Main Responsibilities:
Contributes to the scientific development of clinical development programs and individual studies in alignment with the clinical development plan within the Hematology therapeutic area Provides scientific and clinical development input for the safe, efficient and timely execution of assigned programs, ensuring the highest quality and full compliance of all outputs Author and/or contribute to the development of program and study level documents and training materials aigned with the scientific strategy (e.g. clinical development plan, IB, protocols, eCRF, ICF, study reference manuals, and investigator trainings)Contributes to the development of the medical monitoring oversight strategy for individual clinical studes and implements it to ensure the highest level of patient safety oversight and data integrity, including ongoing review of blinded data May lead development of Clinical Development Program Contributes to authorship and review of manuscripts, conference abstracts, etc. Collaborates with internal and external cross-functional stakeholders to ensure translation of the clinical developent strategy and clinical protocol into operational deliverables Contributes to the scientific analysis and interpretation of clinical data and the writing of clinical study reports, internal and external scientific meeting presentations and peer-reviewed publications, and all regulatory submission documents Manages the process and liaisons required to support external study oversight committees (e.g. steering committees, independent data monitoring committe, and adjudication committee)
Minimum Qualifications:
PhD; Masters Degree; or Bachelor degree in a Science related discipline. Advanced degree (MSc, PhD) in a Science related discipline is preferred as well as a PMP Certification 4+ (PhD); 6+ (MS) or 8+ (BS) years of experience in one or more R&D functions in the biotechnology/pharmaceutical industry 3+ years of clinical research experience Proven in-depth knowledge in the drug development and manufacturing processes for pharmaceuticals (CMC, non-clinical, clinical, Regulatory Affairs)
Competencies:
The ability to work cross-functionally in a matrix environment is essential Excellent communication skills, oral and written, are required Great attention to detail in processes, communications and documentation Proven ability to work independently and in a team setting is essential Ability to think outside the box and problem-solve Experience providing oversight to CROs
