Senior Medical Director, Clinical Development, Solid Tumor

MENARINI Group•New York, NY

4d•$280,000 - $350,000•Remote

About The Position

The Senior Medical Director, Clinical Development, Solid Tumor will drive global clinical development strategy for solid-tumor programs. The role provides medical and scientific input into the development, management, and implementation of Phase 1–4 studies in close collaboration with Clinical Operations, and leads multidisciplinary teams responsible for clinical development and regulatory submissions. The position includes responsibility for designing and executing studies from first-in-human through registration-enabling stages, and for Phase I–III product development. The role represents the clinical science function on global program teams, develops clinical study materials, conducts medical monitoring, and guides data analysis, interpretation, reporting, and communication. It also contributes to study operations, site engagement, patient enrollment, and quality data generation. The successful candidate will develop innovative clinical strategies, act as a clinical lead, and may oversee Medical or Scientific Directors and Clinical Scientists working on the same or related programs. This is a remote-based corporate office position with expected business travel and onsite presence of approximately 20%. The company states that New York state income taxes will be withheld for all corporate office employees, including those working remotely.

Requirements

Medical degree.
At least 5 years of pharmaceutical or biotechnology experience.
Experience developing clinical strategy for oncology products in Phase I–III, leading to successful regulatory submissions.
Training in breast cancer and/or industry experience developing breast-cancer compounds.
Recognized clinical-trial expertise, including working understanding of statistical principles and medical monitoring.
Demonstrated ability to conduct literature research and analyses and author clinical-trial publications.
Working knowledge of GCP, ICH, FDA, and EMEA regulations.
Strong written and verbal communication skills across all levels of an organization.
Ability to work cross-functionally with oncology development functions, including Regulatory, Medical Affairs, Statistics, and PK/PD, as well as Commercial, HEOR, and other functions as required.
Experience communicating and interacting with investigators, KOLs, regulatory agencies, and advisors.
Experience applying data-analysis and interpretation principles and assessing clinical relevance.
Solid knowledge of compliance and global ICH regulatory requirements for pharmaceutical candidate and product development.
Ability to lead a dynamic group in a fast-paced, hands-on environment.
Scientific standing among peers and ability to address issues with scientific rigor and creative solutions.
Comfort with ambiguity, self-motivation, and a timeline-driven approach.

Nice To Haves

Board certification in oncology and/or oncology training is strongly preferred.
Prior leadership experience is preferred.

Responsibilities

Represent the clinical science 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, amendments, study guides, training materials, and other study documents based on the global development plan.
Perform 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 consistent and relevant medical content 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 generation of quality data.
Develop innovative clinical strategies to shorten development cycles in an evolving regulatory landscape.
Lead Phase I–III clinical development of products.
Act as clinical lead and actively solicit opinion-leader interactions related to the disease areas.
May oversee Medical and/or Scientific Directors and Clinical Scientists working on the same or related programs.
Represent the company effectively in interactions with partners and regulatory agencies.
Develop and implement strategic growth plans.