4 дня назад
Clinical Development Director, Obesity/Cardiovascular
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
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
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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