Expert - Clinical Development - Pharma

Clinical Development Expert

1. Clinical Strategy : With scientific understanding, clinical development strategy/plan preparation for differentiated products, generics and products for life cycle management. For high value differentiated products, work on global clinical plan in line with EMIN markets, Cost optimized and time sensitive clinical strategy preparation is expected.

2. Participate in Product Selection : Support Portfolio teams by providing Medical evaluation and Clinical strategy of products, participate in product selection meeting with senior leadership, to present complete clinical strategy with ballpark estimate and timelines for technical discussions

3. Participation in Business-development activities : Critical review of data shared for in licencing product, perform gap analysis, Due-diligence of all in-licensing dossiers for emerging markets, Prepare clinical strategy for such assets with understanding of available data with partner, Medical evaluation of such novel product in order to select best product for in-licencing.

4. Target product profile: Finalize the complete clinical strategy note in collaboration with cross functional team inputs for sign off.

5. Medico-regulatory strategies: Develop clinical development plans for enabling clinic regulatory discussions with regulatory agencies for clinical waivers, positive opinion on innovative clinical approaches through scientific advice meetings.

6. Cross functional team collaboration: Work closely with multiple stake holders- product development teams, preclinical & PK, regulatory, portfolio and medical teams to develop clinical strategy for differentiated products