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2 дня назад

Medical Director, Study Responsible Physician - Late Development, Prostate (Oncology)

199 000 - 343 850$
Формат работы
onsite
Тип работы
fulltime
Грейд
director
Английский
b2
Страна
US
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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TL;DR
Medical Director, Study Responsible Physician - Late Development, Prostate (Oncology): Leading late-stage oncology clinical studies for prostate cancer treatments with an accent on medical oversight, protocol development, cross-functional execution, and regulatory submissions. Focus on reviewing safety and efficacy data, resolving study and recruitment issues, coordinating investigators and vendors, and supporting NDA/MAA filings.

Location: Spring House, Pennsylvania, United States; other posting locations include La Jolla and Los Angeles, California, and Raritan, New Jersey. Travel of approximately 20–30% annually is required.

Salary: $199,000–$343,850 per year

Company

Johnson & Johnson develops healthcare solutions and medicines through its Innovative Medicine and MedTech businesses.

What you will do

  • Lead assigned late-development oncology clinical studies within a global compound development program.
  • Provide medical oversight, including review of serious adverse events, deaths, medical data, and data queries.
  • Support protocol design, amendments, informed consent forms, eCRFs, study manuals, clinical study reports, and regulatory submissions.
  • Coordinate with Clinical Leaders, clinical scientists, Data Management, Biostatistics, Regulatory, GCO, GMS, Quality, and other cross-functional partners.
  • Oversee study start-up, site activation, recruitment, CRO and vendor performance, and corrective action plans.
  • Engage with clinical investigators, key opinion leaders, health authorities, ethics committees, and medical consultants.

Requirements

  • Advanced medical degree, such as an M.D. or equivalent, is required.
  • Board-certified or board-eligible uro-oncologist or oncologist is strongly preferred.
  • Post-doctoral fellowship training and at least 3 years of relevant urology or oncology clinical research experience are required.
  • Strong knowledge of basic and clinical cancer research and its application to cancer drug development.
  • Strong oral, written communication, presentation, influencing, and cross-functional collaboration skills.
  • Experience working in a matrix organization and with clinical development teams.

Nice to have

  • Experience with NDA/MAA preparation, medical publications, IDMCs, investigator meetings, or advisory boards.
  • Knowledge of clinical research regulations, research ethics, regulatory affairs, data management, and scientific evaluation.

Culture & Benefits

  • Inclusive work environment guided by the company’s Credo and focused on patient impact.
  • Participation in retirement, pension, savings, and 401(k) plans.
  • Eligibility for the long-term incentive program.
  • Paid vacation, sick time, holidays, parental, bereavement, caregiver, volunteer, and military spouse leave.

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