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Clinical Development Leader

1 month ago

Princeton, New Jersey, United States Sun Pharmaceutical Industries, Inc. Full time
Job Title: Associate Vice President, Clinical Development

At Sun Pharmaceutical Industries, Inc., we are seeking an experienced Associate Vice President to lead our Clinical Development team. As a key member of our organization, you will be responsible for overseeing the development of new medicines and ensuring their safe and effective use in patients.

Key Responsibilities:
  • Lead a team of clinical professionals in the development of new medicines, from Phase 1 to Phase 3 clinical trials.
  • Develop and implement clinical development strategies to ensure alignment with the company's overall goals and objectives.
  • Oversee the design, planning, execution, and management of clinical trials to evaluate the safety and efficacy of investigational products.
  • Provide broad drug development and functional knowledge and experience, as well as overall clinical scientific leadership for the clinical portfolio.
  • Collaborate with Medical Affairs and Commercial Teams to develop a strong group of Key Opinion Leaders.
  • Support the design and implementation of clinical protocols, data collection systems, digital tools, and data analysis, including statistical analyses.
  • Oversee the analysis and interpretation of clinical trial data, ensuring accurate and meaningful results.
  • Provide support for interactions with external development partners, investigator meetings, and advisory boards, regulatory authorities, and data monitoring boards.
Requirements:
  • MD or MD/PhD degree.
  • 10+ years of biotech and/or pharma drug experience.
  • Successful conduct of clinical development from Phase 1 through registrational Phase 3 studies.
  • Demonstrated ability to develop unique and innovative clinical strategies to significantly shorten the development cycle in the face of an evolving regulatory landscape.
  • Experience designing and developing smaller, yet robust and innovative platform trials, randomized Phase 2 and registrational Phase 3 programs.
  • Prior experience interacting effectively and successfully with regulatory agencies is essential, across the spectrum on FIH/IND, End of Phase 2/pre-Phase 3, and (s)NDA/(s)BLA.
  • Solid knowledge of compliance and global regulatory requirements (ICH) for development of pharmaceutical candidates/products is required.
  • Has working knowledge of GCP, ICH, US FDA, and EMEA regulations.
  • Proven ability to represent the Company's interests effectively in interactions with external partners, investigators, 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 across various development functions.
  • 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.
  • Experience in working with external collaborators, including CROs, national institutes, and multinational pharmaceutical companies is preferred.
  • Strong analytical and problem-solving skills, well-organized, and mastered complex medical/clinical development tasks.
  • Superior written and verbal communication skills within scientific presentation, corporate presentation, and clinical team and clinical trial environments.
  • Works effectively under pressure and has a rigorous work ethic with a focus on details and high-quality results.
  • Ability to work in a matrix environment (dotted-line authority) and lead by influence.
  • Able to assess human resource needs and suggest appropriate prioritizations.