Amgen Medical Data Job: Associate Director, Hyderabad

Amgen is hiring for the role of Associate Director, Medical Data Review at their location in Hyderabad, India. This Amgen medical data job requires an MD/Diploma and relevant experience. Apply by clicking the link below.

Job Details

Company: Amgen

Job Title: Associate Director, Medical Data Review

Location: India – Hyderabad

Remote Type: On Site

Time Type: Full time

Job Requisition ID: R-261000

Career Category: Clinical Development

Amgen Medical Data Job Description

The Associate Director, Medical Data Review leads people, capability, and portfolio delivery for an assigned TA-aligned or adjacent-portfolio group in alignment with CDD priorities. The role ensures that MDR teams have the capacity, skills, controls, and stakeholder support required for high-quality, risk-based delivery.

Roles and Responsibilities

  • Lead and develop the MDR team; set clear expectations and maintain a fair, inclusive, accountable, and scientifically rigorous working environment.

  • Own hiring, onboarding, goal setting, performance management, development planning, succession, readiness, recognition, retention, and appropriate performance intervention for direct reports.

  • Translate portfolio demand into transparent capacity and allocation decisions using study complexity, phase, exposure, review strategy, milestone clustering, quality history, and demonstrated capability.

  • Assign and rebalance MDR capacity across studies, projects, molecules, and adjacent therapeutic areas; resolve competing priorities and manage delivery risk. In this Amgen medical data job, these decisions support timely, high-quality delivery across the portfolio.

  • Assure portfolio delivery through oversight of quality, timeliness, milestone readiness, risk escalation, and fit-for-purpose MDR controls without duplicating L6A or L5 technical accountability.

  • Review portfolio-level performance and risk indicators, identify repeated or systemic issues, and sponsor proportionate corrective or capability actions with accountable partners.

  • Ensure that teams provide scientifically strong IDRP contributions and appropriate medical-interpretation inputs to Medical Monitoring Plans through the designated L6A and L5 roles.

  • Lead portfolio adoption of ACT FAST, risk-based review, approved analytics, visualization, and digital capabilities; use evidence to sustain effective practices and stop low-value activity.

  • Build effective relationships with TA/CDD and GDO leaders, Medical Monitors, Clinical Scientists, Medical Monitoring Groups, study teams, Data Management, Safety, Clinical Operations, Biostatistics, Quality, Regulatory, HR, and technology partners.

  • Establish governance and communication cadences for portfolio capacity, delivery health, quality, risks, dependencies, and decisions.

  • Escalate material participant, quality, delivery, compliance, or capacity risks promptly and ensure actions have clear owners and follow-through.

  • Support audit and inspection readiness by ensuring role clarity, consistent practices, and availability of MDR evidence.

  • Use portfolio insights to guide workforce planning, capability development, succession, and future hiring priorities.

  • Responsible for people training, mentoring, and development as per career framework and supporting in individual development plan of each employee, with driving timely feedback.

  • Responsible for team’s performance management as per Amgen’s MAP process and calibration.

  • Responsibility for portfolio or program delivery capacity decisions, resource projection and efficient management, quality oversight, and senior stakeholder engagement.

  • Role model Amgen culture and drive the same within the department.

  • Responsible for participating in cross functional initiatives, process improvement, driving leadership activities, driving active change management and technology application advancement in MDR process.

  • Owns MDR Business Process as assigned and drives operational implementation.

  • Drives Scientific discussion (e.g. Journal Club) within TAs and encourage scientific and technical expertise for operation execution and efficiency.

Medical Data Review Qualifications and Experience

  • MD/Diploma with 8-10 years of relevant experience. Candidates for this Amgen medical data job should meet this experience requirement.

  • MBBS from an MCI/NMC-recognized medical institution in India with 10-12 years of relevant experience.

  • Substantial experience in clinical development, medical data review, medical monitoring, pharmacovigilance, clinical operations, or a closely related regulated environment.

  • Demonstrated readiness to lead people, including evidence of setting expectations, giving feedback, supporting development, planning work, and addressing issues fairly. Prior formal line-management experience is preferred; first-time managers may be considered with a structured transition and support plan.

  • Demonstrated responsibility for portfolio or program delivery, capacity decisions, resource projection and efficient management, quality oversight, and senior stakeholder engagement.

  • Ability to interpret medical-review risks and make fair, evidence-based people and resource decisions.

Preferred Qualifications and Experience

  • MBBS, MD/Diploma, or another relevant medical or clinical qualification.

  • Experience managing medically or scientifically qualified professionals across multiple studies, projects, or therapeutic areas.

  • Experience with RBQM, integrated data review, analytics, Spotfire, digital adoption, and inspection readiness.

  • Experience partnering with Clinical Development, Medical Monitoring, Data Management, Safety, Quality, and HR.

  • Experience leading organizational change, workforce planning, or capability build in a regulated environment.

CLICK HERE FOR THE ORIGINAL NOTIFICATION / APPLY ONLINE