Clinical Development Manager, Oncology
Site Name: USA - Massachusetts - Waltham
Posted Date: Jan 8 2020
GSK is expanding its oncology organization, and we are looking for experienced professionals to help us rebuild and grow our internal expertise! We have an exciting (and expanding) portfolio and are looking for clinical scientists who have a wide breadth of oncology and clinical development experience, with a particular focus on cell therapy. It's a wonderful time to join our team because we have many opportunities to lead global studies in Phases 1-3 in the areas of immuno-oncology, cell/gene therapy and epigenetics. Apply to learn more!
This role within Global Clinical Oncology R&D
will serve as a clinical a sciences team leader on global oncology studies and contribute to program level activities.
Responsible for the delivery of a delivery of quality study strategy and design, understand the analysis and interpretation of data throughout the study including leading clinical data review ongoing throughout study conduct.
Responsible for the end to end of writing protocols (protocol concept to final study report) delivery. Contributor to informed consent forms development and other study related documents.
Review and/or enhance the technical and scientific robustness of project level clinical development plans.
May support regulatory interactions including contributing to briefing documents, presentations, addressing questions and responses.
Ensure compliance with ICH/GCP guidelines, all applicable laws and regulations, and GSK SOPs, for all products and services delivered for their designated studies.
Contribute to development of end-to-end clinical development strategy.
Make decisions which balance risk/benefit with clear understanding of impact on the study and project; takes action to mitigate risk where appropriate.
Actively partner to build relationships and collaborate with oncology aligned staff in other global functions.
Responsible for cultivating strong relationships and robust communication among the clinical study/project team and GSK's Oncology Clinical Development Organization. This includes training, education, onboarding as well as problem solving in the conduct of clinical trials.
Encourage others within matrix and line teams to seek alternative perspectives and develop solutions.
The Clinical Scientist has accountability for study design and interpretation of study results that provide data to adequately address questions concerning efficacy/effectiveness, safety, applicability to targeted patient population, and clinical and commercial value that are consistent with the compounds' phase of development while ensuring that patient safety is of paramount concern and that regulatory requirements are incorporated through:
• Accountability for Study Team members/stakeholders, as appropriate) and regulatory reporting at the study level by providing leadership at study level to assure overall safety of the study subjects.
Drive/Contributing to clinical components of the IB, and documents for regulatory submissions and advisory requirement, including scientific advice, IND, EoP2, pre-NDA/BLA meetings, NDA/BLA and MAA documents.
Serves as a product, protocol and project subject matter expert to support internal and external customers.
Work with external experts to develop abstracts, manuscripts and study design presentations.
We are looking for professionals with these required skills to achieve our goals:
Bachelor's degree in life sciences or related discipline
Experience in a pharmaceutical industry or CRO environment in the clinical development process
Oncology clinical development experience, particularly in the area of immuno-oncology
In depth knowledge of regulatory guidelines and ICH/GCP
Experience in developing and writing study protocols, study procedures manuals, informed consent forms and clinical study reports.
Proven track record of working with investigators, site staff, external experts, Contract Research Organizations and vendors
Excellent leadership skills
If you have the following characteristics, it would be a plus:
Advanced degree (e.g. MS, PhD, PharmD)
Clinical development experience across all phases of development (I-IV).
Highly developed communication skills appropriate to the target audience, promoting effective decision-making where necessary
Proven expertise in the proactive identification of issues which may impact clinical programs coupled with the ability to contribute to solutions affecting cross-functional matrix teams.
Excellent influencing and negotiation skills
Clinical Development Oncology
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