Medical Director, Clinical Development Lead, Hematology

Responsibilities

• Participates or leads and demonstrates ownership of the design and implementation of multiple clinical development protocols within the haematology clinical program of an asset in support of the overall product development plan.
• Oversees project-related education of investigators, study site personnel, and Menarini-Stemline study staff.
• Has the overall responsibility for monitoring overall study integrity, and review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule.
• Responsible for assessment and reporting of serious adverse events per corporate policy and regulations for those protocols for which they are responsible.
• Responsible, in collaboration with the clinical scientist, for analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study reports, regulatory submissions and responses, and other program documents.
• May oversee the work of Medical and/or Scientific Directors and of Clinical Scientists working on the same or related programs.
• May serve on or lead Clinical Strategy Teams, with responsibility for development of a rigorous, cross-functionally-aligned, vetted Clinical Development Plan with full consideration of contingencies and alternative approaches.
• May acts as clinical lead and actively solicits opinion leader interactions related to the disease area(s); partners with Oncology Development, Regulatory, Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Oncology Clinical Development Plans and protocols as appropriate.

Qualifications

• Medical Doctor (M.D.) or non-US equivalent of M.D. degree with relevant therapeutic specialty in an academic or hospital environment.
• Completion of a residency program strongly preferred.
• Completion of a subspecialty fellowship (in heme-onc) is desirable.
• Minimum of 3 years of Oncology industry experience.
• PREFERRED: 3+ years Oncology experience in Biotech/Pharma industry.
• Clinical trial experience with relevant classes of agents in the pharmaceutical industry, academia, or equivalent.
• Ability to run a complex clinical research program independently.
• Ability to support a global scientific and business strategy.
• Extensive knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials, and experience in development of clinical strategy and the design of study protocols.
• Must possess excellent oral and written English communication skills, including presentation skills.
• Ability to exercise judgment and address complex problems and create solutions for one or more projects.
• Proven leadership skills and ability to bring out the best in others on a cross-functional global team.
• Must be able to lead through influence.
• Proven ability in establishing and maintaining cross-functional relationships with a wide range of internal and external stakeholders.
• Critical thinking skills with unique problem-solving abilities for new and novel obstacles.
• Excellent strategic planning abilities.
• Willingness to travel.
• Strong analytical skills, especially regarding understanding and interpreting scientific and clinical research and literature, are essential.