Manager, Clinical Development – Clinical Sciences

The role

The candidate will contribute to clinical programs for product evaluation, development and testing across multiple therapeutic areas. This role involves leading clinical development plans and working with stakeholders to ensure optimal design and analysis of clinical investigations.

What you will do

• Lead, author or review the clinical development plan including clinical protocol and study-related documents.
• Perform literature searches and strategize clinical designing aspects like sample size, endpoints and duration.
• Participate in conceptualizing and validating ideas with cross-functional teams.
• Implement study-related operational plans.
• Analyze Phase 1 - 2 study data and communicate results.
• Oversee and review project-oriented works at external partnered sites.
• Attend portfolio team meetings and collaborate with program managers.
• Oversee study initiation, monitoring, closeout and communication with CROs.

Required qualifications

• 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.
• Experience in analysis of research data and publications.
• Working knowledge of biostatistics and pharmacokinetics.
• Strong organizational, interpersonal and both verbal and written communication skills.
• Ability to work collaboratively as a member of a cross-functional team.
• Good analytical and problem-solving skills.

Nice to have

• Work experience in 505.b.2 drug development is preferable.
• Proven track record of working with Winnonlin or other PK software.
• M.Pharm/ Pharm.D/ Ph.D preferred in the field of clinical pharmacy or pharmacology.

Before you apply

• By applying, you confirm that you are mentally and physically capable of fulfilling the job responsibilities without any restrictions.

About the company

Azurity Pharmaceuticals is an inclusive workplace and an Equal Opportunity Employer. The company focuses on repurposing proven molecules and reimagining how therapies are designed, delivered, and accessed.