Clinical Development Group Lead

3 days ago


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

Sun Pharmaceutical Industries, Inc. is seeking an experienced Assistant Vice President to lead our Clinical Development team. As a key member of our organization, you will be responsible for overseeing the development of our pharmaceutical products from Phase 1 through registrational Phase 3 studies.

Responsibilities:
  • Lead a team of clinical professionals in guiding clinical development and subsequent regulatory submissions for all portfolio programs.
  • Oversee and contribute to clinical development strategy and activities for all portfolio programs to ensure alignment with the company's overall goals and objectives.
  • Design and plan, execute, and manage clinical trials to evaluate the safety and efficacy of investigational products.
  • Provide broad drug development and functional knowledge and experience and overall clinical scientific leadership for the clinical portfolio.
  • 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 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.
  • Support, review, and be accountable for clinical sections of regulatory documents.
Qualifications:
  • MD, or MD/PhD
  • 10+ years of biotech and/or pharma drug experience
  • Successfully conducted clinical development from Phase 1 through registrational Phase 3 studies
  • Demonstrated ability to develop unique and innovative clinical strategies
  • 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
  • Ability to lead a dynamic group in a fast-paced and hands-on environment

Sun Pharmaceutical Industries, Inc. offers a competitive compensation package, including base salary, annual performance bonus, and comprehensive benefits. We are an equal opportunity employer and welcome applications from diverse candidates.



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