18 Aug
|
Azurity Pharmaceuticals - India
|
Hyderabad
18 Aug
Azurity Pharmaceuticals - India
Hyderabad
Azurity Pharmaceuticals is proud to be an inclusive workplace and an Equal Prospect 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:
As part of the Clinical Development team at Azurity, the role requires contribution to clinical programs for product evaluation, development and testing across multiple therapeutic areas.
Key Responsibilities:
- Independently lead, author or review the clinical development plan including the clinical protocol and study-related documents viz., pre-IND, IND, NDA documents for respective clinical sections while working with internal and external stakeholders.
- Perform literature searches and strategize clinical designing aspects, viz. tentative sample size, study endpoints and duration for Phase 1-3 trials.
- Participate in conceptualizing and validating ideas and contribute with clinical inputs and feasibility while closely working with cross-functional teams.
- Have the ability to implement study-related operational plans.
- Can independently analyze Phase 1 - 2 study data and communicate the results
- Able to oversee and review project-oriented works at external partnered sites and guide wherever necessary.
- Attend portfolio team meetings and collaborate with respective program managers in overall project development plan and milestones.
- Oversee study oversight including study initiation, monitoring and study closeout and routine follow-up and communication with external partners (CROs).
Required Skills and Experience:
- Minimum of 6+ years of experience in drug development with extensive experience in Phase 1 clinical pharmacology studies and moderate experience in late phase trials.
- Knowledge in ICH guidelines and
📌 Manager, Clinical Development (Hyderabad)
🏢 Azurity Pharmaceuticals - India
📍 Hyderabad