21 час назад
Clinical Research Director (Immunology and Inflammation)
206 250 - 343 750$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Clinical Research Director (Immunology and Inflammation) (Solid Organ Transplant): Developing, executing, and reporting clinical trials supporting product registration with an accent on protocol development, medical monitoring, and regulatory submissions. Focus on representing clinical programs with health authorities, evaluating clinical and scientific data, and coordinating cross-functional study and project teams.
Location: Hybrid role based in Cambridge, Massachusetts, or Morristown, New Jersey, United States
Salary: $206,250–$343,750 annually
Company
An R&D-driven, AI-powered biopharmaceutical company developing medicines and vaccines focused on the immune system.
What you will do
- Develop, execute, and report clinical trials supporting product registration in the immunology and inflammation therapeutic area.
- Lead abbreviated protocol and clinical protocol development and represent the clinical function on study and project teams.
- Serve as medical monitor and contribute to study committees, centralized monitoring, risk management, and clinical study reports.
- Support clinical strategy, translational medicine planning, biomarker strategy, and collaborations with external experts and opinion leaders.
- Represent clinical programs at regulatory agency meetings and support registrations, labeling submissions, briefing packages, and advisory committees.
- Ensure clinical development activities comply with FDA, EMEA, CHMP, applicable regulations, and internal policies.
Requirements
- Medical Doctor degree preferred, with clinical expertise in transplant, nephrology, hepatology, or immunology and inflammation.
- At least 2 years of pharmaceutical drug development or clinical research experience.
- Strong scientific and academic background with a deep understanding of the relevant disease area and immunology drug development.
- Experience in clinical research or pharmaceutical medicine within the transplant or immunology field.
- Strong interpersonal, communication, presentation, negotiation, analytical, and organizational skills.
- Fluent English required for verbal and written communication.
Nice to have
- Phase 3 clinical development experience.
- Knowledge of antibody therapeutics.
- Scientific presentations, peer-reviewed publications, successful major clinical studies, or regulatory submissions.
Culture & Benefits
- Supportive, future-focused environment with opportunities for promotion and lateral career development.
- Opportunities to work and develop internationally.
- Rewards package aligned with demonstrated contribution and impact.
- Healthcare, prevention, and wellness benefits.
- At least 14 weeks of gender-neutral parental leave.
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