Clinical Development Manager at Azurity Pharma in Hyderabad – Life Science Candidates Apply Now!
Are you ready to make a significant impact in the world of clinical research? Azurity Pharmaceuticals, a leader in innovative pharmaceutical solutions, is hiring a Clinical Development Manager in Hyderabad. This exciting opportunity offers you the chance to contribute to life-changing clinical trials, regulatory processes, and scientific evaluations that improve patient outcomes. Step into a career that values passion, expertise, and innovation in the pharmaceutical industry.
About Azurity Pharmaceuticals
Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products to meet the needs of underserved patients. Recognized for providing unique, accessible, and high-quality medications, Azurity offers a broad commercial product portfolio spanning various therapeutic areas. The company’s patient-centric approach has positively impacted millions of individuals.
Job Details:
Job Role: Clinical Development Manager
Location: Hyderabad
Azurity Pharmaceuticals is proud to be an inclusive workplace and an Equal Opportunity Employer, dedicated to making a difference in patients’ lives. We are looking for a motivated Clinical Development Manager to join our team.
Job Description
As part of the Clinical Development team at Azurity, the Clinical Development Manager is responsible for supporting departmental activities, including clinical
trials across different phases. The role involves providing scientific evaluations, managing nonclinical and clinical programs, and ensuring compliance with regulatory standards.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 (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
To be considered for this role, candidates should meet the following 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.
Keywords: Azurity Pharmaceuticals, Clinical Development Manager, Hyderabad, Pharmaceutical Company, Clinical Trials, Regulatory Compliance, Scientific Evaluation, Research, Innovation
