3 дня назад
Clinical Development Scientist, Senior Manager (Internal Medicine)
139 100 - 231 900$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Clinical Development Scientist, Senior Manager (Internal Medicine): Providing scientific oversight and clinical deliverables for biopharmaceutical trials with an accent on protocol development, clinical data review, safety evaluation, and regulatory documentation. Focus on managing study quality and data integrity, supporting risk mitigation and monitoring committees, and mentoring clinical development colleagues.
Location: Collegeville, Pennsylvania, United States. Hybrid role requiring residence within commuting distance and onsite work an average of 2.5 days per week. Global travel may be required.
Annual base salary: $139,100–$231,900, plus a 17.5% bonus target and eligibility for a share-based long-term incentive program.
Company
is a biopharmaceutical company developing and delivering medicines through global clinical research and pharmaceutical development.
What you will do
- Provide scientific oversight and clinical support for one or more Internal Medicine studies and program-level deliverables.
- Contribute to protocol design, amendments, informed consent documents, clinical data collection strategies, and statistical analysis planning.
- Review clinical and safety data, track and reconcile serious adverse events, and support safety review activities.
- Support risk management, external data monitoring and adjudication committees, site selection, protocol training, and investigator interactions.
- Ensure clinical documentation, TMF compliance, clinical study reports, regulatory submissions, audits, inspections, and disclosure activities meet quality requirements.
- Supervise, mentor, and develop colleagues while contributing to continuous improvement of clinical trial execution.
Requirements
- Science degree: PhD, PharmD, or equivalent with at least 1 year of relevant clinical research experience; MA/MS with at least 5 years; or BA/BS with at least 6 years.
- Clinical research experience in the biopharmaceutical industry across study design, start-up, conduct, close-out, regulatory submissions, and inspections.
- Knowledge of clinical development, global and regional regulations, and ICH/GCP.
- Ability to discuss scientific and regulatory aspects of drug development and deliver clinical milestones within priorities and budgets.
- Leadership experience with mentoring, coaching, delegation, conflict resolution, and cross-functional collaboration.
- Permanent U.S. work authorization is required; 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 publications, posters, abstracts, or presentations.
- Experience with clinical development in principal disease areas and recent scientific developments.
Culture & Benefits
- Comprehensive medical, prescription drug, dental, and vision benefits.
- 401(k) plan with matching contributions and an additional retirement savings contribution.
- Paid vacation, holidays, personal days, caregiver/parental leave, and medical leave.
- Participation in the Global Performance Plan and a share-based long-term incentive program.
- Relocation assistance may be available based on business needs and eligibility.
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