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 MedTech, 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 https://www.jnj.com

JOB DESCRIPTION:

About Innovative Medicine
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.
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 https://www.jnj.com/innovative-medicine
About Immunology
Our Immunology team leads in the development of transformational medicines for patients with immunological disorders and illnesses. You can influence where medicine is going by restoring health to millions of people living with immune diseases.
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 https://www.jnj.com/innovative-medicine
Our mission drives us. Our patients inspire us. Our CREDO guides us. https://www.jnj.com/credo/ We collaborate with the world for the health of everyone in it.
The Clinical Science group within Immunology Translational Medicine is searching for the best talent to fill an open Clinical Scientist (Associate Director), Immunology Translational Science and Medicine (TSM) role to be based in Spring House, PA. Remote work options may be considered on a case-by-case basis and if approved by the Company.
Immunology TSM is an integrated group of scientists that includes a Translational Science biomarkers and digital health group as well as a Translational Medicine clinical group which designs and conducts early clinical development and experimental medicine clinical studies. While the Immunology therapeutic area has a history of bringing life-changing therapies to patients with immune-mediated diseases, the TSM group provides key learnings/insights on the next wave of novel therapies for these patients. We are looking for someone with a BS, MS, PharmD, PhD or research nursing (RN) background with industry or related experience and preferably a scientific background in Immunology or a related field, to join our Translational Medicine Clinical Science group.
The primary focus of this Associate Director Clinical Scientist (CS) position within the Clinical Science group in the Immunology Translational Science and Medicine (TSM) department is to serve as a key partner to the preclinical Discovery Research and Translational Science groups and to bridge Clinical Research for New Molecular Entities (NMEs) and indication exploration for established assets and drugs. The CS functions in the role of a Study Responsible Scientist (SRS) on early development trial teams and leads the team designing clinical studies outlined in the asset development plan (ADP). This work is at its core a deep collaboration between Disease Area experts, Translational Science (Biomarker) and Translational Medicine (Clinical) experts, Immunologic Pathway experts and many other essential development functions. The CS works with Global Development Operations (GDO) and the entire Trial Team to efficiently and effectively operationalize studies. The Clinical Scientist will also work closely with cross-functional partners to implement translational science and digital health strategies or sub-studies as needed. While the primary responsibilities for this role are that of an SRS, specific responsibilities for medical monitoring may also be required.

QUALIFICATIONS - INTERNAL

• BS, MS, PharmD, PhD or RN (or equivalent degrees) with a scientific background in Immunology or related field, and 6-10 years Clinical Development in industry and/or related experience is required
• Experience with early development clinical trials and innovative trial designs (adaptive, platform, digital, bucket) is preferred. Experience in Immunology and Gastroenterology indications is preferred.
• Proven experience leading complex cross functional teams/workstreams is required
• Passion for managing people, developing others to reach their full potential
• Interactive team member with strong interpersonal skills. The ability to advise, persuade, mentor, and negotiate with colleagues in a supportive and collegial fashion
• Ability to survey and interpret the scientific literature related to the assigned projects is required.
• Excellent written and verbal English communication and presentation skills.
• Working knowledge of the use of Microsoft suite of software products including Excel, Powerpoint and Word. Ability to do more complex data analysis with Excel or similar programs is a plus.
• Good sense of cultural sensitivity and diversity.
• Project and time management skills.
• Strong organizational skills and the ability to work well in a dynamic environment and be able to prioritize and respond to changing needs of the business.
• The ability to work in a matrix organization with (virtual) cross-functional teams is required.
• Ability to operate with limited day-to-day supervision is required.
• Ability to work under pressure to meet deadlines.
• An ability to handle complex projects and to overcome delays and obstacles.
• Willingness and ability to travel, including international travel is required.
  Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
  Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.
  

  LI-Hybrid

LI-Remot

• Writing the Protocol Elements Document (PED; i.e. synopsis) and then working with Medical Writing and content contributors to complete the full protocol. Presents the protocol and addresses questions and comments on protocol design at Protocol Review Committee.
• Oversees projects of and manage the career development of junior Early Development Clinical Scientists who are executing ED Gastrointestinal clinical studies
• Collaborates with other team members within TSM (e.g. working closely with SRP), support the design, execution, analysis, and presentation of TSM studies.
• Collaborates with Discovery Research, Translational Science, Clinical Pharmacology and Pharmacometrics, Global Development Operations (GDO), and others to implement biomarker and translational research plans for early development GI programs.
• Drives the implementation of innovative trial designs including adaptive, platform and basket trials
• In collaboration with Immunologic Pathway experts and Program leads, may be asked to contribute to the development of the scientific background and strategic content of the asset development plan.
• Partners with the GDO group for site feasibility, trial set up, conduct, monitoring, and database locks
• Ensures that study conduct adheres to Good Clinical Practices, International Conference of Harmony (ICH) guidelines, and standard operating procedures.
• Reviews incoming data from the study for accuracy and completeness.
• Participates in the review and interpretation of clinical trial data to enable timely internal decision-making and external communication with investigators and regulatory agencies.
• Helps to identify and collaborate with consultants, investigators, and key opinion leaders to optimize the preparation of early development strategies.
• Participates in the presentation of results and updates of projects at department, project, corporate and scientific meetings.
• Participates in the preparation and assuring the accuracy of the clinical study reports as well as any external publications.
• Actively contributes to the CS leadership team responsible for oversight and improvements in the execution of early development TM studies and career development of junior Clinical Scientists