Role Overview:

As an Associate Director - Clinical Affairs, you will spearhead the strategic planning and execution of clinical programs, ensuring that all research activities align with global regulatory standards and business objectives. You will serve as a pivotal bridge between cross-functional internal teams, including R&D, Regulatory Affairs, and Data Management, and external stakeholders such as investigators and regulatory bodies. Your leadership will directly influence the success of clinical trials, ensuring data integrity and patient safety, which are fundamental to the company's ability to bring life-saving therapies to market efficiently and compliantly.

Key Responsibilities:

- Direct the end-to-end lifecycle of clinical trials, from protocol design to final study reporting, to ensure projects are delivered on time and within budget.

- Oversee clinical data management processes to maintain high standards of data quality and integrity for regulatory submissions.

- Implement robust pharmacovigilance frameworks to proactively monitor and report safety data, ensuring full compliance with international safety regulations.

- Lead and mentor multidisciplinary teams, fostering a culture of operational excellence and scientific rigor across all clinical research initiatives.

- Collaborate with key stakeholders to develop clinical strategy, ensuring that trial outcomes support the broader commercial and scientific goals of the organization.

Required Skillset:

- Demonstrated expertise in managing complex clinical research portfolios with a deep understanding of GCP, ICH guidelines, and regional regulatory requirements.

- Proven ability to lead and influence cross-functional teams, utilizing strong interpersonal skills to navigate high-stakes negotiations with external partners and internal leadership.

- Advanced proficiency in clinical data management and pharmacovigilance systems, with a track record of implementing process improvements that enhance trial efficiency.

- Exceptional analytical and strategic thinking capabilities, allowing for the rapid identification and mitigation of risks within clinical development programs.

- A Master's degree or higher in Life Sciences, Pharmacy, or a related field, reflecting a strong academic foundation in clinical research.

- Ability to thrive in a high-performance, hybrid work environment based in the Mumbai/Thane region, maintaining clear communication and project oversight across distributed teams.