Education, Qualifications, Skills, and Experience :

- MBBS with 7-8 years/ MD with 5-6 years of industry experience in Pharmaceutical Industry or CRO environment in clinical development, preferable experience of supporting early clinical development (phase 1 and Phase 2 studies).

Job Description:

- 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.

- Provide scientific analysis and interpretation of data from ongoing studies and in the literature

- Support and contribute to medical monitoring of trials

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

- Develop and review protocols, informed consent, investigator's brochure.

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

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