Associate Director - Senior Clinical Scientist

5d5 days ago

Bristol Myers Squibb

Hyderābād, IN · Full-time · INR 2,500,000 – INR 4,500,000

About this role

The Senior Clinical Scientist reports through the Clinical Science function which provides scientific expertise necessary to design and deliver clinical studies and programs. This role focuses on implementation, planning, and execution of assigned clinical trial activities. The position serves as Clinical Trial Lead for one or more trials with minimal to moderate supervision.

Day-to-day work includes planning and leading Local Health authority and Subject Expert Committee interactions for assigned projects. The scientist successfully leads trial-level activities for multiple trials while providing scientific and clinical leadership to supporting Clinical Scientists. Study team meetings are co-led in partnership with the GDO protocol manager.

Collaboration occurs with cross-functional study team members and external partners for scientific advice. The role may support clinical development planning through data analysis alongside the Clinical Development Lead. Site-facing activities include training and serving as primary contact for clinical questions.

Bristol Myers Squibb offers opportunities uncommon in scale and scope alongside high-achieving teams. Employees gain resources to pursue goals both at work and in personal lives through a wide variety of competitive benefits and programs that support balance and flexibility.

Requirements

Thorough understanding of assigned protocols and protocol requirements.
Experience leading Local Health authority and Subject Expert Committee interactions.
Ability to lead trial-level activities for multiple trials with minimal to moderate supervision.
Scientific and clinical leadership skills to guide supporting Clinical Scientists.
Experience with protocol and ICF development including cross-functional comment resolution.
Proficiency in clinical data review, query resolution, and trend identification.
Skill in drafting and validating clinical study reports and regulatory documents.
Capability to collaborate as primary liaison with external partners for scientific advice.

Responsibilities

Maintain a thorough understanding of assigned protocols and protocol requirements while educating supporting team members.
Plan and lead interactions with local health authorities including presentation to Subject Expert Committees.
Plan and lead implementation of all study startup, conduct, and close-out activities as applicable.
Provide scientific and clinical leadership to the team of supporting Clinical Scientists through matrix leadership.
Co-lead study team meetings in partnership with the GDO protocol manager and collaborate with cross-functional study team members.
Develop protocol and ICF with minimal guidance including writing, reviewing, and ensuring high clinical quality.
Perform activities related to data generation and validation including CRF design, clinical data review, and query resolution.
Draft, review, and validate clinical study reports and clinical portions of regulatory documents such as IB and DSUR.