Associate Director, Global Development Organization Regional Business Operations - India

• The Associate Director, Global Development Organization Regional Business Operations - India will play a crucial role in supporting the implementation and execution of clinical trials within India. This role will ensure alignment with GDO’s strategic priorities and operational goals working closely with  India Development Lead and leveraging strong clinical operations expertise to foster close connection with all related functions in India, including but not limited with Medical Affairs, Regulatory Affairs, Compliance, Clinical Site Start Up and Engagement and other GDO & R&D functions established in India, as well as GDO functions and CADT (China/Asia Development Team) in RnD China&APAC Region. This position will be responsible for providing operational leadership, and strengthening capabilities that contribute to both RnD China&APAC Region and GDO’s business performance, and operational excellence in India They will work collaboratively to build, implement, and manage business-critical capabilities and cross-functional initiatives and support R&D Leader in India.

ACCOUNTABILITIES:

In close partnership with Sr Director, Global Development Organization Regional Business Operations, Asia, and RnD China&APAC Region Leadership set goals to support increased performance and delivery.

• Strategic Implementation:
  • Support the implementation of RnD China&APAC Region and GDO’s strategic priorities within India, aligning regional activities with CADT and global objectives.
  • Collaborate with CADT and global teams to ensure seamless integration and execution of operations strategy.
• Operational Excellence:
  • Drive operational efficiency and productivity within key GDO functions in India.
  • Identify and implement process improvements to enhance trial execution and resource utilization.
  • Monitor and manage risks in India, escalating issues as necessary to the Sr. Director, GDO Regional Business Operations and CADT.
• Stakeholder Engagement:
  • Build and maintain strong relationships with key stakeholders, including regional and global teams, external partners, and India regulatory bodies.
  • Facilitate effective communication and collaboration across functions to support GDO strategy implementation success in India.
  • Represent GDO in cross functional teams and/or meetings at local, regional and global level as required.
• Resource Management:
  • Support resource management efforts in India.
  • Utilize analytics to inform resource planning and optimize resource utilization in response to portfolio changes.
  • Develop resource levers to maximize resources when there are portfolio changes.
• Compliance and Governance:
  • Ensure compliance with all relevant regulations, guidelines, and internal policies.

EDUCATION & EXPERIENCE:

• Bachelor’s degree in a relevant field.

• 10 or more years’ experience in clinical operations within the biotechnology or pharmaceutical industry.

• Demonstrable expertise in clinical trial management and execution.

• Strong understanding of the regulatory environment and clinical trial requirements in India.

• Excellent time management, organizational, and planning skills.

• Proven ability to build and maintain productive relationships with key stakeholders.

• Strong analytical and problem-solving skills.

• Excellent oral and written communication skills, with the ability to effectively share information and influence decision-making.

• Ability to apply integrated thinking and business acumen to think through complex issues and articulate recommendations.

• Ability to drive change and manage complex situations, particularly with multinational matrix teams.

• Collaborative management style, responsive, flexible, assertive, and personable.