Sr. Manager, Clinical Development

Responsibilities

• Lead cross-functional Study Teams comprising members from Clinical Operations, Regulatory, Biostatistics, Quality Assurance, and Data Management.
• Act as the primary source of medical accountability for one or multiple clinical studies, including overseeing medical monitoring and data review.
• Drive the execution of study deliverables from inception through design and execution, including protocol development and regulatory filings.
• Create study plans aligned with business objectives to provide competitive differentiation and patient benefit.
• Manage and mitigate risks by monitoring study progress and emerging data, proposing adjustments to Project leadership as needed.
• Provide clinical development support for interactions with regulatory authorities and data monitoring boards.
• Serve as an external spokesperson for the Study Team during investigator meetings and advisory boards.

Requirements

• MD, MD/PhD, or MD + DM degree.
• 3+ years of experience in biotech or pharmaceutical drug development.
• Proven experience across multiple phases of drug development.
• Strong working knowledge of global regulatory requirements, including GCP, ICH, US FDA, and EMEA regulations.
• Demonstrated ability to lead in a matrix environment and motivate multi-disciplinary teams.
• Excellent written and verbal communication skills for interacting with all levels of the organization and external stakeholders.

About the Company

Sun Pharmaceutical Industries Ltd is the fourth largest specialty generic pharmaceutical company in the world, with global revenues exceeding $5 billion USD. We provide high-quality, affordable medicines to more than 100 countries. At Sun Pharma, we foster an environment of continuous progress, innovation, and collaboration, driven by our core values of humility, integrity, passion, and innovation.