Director, Clinical Sciences Oncology

Description

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

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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 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-043635

Belgium, Netherlands, Switzerland, Spain - Requisition Number: R-044996

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

We are searching for the best talent for a Director, Clinical Sciences Oncology to provide active scientific and strategic contributions and leadership in a hybrid-based office located in either Belgium, Netherlands, Switzerland or Spain. Remote based options within Spain may be considered on a case by case basis and if approved by the company.

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 Sciences Oncology 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.

Essential Job Duties and 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.

Education and Experience

• 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.

• Requires 10 years of relevant experience in clinical research and development within the pharmaceutical industry, biotech, CRO, or equivalent.

• Oncology experience preferred.

• 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.

#LI - Hybrid

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