Clinical Development Director, Clinical Program Lead
GSK has created a global Full Service Outsourcing (FSO) Delivery group and is looking for qualified and experienced individuals to join the team as Clinical Program Leads. The FSO Delivery team has overall accountability for the clinical book of work that is placed with GSK's preferred CROs and the remit is to ensure effective oversight of this multi-therapeutic portfolio of work. We are looking individuals to join our team who are comfortable in working with CROs in the full service outsourced model and know how to provide effective oversight of the CROs. If you are collaborative, comfortable in leading matrix study teams, can think of alternative solutions and believe in the CRO outsourced model, a role of Clinical Program Lead in GSK's FSO Delivery team may be a great fit for you. Apply to learn more!
This role within Full Service Outsourcing Delivery combines effective oversight principles for the execution and reporting of global studies that are outsourced to GSK's preferred CROs. The role requires individuals who have excellent communication skills, can clearly state GSK delivery expectations to the CRO project team, are comfortable to strike the right balance of oversight as opposed to micro management, know how to make inferences from KPIs and study level dashboards and can identify potential risks, as well as the ability for efficient issue resolution. The Clinical Program Leads will be the Study Accountable Person for their assigned outsourced study(s) and will provide leadership in project teams, across matrix teams, key stakeholders, and external suppliers. This role will also:
- Have primary accountability for delivery of a study(s) in the FSO Delivery model and be key point of contact for GSK matrix study team members / stakeholders.
- Lead key discussions with CRO suppliers to ensure appropriate expectations have been set and GSK / CRO are aligned on delivery strategy.
- Work with matrix partners to develop and manage CRO task order within project budget allocation - ensure a regular cadence of financial review between GSK / CRO teams is in place.
- Develop and foster relationships across both GSK and CRO organizational boundaries
- Embed a culture of empowerment and accountability for CRO to resolve study issues internally, raising to GSK by exception.
- Foster an environment that embraces the use of CRO's processes and use of technology; encourage CRO to take more accountability for quality data delivery.
- Provide holistic oversight of CRO - understand study contribution to program / submission.
- Accountable to ensure that all safety / quality issues impacting subject health and wellbeing are properly escalated / reported per SOP.
- Embed KPIs that support FSO objectives
- Reduce cycle times - through CRO's technology and process improvements, enable superior cycle time reduction.
- Ensure effective Quality & Risk Management Oversight.
- Promote process improvement to support expedited study delivery and create efficiencies for ongoing / future.
- Drive Inspection readiness- both CRO & GSK.
- This role will be in-house based in either Upper Providence, PA, Stockley Park, UK or Stevenage, UK.
Why you?Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
- Bachelor's degree in life sciences or related discipline
- At least 10 years' experience pharmaceutical industry, with experience of outsourced CRO studies, or CRO environment in the clinical development process
- 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
- Strong financial / budget management in CRO contracts, task orders and MSAs.
- Proven track record of working with investigators, external experts, Contract Research Organizations 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 matrix teams in the CRO model to deliver projects, develop clinical plans, and manage change
If you have the following characteristics, it would be a plus:
- Advanced degree (e.g. MS, PhD, PharmD)
- Phase I-IV Oncology, Immuno-Inflammation, Infectious Disease, and / or Respiratory clinical development experience
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:
- Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigour and risk.
- Managing individual and team performance.
- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
- Implementing change initiatives and leading change.
- Sustaining energy and well-being, building resilience in teams.
- Continuously looking for opportunities to learn, build skills and share learning both internally and externally.
- Developing people and building a talent pipeline.
- Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation.
- Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally.
- Budgeting and forecasting, commercial and financial acumen.
*This is a job description to aide in the job posting, but does not include all job evaluation details.
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