24 часа назад
Director, Clinical Development Scientist (Non-MD)
176 600 - 294 300$
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Описание вакансии
Текст:
TL;DR
Director, Clinical Development Scientist (Non-MD) (Clinical Trials/Clinical Development): Leading scientific oversight and clinical execution for one or more biopharmaceutical studies with an accent on protocol development, clinical data review, safety management, and regulatory quality. Focus on managing complex clinical deliverables, coordinating data monitoring and adjudication committees, resolving protocol and safety issues, and guiding cross-functional teams through study design, conduct, and reporting.
Location: United States — Pennsylvania — Collegeville. Hybrid role requiring residence within commuting distance and on-site work an average of 2.5 days per week.
Annual base salary: $176,600–$294,300, plus a 20% bonus target and eligibility for a share-based long-term incentive program.
Company
is a biopharmaceutical company developing medicines through clinical research and pharmaceutical development.
What you will do
- Lead clinical execution and scientific oversight for one or more studies, ensuring clinical deliverables, data integrity, quality, and compliance.
- Develop and amend clinical protocols, informed consent documents, training materials, and clinical responses for investigators and external stakeholders.
- Guide statistical analysis plans, clinical data collection and review strategies, safety review plans, risk management plans, and clinical study reports.
- Review emerging clinical and safety data, manage adverse event tracking and protocol deviations, and support database lock, audits, inspections, and regulatory filings.
- Establish and manage External Data Monitoring and Adjudication Committees, including charters, contracting, data presentation, and recommendations.
- Coordinate with investigators, site-facing colleagues, Global Development Leads, health authorities, and cross-functional clinical teams; mentor and supervise colleagues where applicable.
Requirements
- PhD, PharmD, or equivalent with at least 5 years of relevant clinical research experience; or MA/MS with at least 7 years; or BA/BS with at least 8 years in the biopharmaceutical industry.
- Experience across clinical study design, start-up, conduct, close-out, regulatory submissions, and inspections.
- Extensive knowledge of clinical development, global and regional regulations, and ICH/GCP.
- Capabilities in clinical leadership, project management, scientific and regulatory communication, prioritization, and cross-functional coordination.
- Permanent U.S. work authorization is required; candidates must be authorized to work in the U.S. by any employer.
- U.S. work visa sponsorship is not available now or in the future.
Nice to have
- Cardiometabolic disease experience, including obesity, diabetes, or endocrinology.
- Scientific productivity through publications, posters, abstracts, or presentations.
- Experience launching, managing, and training clinical development teams.
- Experience with pharmaceutical development, complex projects, team mentoring, and conflict resolution.
Culture & Benefits
- Global travel may be required.
- Participation in ’s Global Performance Plan with a 20% bonus target.
- Eligibility for a share-based long-term incentive program.
- Benefits include a 401(k) with matching and retirement contributions, paid vacation and holidays, caregiver, parental and medical leave, and medical, prescription, dental, and vision coverage.
- Relocation assistance may be available based on business needs and eligibility.
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