Global Clinical Development Director - Oncology, Open to flexibility
Global Clinical Development Director - Oncology, Open to flexibility
GSK is expanding its oncology organisation, 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 contribute to individual studies in addition to project level activities, as appropriate. It will also:
- Be responsible for the delivery and quality of all clinical studies from protocol concept to final study report.
- Review and/or enhance the technical and scientific robustness of clinical plans and studies developed by the key partners in the oncology TA.
- Have an established track record of generating alternative solutions and perspectives at project and line level. Encourage others within matrix and line teams to seek alternative perspectives and develop solutions.
- Ensure compliance with ICH/GCP guidelines, all applicable laws and regulations, and GSK SOPs, for all products and services delivered for their designated studies.
- Make decisions which balance risk/benefit with clear understanding of impact on project; takes action to mitigate risk where appropriate.
- Work with matrix partners to develop and manage study level budget within project budget allocation. Look for ways to use resource most effectively to manage workload within IPE/EPE budget and headcount allocation.
- Create and foster strong strategic partnerships with colleagues that include Clinical Development, Global Regulatory Affairs, Clinical Pharmacology, Statistics, Medical Affairs, Data Management, Study Monitoring and pre-Clinical Development.
- Lead the writing of protocols, Informed Consent Forms, clinical study reports and regulatory-related documents.
- Support the writing of subsequent regulatory briefing documents
- Demonstrate substantial and relevant knowledge of scientific and medical literature in oncology and its application to strategic design and operational achievements.
- Work with external experts to develop abstracts, manuscripts, study/program design and presentations.
- Apply scientific and operational knowledge to identify and analyze problems and information of considerable complexity and implement effective plans and solutions.
- Ability to serve as mentor and coach of colleagues.
The role may:
- Have accountability for the management, performance and motivation of all direct reports, as applicable.
- Have primary responsibility for delivery of a program of studies (or indication-specific group of studies) and be key point of contact for portfolio leaders in the Oncology Therapeutic Area (e.g. Early Development Leaders, Medicine Development Leaders, and/or Project Physician Leaders, as appropriate).
- Bachelor's degree in life sciences or related discipline
- Experience in the pharmaceutical industry or a CRO environment in the clinical development process
- Experience in developing and writing study protocols, study procedure manuals, informed consent forms and clinical study reports
- Ability to work independently and proactively and to take on leadership roles on cross-functional study teams
- In depth knowledge of study management, global regulatory guidelines and ICH/GCP
- Proven track record of working with investigators, external experts, Contract Research Organisations and vendors
- Ability to establish and build internal and external relationships at all levels in a highly dynamic and matrixed environment
- 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 leadership skills
- Excellent influencing and negotiation skills
- Demonstrated experience leading in both matrix and line environment to deliver projects, develop clinical plans, and manage change
- Advanced degree (e.g. MS, PhD, PharmD)
- Phase I-IV Oncology clinical development experience
At GSK, our mission is to improve the quality of human life by enabling people to do more, feel better and live longer. Our three world-leading businesses research and deliver innovative medicines, vaccines and consumer healthcare products. We need a talented and motivated workforce to deliver against our strategy. To achieve this, we strive to attract the best people and to create an environment that empowers and inspires.
You may apply for this position online by selecting the Apply now button.
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