Clinical Translational Scientist - (Lead) Clinical Scientist

Job content

The PositionThe Roche iPODD Pediatric Oncology team aims to improve outcomes for children with cancer by developing impactful new therapies from the Roche Oncology portfolio. We cover the full pediatric oncology therapeutic area (Heme, Solid, Brain) and are responsible across the entire Roche Oncology & Hematology portfolio to develop and execute the pediatric clinical development strategies (CDPs), including preclinical prioritization, clinical trials (first-in-child, signal seeking and pivotal) and the associated regulatory activities.The Clinical Translational Scientist (Lead/Clinical Scientist) is responsible for the clinical and biological science aspects of the prioritization of the Roche Oncology & Hematology portfolio for pediatric development and science inputs to the pediatric development for the molecule.This includes coordinating and contributing to the pediatric opportunity assessments of the Roche molecules, planning and executing preclinical proof-of-concept programs and performing prioritization efforts across the portfolio. The Clinical Translational Scientist will also be a member of pediatric molecule teams to contribute translational science aspects to the clinical development plans and regulatory strategies. The Clinical Scientist will also support the Roche participation in external research consortia such as IMI2-ITCCP4, ITN-VAGABOND and COFUND-BUTTERFLY.The Clinical Scientist will have interactions with external stakeholders, e.g. investigators, Therapy Area Experts (TAEs) and vendors. They will participate in external interactions with Health Authorities (HAs).The Clinical Scientist will perform responsibilities independently in close interaction with the iPODD Global Development Lead.PRIMARY DUTIES AND RESPONSIBILITIES:Pediatric Opportunity Assessments and Prioritization

• Monitor and prioritize the Roche portfolio for Pediatric Opportunity Assessments
• Coordinate and contribute to Pediatric Opportunity Assessments for individual molecules, including Mechanism of Action-based scientific reviews of pediatric preclinical biology evidence and “in silico” database analyses
• Plan and implement Pediatric Preclinical Proof of Concept (POC) testing programs in appropriate preclinical models via internal teams, external academic collaborators or Contract Research Organisations

Pediatric Preclinical Proof Of Concept Testing

• Design & plan molecule preclinical in vitro and in vivo PoC testing programs
• Selection of academic partners / CROs for preclinical molecule programs
• Monitor progress and deliverables
• Review & interpret preclinical data reports
• Incorporate into Pediatric Opportunity Assessments

Pediatric Clinical Development Strategy (CDP) Design and Execution

• Contribute preclinical insights to the design of the pediatric CDP of the molecule
• Support the authoring of regulatory documents, like PIP, iPSP, PPSR and waivers
• Contributes to manuscripts for submission to peer-reviewed journals

Regulatory Strategy

• Contribute to CTA/EC written interactions, briefing packs and responses to HA questions; contribution to the strategic approach and cross-functional coordination
• Guided by the CSL, present pre-clinical science aspects of the program at non-reference HA interactions (TC/F2F) and contribute to varied aspects of regulatory submissions

External Stakeholders

• Contribute to investigator engagement, including presenting at investigator meetings to optimize clinical trial conduct
• Guided by the CSL, contribute to TAE interactions (e.g. advisory boards, individual engagements, steering committees) and contribute to building relationships with significant external partnerships/institutions (e.g. business alliance partners, academic institutions) in order to advance clinical studies and programs
• Participate in and support Roche leads in external pediatric research consortia for Pediatric Oncology Drug Development

Internal Roche Local and Global Communities

• Visible in the local site community, e.g. proactively contribute to, and promote scientific discussion in the community, and contribute to site-wide initiatives. Contributes to discussions in the Global PDOH community

EXPERIENCE AND QUALIFICATIONS:

• PhD Degree in Life Sciences is required, MD (Medical Doctor) in Oncology is preferred
• Relevant years experience in translational biology required with a strong background in fundamental scientific approach. Should have a clear approach to rationale experimental design and implementation. Preferred evidence of strong academic publication record or pharma-outputs
• Evidence of broad use of and understanding of a variety of in vitro and in vivo models (solid and haematological malignancies) for proof of concept modelling of biological hypotheses and/or drug-target outcomes (covering small molecule targets, immuno-therapies, and cell therapies) is required
• Experience in translating laboratory science into clinical trials or performing research on clinical trial samples is preferred
• Clear ability to summarise complex outputs (academic publications, experimental results) and to be able to write scientific and regulatory documents (peer-reviewed publications, experimental plans, SOPs, clinical trial/ regulatory documents), as shown by a track record of 1st authorships of peer-reviewed papers (& published papers required)
• Familiarity with governing laws and (pediatric) regulations + guidelines is required. Strong knowledge of medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMA and other relevant guidelines and regulation is required
• Proven ability to work effectively and efficiently within cross-functional teams, e.g. Study Leadership Team. Therapeutic area-relevant clinical trial experience or clear ability to adapt with transferable skills is required

Key Skills and Behaviours

• Independently carry out the majority of Portfolio Prioritization activities and CDP contribution responsibilities with emerging leadership skills for the interaction with internal molecule teams and within external preclinical collaborations
• Experienced in various aspects of translational biology science to support/lead the pediatric oncology prioritization of the Roche Oncology portfolio
• Scientific and communication abilities to drive interactions with adult molecule teams on pediatric opportunities
• Provide insights and educational support to the iPODD Clinical Science team members on molecule MOAs and pediatric tumor biology

Who we areAt Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.Basel is the headquarters of the Roche Group and one of its most important centres of pharmaceutical research. Over 10,700 employees from over 100 countries come together at our Basel/Kaiseraugst site, which is one of Roche`s largest sites. Read more.Besides extensive development and training opportunities, we offer flexible working options, 18 weeks of maternity leave and 10 weeks of gender independent partnership leave. Our employees also benefit from multiple services on site such as child-care facilities, medical services, restaurants and cafeterias, as well as various employee events.We believe in the power of diversity and inclusion, and strive to identify and create opportunities that enable all people to bring their unique selves to Roche.Roche is an Equal Opportunity Employer.