Director, Clinical Development, Interventional Oncology (INTO)
About The Position
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. The Interventional Oncology (INTO) group, a cross-sector initiative at J&J, brings together the pharmaceutical and medical device expertise with the aim to meaningfully alter the course of cancer and improve survival. We conduct sophisticated clinical trials that involve the development of novel procedures and unique routes of administration for investigational cancer therapies. The Johnson & Johnson Interventional Oncology Team is recruiting for a Director of Clinical Development. The incumbent will provide scientific, clinical, and operational direction for clinical programs in oncology.
Requirements
- Minimum of a Bachelor’s degree in a scientific or related discipline is required.
- Ten or more years of clinical/biomedical research experience in or outside of industry setting (pharma, biotech, CRO, etc.) is required.
- Demonstrated ability to present scientific content to diverse audiences required.
- Learning agility and ability to work across multiple sectors (pharm, medical device, and or consumer) is required.
- Ability to travel approximately 10% of the time is required. Travel includes internal meetings in posted locations as well as travel to investigative sites to work with actual and potential study sites and to National and/or International scientific congresses.
Nice To Haves
- Advanced degree in a scientific discipline (e.g. Master’s degree in scientific field or PhD or PharmD) is preferred.
- Experience in oncology medical monitoring is highly preferred.
- Experience in protocol writing and execution is preferred.
- Ability to successfully work in a matrixed environment with both internal and external stakeholders including oncology community highly desired.
Responsibilities
- Contribute to design and approval of clinical protocols and other related materials such (e.g, SAP, CSR outputs, case report forms, operational plans)
- Establish and define medical data review plan in partnership with Study Responsible Physician.
- Lead medical monitoring activities for clinical trial data for pivotal trials including Review, interpretation, and reporting of clinical trial data, ensuring accuracy and integrity for health authority submissions.
- Lead training on study protocol, disease evaluation criteria, and other essential components to enhance the understanding of clinical development processes for clinical trial site staff and internal partners.
- Oversee end-to-end delivery of clinical trial protocols/programs, including study design, initiation, medical safety data monitoring, data dissemination, and closeout activities.
- 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).
- Collaborate with individuals and groups within the organization to share information, transfer technology, and further scientific partnership
- Collaborate with external partners including vendors (e.g. CRO, central labs) to ensure clear expectations and deliverables are met to support clinical development
- Identify opportunities for process improvements and drive the implementation of best practices in clinical trial execution.
- Work cross-sector in pharmaceutical and/or medical device spaces
- Implement and maintain high standards of research conduct ensuring compliance with scientific, organizational, and regulatory standards.
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 period10 days
- Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
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What This Job Offers
Job Type
Full-time
Career Level
Director
