Director of Commercial Systems leading testing, bug triage, and prioritization at GEICO. Collaborating with IT and management to ensure optimal system performance and quality.
About the role
- Director of Clinical Pharmacology at BeOne developing strategies for oncology drug candidates. Leading hands-on analysis and regulatory interactions for clinical development and drug registration.
Responsibilities
- Develop and execute clinical pharmacology and pharmacometrics strategies to mitigate risks and support development of small molecule and/or biologics drug candidates
- Develop clinical pharmacology study designs and collaborate with CROs and Clinical Operations to write study protocols, amendments, and reports
- Conduct hands-on clinical PK and pharmacometric data analysis
- Analyze, interpret, summarize, and present data to internal project teams, senior management, and to global health authorities
- Present data and interpretations to health authorities to enable optimal clinical development and registration of novel drugs
- Author, review, and finalize relevant sections of IND/CTA filings as well as NDA/MAA/BLA submissions
Requirements
- A Ph.D. or equivalent in Pharmacokinetics, Pharmaceutical Sciences, Biomedical Engineering or related discipline
- At least eight years of industry and/or related post-doctoral experience is preferred
- Demonstrable scientific, clinical development and regulatory experience based on prior experience with NDA/BLA/MAA filings and/or publications is essential
- Familiarity with DMPK studies, bioanalytical methods are preferred
- Prior experience in oncology drug development is preferred
- Prior experience with Quantitative System Pharmacology (QSP) modeling, Bispecific antibody, AI ML in drug development, PBPK modeling is a significant plus
Benefits
- Medical
- Dental
- Vision
- 401(k)
- FSA/HSA
- Life Insurance
- Paid Time Off
- Wellness
Job title
Job type
Experience level
Salary
Degree requirement
Location requirements
Senior Director managing Brookings plant operations for medical products at Solventum. Driving operational excellence and fostering a supportive culture for over 1200 employees.
Associate Director leading Biostatistics in drug development at Regeneron. Collaborating across teams and representing statistical issues in regulatory meetings in a hybrid environment.
Associate Director overseeing External Data Management at Regeneron. Leading teams and ensuring compliance with industry best practices and standards.
Director of Enterprise Service Management leading ITSM practices at Acrisure. Overseeing governance, process optimization, and continuous improvement for enhanced service delivery and client value.
Director of QHSE leading quality, hygiene, safety, and environmental policy at INTERWAY. Managing QHSE strategy and compliance across organizational levels with a focus on innovation.
Director of R&D leading enterprise strategy for innovation and emerging technology in financial services. Shaping research agenda to drive business outcomes and maintain competitive advantage.
Director of Innovation Enablement at TruStage, identifying and driving innovative technology solutions for financial services. Collaborating with business leaders and technology teams to deliver measurable outcomes.
Adjoint directeur d'un village vacances en France, gérant les opérations et budget de l'établissement. Assure la promotion et la coordination des équipes sur site.
Funeral Director position at NorthStar Memorial Group in Washington. Providing support and coordinating funeral services with compassion and professionalism.