Director, Clinical Sciences – Oncology
OneTrust
full-time
Posted on:
Location Type: Hybrid
Location: Madrid • Spain
Visit company websiteExplore more
Job Level
Tech Stack
About the role
- 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
- Requires 10 years of relevant experience in clinical research and development within the pharmaceutical industry, biotech, CRO, or equivalent
- 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
Benefits
- Flexible work arrangements
- Professional development
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical development strategyclinical trial protocolsdata analysisGood Clinical Practice (ICH/GCP)data managementquality assurance practicesmedical data monitoringprotocol developmentstudy designclinical data reporting
Soft skills
excellent written communicationexcellent verbal communicationinterpersonal skillsorganizational skillsanalytical skillsproblem-solving skillsmentorshipcollaborative approachproject managementtime management