Senior Medical Director (Early Development Oncology)

Location: North Chicago, Illinois, or Florham Park, New Jersey, United States

Salary: $182,000–$346,000 per year

Company

hirify.global develops medicines and healthcare solutions across therapeutic areas including immunology, oncology, neuroscience, and aesthetics.

What you will do

• Lead product safety strategy and surveillance for assigned oncology pharmaceutical, biological, and drug-device combination products.
• Develop medical safety assessments, regulatory responses, risk management plans, and safety components of NDA and supplemental NDA submissions.
• Analyze aggregate safety data and epidemiological information, communicating interpretations and recommendations to cross-functional teams, executives, and external stakeholders.
• Collaborate with clinical development, medical, pharmacokinetics, toxicology, regulatory, and medical affairs colleagues on dose selection, treatment regimens, eligibility criteria, and safety monitoring.
• Oversee periodic safety reports, including DSURs, PSURs, and PADERs, and implement risk management strategies.
• Coach and mentor colleagues while leading safety activities in a collaborative, fast-paced environment.

Requirements

• MD or DO with at least two years of internal medicine residency and patient management experience.
• 2–5 years of pharmacovigilance or clinical development experience in the pharmaceutical industry.
• Experience analyzing and interpreting clinical data and epidemiological information.
• Ability to write, review, and provide independent input on technical and pharmacovigilance documents.
• Ability to present recommendations internally and externally and lead cross-functional teams collaboratively.
• Experience in oncology is strongly preferred.

Nice to have

• PhD or clinical pharmacology fellowship in addition to an MD or DO.
• Oncology experience.

Culture & Benefits

• Paid time off, including vacation, holidays, and sick leave.
• Medical, dental, and vision insurance for eligible employees.
• 401(k) benefits for eligible employees.
• Eligibility to participate in long-term incentive programs.
• Opportunities to co-author publications and participate in initiatives focused on safety leadership development.