Clinical Biomarker Group Lead, Senior Director

GSK
Collegeville, PA
Competitive
December 17 2020
273344
Pharma
Are you looking for a leadership role that allows you to shape and define an innovative clinical biomarker strategy as part of a new and growing team? Are you passionate about accelerating the delivery of transformational medicines in the Immunology space? Does targeting therapies to the patients who benefit most, appeal to you?

As a Clinical Biomarker Group Lead, you will lead a team of Clinical Biomarker Leads and have responsibility for development and effective implementation of biomarker strategies in support of clinical development projects.

Working as part of the early development / medicine development matrix teams (EDT/MDT), you will establish clear decision-making criteria to enable informed clinical decisions and integrate the biomarker strategy into the clinical development plans. The Clinical Biomarker Lead will employ cutting edge technologies and procedures to discover and clinically validate biomarkers. The implementation of the biomarker strategy as part of a well thought through clinical plan will ensure optimally informed decision making in drug development.

Click on the link to hear more about this role from Robbie Henderson, Head Clinical Biomarkers.

This role will provide YOU the opportunity to drive key activities and responsibilities as follows:
  • Lead a team of Clinical Biomarker Leads who support drug discovery and development programmes across the GSK pipeline. Setting aligned, stretched objectives, driving performance, creating an environment to maximize the outcomes for the team and GSK R&D.
  • Manage resource allocation across projects and work with Clinical Biomarker Head to ensure optimal resource allocation across the portfolio
  • Review team biomarker strategies and provide direction and guidance
  • Enable team deliverables by ensuring the availability of state-of-the art platform technologies and resource is optimal to support biomarker portfolio
  • Work with Head of Clinical Biomarkers to ensure that biomarker strategy aligns with overall Clinical Pharmacology Experimental Medicine strategy
  • Perform Biomarker Lead role for key projects - which will include the following:


1. Developing and maintaining project clinical biomarker strategy including approaches to pharmacodynamic and predictive biomarkers

2. Representing biomarker strategy at the EDT/MDT, study teams and Protocol Review Forum

3. Providing input to clinical teams on biomarker-related elements of study trial design and conduct

4. Establishing and delivering budget plans for biomarkers to EDT/MDT

5. Working with Research Unit project biologist to ensure alignment of preclinical and clinical biomarker strategies

6. Working with internal technology groups, Contract Research Organisations and collaborators to deliver clinically validated biomarker assays into clinical studies

7. Developing companion diagnostic strategies for validation, implementation and regulatory approval of predictive biomarkers

8. Ensuring alignment of biomarker outputs with data management, statistics, and modelling/simulation requirements

9. As required, supporting the expansion of mechanism and disease understanding to generate insights that can be leveraged in indication expansion and marketing

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:
  • PhD-educated scientist (or equivalent) with 5+ years of experience in the application of biomarkers in clinical trials.
  • Experience working with multiple biomarker platforms and their application in therapeutic areas
  • Experience in critiquing the scientific validity of research/development Biomarker strategic approaches.
  • Contributor to scientific rationale for the development of longer term biomarker and translational strategies
  • Experience in conducting clinical trials and working as part of a clinical study team
  • Experience working to GCP principles
  • Experience in the discovery, validation and clinical implementation of biomarkers
  • Experience of predictive biomarkers, including diagnostic development


Preferred Qualifications:

In addition to the minimum qualifications, the ideal candidate will possess the following:
  • Recognised team leader with proven people-management skills
  • Deep expertise in applying networking skills and stakeholder management;
  • Strong interpersonal skills and ability to thrive in a matrix environment, with a proven track record of success in influencing key stakeholders.


Why GSK?

At GSK, we're a company with a special purpose, to help people do more feel better and live longer. Realising our purpose starts with us. When we feel at our best, we perform at our best.

When you set out on your adventure at GSK, we make a deal. You commit to living GSK's values and expectations and performing against our Innovation, Performance and Trust priorities. And in return, GSK commits to providing the right environment for you to thrive. Put simply, it's about you being motivated to do your best work, in a place where you can be you, feel good and keep growing.

Together we build an environment where we can all thrive and focus on what matters most to each of us. It is only through the energy, dedication, drive and passion of all of us that we can be the very best for GSK, and importantly, for our patients and consumers.

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