Posted 3 days ago
Key responsibilities:
- Critical evaluation of clinical data of the investigational products/similar drugs from clinical sciences perspective to build a foundation for clinical development strategies for registration purposes or for evaluation of in-licensing opportunities.
- Closely collaborates with various teams (including Clinical Development team members, Project Management, Clinical Operations, Pharmacovigilance, Regulatory, Global Medical Affairs, Intellectual Property) for clinical development planning, protocol development & finalization, execution support, regulatory presentations and HA interactions etc.
- Medical monitoring and supervision of the clinical oncology studies.
- Develops and maintains collaborative partnerships with oncology stakeholders, key external experts, and allied health professionals ensuring scientific understanding and advocacy around products and therapeutic area
- Closely collaborates with portfolio, business development, Global medical affairs team to provide medical / scientific expertise on due diligence of new product licensing and acquisition opportunities for late-stage compounds and marketed products.
Your profile:
- Medical educational background (MD or equivalent post graduate medical degree) in oncology with an approximate experience of 10 to 12 years of working in clinical sciences, regulatory registration oncology studies or Phase 1- 3 clinical development function of pharmaceutical /biopharmaceutical companies.
- Understanding of the overall drug development process and regulatory path for oncology products in various markets.
- Able to evaluate, interpret and present highly complex data from clinical trials.
- Ability to work in cross functional groups and teams with a complex matrix organization.
- Experience of financial and resource planning and management is essential. Excellent presentation and communication skills with an ability to meet the scientific, commercial needs. – Ability to co-ordinate with multiple stakeholders across different geographies of various markets both within and outside the organisation.
Job Features
Job Category | CLINICAL DEVELOPMENT |