Senior Manager / AD, Clinical Sciences Early Development (Hematology)

Johnson & Johnson • Full-time • US026 PA Spring House - 1400 McKean Rd, United States of America • 1w ago

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:

Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, 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-037228

Belgium - Requisition Number: R-041967

Ireland - Requisition Number: R-042194

The Senior Manager / Associate Director, Clinical Sciences Oncology provides active scientific and strategic contributions and is responsible for contributing to the execution of clinical studies within the Therapeutic Area. This position involves collaborating with cross-functional teams, in close partnership with Study Responsible Physicians/Clinical Leads, to design, plan, and manage complex clinical trials, ensuring compliance with departmental, company, and regulatory standards. This role assists to contribute to the clinical development plan and involves in , the development of clinical trial protocols and materials, and supports the completion of clinical study reports, and supporting regulatory filings. As a core member of the clinical team, the Associate Director of Clinical Science manages matrix interactions among cross-functional members, assists to contribute to the evaluation of scientific opportunities, medical data monitoring, and drives process improvements to enhance trial efficiency and operational excellence. This role may manage direct reports, mentor colleagues, and foster a culture of continuous learning and development within the team.

The Senior Manager/Associate Director, Clinical Sciences Oncology has the following essential job functions:

Contribute to the development and execution of clinical trial strategies and other study-related materials (e.g. case report forms, operational plans) and provide clinical representation for study-related review committees (e.g., protocol review committee).
Contribute to the execution of clinical strategies for clinical trial protocols, ensuring compliance with scientific, organizational and regulatory standards.
Oversee end-to-end delivery of a clinical trial protocol, including study design, initiation, medical data monitoring, data dissemination, and closeout activities.
Contribute to the management and coordination of activities with internal functional partners and external partners to ensure timely scientific and clinical execution of a clinical trial. Contribute to the maintenance of the quality and integrity of clinical data, which is critical to the evaluation of study endpoints.
Support interaction and collaboration with investigators and study teams during the conduct of the trial(s). Lead training on study protocol, disease evaluation criteria, and other essential components to enhance the understanding of clinical development processes.
Collaborate with Study Responsible Physician to assess and evaluate clinical trial data (i.e. adverse events, labs, medications, etc). Establish and define medical data review plan in partnership with Study Responsible Physician. Performs medical data monitoring/reporting and evaluates ongoing clinical trial data.
In partnership with Study Responsible Physician, act as a liaison between the company and clinical investigators, fostering collaborations with key opinion leaders and external advisors.
Develop and maintain relationships with internal and external stakeholders, including research teams and regulatory representatives.
Contribute to mentorship and training of junior team members, fostering a collaborative work environment.
Actively engage in opportunities to enhance clinical development and therapeutic area expertise.
Identify opportunities for process improvements and implement best practices in clinical trial execution.
Drive innovative research methods and operational strategies to enhance clinical development efficiency.
Collaborate with cross-functional partners to align clinical strategies with overall product development goals.
May participate in governance meetings, as appropriate, and cross-functional initiatives to promote business strategies and process improvements.
Prepare and present findings and results of clinical research at internal and external meetings, including regulatory body interactions.
May act as an author of scientific publications, as applicable, to contribute to clinical development practices and advancements.
Research and review medical literature and new technologies to support operational planning and scientific strategy implementation.
Integrate scientific and technological innovations into clinical trial designs, including biomarkers and digital health initiatives.
Interact with external expert advisors , including academic research organizations.

Qualifications:

A minimum of a Bachelor's degree in a scientific or related discipline is required. An advanced degree (e.g., MS, PharmD, PhD) is preferred.
Six to nine years of relevant experience in clinical research and development within the pharmaceutical industry, biotech, CRO or equivalent is required.
Strong understanding of clinical development processes, including trial design, protocol development, data analysis, regulatory guidelines (ICH/GCP), and study execution is required.
Demonstrated experience in managing critical aspects of clinical trials, from conception to closure, including data management and quality assurance practices is required.
Proven ability to interpret scientific literature and apply findings strategically within clinical projects is required.
Proficiency in Microsoft Office Suite, especially Excel, Word, and PowerPoint is required. A familiarity with generative artificial intelligence and clinical trial management software is advantageous.
Excellent written and verbal communication skills in English; ability to effectively present information to the stakeholders is required.
Strong interpersonal skills with a collaborative approach to working within cross-functional and global matrix teams is required.
Excellent organizational skills, ability to manage multiple tasks, prioritize effectively, and respond to changing business needs in a dynamic environment is required.
Proven analytical and problem-solving capabilities, with a detail-oriented mindset is required.
Strong project and time management skills; ability to develop timelines and ensure deliverables are met within project scopes is required.
Willingness to travel domestically and internationally, approximately 10%, as required by project needs, 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 & 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, Corrective and Preventive Action (CAPA), Drug Discovery Development, Entrepreneurship, Good Clinical Practice (GCP), Leadership, Medicines and Device Development and Regulation, Presentation Design, Regulatory Affairs Management, Relationship Building, Research Documents, Safety-Oriented, Scientific Research, Strategic Change, Study Management, Tactical Planning, Technical Credibility

The anticipated base pay range for this position is :

$137,000 - $235,750

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

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