Clinical Development Manager at Azurity Pharmaceuticals – Apply Now
Azurity Pharmaceuticals is seeking a highly motivated Clinical Development Manager to join our team in Hyderabad, Telangana, India. As part of the Clinical Development team, you will play a pivotal role in supporting clinical trials (Phase 1–4) and conducting scientific analyses across multiple therapeutic areas. If you have a passion for research, clinical development, and regulatory compliance, this opportunity is perfect for you. Join a company committed to innovation and patient care!
Clinical Development Manager
Location: Hyderabad, Telangana, India
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:
- 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 to ensure alignment with quality expectations and SOPs.
- 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.
Qualifications & Requirements
- Degree in Life Sciences, Pharmaceuticals, or a related field (Master’s preferred).
- 3+ years of experience in clinical development, pharmaceuticals, biotechnology, or CROs.
- Strong knowledge of clinical research, GCP, GLP, ICH, and FDA regulations.
- Understanding of pharmaceutical drug development lifecycle.
- Excellent communication, analytical, and problem-solving skills.
Physical & Mental Requirements:
Must be able to sit for long periods of time. 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.
Keywords: Azurity Pharmaceuticals, Clinical Development Manager, Hyderabad, Telangana, India, Clinical trials, Pharmaceutical, Equal Opportunity Employer. Clinical Development Manager at Azurity Pharmaceuticals – Apply Now
