The innovative Pediatric Oncology Drug Development’ team (iPODD) is situated in Roche’s global late stage clinical development organization for oncology (PDO).
Roche PDO is based in Basel, San Francisco (Genentech) and Welwyn UK.
iPODD is a specialized 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 13 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 designs and 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 / Medical Director will be responsible for the development and implementation of pediatric oncology CDPs 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.
The medical director will also serve on iPODD study management teams as a medical monitor for clinical trials. The medical director will be a primary contributing author for regulatory submissions, including Pediatric Investigational Plans’ in the EU and initial Pediatric Study Plans’ and Proposed Pediatric Study Requests’ in the US.
The medical director will also participate in global filing teams, when appropriate for the molecule program. Participation in health authority interactions will be an integral part of all above responsibilities.
Furthermore, he / she 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 will 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 / Medical Director can be responsible for the management of direct reports.
Job qualifications :
of-concept testing is preferred
Get in touch with the Recruiting Team Switzerland +41 61 682 25 50
Roche is an equal opportunity employer.
Research & Development, Research & Development >
Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual’s race, color, religion, gender, sexual orientation, gender identity / expression, national origin / ancestry, age, mental / physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.