Head of Clinical Operations

Job Description

We have a long-term commitment to bring high quality affordable biosimilars to patients all over the globe.

About the Role:

The right candidate will have strong leadership skills, be an excellent communicator with an ability to develop meaningful relationships, a strategic thinker that can bridge the complexities of patient care and drug development, a collaborator who can successfully lead and influence external and internal stakeholders, and a highly motivated self-starter who is comfortable innovating in an entrepreneurial and fast-paced company environment.

Responsibilities:

• Provides operational direction in managing and driving Biocon's clinical development programs through all phases of clinical trials in accordance with global standards.
• Provides direct oversight and general management of operations and of personnel involved in clinical operations, data management and clinical trial & supply management.
• Ensures clinical trials are appropriately resourced, managed and executed in accordance with timelines and applicable standards.
• Provides oversight of global/country specific CROs and vendors from identification to selection to close of contracts.
• Meets investigators and site personnel when required.
• Represents clinical operations at senior management/external high-level meetings or discussions.
• Reviews master service agreements, statements of work, and other agreements relating to clinical operations and trials. Provides input on operational components in these documents which are required for CROs/Vendors.
• Provides oversight of study budget as well as CRO/Vendor payments.
• Ensures development of clinical timelines and budget forecasts and track accordingly.
• Implements best practices and standards for trial management in collaboration with other members of the clinical operations team.
• Regularly interacts with Clinical Development team as well as cross-functional teams (Regulatory, Program Management, R&D etc.)
• Motivates, mentors, guides and supports clinical operations team members to elevate their quality to global drug development standards.
• Participates as a key member of the various committees to plan and utilize financial resources required to support operations team and clinical trials.

• Bachelors or Master's degree, equivalent or higher qualification within Life sciences/ Pharmacy/ MBBS /MD/ Healthcare Degree in alternative Medicine/ BDS with at least 15 years of experience in clinical operations.
• Clear understanding of applicable clinical trial guidelines and regulations
• High degree of professionalism, maturity, business understanding, and passion is must.
• Strong written and verbal communication skills as well as strong interpersonal skills, with impeccable attention to detail
• Strong leadership skills with a proven ability to collaborate effectively with internal and external stakeholders at all levels and influence decision-making.
• Highly motivated individual with the flexibility and creativity to excel in a rapidly growing and changing environment; confidence and organizational skills to independently work on multiple tasks
• Must be willing to travel when required