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.
In this role, the candidate will report to the Director, Clinical Development and work with stakeholders and team members to provide scientific excellence, build effective relationships across RD, and ensure optimal design and analysis of clinical investigations.
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 GCP and sound understanding of regulatory guidelines and clinical requirements.
- Work experience in 505.b.2 drug development is preferable.
- Experience in analysis of research data and publications; working knowledge of biostatistics and pharmacokinetics.
- Having proven track record of working with Winnonlin or other PK software (preferred).
- Solid organizational, interpersonal and both verbal and written communication skills and ability to work collaboratively as a member of a cross-functional team.
- Good analytical and problem-solving skills.
Preferred Qualifications:
- M.Pharm/ Pharm.D/ Ph.D preferred in the field of clinical pharmacy or pharmacology.
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