Senior Manager - Clinical Research (TLS)

This role is for one of the Weekday's clients

Min Experience: 10 years

Location: Gurgaon

JobType; full-time

We are seeking an accomplished and dynamic Senior Manager – Clinical Research (TLS) to lead and oversee therapeutic and translational science (TLS) initiatives within our clinical research portfolio. This role is designed for a seasoned professional with 10–20 years of experience in clinical research, drug development, and translational medicine who can effectively bridge scientific innovation with clinical application. The ideal candidate will bring strategic vision, scientific expertise, and leadership capabilities to advance our clinical programs and ensure their alignment with regulatory, scientific, and organizational objectives.

Key Responsibilities

• Strategic Leadership:
• Lead and manage TLS-related clinical research programs from design through execution and reporting.
• Develop strategic plans for clinical and translational research that support product development pipelines and therapeutic area priorities.
• Partner with senior leadership to set goals, milestones, and long-term objectives for TLS projects.
• Clinical Research Oversight:
• Oversee planning, initiation, execution, and close-out of clinical trials with a focus on TLS integration.
• Ensure adherence to Good Clinical Practice (GCP), International Council for Harmonisation (ICH) guidelines, and applicable regulatory requirements.
• Monitor study progress, budgets, and timelines while mitigating risks and ensuring data integrity.
• Scientific Excellence:
• Translate scientific discoveries into clinical applications by identifying biomarkers, endpoints, and translational research strategies.
• Provide subject matter expertise in designing protocols, reviewing clinical data, and contributing to regulatory submissions.
• Stay abreast of advances in clinical research methodologies, TLS approaches, and therapeutic area trends.
• Stakeholder & Cross-Functional Collaboration:
• Collaborate closely with clinical operations, medical affairs, regulatory, and biostatistics teams to ensure seamless program execution.
• Build and maintain strong relationships with external stakeholders, including key opinion leaders (KOLs), investigators, contract research organizations (CROs), and academic collaborators.
• Represent the TLS and clinical research function at internal and external meetings, conferences, and regulatory interactions.
• Team Development & Mentorship:
• Lead, mentor, and develop a high-performing clinical research team with strong TLS capabilities.
• Foster a culture of scientific rigor, innovation, accountability, and continuous learning.
• Provide guidance on career development and ensure team alignment with organizational objectives.

Required Skills & Qualifications

• Experience: 10–20 years in clinical research, with significant exposure to TLS, drug development, and translational medicine.
• Educational Background: Advanced degree (PhD, MD, PharmD, or equivalent) in life sciences, clinical research, or a related discipline preferred.
• Proven expertise in designing, executing, and managing clinical trials across phases (I–IV), with hands-on involvement in TLS-driven studies.
• Strong knowledge of GCP, ICH guidelines, FDA/EMA regulations, and global clinical research requirements.
• Demonstrated ability to interpret complex clinical and translational data and communicate findings to diverse audiences.
• Exceptional leadership skills with experience in managing cross-functional teams and external partners.
• Strong strategic thinking, problem-solving, and decision-making abilities.
• Excellent written and verbal communication, presentation, and stakeholder engagement skills.