Director, Head RCO India

Bristol Myers Squibb; India; On-site; INR 4,000,000 - 6,000,000; Full time

Job summary

Bristol Myers Squibb in India is seeking a senior leader to head the India clinical operations teams, ensuring execution excellence in trial planning, site management, and monitoring of registrational and ISR studies. You will partner with development teams, local medical and key stakeholders to ensure effective management of India conducted trials and support a GDO quality culture.

This role requires deep expertise in GCP/ICH, strategic resourcing, and the ability to align programs with senior

Qualifications

• Bachelor's degree in life sciences or related field.
• Minimum of 10 years of experience in people and project management in pharma/biotech/CRO.
• Significant experience in planning, conduct and management of clinical programs (Phase I-IV).
• Deep knowledge of GCP, ICH guidelines and related regulations.
• Strong leadership, communication and cross-functional collaboration.

Responsibilities

• Executes clinical trials per India Book of Work.
• Ensures timely study start-up and recruitment targets.
• Manages India teams workload across multiple studies.
• Maintains relationships with stakeholders and external institutions.
• Drives continuous improvement and quality culture in GDO.

Skills

Leadership

Project management

GCP/ICH knowledge

Clinical operations

Stakeholder management

Education

Bachelor's degree in life sciences or related

Job description

At Bristol Myers Squibb, our employees often ask, Who are you working for a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

Position Summary

This role will lead the India clinical operations teams and is responsible for execution excellence in operational planning, implementation, trial management, site management and monitoring of clinical trials (registrational, non registrational / Investigator Sponsored Research (ISR)) conducted within India. This leadership role will serve as a member of the RCO APAC Senior Leadership Team and be part of the RCO and GDO extended leadership teams. This role will also serve as a member of the local affiliate leadership team (as applicable) managed by the General Manager, as well as other affiliate senior leadership committees. This role will interact with the development teams, local medical and key BMS stakeholders in order to ensure effective management of India conducted clinical trials. This role will support a GDO Quality culture collaborating with both the GDO Global Clinical Compliance team as well as the GQ Clinical Trial and Safety group.

Key Responsibilities And Major Duties

• Executes clinical trials, as per the India Book of Work.
• Ensures timely studystart-up and that target subject recruitment numbers and database lock timelines are met.
• Proactively evaluates clinical trial feasibility and site selection by collaborating with the BI&A team to evaluate current metrics and data.
• Endorses country and site feasibility targets for India.
• Manages the India teams workload and support of multiple studies.
• Provides continuous assessment of resource needs and anticipates and initiates actions in response to multiple/changing demands and priorities.
• Takes a broad business perspective when making decisions.
• Makes judgements to ensure work is achieved within target timelines.
• Exercises sound judgement in areas of clinical trial management, resource allocation (headcount and budget targets) and recruitment activities.
• Builds and maintains a highly performing team of highly qualified, India based, research professionals and the respective line managers.
• Managing the hiring, development, coaching, mentoring, performance management and succession planning of staff.
• Ensures effective utilization of FSP resources in the execution of clinical trials conducted in the India.
• Meeting or exceeding project deliverables and initiatives with the highest quality through alignment with senior leaders and key stakeholders through flexible and fluid resourcing.
• Develop, maintain and maximize strong working relationships with peers, senior leaders, key stakeholders and external institutions/networks to influence decisions and achieve optimal results focused on our patients.
• Drive alignment across development programs promoting knowledge sharing, operational issue resolution through close collaboration with key stakeholders.
• Identify, maintain and optimally grow clinical investigative site/Institution/Network relationships through direct/personal and/or group engagements in most impactful manner.
• Supports a GDO Quality Culture.
• Ensures a continuous improvement mindset across the group.

Qualification And Experience Requirement

• Bachelors degree required preferably within life sciences or equivalent.
• Minimum of 10 years of experience in people and project management in a pharma/biotech/CRO organization.
• Significant experience in the planning, conduct and management of clinical programs (Phase I-IV).
• Demonstrated ability to drive project related activities.
• Previous experience leading, managing, coaching and developing direct reports.
• In depth understanding of GCP, ICH Guidelines and other local guidance, regulation and codes of practice related to Clinical Research and Medical Affairs.
• Understands the drug development process, from early to late stage, including lifecycle management.
• Deep knowledge of clinical trial operations including monitoring methodologies, systems, regulations/compliance, budget and resource management and site facing engagements.
• Knowledge of the external country clinical trial environment and stakeholders therein.
• Demonstrated organizational and planning skills and independent decision-making ability.
• Highly organized and motivated possessing excellent communication, interpersonal and presentation skills.
• Passionate, accountable and innovative critical thinker who balances risk/speed for maximum results.
• Outstanding interpersonal, oral and written communication skills to influence, inform or guide others.
• Results oriented with proven track record in building strong .