Stellen

We search for our client Adualys Therapeutics a Consultant Translational Medicine Leader. In this role you will drive in alignment with the CMO the overall translational strategy across solid tumor oncology programs and contribute to the preclinical/clinical development plan. This role integrates translational research with clinical development to implement biomarker strategies that support asset development regulatory submissions and decision-making. The position involves cross-functional collaboration with a lean internal team and external collaborators including KOLs and academic partners. You will execute the translational strategy and plan including scientific and preclinical justification and rationale for proposed clinical testing timelines and guidance for operational aspects of the defined translational strategy as the program progresses through various phasesYou will report directly to the CMO.

Tasks

Portfolio Translational Strategy: Drive the Translational strategy in collaboration with CMO and other functional experts to impact on clinical development decision making.

Develop deep understanding of the translational biomarkers for a project/program (and associated clinical studies) focused on compound disease target and pathway biology.

Define and harmonize the translational strategy across programs by ensuring robust plans for patient selection pharmacodynamics mechanism of action and resistance and biomarker readiness for ADC modality.

**Direct Program Ownership:**Personally lead translational strategy of our next generation ADC programsowning biomarker plans vendor and assay strategies resistance analyses and regulatory components through clinical milestones.

**Regulatory Biomarker Leadership:**Provide senior oversight for clinical studies aligning biomarker strategies with FDA/EMA expectations guiding companion diagnostic efforts and ensuring data quality and validation for inclusion in submissions. Support health authorities interactions around biomarkers and translational research.

**Cross-Functional and External Leadership:**Influence program and portfolio decisions; partner across research clinical development operations regulatory and commercial to connect translational insights to business value; participate at major congresses KOL boards and in strategic collaborations.

**Knowledge Integration and Impact:**Drive cross-program learning e.g. on antigen loss and tumor microenvironment; translate insights into combination strategies and next-generation designs that accelerate our pipeline.

Oversee the execution of the workplan.

Manage the project team to ensure deliverables are met according to timelines budget and quality standards.

Contribute to the preparation of regulatory documentations and participate in interactions with health authorities.

Prepare investigator meetings and materials.

Participate in external scientific communications (publications posters and oral presentations).

Design edit write and review pre-clinical protocols and study reports (GLP and non-GLP).

Conduct study tracking support (start-up tracking milestone tracking close-out tracking) and study updates.

Perform document tracking and signature/approval follow-up where applicable including Confidential Disclosure Agreements (CDAs) contracts proposals payments invoices and other study documentation.

Execute meeting logistics (e.g. meeting minutes expense reports and travel coordination).

Requirements

PhD (cancer biology molecular biology biochemistry) and/or MD with substantial experience in oncology or hematology drug development. MD with clinical training in hematology/oncology is highly valued.

5 years of translational research and drug discovery or clinical trial experience in biotech/pharma industry is a mus. Experience in ADC drug-development is a plus.

Experience with and familiarity in quantitative research and data-driven methodologies is preferred. Relevant areas include biostatistics omics profiling artificial intelligence/machine learning (AI/ML) bioinformatics computational biology clinical imaging and data science.

Excellent written and interpersonal skills ability to interface and communicate effectively with executive management and other functions within the organization.

Fluent in spoken and written English additional languages are an asset.

Strong IT and Project Management skills.

Excellent planning and strong organizational skills able to manage multiple tasks simultaneously and set priorities.

Self-motivation and able to work independently in a fast-pace small company environment.

Pro-active and problem-solving attitude.

Willing to work hands-on.

Collaborative and Team player.

Personal resilience perseverance energy and drive.

We are looking for someone with availability for 28 to 30 hours per week over the next six months. Whether an extension beyond this period will be possible can only be assessed at a later stage.

Employment Type : Freelance

Experience: years

Vacancy: 1