01 oct
|
SOLTI #cancerresearch
|
Barcelona
01 oct
SOLTI #cancerresearch
Barcelona
SOLTI is an academic research group that runs high-quality clinical trials in oncology. SOLTI comprises over 550 researchers working across a network of more than 100 hospitals in Spain, Portugal, France and Ireland.
SOLTI develops academic clinical trials of novel targeted therapies, backed by translational research with a focus on biomarker development, precision oncology, quality of life and addressing unmet medical needs. It also works to strengthen international collaboration and to spread best practice in cancer care among its members.
We are looking for a Clinical Science Lead (CSL) to provide scientific leadership across the lifecycle of investigator-driven and collaborative clinical trials. In this role you will help to shape, design and deliver clinical and translational studies, ensuring scientific integrity, supporting the operational team in execution, and driving the dissemination of results.
You will work in a matrix environment with cross-functional teams (Project Management, Data Science, Medical Advisors, Clinical Operations, Translational investigators, Communications), and act as the scientific link with Principal Investigators, KOLs and external partners.
Main responsibilities:
Scientific leadership & trial execution
- Provide scientific guidance across the full lifecycle of assigned trials: concept/protocol (and amendments), start-up, conduct, close-out, CSR and publications.
- Ensure scientific integrity, protocol adherence, a data-quality mindset, and clinically sound execution; serve as the primary scientific escalation point for study teams and investigators.
- Collaborate with Project Managers and cross-functional roles to ensure timely delivery of milestones (protocol/ICF finalization, endpoint quality checks, database lock readiness, CSR clinical sections).
- Lead protocol and ICF development, feasibility input,
and scientific review of the CRF; provide input to operational plans (medical monitoring plan, monitoring plan, biospecimen plan).
- Prepare the governance charter and ensure committee set-up (e.g., Steering Committee, IDMC where applicable).
- Support ethics/regulatory submissions with scientific documentation and responses as required.
- Serve as the main point of contact for study PIs; maintain active communication with internal and external stakeholders, including KOLs and SOLTI members.
- Maintain public registries (e.g., ClinicalTrials.gov) for SOLTI-sponsored trials for which you are responsible.
- Prepare intermediate and final clinical study reports and make sure the scientific message is clear and accurate.
- Design and carry out the publication plan, in line with governance and the study objectives.
- Contribute to identifying, implementing and running translational activities linked to clinical trials.
Qualifications
Education and experience:
- Postgraduate degree in Life Sciences; PhD, MD, or PharmD desirable.
- Demonstrated expertise in oncology clinical and/or translational research.
- Relevant professional experience in translational research, medicine, pharma/biotech, regulatory agencies, and/or academic cooperative groups conducting clinical trials.
Knowledge:
- Advanced oncology knowledge (molecular, biological, and clinical); familiarity with current standards of care and emerging agents/technologies.
- Solid command of GCP and relevant clinical trial regulations/guidelines (FDA, EMA, EU CTD).
- Working knowledge of biological sample management processes and translational research integration into trials.
- Publication planning and medical writing standards for scientific dissemination.
Skills and competencies:
- Strong clinical research methodology and understanding of drug development.
- Proven ability to produce high-quality scientific documents (protocols, synopses, CSR sections, abstracts, manuscripts, slide decks).
- Strong written and oral communication and stakeholder management, with good judgment on when to escalate, in a fast-paced environment.
- Autonomy, good prioritization and the ability to manage changing timelines rigorously.
- Cross-functional collaboration skills in matrix teams.
- Advanced proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook) and scientific literature tools; ability to prepare clear, persuasive presentations.
- Willingness to travel locally and internationally if needed (~15%).
This is a full-time position (38h/week) based in Barcelona (Spain).
What we offer:
Join an organization working on cutting-edge projects with real social impact. In this role, you will be responsible for all science-related activities in a wide range of projects promoted by SOLTI, pharmaceutical companies, and other academic groups. You will be part of the SOLTI Scientific team, which supports your personal growth and career development.
We also offer the option to work from home up to three days a week, a versátil schedule, a well-located office and additional benefits.
If this sounds like you, we would like to hear from you.
Please attach your resume and, if you wish, a motivation letter.
SOLTI is an employer committed to equal opportunities regardless of sex, gender, sexual orientation, race, age, origin or disability.
Get to know us at: www.gruposolti.org
📌 Clinical Science Lead (CSL) (Barcelona)
🏢 SOLTI #cancerresearch
📍 Barcelona