Global Clinical Development Director, Clinical Operations Asset Lead
The GSK Respiratory & Specialty area is looking for an experienced Global Clinical Operations Asset Lead. We have an exciting portfolio and are looking for and experienced professional in the development of Late- Stage Assets. Apply to learn more! The role:
Reporting to the Therapy Area Head, the Clinical Operations Asset Lead represents all Clinical Operations functions at the program (asset) level in Global Early Development Teams (EDTs), Global Medicine Development Teams (MDTs) and at governance interactions. The role is accountable for the clinical program operational strategy development and execution to time, cost, and quality, working in partnership with functional subject matter experts.
The Clinical Operations Asset Lead Role is a highly visible and critical role within Global Clinical Operations and Asset Development Teams. This role requires exceptional leadership skills, ability to navigate uncertainty and change and ability to develop trusting and transparent relationships cross-functionally and stakeholders within and outside of GSK.
The role may span multiple assets in early and in late phase of development and include delivery through one or more of in-house, outsourced and alliance delivery models. Key responsibilities :
Why You? Basic Qualifications
- Provides strategic operational and design inputs to the Asset Clinical Development Plan during co-development with other members of the EDT and MDT.
- Develops innovative and robust operational strategy options based on asset value drivers, with comprehensive risk management plans.
- Represents Clinical Operations and proposed operational strategy during program governance interactions including scientific review by GSK Development Review Board (DRB) and GSK Portfolio/Research Investment Boards (PIB/RIB).
- Creates strong strategic partnerships with colleagues in Clinical Development, Clinical Science, Regulatory, Clinical Pharmacology, Statistics, Medical Affairs, Data Management and Study Monitoring to ensure consistent approaches to study delivery, data collection and reporting across a program.
- Leads resourcing discussions on behalf of Clinical Operations and make recommendations on delivery model and vendor selection strategy.
- Oversees (potentially with support from an Associate Asset Lead (Associate Director)) study delivery quality through to CSR/submission delivery, ensure inspection readiness at all times, and interact regularly with Study Delivery Leads around issues / risks / successes with study delivery.
- Drives innovative approaches to study delivery through external facing advances in technology and sciences.
- Works with matrix partners to develop and manage study level budget within project budget allocation.
- Bachelor's degree in life sciences or related discipline.
- Leadership experience in a director position with strength in senior stakeholder management.
- Experience in the pharmaceutical industry or CRO environment.
- In depth knowledge of program management (including resource and financial management), global regulatory guidelines and ICH/GCP.
- Experience working with investigators, external experts, Contract Research Organizations and vendors.
- Advanced degree (e.g. MS, PhD, PharmD).
- Program management qualification (e.g. PRINCE2, PMP).
- Experience of innovative trial designs (platform, basket, umbrella, adaptive designs).
- Experience of marketing application submissions (e.g, MAA, NDA, BLA, JNDA etc).
- Demonstrated ability to establish and build highly functional internal and external relationships at all levels both within and outside GSK in a highly dynamic and matrixed environment.
- Demonstrated ability to use robust analytical rigor to identity the critical issue in complex situations and to frame issues and opportunities in such a way that new perspectives can be found.
- Highly developed communication skills appropriate to the target audience which promote effective decision-making.
- Demonstrated experience leading in a matrix environment to deliver projects, develop clinical plans, and manage change and ambiguity.
- Ability to work independently and proactively and to take on leadership roles on cross-functional study teams.
- Creative thinker able to modernize approach to clinical delivery, leverage external technology and networks and build internal capability.
- Actively promotes a culture of empowerment and identifies opportunities to delegate responsibility.
- Enterprise thinker with an ability to understand and balance the broader business needs with the needs of their specific project.
At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader inConsumer Health, strengthening our leadership, and transforming our commercial execution. Now, we're making the biggestchanges we've made to our business in over 20 years.We're on track to separate and create two new companies in 2022:
New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and geneticsscience; and a new world-leading consumer healthcare company of loved and trusted brands.
With new ambition comes new purpose. For New GSK, this is to unite science, talent and technology to get ahead of diseasetogether - all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; andas a new GSK where outstanding people thrive.
Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culturethat isambitious for patients
- so we deliver what matters better and faster;accountable for impact
- with clear ownership ofgoals and support to succeed; andwhere we do the right thing
. So, if you're ready to improve the lives of billions, join us at thisexciting moment in our journey. Join our challenge to get Ahead Together.
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