Sr. Manager – Clinical Development

Roles and Responsibilities

• Provide scientific leadership in the innovative design, execution and interpretation of clinical trials in development programs (all stages of development).

• Provide expert scientific input into the preparation of regulatory documents and interactions with regulatory authorities.

• Lead and participate in activities that ensure quality, consistency and integration of clinical study related deliverables and ensure safety evaluation process within the clinical team.

• Present protocol and scientific results to multidisciplinary teams and key partners

• Effectively collaborate with colleagues in other functions including Patient Safety, Regulatory Affairs, and Clinical Operations, and early development groups.

• Support and contribute to medical monitoring of trials

• Lead development of quality metrics and data review plan for assigned studies

• Assist in planning for and participate in investigator and coordinator meetings.

• Actively engage and integrate external academic and clinical trial expertise and resource to enhance quality and delivery of experimental and clinical development trials.

• MD with 4-6 years of industry experience in Pharmaceutical Industry or CRO environment in clinical development, preferable experience of supporting early clinical development/ Drug development (phase 1 and Phase 2 studies). OR MBBS/MD (Pharmacology) freshers