Associate Director, Clinical Sciences, Oncology
Job in
Raritan, Somerset County, New Jersey, 08869, USA
Listed on 2026-07-09
Listing for:
Johnson & Johnson Innovative Medicine
Full Time
position Listed on 2026-07-09
Job specializations:
-
Research/Development
Regulatory Compliance Specialist, Clinical Research
Job Description & How to Apply Below
Associate Director, Clinical Sciences – Oncology
Johnson & Johnson Innovative Medicine seeks an Associate Director, Clinical Sciences for its Oncology team. The role is hybrid (at least three days onsite) and available at Raritan, New Jersey or Spring House, Pennsylvania.
Job SummaryThe Associate Director provides scientific and strategic leadership for the planning, execution, and oversight of clinical studies in oncology. Working closely with Study Responsible Physicians, Clinical Leads, and cross‑functional partners, you will develop trial protocols, manage study operations, ensure data integrity, and support regulatory submissions. The position may include mentoring junior staff and driving process improvements.
Key Responsibilities- Develop and execute clinical trial strategies and study‑related materials (e.g., case report forms, operational plans). Provide clinical representation on review committees.
- Ensure compliance with scientific, regulatory, and organizational standards throughout the trial lifecycle.
- Oversee end‑to‑end delivery of clinical trial protocols, including study design, initiation, data monitoring, dissemination, and closeout.
- Coordinate activities with internal partners and external CROs or vendors to maintain schedule and quality.
- Maintain data quality and integrity to support study endpoints.
- Collaborate with investigators and study teams, including training on protocols and evaluation criteria.
- Review, interpret, and report clinical data for regulatory submissions.
- Prepare documents for reporting (e.g., clinical study reports, investigator brochures, safety updates).
- Partner with Study Responsible Scientist and Physician to establish medical data review plans and monitor safety.
- Act as liaison between company and investigators, fostering relationships with key opinion leaders.
- Develop and maintain relationships with senior management, cross‑functional teams, and external partners.
- Mentor and train junior team members.
- Identify and implement process improvements to enhance trial efficiency.
- Collaborate on cross‑functional initiatives and governance meetings as needed.
- Present findings at internal and external meetings.
- Contribute to scientific publications when applicable.
- Research medical literature and new technologies to support scientific strategy.
- Integrate biomarkers and digital health initiatives into study designs.
- Bachelor’s degree in a scientific or related discipline (advanced degree preferred).
- 6+ years of clinical research & development experience in pharma, biotech, CRO, or equivalent.
- Experience with prostate cancer and/or solid tumors is preferred.
- Strong understanding of clinical development processes, trial design, protocol development, data analysis, regulatory guidelines, and ICH/GCP.
- Demonstrated experience managing critical aspects of clinical trials from conception to closure.
- Proven ability to interpret scientific literature and apply findings strategically.
- Proficiency in Microsoft Office (Excel, Word, PowerPoint) and familiarity with clinical trial management software and generative AI are advantageous.
- Excellent written and verbal communication in English.
- Strong interpersonal skills and collaborative approach in cross‑functional, global teams.
- Excellent organizational and multi‑tasking abilities.
- Analytical, problem‑solving capabilities with a detail‑oriented mindset.
- Ability to identify and escale program‑level issues.
- Experience managing complex projects, overcoming delays, and meeting deadlines.
- Experience leading scientific teams and providing mentorship.
- Strong project and time‑management skills with the ability to deliver within scope.
- Willingness to travel domestically and internationally (~10%).
- Commitment to high ethical standards and inclusion.
- Clinical Data Management
- Clinical Evaluations
- Data Governance
- Drug Discovery & Development
- Good Clinical Practice (GCP)
- Leadership & Inclusive Leadership
- Medicines & Device Development and Regulation
- Operational Excellence
- Regulatory Affairs Management
- Relationship Building
- Safety‑Oriented
- Scientific Research
- Strategic Change
- Study Management
- Team Management
Base pay…
Position Requirements
10+ Years
work experience
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