Director, Clinical Sciences, Oncology

Johnson & Johnson Innovative Medicine • Ambler, PA

15h • Hybrid

About The Position

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 jnj.com 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 – Non-MD Job Category: Scientific/Technology All Job Posting Locations: Raritan, New Jersey, United States of America, 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 Johnson & Johnson Innovative Medicine is currently searching for the best talent for a Director, Clinical Science / Sr. Clinical Science Group Leader. This is a hybrid-based role (≥ three days onsite) at any of the locations listed within the job posting. Remote based options may be considered on a case-by-case basis and if approved by the company. The Director, Clinical Science / Sr. Clinical Science Group Leader provides active scientific and strategic contributions and leadership. 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 contributes to the clinical development plan and drives the development of clinical trial protocols and materials and supports the completion of clinical study reports and regulatory filings. As a core member of the clinical team, the Director, Clinical Science / Sr. Clinical Science Group Leader leads matrix interactions among cross-functional members, contributes to the evaluation of scientific opportunities, medical data monitoring, and drives process improvements to enhance trial efficiency and operational excellence. This role may also manage direct reports, mentor colleagues, and foster a culture of continuous learning and development within the team.

Requirements

• A minimum of a bachelor’s degree in a scientific or related discipline is required.
• Requires 10 years of relevant experience in clinical research and development within the pharmaceutical industry, biotech, CRO, or equivalent.
• Strong understanding of clinical development processes, including trial design, protocol development, data analysis, regulatory guidelines, Good Clinical Practice (ICH/GCP), and study execution.
• Demonstrated experience in managing all aspects of clinical trials, from conception to closure, including data management and quality assurance practices.
• Proven the ability to interpret scientific literature and apply findings strategically within clinical projects.
• Proficiency in Microsoft Office Suite, especially Excel, Word, and PowerPoint, and 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 and negotiate with stakeholders.
• Excellent interpersonal skills with a collaborative approach to working within cross-functional and global matrix teams.
• Exceptional organizational skills, ability to manage multiple tasks, prioritize effectively, and respond to changing business needs in a dynamic environment.
• Proven analytical and problem-solving capabilities, with a detail-oriented mindset.
• Ability to proactively identify program level issues/discussions that require escalation
• Ability to handle complex projects to overcome delays and obstacles to meet deadlines.
• Experience leading scientific teams, providing mentorship, and managing direct or indirect reports.
• Strong project and time management skills; ability to develop timelines and ensure deliverables are met within project scopes.
• Willingness to travel domestically and internationally, approximately 10%, as required by project needs.
• A commitment to maintaining high ethical standards and fostering a culture of inclusivity in the workplace.

Nice To Haves

• An advanced degree (e.g., MS, PharmD, PhD) is preferred.
• Knowledge and experience in solid tumor cancers specifically prostate cancer is preferred

Responsibilities

• Drive clinical development strategy, contribute to the development of other study-related materials (e.g. ADP, SAP, CSR outputs, case report forms, operational plans) and provide clinical representation for study-related review committees (e.g., first in human committee, protocol review committee).
• Lead the execution of clinical trial protocols within the clinical development program, ensuring compliance with scientific, organizational, and regulatory standards.
• Oversee end-to-end delivery of clinical trial protocols/programs, including study design, initiation, medical safety data monitoring, data dissemination, and closeout activities.
• Manage and coordinate activities with internal functional partners and external partners to ensure timely scientific and clinical execution of clinical studies.
• Maintain the quality and integrity of clinical data critical to the evaluation of study endpoints. Interact and collaborate 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.
• Review, interpret, and report clinical trial data, ensuring accuracy and integrity for health authority submissions.
• Draft documents for reporting clinical trial data (e.g., clinical study reports, patient narratives, investigator brochures, and periodic safety updates).
• Collaborate with Study Responsible Scientist and Study Responsible Physician to assess and evaluate clinical trial medical/safety data (i.e. adverse events, labs, medications, etc.). Establish and define medical data review plan in partnership with Study Responsible Physician. Leads and 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 credible relationships with internal and external stakeholders, including senior management, cross-functional trial teams, and external partners/vendors (e.g. CRO, ARO).
• Provide mentorship and training to junior team members, fostering a collaborative work environment.
• Guide and support colleagues in clinical development processes and standards.
• Identify opportunities for process improvements and drive the implementation of 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.
• 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 and academic partners.
• May act as an author for scientific publications, as applicable, to influence 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.

Benefits

• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 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
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 5,001-10,000 employees