Clinical Scientist - innovative Pediatric Oncology Drug Development (iPODD) Preclinical Molecule Program

Job description

·  Job facts

Roche's Clinical Development organization is structured by therapeutic area and is responsible for developing and executing the late development (Phase II – IIIA) clinical strategies and plans to delivermedically-differentiatedtherapies that provide meaningful improvement to patients. For pediatric oncology, the innovative Pediatric Oncology Drug Development (iPODD) team is also responsible for early clinical development (Phase I clinical trials) within pediatric oncology, as well as preclinical research that supports clinical development planning. The PD Clinical Scientist participates in the development of the Clinical Development (CD) plan and supports the assigned PD Medical Director(s) with various deliverables necessary for effective and efficient CD plan execution for the assignedmolecule(s)/indication(s).In this role, the PD Clinical Scientist will support the preclinical aspects of CD planning across the entire oncology pipeline. Responsibilities include working with the program lead to design preclinical evaluations of molecules in the pipeline (including identification of collaborators, negotiation of research projects, maintaining timelines, interpreting data, and reporting to molecule teams), participation in various sub-teams or other appropriate forums, acting as a primary point-of-contact for questions regarding pediatric oncology preclinical programs, coordination of the pediatric preclinical infrastructure and research projects, and providing input into study and regulatory documents.PD Clinical Scientists are likely to have external interactions with academic investigators, cooperative groups, key opinion leaders (KOLs), external vendors, etc.

PRIMARY DUTIES ANDRESPONSIBILITIES:

1. Cross-Functional Team Membership – including iPODD Clinical Science Team (CST) and Pediatric Strategic Workbook (PSW) team, as well as ad hoc member of molecule subteams when preclinical data is needed.

2. Pediatric Preclinical Data Packages - Develop preclinical molecule testing programs for Roche/Genentech pipeline molecules, based on pediatric target actionability reviews and additional non-published molecule data. Molecule testing will be conducted in internal labs (gRED/pRED), in academic collaborator labs, and/or with contract research organizations (CROs), depending on availability and suitability of models. Single agent and rational combinations will be investigated, including in vitro and in vivo methodologies

3. Global Clinical Development Planning - Collaborates with a variety of internal and external partners and stakeholders, such as scientists, CROs, and KOLs, as well as multidisciplinary internal groups, including other groups in PD, research, business development, commercial operations, legal, etc. in order to gather and analyze data and information necessary to support the CDP for pipeline molecules

4. Pediatric Preclinical Program (PPP) Infrastructure Management -Develop, maintain, and manage an integrated project database to enable accurate reporting and decision making and communicate effectively with team members in iPODD and molecule teams, with senior leaders, and the broader organization and to proactively provide routine and timely updates of preclinical data

5. Pediatric Strategic Workbook (PSW) - Develop pediatric molecule specific snapshots to build a prioritization recommendation for pediatric development and plan to mitigate risks during clinical development.

SELECTION CRITERIA: Candidates for this position should hold the following qualifications, have the following experience, and be able to demonstrate the following abilities to be considered as a suitable applicant. Please note that except where specified as “preferred,” or as a “plus,” all points listed below are considered minimum requirements.

QUALIFICATIONS & EXPERIENCE:

We are looking for a professional with Bachelors Degree required (life sciences preferred), advanced Clinical/Science Degree is preferred (e.g., PharmD, PhD, MSN, MPH, etc.) and 5 or more years clinical trial experience (must demonstrate a minimum of 2 years clinical trial experience in or working with pharma/biotech industry).

• Experience designing experimental testing programs and interpretation of preclinical study results and conclusions

• Relevant therapeutic area biological experience

• In-depth understanding of translational research, as well as Phase I – III drug development

• Experience in the principles and techniques of data analysis, interpretation, and clinical relevance

ABILITIES:

• Has impeccable ethics. Demonstrates, or proven abilities to demonstrate, Roche Values

• Outstandingattention-to-detail

• Proven abilities to perform responsibilities with increasing expertise and independence

• Excels at making scientifically sound decisions (experimental design, data interpretation)

• Good business acumen

• Excellent project management skills: can prioritize multiple tasks and goals and ensure the timely, on-target and within-budget accomplishment of such

• Strong verbal and written communication skills; able to clearly communicate the design and results of PPP programs to multi-disciplinary teams; can influence withoutauthority

• Good business presentation skills; is comfortable and effective when presenting to others, internally or externally

• Good negotiation skills: knows how to complete deliverables by working effectively with others internally andexternally (academicinvestigators and CROs)

• Good judgment and decision-making skills; knows how to make trade-off decisions while balancing ethics and efficacy

• Works well within teams and is effective in collaborating with others internally and externally

• Ability to travel (<5%)

·  Who we are

At Roche, 94,000 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.

Roche is an equal opportunity employer.