4 дня назад
Senior Director, Clinical Development/Clinical Scientist (Oncology)
256 500 - 332 000$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Director, Clinical Development/Clinical Scientist (Oncology): Leading early clinical development programs and clinical study execution with an accent on oncology, clinical trial strategy, regulatory documentation, and cross-functional collaboration. Focus on designing and conducting clinical studies, interpreting trial data, supporting medical monitoring, and mentoring Clinical Scientists.
Location: Woburn, Massachusetts, United States; on-site
Salary: $256,500–$332,000 annual base pay, plus performance incentive bonus, new hire equity, and ongoing performance-based equity.
Company
is a biotechnology company developing oncolytic immunotherapies designed to activate systemic anti-tumor immune responses and transform cancer treatment.
What you will do
- Lead clinical and scientific aspects of early clinical development programs and clinical study design, implementation, conduct, analysis, interpretation, and documentation.
- Generate, author, update, and review clinical and regulatory documents, including protocols, informed consent documents, investigator brochures, clinical study reports, manuscripts, INDs, NDAs, and safety reports.
- Partner with clinical operations, data management, pharmacovigilance, regulatory, biometrics, translational medicine, program leadership, CROs, investigators, and external collaborators.
- Provide scientific and medical support during trials, including investigator and vendor selection, staff training, medical monitoring, patient eligibility decisions, and responses to clinical questions.
- Present clinical trial data, prepare internal and external materials, build investigator and opinion-leader networks, and support advisory boards and investigator meetings.
- Mentor Clinical Scientists, support budgets and resource planning, optimize processes, and ensure compliant execution of clinical development activities.
Requirements
- MD, PharmD, or PhD in a clinical or scientific profession, or equivalent professional education, training, and experience.
- Minimum 12 years of successful experience in biotechnology or pharmaceutical companies, including clinical development program participation.
- Experience across most stages of clinical trials, ideally taking at least one study from start-up through final study report.
- Clinical oncology experience, or exceptional experience in another therapeutic area with clear potential to transfer skills to oncology.
- Expert understanding of global clinical study design and the drug development process from discovery through registration and post-marketing.
- Knowledge of GCP and ICH Guidelines, clinical development IT solutions, SOPs and policies, with demonstrated leadership, communication, influencing, and cross-functional collaboration skills.
Nice to have
- Experience developed partly in high-profile academic institutions.
- Experience working with global colleagues and external academicians or collaboration partners.
Culture & Benefits
- Values-based environment centered on collaboration, boldness, commitment, honesty, and patient impact.
- Approximately 25% work-related travel is expected.
- Medical, dental, and vision insurance.
- 401(k) match, flexible time off, and paid holidays including a year-end shutdown.
- Annual performance incentive bonus and equity opportunities.
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