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 Function:

Discovery & Pre-Clinical/Clinical Development

Job Sub Function:

Clinical Development & Research – Non-MD

Job Category:

Scientific/Technology

All Job Posting Locations:

Spring House, Pennsylvania, United States of America

Job Description:

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 https://www.jnj.com/innovative-medicine

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):

USA - Requisition Number: R-041721

Belgium - Requisition Number:R-043114

Ireland - Requisition Number: R-042966

The Manager, Clinical Sciences Early Development (Hematology) works in the Oncology Therapeutic Area Development group, and participates in the development, oversight, and execution of Ph I-IV clinical research trials working closely with Study Responsible Physicians and other Clinical Project Scientists. The position reports to a more senior Clinical Project Scientist.

The Manager, Clinical Sciences Early Development (Hematology) has the following essential job functions:

Essential Functions:

• For ongoing clinical trials, this individual in collaboration with the Study Responsible Physician/other Clinical Project Scientists, will participate in or lead aspects of aggregate and participant level data, including patient screening/eligibility evaluation, PK/PD data, adverse events, efficacy, coding, and other data critical to study endpoints

• May participate in drafting protocol synopses, sections of full protocols, informed consent documents, and will review Case Report Forms (CRFs) and other data collection tools against draft protocols and central vendor scope of work

• May partner with the lead CPS/Cross Functional Trial Team to mitigate issues in initiation of clinical trials and may participate in review of Monitoring Guidelines, SET/IDMC Charter, Statistical Analysis Plan, Data Management, and Safety Management Plans

• May perform medical monitoring/reporting, evaluates ongoing clinical trial data

• May partner with the lead CPS drafting Medical Review Plan and Medical Review Forms

• May liaise with vendor laboratories, Translational Research lead, pharmacokinetic operations and/or biomarker operations to ensure sample collection, processing, and tracking

• May liaise with Integrated Data Analysis & Reporting team in set-up of data visualization tools (e.g., iDARTs)

• May participate in or lead aspects of training the central study team, local study team, site personnel or external vendors on protocol, disease evaluation criteria, or other specific aspects of the clinical study

• May participate in data review and drafting documents for Health Care Authority interactions.

• Will actively participate in mentorship and training opportunities to expand clinical development knowledge, therapeutic area expertise, and leadership capabilities

Qualifications:

• Minimum of a bachelor’s degree in a scientific discipline is required, with advance degree (i.e., MSc, Ph.D., or Pharm D) preferred

• A minimum of 4 years of experience in a related clinical research position is required, spending at least part of the time within the pharmaceutical industry, is preferred.

• Knowledge of scientific research with an understanding of applications to drug development is required.

• The ability to work in a matrix team environment and adherence to the highest personal and ethical standards with a commitment to patient-centered clinical research is required.

• Fluent in written and spoken English with excellent communication skills is required.

• Working knowledge of the use of Microsoft suite of software products is required.

• Knowledge of Good Clinical Practices ICH/GCP, drug development process, regulatory requirements for the conduct of high-quality clinical trials including protocol development, medical review, oversight of study conduct, data quality and safety is preferred

• Ability to travel approximately 10% domestic/international travel may be 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 & 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, external applicants please contact us via https://www.jnj.com/contact-us/careers Internal employees contact AskGS to be directed to your accommodation resource.

#LI-Hybrid

Required Skills:

Preferred Skills:

Clinical Evaluations, Coaching, Critical Thinking, Drug Discovery Development, Entrepreneurship, Good Clinical Practice (GCP), Leadership, Medicines and Device Development and Regulation, Organizing, Regulatory Affairs Management, Relationship Building, Research Documents, Safety-Oriented, Scientific Research, Standard Scientific Processes and Procedures, Strategic Change, Study Management

The anticipated base pay range for this position is :

$117,000 - $201,250

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company’s long-term incentive program. Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation –120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year Holiday pay, including Floating Holidays –13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave – 10 days Volunteer Leave – 4 days Military Spouse Time-Off – 80 hours Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits Co-Ops and Intern Positions: Co-Ops/Interns are eligible to participate in Company sponsored employee medical benefits in accordance with the terms of the plan. Co-Ops and Interns are eligible for the following sick time benefits: up to 40 hours per calendar year; for employees who reside in the State of Washington, up to 56 hours per calendar year Co-Ops and Interns are eligible to participate in the Company’s consolidated retirement plan (pension) Positions Represented by CBA: This position is eligible for benefits to include medical, dental, vision and time off, as well as any others as provided for in the applicable Collective Bargaining Agreement. The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

Push the boundaries of science to transform health—and your career.

Join us and advance life-changing treatments for people who need them most. At Johnson & Johnson, our focus is on improving global health equity and developing MedTech and pharmaceutical innovations that impact the future of health. Using AI and robotics to transform surgery or helping data scientists and clinicians formulate new ways to diagnose and treat disease, this work may sound like sci-fi, but it’s all science, all real, and could be your career. Whatever your background, skills, or career goals, there’s a place for you to help solve some of the world’s most pressing health challenges with us.

Accelerate your career while changing the world.

Each of our broadly-based family of companies offers an inclusive and empowering culture and employee benefits (like paid time off to volunteer, transgender-inclusive and same-sex partner health insurance coverage, and more) designed to help you live your best life, however you define it. And our best-in-class learning and development approaches, mentorship, and access to innovators across the world will help you grow your skills and reach your career goals. Because when you're at your best, nothing stands between you and your next breakthrough.