Senior Director Clinical Operations Asset Lead - Hepatology, renal and cardiovascular disease - #2097375

443620

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.

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.

• 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.

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.

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.

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...