Oncology Global Clinical Development Manager
- Collegeville, PA
GSK is still growing its oncology organization! Our robust pipeline continues to expand, and therefore so does our department. Within Clinical Operations we are looking for study managers and study leaders 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 support and lead global studies in Phases 1-3 in the areas of immuno-oncology, cell/gene therapy, epigenetics and synthetic lethality. Apply to learn more!
This position within Global Clinical and Study Delivery (GCSD) is accountable for planning and leading the delivery of oncology studies to time, quality, budget, company standards and scientific requirements as outlined in the clinical study proposal.
- Accountable for coordination of a fully feasible Study Protocol, Informed Consent Forms, Study Procedures Manuals and Clinical Study Reports.
- Accountable for the study delivery strategy (e.g. country selection, diversity, patient engagement strategy, recruitment plan, etc)
- Drive assessment, selection, engagement, and management of appropriate vendors.
- 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 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.
We are looking for professionals with these required skills to achieve our goals:
- Bachelor's degree in life sciences or related discipline
- 5-10 years of experience in the pharmaceutical industry
- Regional or global oncology clinical operations leadership 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 expectationsare 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:
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