Manager, Clinical Development – Clinical Sciences

Azurity Pharmaceuticals - US; Hyderabad; In loco; INR 3.000.000 - 5.000.000; Tempo pieno

Descrizione del lavoro

Azurity Pharmaceuticals is seeking a highly experienced Clinical Development professional to contribute to product evaluation, development and testing across multiple therapeutic areas. The role reports to the Director, Clinical Development and collaborates with R&D stakeholders to ensure robust study design, analysis and regulatory-compliant documents (pre-IND, IND, NDA).

Responsibilities include leading protocol development, literature review, PK/biostatistics input, and coordination with CROs

Competenze

• 6+ years of drug development experience with Phase 1 pharmacology and late-phase trials.
• Knowledge of ICH guidelines and GCP; regulatory awareness for drug development.
• Experience with 505(b)(2) drug development is preferable.
• Experience in data analysis, publications; biostatistics and pharmacokinetics.
• Proven ability to use WinNonlin or similar PK software.
• Strong organizational, interpersonal and communication skills; cross-functional teamwork.
• Analytical and problem-solving capabilities.

Mansioni

• Independently lead, author or review the clinical development plan and related documents (pre-IND, IND, NDA).
• Perform literature searches; strategize design aspects: sample size, endpoints, duration for Phase 1-3 trials.
• Collaborate with cross-functional teams; contribute clinical input and feasibility assessments.
• Implement study-related operational plans for trials and oversight of external sites and CROs.
• Analyze Phase 1-2 data; communicate results to stakeholders and program teams.
• Attend portfolio and program meetings; help drive milestones and development plans.
• Oversee study initiation, monitoring, closeout and routine follow-up with external partners.

Conoscenze

Clinical pharmacology

GCP/ICH knowledge

Regulatory knowledge

Analytical skills

Cross-functional collaboration

Biostatistics

Communication skills

Formazione

M.Pharm/Pharm.D/Ph.D

Strumenti

WinNonlin

Descrizione del lavoro

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.

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.

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 R&D, 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).
• Strong 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.

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.