Medical Director of Clinical R&D – Hematology
Luitpold Pharmaceuticals, Inc., a Daiichi Sankyo Group Company, is dedicated to the development and marketing of innovative, quality drugs and medical devices for healthcare professionals, clinics, and hospitals across the United States and Canada. We specialize in sterile injectables, bone regeneration materials for dental procedures, as well as innovative products for acute pain control and veterinary medicine use. The Medical Director of Clinical R&D will lead the hematologic assessment and review of all the clinical programs for the product Injectafer. This role will have direct report to the Head of Clinical Research and Development.
Essential Duties and Responsibilities
•Characterize the unmet needs in North America for therapeutic areas under development and inform on business development opportunities.
•Leadership of a professional team focused on evidence generation and evidence synthesis to meet the unmet needs of iron deficiency.
•Communicate effectively with partners, affiliates, and stakeholders to ensure alignment and time-bound clinical and business commitments.
•Adhere to both Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP) aligned with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).
•Perform any other tasks/duties as assigned by management.
•Drives QUALITY culture and Core Competency Model initiatives in support of enhanced organizational performance.
Requirements:
• Medical degree with United States board certification in hematology.
•Six or more years of experience in the pharmaceutical industry or relevant clinical research experience in the academic setting.
•Strong analytic skills, problem-solving skills, and medical writing skills. Experience in writing and implementing research protocols, reviewing and
interpreting data, preparation of study reports, data analysis, and presenting data to internal and external audiences.
•Strong skills in public speaking, interpersonal relationships, team building, and capability of change.
•Ability to travel and work hours necessary to meet deadlines, including week-ends, as needed
•Physical Environment and Physical Requirements
•Business travel as required for clinical and regulatory activities.
•On-site employment with some flexibility.
Physical Environment and Physical Requirements
•While performing duties of the job, incumbent is occasionally required to stand; walk; sit; use hands to finger, handle or feel objects, tools or controls; reach with hands and arms; balance; talk and hear
We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
