Назад
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4 дня назад

Clinical Development Director, Obesity/Cardiovascular

Формат работы
remote (только USA)
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
Clinical Development Director, Obesity/Cardiovascular (Clinical Research/Obesity): Leading late-phase clinical development for the AMG 133 obesity and cardiometabolic program with an accent on Phase 3 evidence generation, trial design, medical monitoring, and regulatory collaboration. Focus on reviewing clinical data, interpreting safety and efficacy results, authoring regulatory documents, and presenting scientific findings to external experts.

Location: United States - Remote

Salary: Annual salary range in USD is provided for the U.S., excluding Puerto Rico, but no numerical amount is specified.

Company

hirify.global is a biotechnology company developing medicines for serious illnesses across oncology, inflammation, general medicine, rare disease, cardiovascular disease, and obesity-related conditions.

What you will do

  • Lead clinical and scientific input into the global evidence generation plan for the Phase 3 AMG 133 program in obesity and related metabolic diseases.
  • Translate clinical strategy into study concepts, protocols, and related development documents with cross-functional teams.
  • Provide clinical input into trial implementation, delivery, data review, and interpretation of results.
  • Serve as medical monitor for ongoing clinical trials and review data for accuracy, completeness, protocol adherence, and regulatory compliance.
  • Support safety and regulatory interactions and author clinical study reports, publications, and regulatory submissions.
  • Develop relationships with key opinion leaders and present scientific findings at advisory boards and scientific meetings.

Requirements

  • MD or DO degree from an accredited medical school.
  • At least 3 years of clinical research experience.
  • Experience with clinical development and clinical trials in obesity, diabetes, cardiovascular, cardiometabolic, or adjacent therapeutic areas.
  • Knowledge of pharmaceutical product development, clinical data review, medical monitoring, safety interpretation, and regulatory submissions.
  • Knowledge of Good Clinical Practices, FDA, EMEA/CHMP, and applicable international regulatory requirements.
  • Strong scientific communication, presentation, interpersonal, problem-solving, and leadership skills.

Nice to have

  • Three or more years of clinical research experience in the biopharmaceutical, biotechnology, pharmaceutical, or CRO industry.
  • Five or more years of combined clinical research, basic science research, clinical teaching, and patient care experience.
  • Experience designing Phase 2 or Phase 3 studies with biostatistics, observational research, and patient-reported outcomes input.
  • Experience with electronic aggregate data review tools and clinical regulatory responses.

Culture & Benefits

  • Collaborative, innovative, and science-based work environment.
  • Health, dental, and vision coverage, life and disability insurance, and flexible spending accounts.
  • Retirement and savings plan with company contributions.
  • Discretionary annual bonus program and stock-based long-term incentives.
  • Paid time off, work-life balance support, and career development opportunities.

Hiring process

  • Applications are accepted until a sufficient number of candidates are received or a candidate is selected.
  • Sponsorship for this role is not guaranteed.

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