Associate Director, Global Clinical Scientist
About The Position
The Associate Director, Global Clinical Scientist is a multifunctional clinical project leadership role within the Clinical Development group, supporting the Hematology Therapeutic Area. Depending on program needs, the position may be delegated aspects of Clinical Development Team leadership. The incumbent works closely with other Clinical Representatives on delegated tasks supporting clinical development programs, including approximately 30–40% external innovation assessment, Search & Evaluation support, and due diligence responsibilities, depending on program needs and status. The role provides scientific leadership across clinical programs and studies, contributes to clinical strategy and regulatory activities, and supports high-quality, compliant study execution. It also involves collaboration with internal and external stakeholders, medical monitoring and study oversight, interpretation and communication of clinical data, and continuous process improvement. This is a hybrid position requiring a minimum of three days onsite each week. Relocation assistance and visa sponsorship are not provided.
Requirements
- Bachelor's degree or equivalent in a science-related field.
- At least 8 years of clinical research experience in one or more Clinical Development functions within the biotechnology or pharmaceutical industry.
- Demonstrated experience in clinical development strategy, protocol design, clinical study execution, data interpretation, and scientific document authorship.
- Advanced ability and experience working across multiple studies to incorporate consistent medical and scientific concepts in multiple protocols and ensure alignment with strategic program objectives.
- In-depth understanding of the drug development process.
- Demonstrated experience in regulatory interactions, including preparing submissions such as IND, NDA/BLA, MAA, PIP, protocols, and briefing books, and responding to health authority questions across different meeting types.
- Experience providing oversight to contract research organizations (CROs).
Nice To Haves
- Advanced degree (MSc or PhD) in science, PMP certification, or equivalent.
- Experience evaluating external opportunities, conducting scientific due diligence, supporting portfolio assessments, or contributing to business development activities.
- Clinical development experience leading a matrix team or complex clinical program, with working knowledge of pharmaceutical and regulatory development processes.
- Formal leadership or management training, including matrix team management.
Responsibilities
- Provide scientific leadership in developing clinical programs, ensuring scientific consistency and alignment with the clinical development plan in the Hematology therapeutic area.
- Provide scientific and clinical development input for the safe, efficient, and timely execution of assigned clinical studies, ensuring high-quality and compliant outputs.
- Author or contribute to clinical study documents and training materials aligned with scientific strategy, including protocols, eCRFs, informed consent forms, study reference manuals, and investigator training materials.
- Collaborate with internal and external cross-functional stakeholders to translate clinical development strategy and study protocols into operational deliverables.
- Define and implement medical monitoring and oversight strategies for individual studies, including ongoing review of blinded data, to support patient safety and data integrity.
- Manage processes and liaison activities supporting external study oversight committees, such as steering committees, independent data monitoring committees, and adjudication committees.
- Contribute to scientific analysis and interpretation of clinical study data and to clinical study reports, scientific meeting presentations, peer-reviewed publications, and regulatory submission documents.
- Support the Global Clinical Program Lead (GCPL) in program-level responsibilities, including regulatory interactions, clinical strategy, the Clinical Development Plan, and development or updating of the Investigator's Brochure.
- Contribute to multidisciplinary working groups supporting continuous process improvement.
Benefits
- Incentive compensation may be included in total compensation.
- Equity may be included in total compensation.
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What This Job Offers
Job Type
Full-time
Career Level
Director
