Senior Director- Global Development Scientist
About The Position
Within Hematology Research and Development, this role supports early- and late-phase hematology development across a combination-focused pipeline. The Global Development Scientist Director is an important member of the Clinical Project Team (CPT) and Global Study Team (GST), working cross-functionally in a matrix environment with clinical colleagues, Site Management & Monitoring, field-based liaisons, site personnel, and the Global Development Medical Director. The position shares responsibility with Clinical Operations for planning and executing clinical studies, including recruitment and delivery. It provides scientific input to clinical program strategies, trial design and implementation, clinical data review and cleaning, interpretation and reporting of results, and activities supporting worldwide product registration, including clinical input to NDA/BLA submissions. Depending on experience, the role may lead or contribute to process-improvement initiatives and cross-asset or cross-indication working groups, and mentor less experienced clinical team members. The role requires collaborative communication and the ability to engage and influence stakeholders inside and outside the organization. Work must meet high ethical standards and comply with internal SOPs, local regulations, laws, Good Clinical Practice (GCP), and other regulatory requirements.
Requirements
- Bachelor of Science degree required.
- At least 7 years of relevant experience.
- Significant industry or academic experience in drug development.
- Technical knowledge sufficient to interact confidently with internal and external partners.
- Foundational knowledge of FDA and other major-country regulations, and detailed knowledge of GCP and other regulations governing clinical research.
- General knowledge of medical monitoring, regulatory approval processes in relevant countries, pharmaceutical industry and R&D operations, and marketing and commercial fundamentals.
- Demonstrated ability to independently complete and lead peers in developing components of sophisticated drug-development plans, related documents, methodologies, measures, analytical plans, and evaluation tools.
- Ability to drive or contribute to protocol design, writing, and implementation.
Nice To Haves
- PhD in a scientific field, PharmD, or MD.
- Significant experience in malignant hematology clinical trials.
- Haemato-oncology background.
Responsibilities
- Work cross-functionally within the Clinical Project Team to translate clinical strategy into study concept documents, protocols, and related documents.
- Establish key relationships with internal clinical project teams and external regulatory bodies and service providers.
- Provide scientific input into clinical trial design and implementation, delivery, clinical data review and cleaning, interpretation of results, timely reporting, and worldwide product registration activities, including clinical input to NDA/BLA submissions.
- Ensure the relevance and accuracy of the clinical science underpinning studies through scientific review and consultation; provide clinical and scientific leadership and integrity for protocols and clinical-plan components; and deliver final protocols for governance approval.
- Lead development of protocols and related documents, and develop and deliver clinical study reports in accordance with GCP, ICH, and company quality standards.
- Lead cross-functional projects supporting drug development through its phases, or contribute as a technical expert to project elements.
- Review and interpret medical and clinical trial data and develop conclusions.
- Respond promptly to investigational study sites regarding local informed consent form changes and protocol or EC/IRB questions and requests.
- Support development of clinical components of regulatory and EC/IRB submission documents when marketing approval is sought.
- Prepare or contribute to clinical study reports and clinical sections of regulatory documents, including IB, DSUR, PSUR, and regulatory responses.
- Contribute to the development and delivery of in-person or virtual investigator training and supervise training.
- Participate in or lead reviews and assessments of new opportunities and ESRs as needed.
- Mentor less experienced Global Development Scientist Directors and other clinical team members, depending on experience.
Benefits
- Eligibility for short-term incentive bonuses.
- Equity-based awards for salaried roles.
- Qualified retirement programs.
- Paid time off, including vacation, holidays, and leaves.
- Health coverage.
- Dental coverage.
- Vision coverage.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
