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
As part of the Clinical Development team at Azurity, the Clinical Development Manager, is primarily responsible for supporting departmental activities including but not limited to clinical trials (phase 1 to phase 4), conducting targeted scientific analyses for projects across therapeutic areas for nonclinical and clinical programs at Azurity. In this role, the candidate will report to the Associate Director, Clinical Development.
Principle Responsibilities
This should specifically outline, in bullet form, the responsibilities of the job:
- Ability to understand integrated data (formulation, pharmacokinetics/genomics, pharmacodynamics, pharmacovigilance, etc.) from clinical trials, treatment guidelines, and other resources to provide scientific evaluations and develop risk assessments.
- Provides operational and scientific oversight of nonclinical and clinical studies from study design to study closeout ensuring GCP/ICH/regulatory compliance of study documents, processes and procedures.
- Author study documents, including protocols, consents, management plans, amendments, etc.
- Review of CRO/3rd party documents (e.g., SOPs, CRFs, EDC, TFLs, etc.) to ensure alignment with Azurity’s quality expectations and SOPs, if needed.
- Drafting responses to competent authorities or ethical committees.
- Vendor and site monitoring.
- Identify logistical/scientific/ethical/regulatory hurdles/risks and propose solutions.
- Provide clinical updates on assigned programs.
- Identify key scientific sources/findings to support clinical development contributions to regulatory communications (e.g., meeting requests, briefing books, IND/NDA submissions, annual reports, etc.)
- Identify KOLs, external experts/consultants across diverse therapeutic areas to contribute to clinical development objectives.
- Draft abstracts, posters, oral presentations, and manuscripts.
- Contribute to process improvement initiatives within clinical development or in collaboration with other functions.
- Facilitate contractual requirements (CDAs, MSAs, etc.) for clinical development projects in collaboration with applicable Azurity functions.
- Collaborate with PM function to ensure visibility of project deliverables.
Qualifications And Education Requirements
This section should include relevant qualifications and education requirements.
- Degree in scientific/life-sciences field, Master’s degree preferred.
- 3+ years of experience in clinical development or related role within the pharmaceutical, biotechnology or CRO industry.
- Working knowledge of clinical research, GCP, GLP, ICH, and FDA regulations.
- Understanding of pharmaceutical drug lifecycle preferred.
- Strong communication skills (both written and verbal) with an ability to express complex information clearly and concisely.
- Exceptional analytical and problem-solving skills.
- Experience in analysis of research data and publications.
- Demonstrates passion for research and willingness to learn.
- Brings innovation and creativity to challenging projects.
By applying for this role, you confirm that you are mentally and physically capable of fulfilling the job responsibilities detailed in the job description without any restrictions. If you have any concerns or even the slightest disability that may affect your ability to perform the job, please inform HR in advance.
