Director, Clinical Development Lead, Hematologic Malignancies

Director, Clinical Development Lead, Hematologic Malignancies

Menarini Stemline | Posted Mar 13

Full-time

New York

Negotiable

Unknown

Overview

The (Senior) Clinical Development Director will lead the clinical direction, planning, execution, and interpretation of clinical trials of one or more Heme‑oncology clinical development programs, in close collaboration with the Alliance partner. They will participate in and may lead cross‑functional teams to generate, deliver, and disseminate high‑quality clinical data supporting overall product scientific and business strategy. The focus will be primarily on the clinical development of the Menarini‑Stemline Haematology Portfolio.

Responsibilities

• Design and implement multiple clinical development protocols within the haematology clinical program, ensuring compliance with medical, scientific, and regulatory requirements.
• Oversee the education of investigators, study site personnel, and Menarini‑Stemline study staff.
• Monitor study integrity, review, interpret, and communicate accumulating safety and efficacy data, and manage study timelines and enrollment.
• Assess and report serious adverse events per corporate policy and regulations.
• Analyze, interpret, and report scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions, and other program documents in collaboration with the clinical scientist.
• Supervise or collaborate with Medical and/or Scientific Directors and Clinical Scientists on related programs.
• Lead Clinical Strategy Teams, develop rigorous Clinical Development Plans, and represent clinical expertise to Asset Development teams.
• Act as an in‑house clinical expert for molecules and diseases in the therapeutic area, coordinating scientific, clinical, and medical activities with internal stakeholders.
• Contribute to due diligence and business development activities, and collaborate with Discovery colleagues on translational strategies.
• Serve as clinical lead for opinion‑leader interactions and partner with Oncology Development, Regulatory, Medical Affairs, Commercial and other functions as required.
• Stay abreast of professional information and technology through conferences and medical literature, and represent Menarini‑Stemline at key external meetings.
• Ensure compliance with Good Clinical Practices, pharmacovigilance standards, SOPs, and other quality standards.

Qualifications

• Medical Doctor (M.D.) or equivalent with relevant therapeutic specialty in an academic or hospital environment. Residency completion strongly preferred; subspecialty fellowship in heme‑oncology desired.
• Minimum of 3 years of oncology industry experience (preferably 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.
• Ability to support a global scientific and business strategy.
• Extensive knowledge of clinical trial methodology, regulatory and compliance requirements, and experience in developing clinical strategy and protocol design.
• Excellent oral and written English communication skills, including presentation skills.
• Strong judgment, problem‑solving, and solution‑creation capabilities for multiple projects.
• Proven leadership and ability to influence cross‑functional global teams.
• Proven ability to establish and maintain relationships with diverse internal and external stakeholders.
• Critical thinking and innovative problem‑solving skills for new and novel obstacles.
• Excellent strategic planning abilities.
• Willingness to travel.
• Strong analytical skills, especially in interpreting scientific and clinical research literature.

Base Salary Range of $280,000 - $340,000 plus annual bonus & long‑term incentives. Menarini Stemline offers generous compensation and benefits packages, including Fidelity 401(k) (with company match), Anthem Premier PPO and HDHP insurance plans, company‑paid Basic Life & AD&D insurance, and pre‑tax FSA/HSA programs.

Menarini Stemline is committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.