The ‘innovative Pediatric Oncology Drug Development’ team (iPODD) is part of Roche’s global late stage clinical development organization for oncology (PDO). Roche PDO is based in Basel (CH), San Francisco (Genentech, US) and Welwyn (UK).
iPODD is a specialized cross-functional pediatric team with the aim to improve outcomes for children with cancer by developing the Roche oncology portfolio using rational, science-driven and regulatory-compliant strategies. iPODD is currently responsible for the pediatric development activities of more than 15 anti-cancer drugs from our late stage portfolio, including direct tumor targeting drugs, antibody-drug conjugates and several cancer immune molecules.
iPODD designs and executes the early and late development (Phase I - II – III) clinical strategies and plans, and also implements the molecule regulatory strategies, including filing plans. iPODD delivers the basis for molecule ‘clinical development plans’ (CDPs) by matching the’ mechanism of action’ (MOA) of portfolio molecules with potential pediatric indications through analyses of preclinical proof-of-concept in pediatric models and by assessing the pediatric developability for each molecule considering nonclinical, pharmacologic, safety, and regulatory concerns. Additionally iPODD conducts cross-molecule projects and initiatives including the iMATRIX trial platform (a strategic initiative for early phase assessment and signal seeking in early phase pediatric trials), the Adolescent and Young Adult project to increase early participation of adolescent cancer patients in ‘adult’ trials and developing a pediatric Cancer Immuno-Phenotype landscape and ‘Cancer Immuno-Therapy’ (CIT) framework to guide pediatric development of CIT drugs.
The Associate Medical Director or Clinical Scientist participates in the development and implementation of pediatric oncology clinical development strategies, plans and protocols, including early phase and pivotal trials. He/she will participate and/or can lead molecule-specific cross-functional global development teams to develop the molecule CDP and setup the clinical trial(s) for 1 or more molecules. He/she will further serve on iPODD study management teams including medical monitor responsibilities for clinical trials, act as primary contributing author for regulatory submission documents, including ‘Pediatric Investigational Plans’ in the EU and ‘initial Pediatric Study Plans’ and ‘Proposed Pediatric Study Requests’ in the US. He/she will also participate in global filing teams, when appropriate for the molecule program, and participate in health authority interactions.
Furthermore, the associate medical director will contribute clinical pediatric oncology expertise to other clinical science team members to support CDP development, early and late stage trial designs and implementation, data analyses and reporting, filing plans and regulatory strategies. He/she may also participate and contribute to our program for MOA-based preclinical molecule prioritization for pediatric development by performing ‘Target Actionability Reviews’ of scientific literature and interpret ‘in silico’ database analyses of target patterns in pediatric clinical series and preclinical Proof-of-Concept testing results in pediatric models.
Depending on experience and skills the Associate Medical Director / Clinical Scientist may be responsible for the management of direct reports.
Job qualifications for the Associate Medical Director:
M.D. , Pediatric or Medical Oncologist with relevant clinical oncology experience
2 or more years active experience with clinical trials across Phase I - II - III drug development
2 or more years pharma/biotech industry experience
Experience in working with the principles and techniques of data analysis, interpretation and clinical relevance is required
Experience with assessing preclinical datasets for drug target identification + validation and preclinical molecule proof-of-concept testing is a plus
Academic/teaching background is a plus
Excellent project management skills, good interpersonal, verbal communication and influencing skills, works well within teams and is effective in collaborating with others internally and externally
Job qualifications for the Clinical Scientist:
Bachelor's Degree required (life sciences preferred)
Advanced Clinical/Science Degree is preferred (e.g., PharmD, PhD, MSN, MPH)
2 or more years of clinical trial experience including data listing review in pharma/biotech industry including strong relevant therapeutic area experience
Experience authoring aspects of a global clinical development plan or full clinical study protocol and publishing results of a clinical drug trial in a referred journal
Extensive knowledge of clinical research including medical aspects of GCP, ICH, FDA, EMEA and other relevant guidelines and regulations
Has successfully worked across Phase I-II–III drug development projects
Broad experience in the principles and techniques of data analysis, interpretation and clinical relevance (e.g., ISS, ISE, competitor data, etc.)
Excellent project management skills, good interpersonal, verbal communication and influencing skills, works well within teams and is effective in collaborating with others internally and externally