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Global Clinical Development Manager

Sandoz
2+ years
Not Disclosed
Remote, India, Telangana, India
10 June 9, 2026
Job Description
Job Type: Full Time, Hybrid, Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Clinical Trials, Detail-Oriented, Drug Development, Lifesciences, Negotiation Skills, Regulatory Compliance, Communication Skills, CPC Certified, Data Analysis, Document Management, Life Science, Regulatory Compliance, Waterfall Model, 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, mRS and EQ-5D-5L, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Global Clinical Development Manager
Job ID: REQ-10028852
Location: India (Telangana)
Company: Sandoz
Division: Sandoz
Business Unit: Development
Functional Area: Research & Development
Employment Type: Full-Time, Regular
Shift Work: No


Position Summary

The Global Clinical Development Manager (GCDM) supports the planning, execution, monitoring, and reporting of global clinical development programs. The role provides clinical research and medical expertise throughout the clinical trial lifecycle while ensuring regulatory compliance, scientific rigor, quality standards, and timely project delivery.


Key Responsibilities

Clinical Development & Trial Management

  • Contribute to the regulatory strategy for clinical development programs.

  • Support and co-author Clinical Development Plans (CDPs).

  • Design, conduct, monitor, and report clinical trials in collaboration with Contract Research Organizations (CROs).

  • Provide clinical research and medical expertise across development activities.

Protocol Development & Study Oversight

  • Oversee development of Phase I, Phase III, and adaptive trial protocols prepared by CROs.

  • Ensure protocols align with strategic study concepts, current clinical practices, regulatory requirements, and modern clinical development methodologies.

  • Ensure studies generate scientifically robust and conclusive results.

Clinical Trial Monitoring

  • Monitor CRO-led trial activities to ensure timely completion.

  • Serve as Chair or Co-Chair of Joint Clinical Teams when required.

  • Support medical monitoring activities and clinical decision-making.

Safety & Pharmacovigilance

  • Support signal detection activities alongside CRO medical leads, Global Program Medical Directors (GPMDs), and Safety Leads.

  • Oversee CRO safety contributions.

  • Contribute to pharmacovigilance documentation, including:

    • Development Safety Update Reports (DSURs)

    • Periodic Safety Update Reports (PSURs)

    • Risk Management Plans (RMPs)

Quality & Compliance

  • Collaborate with Clinical Quality Assurance teams.

  • Provide medical oversight of CRO activities.

  • Author or review Clinical Development Standard Operating Procedures (SOPs).

  • Conduct reviews and gap analyses of CRO SOPs to ensure compliance with quality standards.

  • Support inspection readiness activities.

Regulatory Affairs Support

  • Assist in preparing regulatory submissions and documentation.

  • Partner closely with regulatory teams and CROs.

  • Act as deputy to the Global Program Medical Director when required.

  • Represent the organization during pre-IND meetings, Health Authority interactions, and regulatory discussions.

Portfolio & Strategic Development

  • Contribute to early-stage development strategies.

  • Support portfolio management activities.

  • Participate in due diligence assessments for business development opportunities.

Device Development Support

  • Provide clinical and medical input for device development programs when required.

Budget & Project Management

  • Support project planning and clinical development budget management.

  • Collaborate with Clinical Operations and GPMDs on resource allocation and project execution.

Leadership & Mentoring

  • Participate in onboarding and training activities.

  • Mentor team members and share best practices.

  • Promote continuous improvement through lessons learned and knowledge sharing.

Publications & Data Transparency

  • Support publication planning in collaboration with Medical Affairs.

  • Oversee clinical trial registry postings and disclosure of study results.


Required Expertise

Technical Competencies

  • Clinical Development

  • Clinical Trial Design & Execution

  • Medical Monitoring

  • Regulatory Affairs

  • Pharmacovigilance

  • Quality Assurance

  • CRO Management

  • Risk Management

  • Scientific Writing & Documentation

Leadership Competencies

  • Cross-functional Collaboration

  • Stakeholder Management

  • Project Leadership

  • Team Mentoring & Coaching

  • Strategic Thinking

  • Budget Oversight


About Sandoz

Sandoz is a global leader in biosimilars and generic medicines, serving over 1 billion people across more than 100 countries. The company focuses on improving access to affordable, high-quality healthcare through innovation, partnerships, and sustainable growth.


Ideal Candidate Profile

  • Strong experience in global clinical development and clinical research.

  • Expertise in managing Phase I–III clinical trials.

  • Knowledge of global regulatory requirements and pharmacovigilance.

  • Experience working with CROs and cross-functional global teams.

  • Strong scientific, medical, and project management skills.

  • Ability to lead complex development programs and regulatory interactions.