Clinical Development Leader

2 days ago


Princeton, New Jersey, United States Sun Pharmaceutical Industries, Inc. Full time

Job Summary:

Sun Pharmaceutical Industries, Inc. is seeking an experienced Clinical Development Leader to join its team in Princeton, NJ. As a key member of the Clinical Development organization, the successful candidate will be responsible for leading the development of clinical trials, ensuring compliance with regulatory requirements, and collaborating with cross-functional teams to drive business growth.

Key Responsibilities:

  • Lead the development of clinical trials, including study design, protocol development, and data analysis.
  • Ensure compliance with regulatory requirements, including ICH, US FDA, and EMEA regulations.
  • Collaborate with cross-functional teams, including Medical Affairs, Commercial, and Research and Development, to drive business growth.
  • Provide scientific leadership and guidance to clinical development teams, including study directors, medical monitors, and clinical scientists.
  • Develop and implement clinical development strategies, including design and planning, execution, and management of clinical trials.
  • Provide recommendations and insights regarding study feasibility and operational risks and challenges.
  • Support the design and implementation of clinical protocols, data collection systems, digital tools, and data analysis.
  • Oversee the analysis and interpretation of clinical trial data, ensuring accurate and meaningful results.
  • Collaborate with external partners, including CROs, national institutes, and multinational pharmaceutical companies.
  • Provide support for interactions with regulatory authorities, data monitoring boards, and advisory boards.

Requirements:

  • MD or MD/PhD degree.
  • 10+ years of biotech and/or pharma drug experience.
  • Successful experience in clinical development, including hands-on experience managing clinical trials.
  • Demonstrated ability to develop unique and innovative clinical strategies to shorten the development cycle.
  • Experience designing and developing smaller, yet robust and innovative platform trials.
  • Prior experience interacting effectively and successfully with regulatory agencies.
  • Solid knowledge of compliance and global regulatory requirements.
  • Proven ability to represent the Company's interests effectively in interactions with external partners and regulatory agencies.
  • Ability to lead a dynamic group in a fast-paced and hands-on environment.
  • Strong consensus-building skills and the ability to lead multi-disciplinary teams towards sound decision-making.
  • Outstanding leadership and management capabilities to motivate and guide a strong Clinical Development team.
  • Excellent scientific standing among peers and the ability to address issues with scientific rigor and creative solutions.

What We Offer:

  • Competitive base compensation and performance-based bonus plan.
  • Comprehensive benefits package, including medical, dental, and vision coverage, life insurance, disability insurance, 401(k) savings plan, flexible spending accounts, and employee assistance program.
  • Various paid time off benefits, including vacation time and sick time.

Equal Employment Opportunities:

Sun Pharmaceutical Industries, Inc. is an equal employment opportunity employer and welcomes applications from diverse candidates. We are committed to creating an inclusive and respectful work environment that values diversity and promotes equal opportunities for all employees and applicants.



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