Director, Head RCO India

Bristol-Myers Squibb; Mumbai; On-site; INR 4,000,000 - 7,000,000; Full time

Job summary

Bristol-Myers Squibb in Mumbai, India, seeks a Director to lead the India clinical operations teams, driving execution excellence in planning, trial management, site management and monitoring of trials conducted within India. The role partners with global teams to ensure quality and timely delivery.

The role requires a Bachelor in life sciences, 10+ years in pharma/biotech, and proven leadership in managing complex programs (Phase I-IV) with strong GCP/ICH knowledge.

Qualifications

• Bachelor's degree in 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 and lead, coach and develop staff.
• Deep knowledge of GCP, ICH Guidelines and other local guidance, regulation and codes of practice related to Clinical Research and Medical Affairs.

Responsibilities

• Executes clinical trials per the India Book of Work and ensures timely study start-up and recruitment targets.
• Evaluates feasibility and site selection by collaborating with BI&A team and endorses country/site targets for India.
• Manages team workload and supports multiple studies with resource planning and budget targets.
• Builds and maintains a high-performing India-based research team and mentors staff.
• Ensures utilization of FSP resources in India, meeting project deliverables with high quality.
• Develops relationships with peers, senior leaders, stakeholders and external institutions to drive optimal results.

Skills

Leadership

Project Mgmt

Stakeholder Mgmt

GCP/ICH

Clinical Trials

People Management

Budgeting

Communication

Data-Driven Decisions

Education

Bachelor's degree in life sciences or equivalent

Job description

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 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 study start-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 team’s 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, collaborative relationships with internal and external stakeholders to manage the India book of work Good verbal and written communication skills (both in English and local language).

How We Work

Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.

Supporting People with Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [e-mail]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. For roles based in Los Angeles County only: If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. R1605822 : Director, Head RCO India Data Privacy Link

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