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Sr. Director

2 months ago

Dublin, Dublin City, Ireland eli lilly and company Full time
Sr. Director - Global Regulatory Scientist - Early Clinical Development

Location: Ireland, Cork
Employment Type: Full time

At Lilly, we combine compassion with exploration to enhance the quality of life for individuals worldwide. As a prominent player in the healthcare sector situated in Indianapolis, Indiana, we are dedicated to uncovering and introducing transformative medications to those in need, enriching the understanding and control of illnesses, and contributing to our communities through charitable deeds and volunteerism. Committed to prioritizing individuals, we are on the lookout for determined individuals who are passionate about enriching lives globally.

Lilly provides an exceptional workspace at our Little Island campus, offering versatile hybrid working options, healthcare, pension, and life insurance benefits, a subsidized canteen, on-site gym, travel grants, and parking facilities. Our in-house People Development services, Educational Assistance, and 'Live Your BEST Life' well-being programs are just a few of the comprehensive offerings that amplify the professional journey for our team members.

Join our team - Be Creative, Be an Innovator, and above all, Be Yourself

Responsibilities:

  • Lead the development and implementation of innovative regulatory strategies
  • Independently navigate roles that demonstrate significant influence within and across departments, such as guiding cross-functional teams on clinical development strategies and trial design
  • Serve as a direct point of contact with the FDA and Health Canada
  • Elicit high-quality communication with regulators and internal stakeholders to convey and ensure comprehension of regulatory strategies and intricate matters
  • Proactively seek to broaden regulatory expertise through ongoing learning
  • Readily share information and regulatory insights with peers
  • Engage in and influence external endeavors related to portfolio assets

Basic Requirements:

  • Bachelor's degree in a scientific discipline with a minimum of 10 years of experience in regulatory affairs and/or drug development
  • -OR-
  • An advanced scientific degree (e.g., PhD, PharmD) with at least 8 years of experience in regulatory affairs and/or drug development

Additional Skills/Preferences:

  • Familiarity with FDA and Health Canada protocols and practices and awareness of evolving regulatory initiatives
  • Demonstrated profound understanding of the drug development process
  • Demonstrated capacity to evaluate and manage risk in a highly regulated setting
  • Strong written, verbal, and presentation communication skills
  • Aptitude for negotiation and influence
  • Meticulous attention to detail
  • Effective teamwork skills; capable of adapting to various interpersonal styles

Additional Information:

  • Must be willing to travel to the US as needed (10-25% of the time)
  • Location: Cork, Ireland

Eli Lilly and Company, Lilly USA, LLC, and our subsidiaries are dedicated to assisting individuals with disabilities in entering the workforce and ensuring equal job opportunities. We foster an inclusive environment and prohibit discrimination on various grounds.

About Lilly: We endeavor to integrate our employees into a team that values them and our joint objective of improving lives globally. We aim to incorporate, innovate, accelerate, and deliver while upholding integrity, excellence, and respect for individuals. Join us on our quest to develop medicines and enhance patient outcomes worldwide

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