Valuation Services Director providing top - tier valuation services to corporate clients. Manage teams, execute assignments, and foster client relationships in a hybrid working environment.
About the role
- Director of Clinical Sciences Oncology leading clinical development in innovative medicine at Johnson & Johnson. Driving cancer treatment research and overseeing clinical trial execution with cross-functional teams.
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.
Requirements
- 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.
Benefits
- Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
- This position is eligible to participate in the Company’s long-term incentive program.
- Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off 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
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