Associate Vice President, Clinical Development

1 day ago

US Trenton NJ USA Sun Pharmaceutical Industries, Inc. Full time
Job Title: Assistant Vice President, Clinical Development

Join Sun Pharmaceutical Industries, Inc. as we seek an experienced Assistant Vice President, Clinical Development to lead our Clinical Development organization in Princeton, NJ.

Job Summary:

We are seeking a highly skilled and experienced Assistant Vice President, Clinical Development to lead our Clinical Development organization. The successful candidate will be responsible for providing strategic leadership and guidance to a team of clinical professionals, overseeing clinical development strategy and activities, and contributing to the design and planning of clinical trials.

Key Responsibilities:
  • Provide strategic leadership and guidance to a team of clinical professionals, including study directors, medical monitors, and clinical scientists.
  • Oversee clinical development strategy and activities, ensuring alignment with the company's overall goals and objectives.
  • Contribute to the design and planning of clinical trials, including the development of clinical protocols, data collection systems, and data analysis.
  • Provide recommendations and insights regarding study feasibility and operational risks and challenges.
  • Support the analysis and interpretation of clinical trial data, ensuring accurate and meaningful results.
  • Collaborate with Medical Affairs and Commercial Teams to develop a strong group of Key Opinion Leaders.
  • Support study teams to manage clinical development budgets and resources effectively, optimizing timelines, costs, and quality.
  • Support the development of clinical sections of regulatory documents, including Investigators' Brochures, briefing books, and IND/BLA submission documents.
  • Collaborate across multiple internal multidisciplinary functions, prioritizing internal and external activities based on impact and strategic goals.
Qualifications:
  • 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 shorten the development cycle.
  • Experience designing and developing smaller, yet robust and innovative platform trials.
  • Prior experience interacting effectively with regulatory agencies is essential.
  • Solid knowledge of compliance and global regulatory requirements (ICH) for development of pharmaceutical candidates/products.
  • 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.
  • 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:

As a valued member of our team, you will receive a competitive salary, annual performance bonus plan, and comprehensive benefits package, including medical, dental, and vision coverage, life insurance, disability insurance, 401(k) savings plan, flexible spending accounts, and employee assistance program. You will also receive various paid time off benefits, including vacation time and sick time.

The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time.

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