Nature and Scope

Lead the pediatric clinical programs for New and Existing products inclusive of a key role in the design, execution, and analyses of studies to support regulatory Pediatric Research Equity Act (PREA) commitments. This role will have direct report to the Head of Clinical Research and Development.

Essential Duties and Responsibilities

• Characterize the unmet needs in pediatric populations for new and existing drugs in pipeline and inform on business development opportunities for the use of drugs in pediatric populations.
• Leadership of a professional team focused on evidence generation and evidence synthesis to meet the unmet needs of adolescent, pediatric, and neonatal populations.
• Communicate effectively with partners, affiliates, and stakeholders to ensure alignment and time-bound clinical and business commitments.
• Adhere to both Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP) aligned with the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH).

Education Requirements and Qualifications

• M.D., or Ph.D, or PharmD. in Biology, Biochemistry, Bioinformatics, Analytical Chemistry, Chemical Engineering, or a closely related field. M.D. preferred but not required with sufficient experience in pediatric drug development in an industry setting.
• Minimum six years of experience in the biotech or pharmaceutical. Experience in pediatric drug development in industry is essential.
• Strong analytic skills, problem-solving skills, and medical writing skills.
• Experience in writing and implementing research protocols, reviewing and interpreting data, preparation of study reports, data analysis
• Ability to present data to internal and external audiences.
• Strong skills in public speaking, interpersonal relationships, team building, and capability of change.

Preferred Qualifications

• Medical degree preferred or with United States Board Certification in pediatrics preferred.
• Leadership experience in industry (e.g. associate director) would be ideal

American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.

American Regent Inc. endeavors to make accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact John Rossini, Talent Acquisition Director at 631-690-7201 or email at HRTalentAcquisition@americanregent.com