Senior Clinical Development Manager

Sandoz; Telangana; On-site; INR 3,500,000 - 5,500,000; Full time

Job summary

Sandoz India seeks a senior clinical development leader to drive complex formulations development, set clinical strategy, and oversee studies in alignment with project goals, timelines, and regulatory standards.

You will mentor CD associates, ensure GxP training and audit readiness, lead cross-functional collaboration, and contribute to developing plans and excellence framework within Sandoz' biosimilar and generic medicines portfolio.

Qualifications

• Minimum 8 years of experience in clinical development.
• Solid knowledge of GCP and worldwide regulatory requirements.
• Experience in developing Clinical development Plans.
• Knowledge of pharmacy, pharmacokinetics, pharmacodynamics, bioanalysis, statistics and/or clinical trials.
• Mentor and guide CD associates and interns per Sandoz standards.

Responsibilities

• Lead, plan and oversee complex clinical studies per strategy.
• Manage CRO activities, cost optimization, regulatory compliance.
• On-board and mentor CD associates and interns.
• Ensure GxP standard implementation and training.
• Maintain readiness for Self-Inspection and GCP audits.
• Collaborate in clinical development team to harmonize processes.
• Contribute to vision and strategy for Product development.

Skills

Clinical development

GxP compliance

GCP auditing

Regulatory affairs

Mentoring and leadership

Project management

Budget optimization

Job description

• Active participation in development of complex formulations. Setting clinical strategy for projects. Independently plan, manage, and oversee complex clinical studies in accordance with project strategy, resources, timelines, and regulatory and professional standards.
• Lead operation related activities in close collaboration with Group head. Selection and management of activities performed by contract organizations; cost optimization; professional and regulatory compliance; efficient coordination and management of costs for activities performed by contract organizations.
• Lead, on-board, mentor and guide CD associate(s) and interns for clinical processes and compliance for day-to-day activities as per Sandoz standards and regulatory requirements
• Responsibility for GxP standard implementation and ensuring that these standards are trained on, known, and understood, and that implementation is controlled
• Ensures Self-Inspection and GCP audit readiness.
• Play active role as a member of the clinical development team to continuous harmonization, process improvement initiatives, knowledge sharing, and setting of the excellence framework for clinical research, as well as contributing to implementing the vision and strategy for Product development small molecule clinical development. Other tasks determined during the annual objectives setting process and by KPIs
• Other tasks as assigned by the supervisor, and tasks based on a specific appointment
• Minimum 8 years of experience in clinical development or associated fields
• Knowledge of pharmacy, pharmacokinetics, pharmacodynamics, bioanalysis, statistics and/or clinical trials.
• Experience in developing Clinical development Plans
• Solid knowledge of GCP and worldwide regulatory requirements related to assigned area

Why Sandoz?

Sandoz is the global leader in Biosimilar and Generic medicines, a segment of the healthcare industry that delivers 80% of the world’s medicines at 30% of the cost, touching the lives of more than 1 billion people across 100+ countries! While we are proud of our achievements, we have an ambition to do more so that everyone can achieve the basic humanrightof good health.

With investments in new development capabilities, production sites, new acquisitions, and partnerships, wehave the opportunity toshape the future of Sandoz and help even more people gain access to low-cost, high-quality medicines, sustainably.

Our momentum is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills, experience an agile and collegiate environment with impactful careers, where diversity of thought is welcomed and where personal growth is supported!

Join us, help us make healthcare fairer and faster.

Commitment to Diversity & Inclusion:

We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

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