3 дня назад
Global Development Lead, Internal Medicine (Sr. Director)
214 900 - 358 100$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Global Development Lead, Internal Medicine (Sr. Director) (Clinical Development): Leading global clinical development programs for cardiometabolic and internal medicine assets, including type 2 diabetes, with an accent on clinical strategy, trial design, regulatory submissions, and cross-functional leadership. Focus on designing development plans, interpreting clinical data, managing late-stage studies, and securing worldwide regulatory approval and reimbursement.
Location: New York City, United States; hybrid role requiring commuting distance and on-site work an average of 2.5 days per week. Up to 30% travel may be required. Relocation support may be available.
Annual base salary: $214,900–$358,100, plus a 22.5% bonus target and eligibility for a share-based long-term incentive program.
Company
is a pharmaceutical company developing medicines through global research, clinical development, and regulatory programs.
What you will do
- Lead cross-functional Clinical Development Teams across clinical, clinical pharmacology, statistics, safety, commercial, patient access, and operations.
- Create and gain endorsement for clinical development plans, pediatric plans, protocols, and target product profiles.
- Lead design, execution, interpretation, and reporting of late-stage cardiometabolic clinical trials, including type 2 diabetes programs.
- Direct regulatory submission deliverables, including clinical overviews, SCE, SCS, DSUR, PBRER, safety narratives, and product labeling.
- Engage external stakeholders, including advisory boards, steering committees, data monitoring committees, patients, and patient advocates.
- Partner with statistics, programming, trial clinicians, and product team leaders to deliver programs within agreed timelines and budgets.
Requirements
- BS with 12 years or PhD with 7 years of relevant clinical or industry experience.
- Experience leading cardiometabolic late-stage development programs, including type 2 diabetes.
- Extensive knowledge of clinical development, global and regional regulations, ICH/GCP, and adverse event management.
- Demonstrated clinical, medical, administrative, project management, communication, and cross-functional leadership capabilities.
- Experience managing and training large clinical development teams.
- Permanent work authorization in the United States and authorization to work in the U.S. by any employer are required; U.S. work visa sponsorship is not available.
Nice to have
- Experience in academia and/or the biopharmaceutical industry with a successful clinical research and development track record.
- Experience designing and launching large teams.
Culture & Benefits
- Hybrid work arrangement with commuting-distance access to the New York City site.
- 401(k) plan with matching and additional retirement savings contributions.
- Paid vacation, holidays, personal days, caregiver/parental leave, and medical leave.
- Medical, prescription drug, dental, and vision coverage.
- Participation in global performance and share-based long-term incentive programs.
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