58 минут назад
Associate Medical Director, Clinical Development (Vaccines)
180 000 - 240 000$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Associate Medical Director, Clinical Development (Vaccines) (Vaccinology and immunology): Advancing vaccine and prophylactic monoclonal antibody programs through clinical strategy, Phase 1–3 trial design and execution, data interpretation, and regulatory documentation with an accent on immunogenicity, infectious diseases, and patient safety. Focus on leading scientific oversight, interpreting complex clinical datasets, collaborating across clinical and regulatory functions, and assessing trial progress at investigative sites and endemic areas.
Location: Berkeley Heights, New Jersey, United States. Travel to clinical trial sites and endemic areas may be required, up to 20%.
Salary: $180,000–$240,000 USD per year
Company
is a commercial-stage biotechnology company developing CNS and immunology treatments, including marketed products and investigational vaccines, monoclonal antibodies, and other biologics.
What you will do
- Contribute scientific leadership to clinical development strategies for vaccine and prophylactic monoclonal antibody candidates.
- Lead and support the design, execution, and interpretation of Phase 1–3 clinical trials.
- Author clinical protocols, study reports, investigator brochures, statistical analysis plans, and regulatory documents.
- Review safety, tolerability, immunogenicity, efficacy, laboratory, adverse-event, and other clinical trial data.
- Partner with Clinical Operations, Biostatistics, Data Management, Regulatory Affairs, Pharmacovigilance, laboratories, investigators, and CROs.
- Support regulatory submissions, scientific communications, publications, and clinical program decision-making.
Requirements
- PhD, PharmD, MD, or equivalent advanced degree in a relevant scientific or medical discipline; MD preferred.
- 5+ years of relevant clinical development experience in the biotechnology or pharmaceutical industry.
- Direct experience supporting vaccine clinical development and leading or providing scientific oversight for clinical trials.
- Strong foundation in vaccinology, immunology, infectious diseases, clinical trial methodology, GCP, clinical endpoints, statistical concepts, and benefit-risk assessment.
- Experience interpreting clinical datasets and contributing to protocols, study reports, regulatory documents, publications, or presentations.
- Willingness and ability to travel up to 20% to clinical trial sites and endemic areas.
Nice to have
- Experience with vaccine, infectious disease, or prophylactic monoclonal antibody clinical development.
- Familiarity with immunogenicity assessments, including antibody and cellular immune-response measurements.
Culture & Benefits
- Individual contributor role with significant ownership of clinical development activities.
- Cross-functional work in a fast-paced biopharmaceutical environment.
- Medical, dental, vision, life, disability, flexible spending, health savings, and employee assistance programs.
- Pet insurance, 401(k) with company match, and annual discretionary stock options.
- Paid time off, sick time, paid holidays, and career development and training.
- Visa sponsorship is not offered for this role.
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