Oncology Global Clinical Development Manager
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. 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 and Study Delivery (GCSD) combines end-to-end design, execution, and reporting of global studies with leadership in project teams and across matrix teams.
This role will serve as a clinical and operational team leader on global and regional oncology studies, and will also contribute to project level activities. This includes responsibility and accountability for the set-up, coordination, execution and delivery of one or more studies supporting an oncology asset.
- Responsible for the independent management and delivery of a clinical study or studies from protocol concept to final study report, as per agreed timeline and budget. Equally responsible for the quality and validity of all data originating from studies.
- Responsible for writing protocols, informed consent forms and clinical study reports.
- 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.
- Work with matrix partners, asset lead and/or manager to develop and manage study level budget within project budget allocation.
- Actively partner to build relationships and collaborate with oncology aligned staff in other global functions.
- Encourage others within matrix and line teams to seek alternative perspectives and develop solutions.
- 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
- In depth knowledge of study management, global 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, 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
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 judgment to balance pace, rigor 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
To learn more about oncology at GSK, watch this video: GSK YouTube
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GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
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