Job Description

Job Title

Clinical Development Senior Manager

Job Responsibilities:
• Manages talent across the team, while driving employee selection, performance management, compensation management, career development, and ensuring effective operational management.
• Setting clear goals and expectations, providing regular feedback and recognition, direction and goals/KPIs for the team to ensure operational excellence.
• Ensuring open and effective communication, cultivate a positive and motivating work environment to foster engagement, development and retention.
• Oversees the recruitment, hiring, onboarding, and managing the performance of Clinical Development Scientists, ensuring they have the necessary skills and knowledge to meet project objectives and regulatory requirements.
• Coaches and guides newly hired and existing Clinical Development Scientists, enabling a culture of continuous learning and development, and enhancing the team's capability to produce compliant and high-quality clinical documentation.
• Evaluates and recognizes opportunities for process improvements in clinical development, leading initiatives to streamline operations, enhance organizational capabilities, and drive innovation in evidence generation and dissemination.
• Represents the clinical development team in interactions with senior management or executive levels, providing strategic guidance and insights based on in-depth analysis of organizational objectives and performance data to inform decision-making and drive clinical development success.
• Aligns clinical development strategies with organizational goals by collaborating with senior leadership and key stakeholders, ensuring that clinical initiatives support broader business objectives and regulatory requirements.
• Champions best practices and global regulatory standards for clinical development activities, including product development, clinical evaluations, clinical trials, and safety assessments, to secure regulatory approvals and fulfill post-market requirements.
• Conducts relationship management activities within the Clinical and Medical functions, and cross-functionally with Regulatory, Risk Management, Engineering, Marketing, Quality, HEMAR, Biostatistics, and Data Management, to achieve project objectives.
• Develops and implements solutions to complex clinical development problems, utilizing ingenuity and creativity to ensure consistency with organizational objectives and compliance with regulatory standards.
• Delegates tasks and responsibilities strategically, optimizing resource allocation to support the execution of clinical development plans, and ensuring that project timelines and deliverables are met while managing costs effectively.
• Guides the production of clean, clear, concise, and compliant clinical documentation through expert-level use of standard software tools and systems, and by applying internal procedures and external regulatory standards.
• Leads initiatives to improve clinical and economic research processes, design principles, and execution for evidence generation, partnering effectively with business leaders to drive innovation and efficiency.

Minimum required Education:
Bachelor's/ Master's Degree in Science or equivalent.

Minimum required Experience:
Minimum 5 years of experience with Bachelor's OR Master's in areas such as Clinical Development, Evaluation or Innovation or equivalent.

Preferred Experience:
8-10 years of experience in Clinical Development, Evaluation or Innovation or equivalent.
5+ years of management experience.

Preferred Skills:
• Regulatory Compliance
• Data Analysis & Interpretation
• Continuous Improvement
• Business Acumen
• People Management
• Project Management
• Risk Management
• Strategic Planning
• KPI Management
• Document Auditing
• Medical Terminology
• Regulatory Requirements
• Clinical Evaluation Methodologies
• Clinical Evidence Generation Strategy