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Lead- Clinical Operations

Roche
Roche
10-15 years
preferred by company
10 Jan. 29, 2026
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Lead – Clinical Operations
Job ID: 202601-100772
Location: Mumbai, Maharashtra, India
Category: Research & Development
Employment Type: Full-time


About Roche

Roche is a global pioneer in pharmaceuticals and diagnostics, driven by a singular purpose: advancing science to improve people’s lives. With more than 100,000 employees worldwide, Roche is committed to innovation, inclusion, and delivering sustainable healthcare solutions that enable access to quality care for present and future generations. Roche fosters a culture of openness, respect, and collaboration, where every voice matters and individuals are empowered to grow personally and professionally.


Position Overview

Roche is seeking an experienced Lead – Clinical Operations to drive and oversee clinical operations strategy in India. This leadership role is responsible for defining and executing clinical trial, data generation, and operational strategies to support timely product launches while ensuring compliance with global and country-specific regulatory requirements. The position plays a critical role in addressing scientific data gaps through well-designed clinical studies and research initiatives.


Key Responsibilities

  • Define and lead clinical operations, clinical trial execution, and data generation strategies aligned with Roche’s global and local objectives

  • Ensure timely and compliant execution of clinical trials to support product launches and maximize patient impact

  • Develop and oversee data generation strategies for clinical trials, post-trial access, and compassionate use programs

  • Plan, monitor, and manage clinical trials conducted internally at Roche or in collaboration with external investigators and healthcare institutions

  • Oversee protocol development, trial execution, and monitoring of critical milestones, ensuring adherence to regulatory guidelines, policies, and procedures

  • Address and resolve escalated operational, compliance, and scientific issues during trial execution

  • Generate actionable clinical and patient insights to bridge local data gaps and meet regulatory commitments

  • Engage with key stakeholders including investigators, hospitals, regulatory authorities, government bodies, and industry associations to ensure regulatory alignment and policy input

  • Collaborate with global Roche leadership to advocate for inclusion of India in global clinical development programs

  • Provide strong people leadership by mentoring, coaching, and developing clinical operations teams in line with Roche’s leadership commitments

  • Support talent acquisition, performance management, training needs assessment, and capability development within the function

  • Foster a high-performance, inclusive, and collaborative team culture focused on scientific excellence and operational rigor


Education & Experience Requirements

  • Graduate degree in Life Sciences

  • PhD or Postgraduate degree in Medical Sciences is preferred

  • Minimum 10–15 years of relevant experience in clinical operations, clinical research, or medical affairs within the pharmaceutical or biotechnology industry

  • Proven experience in leading clinical trials, protocol development, regulatory compliance, and stakeholder engagement

  • Strong understanding of global and local clinical trial regulations and data generation requirements


Key Skills & Competencies

  • Strategic leadership in clinical operations and trial execution

  • Deep knowledge of clinical development processes and regulatory frameworks

  • Strong stakeholder management and cross-functional collaboration skills

  • Ability to lead, mentor, and develop high-performing teams

  • Excellent analytical, problem-solving, and decision-making capabilities

  • Effective communication skills with the ability to influence at senior and global leadership levels


Why Join Roche?

  • Be part of a purpose-driven organization shaping the future of healthcare

  • Lead impactful clinical research that improves patient outcomes

  • Work in a culture that values diversity, inclusion, and individual contribution

  • Collaborate with global experts and contribute to cutting-edge scientific innovation

  • Build a long-term leadership career with continuous learning and growth opportunities


Equal Opportunity Statement

Roche is an equal opportunity employer and is committed to fostering an inclusive workplace. All qualified applicants will receive consideration without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, disability, or any other protected characteristic.


Apply now on ThePharmaDaily.com to explore this senior leadership opportunity in clinical operations with Roche and contribute to advancing global healthcare through science and innovation.