Clinical Strategy Role - Pharmaceutical - MD

Desired qualification: MD (Pharmacology) with 5 to 7 years- experience in Clinical research

1.Clinical Strategy:

a. Conceptualize clinical development strategy/plan for complex generic and differentiated products:

- The complex generic products include (but not limited to) liposomal, respiratory, ophthalmic and transdermal preparations for development in regulatory regions including US, EU and China

- The differentiated products include products that include novel delivery systems or novel indications to target unmet medical need

b. Design Clinical endpoint and PK-PD studies for complex generic products

c. Prepare clinical trial synopsis and protocols for clinical trials in diverse therapeutic areas for complex generics and differentiated products

d. Interact with regulatory authorities (EMA, FDA, MHRA, Chinese FDA etc) for agreement over the clinical development plan/studies.

e. Deliver presentations to Subject expert committee (SEC) for differentiated products in order to obtain approvals for conduct of clinical trials

2. Medical evaluation and Product selection:

a. Evaluate new products from medical perspective (medical rationale, efficacy, safety, place in therapy etc) and provide inputs to portfolio teams for pipeline selection

b. Keep a track of clinical and regulatory landscape in multiple therapeutic areas to anticipate and project clinical and business value for new drugs

c. Provide medical evaluation of projects for Business development (in-licensing) activities

3. Prepare medical rationale documents and response to regulatory queries in order to support marketing authorization applications globally.

4. Liaison with KOLs for obtaining critical strategy inputs

5. Provide medical support to clinical operations team as required during conduct of clinical studies

Desired skills and knowledge:

- Sound scientific knowledge for diverse therapeutic areas

- Strategic thinking

- Excellent inter-personal and communication skills

- Well versed with clinical study design and statistical methodologies