Director of Drug Development & Regulatory Strategy

This position is not eligible for visa sponsorship.

Position Summary

The Director of Drug Development and Regulatory Strategy is an individual contributor who will provide scientific and regulatory strategy leadership and direction to the client and to Labcorp Development Team(s) for potential and awarded programs. As an expert in drug development, they will provide clients with consultancy and advisory services to help them develop their compound(s) in an efficient and timely manner to achieve their goals, with an ability to guide the overall development strategy.

Being well versed in the regulatory requirements for nonclinical testing, they must have the ability to understand the scientific rationale for the development of a wide variety of compounds/modalities and understand the interplay between clinical and nonclinical plans. Expertise in nonclinical regulatory writing, supporting regulatory agency meetings & interactions and reviewing nonclinical regulatory documentation related to the US and EU processes is essential.

Minimum Education and Experience Requirements:

• PhD in an appropriate scientific discipline and/or additional advanced degree.
• 12-15 years scientific expertise demonstrated in the pharmaceutical industry, specifically related to the drug development process, with an emphasis on biopharmaceutical and ATMP, in addition to small molecule development.
  
  
  • Background and training in toxicology, immunology, vaccines, CMC, or DMPK.
• 5+ years representing a functional area, such as Toxicology, CMC, Project Management, ADME, Regulatory Strategy on molecule development teams.
• An up-to-date awareness of ICH and regional Regulatory Guidelines as well as industry trends is essential.
• Demonstrated ability to get work done through influencing others.
• Strong people skills (including teamwork, negotiation, communication, presentation)
• Ability to work independently, often under pressure.
• Proven leadership and personal initiative.
• Project management training or certification is an advantage.

Application window open through: 10/22/2025

Pay Range: $180k - $230k annual salary (USD)

All job offers will be based on a candidate's skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data.

The position is also eligible for an annual bonus under the Labcorp Bonus Plan. Bonuses are payable based on corporate and/or business segment performance and are subject to individual performance modifiers.

Benefits: Employees regularly scheduled to work 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(k), Paid Time Off (PTO) or Flexible Time Off (FTO), Tuition Reimbursement and Employee Stock Purchase Plan. Casual, PRN & Part Time employees regularly scheduled to work less than 20 hours are eligible to participate in the 401(k) Plan only. For more detailed information, please click here.

Why People choose to work at Labcorp:
At Labcorp, it is our people that make us great - it is what our clients, our partners and, most importantly, what our employees say. Here, you will have the opportunity to collaborate with extraordinary people with diverse viewpoints. You will discover your own outstanding potential as we build an even stronger organization with industry leaders from early development to the clinic and beyond. We help our clients develop medicines that improve health and improve lives of their family and friends.

Labcorp is proud to be an Equal Opportunity Employer:

Labcorp strives for inclusion and belonging in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications and merit of the individual. Qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. Additionally, all qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law.

We encourage all to apply

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Client-provided location(s): Flexible / Remote

Job ID: labcorp-2534960_2041593906

Employment Type: OTHER

Posted: 2025-10-17T20:10:09