Manager, Proj Mgmt - Bioequivalence

Apotex; Bengaluru; Sur place; INR 3 500 000 - 7 000 000; Plein temps

Résumé du poste

Apotex is seeking a senior leader to drive end-to-end execution of BE, Patient PK, POC, 505(b)(2), and CRO‑outsourced clinical studies. You will lead project planning, CRO oversight, regulatory coordination, and risk management to ensure timely milestones from feasibility to final report.

The role requires advanced BE proficiency, large-scale program management, and 15+ years of experience in clinical operations, with cross-functional collaboration across SOPs, GCP, and global regulations.

Qualifications

• Education: M.Pharm./ MSc./ MBA required.
• Advanced proficiency in Bioequivalence studies.
• Minimum 15 years of experience in clinical project leadership.
• Experience with BE, Patient PK, POC, and 505(b)(2) programs.
• CRO vendor oversight and regulatory coordination.

Responsabilités

• Serve as the single point of accountability for assigned studies and clinical programs.
• Develop project plans, timelines, resource allocation, budgets, and risk mitigation strategies.
• Drive on-time delivery of project milestones, reports, and study closures.
• Oversee execution of BE, Patient PK, POC, and 505(b)(2) studies.
• Ensure study objectives are achieved while maintaining quality, compliance, and timeline commitments.
• Monitor critical path activities and proactively resolve operational issues.
• Identify, qualify, and manage CROs, laboratories, and vendors.
• Track CRO performance, study deliverables, budgets, and compliance metrics.
• Escalate and resolve project risks impacting scope, quality, cost, or timelines.
• Coordinate regulatory submissions, ethics approvals, and inspection readiness.
• Ensure compliance with GCP, SOPs, protocol requirements, and applicable global regulations.
• Collaborate with Clinical Operations, Bioanalytical, Regulatory Affairs, Data Management, Medical Writing, QA, Supply Chain, and Sponsors.
• Facilitate effective communication and alignment among all stakeholders.
• Maintain project dashboards, risk registers, trackers, and KPI metrics.
• Provide regular project updates and management reports to leadership and sponsors.

Connaissances

Project Management

Leadership

Communication

Planning & Prioritizing

Risk Management

Vendor Oversight

Stakeholder Management

Change Management

Decision Making

Formation

M.Pharm./ MSc./ MBA

Description du poste

Job Summary

Lead and manage end-to-end execution of Bioequivalence (BE), Patient PK, POC, 505(b)(2), and CRO-outsourced clinical studies. Responsible for project planning, stakeholder management, CRO oversight, regulatory coordination, risk mitigation, budget control, and timely delivery of study milestones from feasibility through final report and archival

Job Responsibilities

• Serve as the single point of accountability for assigned studies and clinical programs.
• Develop project plans, timelines, resource allocation, budgets, and risk mitigation strategies.
• Drive on-time delivery of project milestones, reports, and study closures.
• Oversee execution of BE, Patient PK, POC, and 505(b)(2) studies.
• Ensure study objectives are achieved while maintaining quality, compliance, and timeline commitments.
• Monitor critical path activities and proactively resolve operational issues.
• Identify, qualify, and manage CROs, laboratories, and vendors.
• Track CRO performance, study deliverables, budgets, and compliance metrics.
• Escalate and resolve project risks impacting scope, quality, cost, or timelines.
• Coordinate regulatory submissions, ethics approvals, and inspection readiness.
• Ensure compliance with GCP, SOPs, protocol requirements, and applicable global regulations.
• Collaborate with Clinical Operations, Bioanalytical, Regulatory Affairs, Data Management, Medical Writing, QA, Supply Chain, and Sponsors.
• Facilitate effective communication and alignment among all stakeholders.
• Maintain project dashboards, risk registers, trackers, and KPI metrics.
• Provide regular project updates and management reports to leadership and sponsors.

Job Requirements

• Education: Minimum M.Pharm./ MSc./ MBA.
• Minimum of Advanced proficiency level in Bioequivalence studies.
• Project Management
• Patient PK Studies
• POC 505(b)(2) Programs
• CRO Vendor Oversight
• Risk Budget Management
• Communication Interpersonal skills
• Change Management
• Drive for Results
• Planning Prioritizing
• Leadership
• Judgement Decision Making
• Minimum 15 years of experience