Medical Director​/Senior Medical Director, Early Development Oncology

Location: Spring House

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and Med Tech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn

more at  

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.  We provide an inclusive work environment where each person is considered as an individual.  At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

** Job Function:*
* Discovery & Pre-Clinical/Clinical Development

** Job Sub*
* ** Function:*
* Clinical Development & Research - MD

** Job Category:*
* People Leader

** All Job Posting Locations:*
* Spring House, Pennsylvania, United States of America

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* Job Description:

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* Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Our Oncology team is focused on the elimination of cancer by discovering new pathways and modalities to finding treatments and cures. We lead where medicine is going and need innovators with an unwavering commitment to results.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at  

Johnson & Johnson Innovative Medicine is recruiting for a Medical Director/Senior Medical Director-Clinical Research.  They will be a member of a matrix team dedicated to the implementation of clinical research studies that are part of a global compound development program,  
** with a strong focus on breast cancer and related solid tumor indications** .

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Responsibilities include:

+ Leads execution of research programs for an area of clinical development to meet research objectives, support product development, and manage reports,  
** including programs in prostate cancer drug development across early‑phase clinical trials** .

+ Acts as the clinical functional head for providing active scientific contributions to a cross-department compound development team,  
** bringing deep disease‑area expertise in oncology*
* + Works in close partnership with the Compound Development Team (CDTL) and project management, global regulatory affairs, clinical pharmacology, health economics, and the disease area leader to share information,  
** particularly as it relates to prostate/solid cancer development strategy and lifecycle planning** .

+ Acts as a liaison between the company and the clinical investigators, evaluates scientific information, and creates new ideas to assist in identifying new research opportunities  
** in prostate cancer and relevant biomarker‑defined populations** .

+ Develops the strategy and content for scientific communications for assigned compound through close partnership with the compound global medical affairs leader  
** including  oncology congresses and publications** .

+ Serves as the clinical leader for product evaluation and develops the strategy and the content for regulatory documents,  
** with experience supporting prostate cancer indications and interactions with global health authorities** .

+ Works with senior clinical staff, establishes credible relationships with external stakeholders such as opinion leaders and regulators, and provides substantial expertise in drug development (including experience with IND and NDA submissions).

+ Able to manage study start-up, and directs and guides study team in study execution, data cleaning, medical review, database lock, managing health authority responses,  
** including prostate cancer-specific safety, efficacy, and benefit-risk considerations** .

+ May provide determination of pathology diagnosis and act as a signatory to primary and peer review pathology reports.

+ Develops a…