable standard operating procedures; participate in planning quality assurance activities, coordinate resolution of audit findings, and maintain audit-ready clinical trial documentation, including central clinical files, the Trial Master File, and clinical trial registry submissions.
Ensure inspection readiness and compliance with International Council for Harmonisation Good Clinical Practice, U.S. Food and Drug Administration, European Medicines Agency, and applicable regulatory requirements.

Desired Qualifications

At least 5 years of clinical trial management experience for late-phase studies.
Experience with investigational medicinal product or clinical drug supply logistics, planning, and labeling activities in late-phase studies.
Ability to manage multiple priorities while building strong internal relationships across departments.

At Azurity, we're redefining medicine for the real world. Most medicines are designed for how they're approved; ours are built for real life. That shift drives everything we do. We challenge the status quo — repurposing proven molecules with intention, reimagininghow therapies are designed, delivered, and accessed so they work in the realities of everyday life. And with a diversified and growing portfolio, we bring the agility, scale, and global reach to deliver meaningful solutions to patients, providers, and healthcare systems around the world. Because medicine should fit into life, not force life to fit around it. With more than 70 medicines across 11 therapeutic areas, Azurity’s mission is fueled by a growing portfolio that reaches millions of people in more than 50 countries. Learn more at www.azurity.com and LinkedIn.

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

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About the Company

Azurity Pharmaceuticals

Reformulates established medicines into alternative doses

Azurity Pharmaceuticals focuses on developing specialized dose forms of existing medicines to meet unmet patient needs in the U.S., especially for those who have difficulty swallowing or require precise dosing. It creates formulations like oral suspensions across therapeutic areas including cardiovascular, CNS, endocrine, GI, anti-infective, and oncology, marketed to providers, hospitals, and pharmacies. Unlike firms that launch new chemical entities, Azurity expands access by reformulating approved drugs into tailored, regulatory-compliant products such as FIRVANQ, HORIZANT, GLIADEL Wafer, SOTYLIZE, VIVIMUSTA, and others. Its goal is to improve patient outcomes by making FDA-approved medicines easier to use and accessible for overlooked patient populations.

Company size: 201-500
Company stage: Growth Equity (Venture Capital)
Total funding: $182.2M
Headquarters: Woburn, MA
Founded: 2000

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