Senior Clinical Development Leader

1 day ago

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

Assistant Vice President, Clinical Development Group Lead

Sun Pharmaceutical Industries, Inc. is a leading global pharmaceutical company with a strong presence in the specialty generic market. We are committed to delivering high-quality, affordable medicines to patients worldwide. Our Clinical Development organization plays a critical role in advancing our pipeline and ensuring the safe and effective development of our products.

Key Responsibilities:

  • Lead a team of clinical professionals in the development and execution of clinical trials, ensuring compliance with regulatory requirements and industry best practices.
  • Collaborate with cross-functional teams to develop and implement clinical development strategies, aligning with business goals and objectives.
  • Provide scientific leadership and guidance on clinical trial design, execution, and management, ensuring high-quality data and timely results.
  • Develop and maintain relationships with external partners, including CROs, investigators, and regulatory agencies, to ensure successful trial execution and regulatory submissions.
  • Oversee the analysis and interpretation of clinical trial data, ensuring accurate and meaningful results, and providing recommendations for future development strategies.
  • Support the development of regulatory documents, including Investigators' Brochures, briefing books, and IND/BLA submission documents.
  • Collaborate with Medical Affairs and Commercial Teams to develop a strong network of Key Opinion Leaders and support the development of clinical trial protocols.

Requirements:

  • MD or MD/PhD degree
  • 10+ years of experience in biotech and/or pharma drug development, with a strong background in clinical research and drug development.
  • Proven track record of leading cross-functional teams and developing innovative clinical strategies to advance pipeline products.
  • Experience with regulatory agencies, including FDA and EMEA, and knowledge of global regulatory requirements (ICH) for development of pharmaceutical candidates/products.
  • Strong leadership and team management skills, with a proven ability to motivate and guide a team towards sound decision-making.
  • Excellent scientific standing among peers, with a strong understanding of pre-clinical development and clinical trial methodologies.
  • Ability to work in a fast-paced, dynamic environment, with a focus on detail and high-quality results.

What We Offer:

  • Competitive base compensation and annual performance bonus plan
  • Comprehensive benefits package, including medical, dental, and vision coverage, life insurance, disability insurance, and 401(k) savings plan
  • Flexible spending accounts and employee assistance program
  • Paid time off benefits, including vacation time and sick time

Sun Pharmaceutical Industries, Inc. is an equal employment opportunity employer, committed to diversity and inclusion in the workplace. We welcome applications from qualified candidates who share our values and are passionate about delivering high-quality medicines to patients worldwide.

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