Associate Director, Global Clinical Scientist

Minimum Qualifications

• Bachelor’s degree, or equivalent in a Science related field is required. An advanced degree (MSc, PhD) in Science, PMP certification, or equivalent is preferred
• 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

• Demonstrated advanced ability and level of experience with working across multiple studies for incorporation of consistent medical/scientific concepts in multiple protocols and ensuring they meet strategic program objectives

• Demonstrated in-depth understanding of the drug development process

• Experience evaluating external opportunities, conducting scientific due diligence, supporting portfolio assessments, or contributing to business development activities is preferred.

• Experience providing oversight to CROs
• Demonstrated experience in regulatory interactions, including preparation of submissions (eg IND, NDA/BLA, MAA, PIP, protocols, briefing books) and responses to health authority questions across different meeting types (eg. FDA type A-D, EMA scientific advice, PMDA, etc)
• Clinical development experience leading a matrix team or complex clinical program with a working knowledge of pharmaceutical and regulatory development processes is a plus
• Formal leadership or management training, including matrix team management is a plus

• Provide scientific leadership in the development of clinical programs, ensuring scientific consistency and alignment with the clinical development plan within the Hematology therapeutic area
• Provide scientific and clinical development input for the safe, efficient, and timely execution of assigned clinical studies, ensuring the highest quality and full compliance of all outputs
• Author and/or contribute to the development of clinical studies and study level documents and training materials aligned with the scientific strategy (e.g., protocols, eCRF, ICF, study reference manuals, investigator trainings etc.)
• Collaborate with internal and external cross-functional stakeholders to ensure translation of the and clinical study protocol into operational deliverables taking the clinical development strategy into consideration
• Define and implement the medical monitoring and oversight strategy of individual clinical studies to ensure the highest level of patient safety and data integrity, including ongoing review of blinded data
• Manage the processes and liaisons required to support external study oversight committees (e.g. Steering committee, independent data monitoring committee, adjudication committee)
• Contribute to the scientific analysis and interpretation of clinical study data and the writing of clinical study reports, internal and external scientific meeting presentations and peer-reviewed publications, and all regulatory submission documents
• Support the GCPL in program-level responsibilities, such as regulatory interactions, development of the clinical strategy and writing up the Clinical Development Plan, development/update IB
• Contribute to multidisciplinary working groups to support continuous process improvement as requested