OverviewThe Medical Director, Clinical Development Lead, Hematology 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. Participates in and may lead cross-functional teams to generate, deliver, and disseminate high-quality clinical data supporting overall product scientific and business strategy. The (Senior) Clinical Development Director will be focused primarily on Clinical development of the Menarini-Stemline Haematology Portfolio.
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, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, Menarini-Stemline's customers, markets, business operations, and emerging issues. 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. Along with Clinical Operations, may be responsible for ensuring agreed-upon study enrollment and overall timelines for key deliverables.
- 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. In the role of CST Lead, responsibilities may include supervision of matrix team members and serving as Clinical Research representative to lend clinical development and medical expertise to Asset Development teams.
- May serves as an in-house clinical expert for one or more molecules and diseases in the therapeutic area, coordinating and leading appropriate scientific, clinical and medical activities with internal stakeholders as they relate to ongoing projects.
- May participate in or lead clinical development contributions to due diligence or other business development activity. As required by program needs, contributes to partnership with Discovery colleagues to design and implementation of clinical translational strategies.
- 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.
- Stays abreast of professional information and technology through conferences, medical literature, and other available training, to augment expertise in the therapeutic area. May represent Menarini-Stemline at key external meetings.
- Responsible for understanding the regulatory requirements related to clinical studies and global drug development and accountable for complying with those requirements. May serves as a clinical representative for key regulatory discussions.
- Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research.
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
Please note: This position is classified as a corporate office position. 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 whether these employees work in New York or remotely.
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.
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