lmmuno-Oncology Biomarker Manager
- Collegeville, PA
Site Name: USA - Massachusetts - Waltham, USA - Pennsylvania - Upper Providence
Posted Date: Aug 31 2020
Are you interested in developing, integrating, and implementing innovative biomarker strategies for Oncology clinical development programs, including validation and integration of biomarker assays into clinical trials? If so, this Immuno-Oncology Biomarker Leader role could be an ideal opportunity to explore.
As an Immuno-Oncology Biomarker Leader, you will lead efforts to enhance innovation through the use of novel techniques to drive scientific excellence. You will contribute to the scientific leadership for the Immuno-Oncology Biomarkers Group within the EMU whose objectives include determining drug mechanism of action, activity and relevant biological effects in patients. In addition, you will collaborate closely with the Companion Diagnostics group to guide and implement strategies and assays that will advance patient stratification and further development of predictive diagnostics. This candidate will also be expected to form working relationships with the Immuno-Oncology Research Unit, as well as early clinical development teams, safety, and clinical pharmacology groups
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following :
- Lead the Immuno-Oncology biomarker strategy within early and late stage clinical development programs to generate data that informs on target engagement, pharmacodynamics, mechanism of action and patient selection.
- Be accountable for all aspects of biomarker development from conception of the strategy to execution. This will be accomplished by interfacing with colleagues across teams at GSK, as well as external CRO partners, to deliver the biomarker strategy and generate impactful and innovative data to drive clinical programs to be successful.
- Innovate to accelerate and optimize clinical development strategies by providing biological guided combination strategies, optimization of combination dosing schedules, and novel approaches for non-invasive characterization of immune responses.
- Align with the companion diagnostics team to deliver novel precision medicine approaches to select patients for treatment.
- Oversee all technical aspects of biomarker assay development and implementation.
- Act as the key point of contactto clinical teams within Oncology,driving fully-developed asset-specific biomarker strategies.
- Lead the writing and editing of the biomarker sections of the clinical protocol, study procedural manualsand consent forms.
- Collaborate with clinical operations and sample management to ensure biomarker testing and data generation is compliant with all regulatory requirements
- Ensure successful implementation of biomarker strategies in compliance with GSK policies and procedures including the Human Biological Sample Management. These include SOP development, appropriate language for protocol and consent forms, data standards, assessment of biomarker research proposals.
- Interact with Oncology clinical sites and partners to ensure accurate and appropriate clinical sample collection to support the biomarker strategy.
- Serve as a point of contact for external vendors and collaborators in support of data generation.
- Establish links with external experts to initiate and expedite biomarker initiatives in oncology clinical trials.
- Represent the Immuno-Oncology Biomarker Group and Experimental Medicine Unit at internal and external meetings.
- Contribute to group's awareness of the emerging key scientific and technical innovations to help drive our continuous improvement
- Provide frequent project status updates related to biomarker deliverables.
We are looking for professionals with these required skills to achieve our goals:
- MA/MS in immunology, molecular biology, molecular oncology, pathology or related field.
- A minimum of 4 years of relevant industrial experience is required with experience in translational or clinical research
- Specific experience in the application of biomarkers to clinical translational research during the development process of Immuno-Oncology assets is required
- A proficient understanding of immunology and immunotherapy is required
- Proven track record of supporting clinical biomarker strategies and delivery of results
- Understanding of clinical trial design and execution (efficacy endpoints, biomarker testing), sample operations, data management and human biological specimen management)
If you have the following characteristics, it would be a plus:
- Ph.D. in immunology, molecular biology, molecular oncology, pathology or related field
- Knowledge of IVD/diagnostics development
- Experience in managing research collaborations, contract laboratories and budgets
- Demonstrated scientific capability as evidenced by publications, research reports, and external presentations.
- Effective verbal and written communication skills relating to colleagues and associates both inside and outside the corporation
- Ability to productively collaborate with multiple groups in a matrix environment
- Detailed oriented with strong organizational skills in order to manage and meet deliverables
- Flexibility to work on multiple projects as the portfolio evolves over time.
- Knowledge of the microbiome and relation to immuno-oncology treatment responses.
- Intermediate to advanced level experience with MS Office products (Word, Excel, PowerPoint, SharePoint, Project) and remote meeting tools such as WebEx and Skype
Our values and expectations are at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Continuously looking for opportunities to learn, build skills and share learning. Sustaining energy and well-being. Building strong relationships and collaboration, honest and open conversations. Budgeting and cost-consciousness.
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