Associate Director, Global Clinical Scientist

Position Overview:

The Associate Director, Global Clinical Scientist role is a key leadership role in the Clinical Development group and is a multifunctional, clinical project position that will support the Hematology Therapeutic Area. The position may be delegated aspects of Clinical Development Team (CDT) leadership depending on the needs of the program. The incumbent works closely with other Clinical Representatives in performing delegated tasks in support of the clinical development program as dictated by therapeutic area/ project needs, including approximately 30-40% external innovation assessment, Search & Evaluation support, and due diligence responsibilities, depending on program needs and status.

Work Environment:

*** This is a hybrid position with a minimum of 3 days onsite required on a weekly basis. Relocation assistance and visa sponsorship are not provided.

Key Responsibilities:

• 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

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

Competencies:

• Recommends operational strategies and plans with direct impact on overall functional results

• Requires ability to influence others to accept new practices and approaches, and ability to influence executive leadership on matters of strategic importance

• Thinks beyond and helps teams respond to the external environment

• Builds bridges and proactively improves cross-business collaboration

• Unleashes outcomes and empowers team member accountability and decision making

• Ignites agility and leads effective organizational change

• Inspires the future and ensures teams buy into the strategy

• Cultivates talent and creates development opportunities

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