(Senior) Medical Director, Clinical Development, Solid Tumors

Menarini Biotech S.r.l.; New York (NY); Remote; USD 280,000 - 350,000; Full time

Benefits offered by this job

401(k) match

Health insurance

Life insurance

FSA/HSA

Job summary

Stemline Therapeutics Inc is seeking a (Senior) Medical Director, Clinical Development with a focus on solid tumors to lead global Phase 1–4 programs and shape clinical strategy. The role involves medical monitoring, protocol development, data interpretation, and regulatory interactions in a fast-paced environment.

The position is remote-based with approx. 20% onsite travel, reporting to the VP, Clinical Development, Solid Tumor.

Qualifications

• Medical Degree with 5+ years pharma/biotech experience.
• Board certified oncologist and/or training in oncology is strongly preferred.
• Experience developing clinical strategy for oncology products (Phase I-III) leading to successful regulatory submission(s) is required.
• Training in Breast Cancer and/or experience developing Breast Cancer compounds within the industry is required.
• Recognized expert in clinical trials: working understanding of statistical principles, medical monitoring; demonstrated ability to perform literature research, analyses, and author clinical trial publications.
• Working knowledge of GCP, ICH, FDA, and EMEA regulations.
• Excellent and effective written and verbal communication skills with all levels of the organization.
• Ability to work cross-functionally, partners with oncology development functions such as Regulatory, Medical Affairs, Statistics, PK/PD and others.
• Experience communicating and interacting with investigators, KOLs, regulatory agencies, and advisors.
• Experience working with the principles and techniques of data analysis, interpretation, and clinical relevance.
• Solid knowledge of compliance and global regulatory requirements (ICH) for development of pharmaceutical candidates/products (required).
• Proven ability to represent the Company’s interest effectively in interactions with partners and regulatory agencies.
• Acts as clinical lead and actively solicits opinion leader interactions related to the disease area(s)
• Ability to lead a dynamic group in a fast-paced and hands-on environment.
• Excellent scientific standing among peers and the ability to address issues with scientific rigor and creative solutions.
• Ability to develop and implement strategic growth plans.
• Prior leadership experience preferred.

Responsibilities

• Represent the clinical science line function on global program team(s) and contribute to strategic planning and execution of clinical development plan for the assigned assets being developed in solid tumors.
• Lead the development of clinical study protocols, protocol amendments, study guides, protocol training materials and other clinical study related documents based on the global development plan.
• Perform medical monitoring (safety data review and identify potential signals), responses to site inquiries, and work with CRO medical monitors when appropriate.
• Take medical responsibility in data analysis and interpretation, reporting and communication to ensure consistency and relevance of medical content and scientific messages across Clinical Study Report, health authority briefing books, and NDA/BLA submission documents, etc.
• Contribute to operational aspects of study conduct and patient enrolment efforts including participation in site training, initiation and activation and subsequent site engagement activities.
• Maintain focus on robust study conduct and quality data generation.
• Demonstrate the ability to develop unique and innovative clinical strategies to significantly shorten the development cycle in the face of an evolving regulatory landscape.
• Responsible for phase I – III clinical development of products.
• May oversee the work of Medical and/or Scientific Directors and of Clinical Scientists working on the same or related programs.

Education

Medical Degree

Job description

## (Senior) Medical Director, Clinical Development, Solid TumorsApply: New York, New York, USA: Full time: Posted 6 Days Ago: JR100070**Company:**0750 Stemline Therapeutics Inc**Contract Type:**Permanent **Join us in shaping the future of Menarini - with passion, integrity, and a deep commitment to people.**About Menarini Group - Menarini is a leading international biopharmaceutical company committed to advancing health through innovation, research, and quality. For more than 135 years, we have worked to improve patients’ lives across a broad range of therapeutic areas through our dedication to science, integrity, and care for people. With a strong foundation in scientific excellence and a purpose-driven culture, Menarini offers diverse career opportunities for professionals eager to make a meaningful impact on global health.**Position Title: (Senior) Medical Director, Clinical Development, Solid Tumors** **Reports to: Vice President, Clinical Development, Solid Tumor**s **Overview:** The Medical Director, Clinical Development Solid Tumor will be responsible for driving the global clinical development strategy in solid tumors. The incumbent will be responsible for providing critical input into the development, management, and implementation of Phase 1-4 clinical studies by closely working with the Clin Ops colleagues; leading multi-disciplinary teams charged with guiding clinical development and subsequent regulatory submissions. This includes responsibility for the design and execution of first-in-human through registration-enabling studies. **Responsibilities:** * Represent the clinical science line function on global program team(s) and contribute to strategic planning and execution of clinical development plan for the assigned assets being developed in solid tumors.* Lead the development of clinical study protocols, protocol amendments, study guides, protocol training materials and other clinical study related documents based on the global development plan.* Perform medical monitoring (safety data review and identify potential signals), responses to site inquiries, and work with CRO medical monitors when appropriate.* Take medical responsibility in data analysis and interpretation, reporting and communication to ensure consistency and relevance of medical content and scientific messages across Clinical Study Report, health authority briefing books, and NDA/BLA submission documents, etc.* Contribute to operational aspects of study conduct and patient enrolment efforts including participation in site training, initiation and activation and subsequent site engagement activities.* Maintain focus on robust study conduct and quality data generation.* Demonstrate the ability to develop unique and innovative clinical strategies to significantly shorten the development cycle in the face of an evolving regulatory landscape.* Responsible for phase I – III clinical development of products.* May oversee the work of Medical and/or Scientific Directors and of Clinical Scientists working on the same or related programs. **Qualifications:** * Medical Degree with 5+ years pharma/biotech experience. Board certified oncologist and/or training in oncology is strongly preferred.* Experience developing clinical strategy for oncology products (Phase I-III) leading to successful regulatory submission(s) is required.* Training in Breast Cancer and/or experience developing Breast Cancer compounds within the industry is required.* Recognized expert in clinical trials: working understanding of statistical principles, medical monitoring; demonstrated ability to perform literature research, analyses, and author clinical trial publications.* Working knowledge of GCP, ICH, FDA, and EMEA regulations.* Excellent and effective written and verbal communication skills with all levels of the organization.* Ability to work cross-functionally, partners with oncology development functions such as: Regulatory, Medical Affairs, Statistics, PK/PD and others such as commercial and/or HEOR or other functions as required,* Experience communicating and interacting with investigations, KOLs, regulatory agencies, and advisors.* Experience working with the principles and techniques of data analysis, interpretation, and clinical relevance.* Solid knowledge of compliance and global regulatory requirements (ICH) for development of pharmaceutical candidates/products (required).* Proven ability to represent the Company’s interest effectively in interactions with partners and regulatory agencies.* Acts as clinical lead and actively solicits opinion leader interactions related to the disease area(s)* Ability to lead a dynamic group in a fast-paced and hands-on environment.* Excellent scientific standing among peers and the ability to address issues with scientific rigor and creative solutions.* Ability to develop and implement strategic growth plans.* Prior leadership experience preferred.* Comfortable with ambiguity yet be self-motivated and timeline driven.*NOTE: Role is remote based, with expectations for business travel and onsite presence approx. 20%**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 - 350,000. Menarini Stemline offers generous compensation and benefits packages, including, Fidelity 401(k) (with company match), PPO and HDHP insurance plans, Company paid Basic Life & AD&D insurance and pre-tax FSA/HSA programs.**Menarini Stemline is committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions. To request an accommodation, please contact hrus@menarinistemline. com prior to your interview.*