Medical Director, Clinical Development Hematology

MENARINI Group•New York, NY

9d•$280,000 - $340,000

About The Position

The Medical Director, Clinical Development, Hematology leads the clinical direction, planning, execution, and interpretation of clinical trials for one or more hematology-oncology development programs, in close collaboration with alliance partners. The role participates in and may lead cross-functional teams to generate, deliver, and disseminate high-quality clinical data that supports product scientific and business strategy, primarily within the Menarini-Stemline Hematology Portfolio. The position provides medical and scientific leadership across clinical protocols and programs, including oversight of study integrity, safety and efficacy data, serious adverse event reporting, and the preparation and interpretation of clinical and regulatory documents. It may also lead clinical strategy teams, oversee colleagues, contribute to business development and translational strategies, and serve as a clinical expert and representative in internal and external settings. The role is classified as a corporate office position; the posting notes that New York state income taxes will be withheld for corporate office employees regardless of whether they work in New York or remotely.

Requirements

Medical Doctor (M.D.) degree or non-U.S. equivalent, with relevant therapeutic specialty experience in an academic or hospital environment.
At least 3 years of oncology industry experience.
Clinical trial experience with relevant classes of agents in the pharmaceutical industry, academia, or an equivalent setting.
Ability to independently run a complex clinical research program.
Ability to support a global scientific and business strategy.
Extensive knowledge of clinical trial methodology and regulatory and compliance requirements governing clinical trials, with experience developing clinical strategy and designing study protocols.
Excellent oral and written English communication skills, including presentation skills.
Ability to exercise judgment, 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 and lead through influence.
Proven ability to establish and maintain cross-functional relationships with a wide range of internal and external stakeholders.
Critical thinking and problem-solving skills for new and novel obstacles.
Excellent strategic planning abilities.
Willingness to travel.
Strong analytical skills, particularly in understanding and interpreting scientific and clinical research and literature.

Nice To Haves

Completion of a residency program is strongly preferred.
Completion of a subspecialty fellowship in hematology-oncology is desirable.
Three or more years of oncology experience in the biotechnology or pharmaceutical industry is preferred.

Responsibilities

Participate in or lead the design and implementation of multiple clinical development protocols within a hematology program, supporting the overall product development plan and applying medical and scientific principles and knowledge of compliance and regulatory requirements.
Oversee project-related education for investigators, study site personnel, and company study staff.
Monitor overall study integrity and review, interpret, and communicate accumulating safety and efficacy data.
Work with Clinical Operations, as applicable, to help ensure agreed study enrollment and timelines for key deliverables.
Assess and report serious adverse events in accordance with corporate policy and regulations for assigned protocols.
Collaborate with clinical scientists to analyze, interpret, and report scientific content for protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses, and other program documents.
As applicable, oversee Medical and/or Scientific Directors and Clinical Scientists working on the same or related programs.
Serve on or lead Clinical Strategy Teams and develop rigorous, cross-functionally aligned Clinical Development Plans that consider contingencies and alternative approaches.
As a Clinical Strategy Team lead, potentially supervise matrix team members and represent Clinical Research on Asset Development teams, providing clinical development and medical expertise.
Serve as an in-house clinical expert for assigned molecules and diseases, coordinating scientific, clinical, and medical activities with internal stakeholders.
Participate in or lead clinical development contributions to due diligence or other business development activities.
Partner with Discovery colleagues, as needed, to design and implement clinical translational strategies.
Act as clinical lead and solicit opinion-leader interactions, partnering with Oncology Development, Regulatory, Medical Affairs, Commercial, and other functions as appropriate and consistent with company policies.
Stay current with professional information and technology through conferences, medical literature, and training; potentially represent Menarini-Stemline at external meetings.
Understand and comply with regulatory requirements related to clinical studies and global drug development; potentially serve as a clinical representative in key regulatory discussions.
Ensure adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures, and other quality standards in research.