Director, Clinical Development Lead, Hematologic Malignancies

This position is classified as a corporate office role. In accordance with the New York state employer convenience rule, Stemline will withhold New York state income taxes for all corporate office employees, regardless of work location.

About the role

Lead the clinical direction, planning, execution, and interpretation of clinical trials for one or more Heme-oncology clinical development programs in close collaboration with the Alliance partner. Participate in and may lead cross-functional teams to generate, deliver, and disseminate high-quality clinical data supporting overall product scientific and business strategy, primarily focused on the Menarini-Stemline Hematology Portfolio.

Responsibilities

• Participate or lead and demonstrate ownership of the design and implementation of multiple clinical development protocols within the hematology clinical program of an asset, supporting the overall product development plan based on strong medical and scientific principles, compliance and regulatory requirements, and business operations.
• Oversee project-related education of investigators, study site personnel, and Menarini-Stemline study staff.
• Monitor overall study integrity, and review, interpret, and communicate accumulating data pertaining to safety and efficacy of the molecule.
• Ensure agreed-upon study enrollment and overall timelines for key deliverables, in collaboration with Clinical Operations.
• Assess and report serious adverse events per corporate policy and regulations for assigned protocols.
• Collaborate with the clinical scientist for analysis, interpretation, and reporting of scientific content in 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 Clinical Scientists on the same or related programs.
• Serve on or lead Clinical Strategy Teams, developing rigorous, cross-functionally-aligned Clinical Development Plans with consideration of contingencies and alternative approaches.
• As CST Lead, supervise matrix team members and serve as Clinical Research representative to lend clinical development and medical expertise to Asset Development teams.
• Act as an in-house clinical expert for one or more molecules and diseases in the therapeutic area, coordinating and leading scientific, clinical, and medical activities with internal stakeholders.
• Contribute to clinical development for due diligence or other business development activities.
• Partner with Discovery colleagues to design and implement clinical translational strategies as required by program needs.
• Act as clinical lead and solicit opinion leader interactions related to the disease area(s), partnering with Oncology Development, Regulatory, Medical Affairs, Commercial, and other functions.
• Stay abreast of professional information and technology through conferences, medical literature, and training to augment expertise in the therapeutic area.
• Represent Menarini-Stemline at key external meetings.
• Understand and comply with regulatory requirements related to clinical studies and global drug development, serving as a clinical representative for key regulatory discussions.
• Ensure adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures, and all other quality standards in conducting research.

Qualifications

• Medical Doctor (M.D.) or non-U.S. equivalent with relevant therapeutic specialty in an academic or hospital environment.
• Completion of a residency program strongly preferred.
• Completion of a subspecialty fellowship in hematology-oncology is desirable.
• Minimum of 3 years of Oncology industry experience; preferred 3+ years in Biotech/Pharma.
• Clinical trial experience with relevant classes of agents in the pharmaceutical industry, academia, or equivalent.
• Ability to run a complex clinical research program independently and support a global scientific and business strategy.
• Extensive knowledge of clinical trial methodology, regulatory and compliance requirements, and experience in clinical strategy and study protocol design.
• Excellent oral and written English communication skills, including presentation skills.
• Ability to exercise judgment and address complex problems, creating solutions for one or more projects.
• Proven leadership skills and ability to lead cross-functional global teams through influence.
• Ability to establish and maintain 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 in understanding and interpreting scientific and clinical research and literature.

Pay

Base Salary Range of $280,000 - $340,000 plus annual bonus and long-term incentives.

Benefits

• Fidelity 401(k) with company match.
• Anthem Premier PPO and HDHP insurance plans.
• Company-paid Basic Life & AD&D insurance.
• Pre-tax FSA/HSA programs.