Executive Medical Director, Clinical Development, Breast Cancer

MENARINI Group•New York, NY

6d•$300,000 - $400,000

About The Position

The Executive Medical Director, Clinical Development, Solid Tumors will drive global clinical development strategy for Stemline’s breast cancer product, Elacestrant. The role provides strategic input and oversees the development, management, and implementation of Phase 1–4 clinical studies, including a pivotal registration-enabling Phase 3 study. The incumbent works closely with Clinical Operations colleagues and leads multidisciplinary teams responsible for clinical development and subsequent regulatory submissions. The position is classified as a corporate office position. Stemline withholds New York state income taxes for corporate office employees, whether they work in New York or remotely. The listed base salary range is $300,000–$400,000.

Requirements

Medical degree and 12 or more years of pharmaceutical or biotechnology experience.
Experience developing clinical strategy for oncology products across Phase I–IV, leading to successful regulatory submissions.
Recognized clinical-trial expertise, including understanding of statistical principles and medical monitoring; ability to conduct literature research and analyses and author clinical-trial publications.
Working knowledge of GCP, ICH, FDA, and EMEA regulations.
Solid knowledge of compliance and global regulatory requirements (ICH) for pharmaceutical candidate and product development.
Excellent written and verbal communication skills with all levels of an organization.
Ability to work cross-functionally with functions such as Operations, Regulatory, Medical Affairs, Statistics, PK/PD, Commercial, and HEOR.
Experience communicating and interacting with investigators, KOLs, regulatory agencies, and advisors.
Experience with data analysis, interpretation, and assessment of clinical relevance.
Ability to lead a dynamic group in a fast-paced, hands-on environment.
Scientific credibility among peers and ability to address issues with rigor and creative solutions.
Ability to develop and implement strategic growth plans.
Comfort with ambiguity, self-motivation, and a timeline-driven approach.

Nice To Haves

Board-certified oncologist and/or oncology training.
Training in breast cancer and/or industry experience developing breast cancer compounds.
Prior leadership experience.

Responsibilities

Represent the clinical line function on global program teams and contribute to strategic planning and execution of clinical development plans for assigned solid-tumor assets.
Lead development of clinical study protocols, protocol amendments, study guides, protocol training materials, and other study documents based on the global development plan.
Conduct medical monitoring, including safety-data review and identification of potential signals; respond to site inquiries and work with CRO medical monitors when appropriate.
Take medical responsibility for data analysis and interpretation, reporting, and communication, ensuring consistency and relevance of medical content and scientific messages across clinical study reports, health-authority briefing books, and NDA/BLA submission documents.
Contribute to study operations and patient enrollment, including site training, initiation, activation, and ongoing site engagement.
Maintain focus on robust study conduct and quality data generation.
Develop innovative clinical strategies to shorten development timelines in an evolving regulatory landscape.
Lead Phase I–IV clinical development, with a primary focus on a pivotal Phase 3 trial.
May oversee Medical and/or Scientific Directors and Clinical Scientists working on the same or related programs.
Act as clinical lead and actively solicit opinion-leader interactions related to the disease area.
Represent the company effectively in interactions with partners and regulatory agencies.