- South San Francisco, CA, US
GENERAL POSITION SUMMARY/PURPOSE:
Roches Product Development organization is responsible for developing and executing late stage (Phase III IV) clinical trials to establish efficacy and clinical utility of novel therapies The purpose of these trials is provide critical data for regulatory approval and post-market expansion of therapeutic use. The PD PHC Clinical Imaging Scientist is responsible for developing and ensuring effective and efficient execution of Clinical Development Programs involving clinical imaging.
JOB DESCRIPTION PRIMARY DUTIES AND RESPONSIBILITIES:
- Provide imaging scientific leadership for study/project teams and during interactions with imaging service providers in ophthalmology or oncology.
- Align imaging strategies between clinical development teams with ensuring establishment and sharing of best practices and processes
- Employ imaging expertise to answer questions and address issues that arise during ongoing clinical trials, for instance, advise on criteria/ modality- related/ or medical questions raised by medical monitors.
- Lead finalization imaging charters (ex. RECIST or Lugano) and provide input on which additional criteria add value to the specific protocol
- Ensure proactive consideration of imaging strategies during clinical development planning
- Facilitate communications with reading centers and support creation/editing of imaging manuals, imaging review charters/grading protocols, image transfer agreements, etc.
- Perform tasks related to image data management, image transfer, and organization
- Oversee and perform hands-on analysis of a variety of retinal imaging data (including color fundus and OCT) or oncology imaging data (PET, CT, MRI)
- Collaborate with other scientists within the personalized healthcare (PHC) imaging, clinical imaging groups, biomarker, biostatistics and clinical science groups on designing image analysis strategies and presenting results.
- Develop and maintain clinical, scientific, and technical expertise in ophthalmology, oncology or other therapeutic areas as needed
- Adhere to corporate compliance in all activities, including governing laws, regulations, Standard Operating Procedures (SOPs) and other guidelines
- Provide imaging expertise for collaborative efforts to assess and obtain real world clinical imaging data for PHC Imaging biomarker development efforts.
- Identify opportunities and coordinate inclusion of novel automated imaging analysis biomarker in late stage clinical trials
QUALIFICATIONS & EXPERIENCE:
- 6 years for Masters of Science or Masters of Engineering degree; 3 years for PhD in relevant scientific/engineering discipline preferred.
- At least 2 years pharmaceutical/biotechnology/academic experience or other relevant experience of using imaging in clinical trials.
- Ability to work on cross-functional teams; excellent communication and presentation skills.
- An understanding of ophthalmology centralized reading center (ophthalmology or oncology) processes would be an important advantage
- A good understanding of the basic principles of retinal or oncology imaging
- Experience with hands-on quantitative analysis of imaging data in clinical trials; familiarity with retinal imaging (such as optical coherence tomography) on oncology (PET, CT, MRI) imaging would be preferred
- Knowledge of image file formats and structures used in ophthalmic imaging
- Programming skills; experience working with MATLAB or Python preferred
- A good working knowledge of statistics and its applications within the biomedical sciences
- Knowledge of other clinical imaging modalities is a plus
- An understanding of Phase I-IV drug development would be an advantage
- Confident and competent when interacting with varying levels of internal/external management, KOLs, etc.: stays focused and on-point, and is able to raise problems or challenges in a productive and mature manner
- Proven track record of effective decision-making: makes good business decisions and exercises sound judgment. Consistently and effectively identifies and addresses important factors affecting imaging trial design and execution
- Self-motivated and achievement driven with strong customer orientation and entrepreneurial mindset
Additional requirements for a more senior position:
- Recognized as a subject matter expert in imaging in clinical drug development across all phases (includes external recognition as an expert); able to evaluate, interpret and present highly complex data for a series of studies (prospective and retrospective); has made significant contributions to an organization's drug development (whether for Roche or another organization);
- Has proven abilities to influence internal partners and stakeholders, thought leaders, national advocacy organizations, national standard-setting bodies, regulatory bodies, and other relevant external parties
Who We Are
A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.
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Job FactsJOB FUNCTION
Modelling & Simulation COMPANY/DIVISION
Full time JOB TYPE