Director, Clinical Sciences Oncology

Job Overview

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 Spring House, PA;
Raritan, NJ; or San Diego, CA. Remote based options within the USA may be considered on a case‑by‑case basis and if approved by the company. This role involves collaborating with cross‑functional teams, in close partnership with Study Responsible Physicians/Clinical Leads, to design, plan, and manage complex clinical trials while ensuring compliance with departmental, company, and regulatory standards.

• Drive clinical development strategy, contribute to the development of study‑related materials (e.g., ADP, SAP, CSR outputs, case report forms, operational plans), and represent the study in review committees.
• 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 time‑to‑completion 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 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.
• Establish and define medical data review plan in partnership with Study Responsible Physician.
• Perform medical data monitoring/reporting and evaluate ongoing clinical trial data.
• 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.
• Provide mentorship and training to junior team members, fostering a collaborative work environment.
• 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 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.
• 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.

• Minimum bachelor’s degree in a scientific or related discipline; advanced degree (MS, Pharm
  
  D, PhD) preferred.
• 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 (trial design, protocol development, data analysis, regulatory guidelines, Good Clinical Practice).
• Proven experience managing all aspects of clinical trials from conception to closure, including data…