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Senior Director Clinical Operations Asset Lead - Hepatology, renal and cardiovascular disease

$242.55k - $404.25k
Full-time

GSK

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together. Position Summary This is a senior leadership role at the forefront of clinical delivery representing development Operations at the asset level. As Senior Clinical Operations Lead, you will hold strategic accountability for highly complex assets spanning multiple indications covering — including large Phase III global outcomes trials, rare disease programmes and co-development partnerships — across therapeutic areas including hepatology, renal and cardiovascular disease. The Senior Clinical Operations Lead is accountable for asset level operational strategy and delivery plans to execute scientific strategy, enabling delivery to time, cost and quality. Key Responsibilities: Hold senior clinical operational accountability across a portfolio of highly complex assets spanning multiple indications and disease areas, or a single programme of exceptional scope such as a rare disease or co-development. Define and drive clinical operational delivery strategy at programme level — including country and site selection, diversity and health equity strategy, patient recruitment and implemention of innovative approaches to delivery of clinical programs Own the portfolio-level risk register; lead scenario modelling and contingency planning, escalating material risks to senior R&D leadership as appropriate. Ensure rigorous clinical operational input into clinical development plans and integrated evidence plans; integrate non-interventional and real-world evidence strategies as part of the full evidence generation plan. Represent GSK Clinical Operations at multiple senior programme governance forums, serving as the primary operational escalation point across the asset portfolio. Lead senior CRO and vendor relationships at programme level, overseeing contract governance, performance management and strategic vendor reviews. Provide operational input into business development activities including rare disease licensing and co-development partnerships; lead clinical operations due diligence for in-licensing opportunities. Deliver specialist operational leadership for rare disease programmes — including small patient population recruitment models, accelerated regulatory pathways and patient advocacy group engagement. Directly manage, coach and develop a team of clinical operations leaders; set the standard for delivery excellence and contribute to capability development across the function. Drive portfolio-level inspection readiness and quality compliance, acting as senior escalation point for quality issues across the team. Leading with data and an enterprise mindset We are looking for a leader who goes beyond operational delivery — someone who uses data as a strategic asset and thinks beyond their own portfolio. Drive data-led decision making: use portfolio analytics, delivery metrics and external benchmarks to anticipate risk, prioritise investment and communicate performance clearly to senior stakeholders. Champion data quality and integrity — ensuring operational data is accurate, timely and decision-ready to support both in-flight delivery and long-range planning. Apply an enterprise mindset: consider the impact of decisions on the wider organisation, not just your portfolio, and actively contribute to function-wide strategy and capability building. Champion the adoption of innovative trial methodologies — including digital patient-reported outcomes, decentralised and hybrid study elements, and adaptive platform design — where they add genuine value for patients and programmes. Represent GSK externally as a subject matter expert; bring competitive intelligence and industry insight back into the organisation to keep our approach ahead of the curve. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Degree in pharmacy, life sciences, medicine or a related discipline Significant senior clinical operations leadership experience in a pharmaceutical or CRO environment, with a track record of delivering highly complex, multi-asset programmes across therapeutic areas including hepatology, renal and cardiovascular diseases. Extensive late-phase global trial experience — particularly large Phase III outcomes trials with morbidity/mortality endpoints across multi-national populations. Experience in rare disease programmes, orphan drug pathways, accelerated regulatory strategies or co-development models is highly desirable. Proven track record of direct line management and developing high-performing teams in a matrix environment. Strong analytical capability — comfortable interrogating data, drawing insight and translating it into clear strategic choices for senior audiences. Enterprise-level thinking: able to balance operational detail with strategic perspective, and to align decisions with priorities beyond your immediate remit. Exceptional stakeholder influencing skills across scientific, commercial, regulatory and external partner audiences. Experience in outsourcing strategy, CRO governance and budget management for large-scale clinical programmes. Scientific literacy sufficient to engage credibly with medical, regulatory and clinical science functions on complex late-phase programmes. Preferred Qualifications: If you have the following characteristics, it would be a plus: Advanced qualification preferred #LI-GSK* • If you are based in Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA, the annual base salary for new hires in this position ranges $242,550 to $404,250. The US salary ranges take into account a number of factors including work location within the US market, the candidate’s skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave. If salary ranges are not displayed in the job posting for a specific country, the relevant compensation will be discussed during the recruitment process. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale. People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people. GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law. We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are. Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us at View email address on click.appcast.io where you can also request a call. Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a Recruitment FAQ guide. Click the Link where you will find answers to multiple questions we receive Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at We are a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. Find out more on our career site.

Vacancy posted 2 days ago
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