(Senior) Medical Director, Clinical Development, Solid Tumors

MENARINI Group•New York, NY

4d•$280,000 - $350,000•Remote

About The Position

The Medical Director, Clinical Development, Solid Tumors is responsible for driving global clinical development strategy for solid tumor programs. The role provides input into the development, management, and implementation of Phase 1–4 clinical studies in close partnership with Clinical Operations, and leads multidisciplinary teams guiding clinical development and regulatory submissions. Responsibilities include the design and execution of first-in-human through registration-enabling studies and Phase I–III clinical development of products. The role may oversee Medical and/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 stated base salary range is $280,000–$350,000. The company describes its compensation and benefits as including a Fidelity 401(k) with company match, PPO and HDHP healthcare plans, company-paid Basic Life and AD&D insurance, and pre-tax FSA/HSA programs. New York state income taxes will be withheld for corporate office employees under the state employer convenience rule, including employees 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, ability to conduct literature research and analyses, and ability to author clinical-trial publications.
Working knowledge of GCP, ICH, FDA, and EMEA regulations.
Excellent written and verbal communication skills with all organizational levels.
Ability to work cross-functionally with oncology development functions such as Regulatory, Medical Affairs, Statistics, and PK/PD, and with Commercial, HEOR, or other functions as needed.
Experience communicating and interacting with investigators, key opinion leaders, regulatory agencies, and advisors.
Experience with data analysis, interpretation, and assessment of clinical relevance.
Solid knowledge of compliance and global ICH regulatory requirements for pharmaceutical product development.
Proven ability to represent company interests effectively with partners and regulatory agencies.
Ability to lead a dynamic group in a fast-paced, hands-on environment.
Strong scientific standing among peers and ability to address issues with scientific 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 certification in oncology and/or oncology training is strongly preferred.
Prior leadership experience is preferred.

Responsibilities

Represent the clinical science 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.
Conduct medical monitoring, including safety data review and signal identification; respond to site inquiries and work with CRO medical monitors when appropriate.
Provide medical responsibility for data analysis and interpretation, reporting, and communication, ensuring consistent and relevant 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 robust study conduct and quality data generation.
Develop innovative clinical strategies to shorten development timelines in an evolving regulatory landscape.
Lead Phase I–III clinical development of products.
Potentially 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.