Remote Senior Medical Director: Clinical Development, Solid Tumors

Menarini Stemline; New York (NY); On-site; USD 280,000 - 350,000; Full time

Benefits offered by this job

Fidelity 401(k) with company match

Health insurance

Life & AD&D insurance

Pre-tax FSA/HSA programs

Job summary

Menarini Stemline seeks a Medical Director, Clinical Development in solid tumors to lead global strategy from Phase 1 to 4 and oversee cross-functional teams. You will shape study designs, safety monitoring, and regulatory submissions to advance assets in solid tumors.

Qualifications include an MD/DO with 5+ years pharma/biotech experience and oncology leadership. The role is remote with ~20% travel and includes a strong compensation package with bonus and incentives.

Qualifications

• Medical Degree with 5+ years pharma/biotech experience.
• Board certified oncologist and/or training in oncology strongly preferred.
• Experience developing clinical strategy for oncology products (Phase I-III) leading to regulatory submission(s).
• Training in Breast Cancer and/or experience developing Breast Cancer compounds within the industry.
• Recognized expert in clinical trials: statistics, medical monitoring, literature review, and publications.
• Working knowledge of GCP, ICH, FDA, and EMEA regulations.
• Excellent written and verbal communication skills with all levels of the organization.
• Ability to work cross-functionally with Regulatory, Medical Affairs, Statistics, PK/PD and others.
• Prior leadership experience preferred and ability to lead a dynamic group.

Responsibilities

• Represent the clinical science line function on global program teams and contribute to strategic planning and execution of clinical development plans.
• Lead the development of clinical study protocols and related documents based on the global development plan.
• Perform medical monitoring, data analysis, safety review, and respond to site inquiries with CRO monitors as needed.
• Ensure medical content consistency across CSR, briefing books, and NDA/BLA submissions.
• Contribute to operational aspects of study conduct and patient enrollment activities.
• Maintain focus on robust study conduct and high-quality data generation.
• Develop and implement innovative clinical strategies to shorten development cycles.

Skills

Medical degree

Board certified oncologist

Clinical development strategy

GCP/ICH knowledge

Leadership

Communication skills

Education

MD/DO or equivalent

Job description

Menarini Stemline seeks a Medical Director, Clinical Development in solid tumors to lead global strategy from Phase 1 to 4 and oversee cross-functional teams. You will shape study designs, safety monitoring, and regulatory submissions to advance assets in solid tumors.

Qualifications include an MD/DO with 5+ years pharma/biotech experience and oncology leadership. The role is remote with ~20% travel and includes a strong compensation package with bonus and incentives.