Clinical Development Director- Nephrology

For candidates seeking to be located at our Stevenage site this role will temporarily be based at Stevenage. However the Company plans to relocate its offices to Cambridge UK. The location of this role will therefore subsequently change to Cambridge UK in accordance with timelines to be set by the Company. The relocation is currentlyproposed to take effect by early 2029.

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 peoples 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. Were uniting science technology and talent to get ahead of disease together.
Find out more:
Our approach to R&D

We are seeking an experienced Clinical Development Director to join GSKs Respiratory Immunology & Inflammation Research Unit. The Director Clinical Development Nephrology provides scientific leadership across defined components of study design conduct data review and interpretation within assigned clinical programs. This role operates within the asset-level clinical strategy and contributes scientific depth and rigor to the execution of the Clinical Development Plan (CDP). The Director Clinical Development partners closely with the Senior Scientist and cross-functional teams to support delivery of clinical studies ensuring scientific quality data integrity and robust interpretation of clinical data. This is a scientific individual contributor role requiring deep clinical development expertise strong analytical and collaboration skills and the ability to operate effectively within a complex matrixed environment. You will work cross-functionally to develop and execute CDPs and translational and biomarker capabilities within a department that prioritizes understanding mechanism unmet need and innovative clinical addition you may contribute (without holding accountability) to the assessment of potential mechanisms and targets target validation programs life-cycle expansion and innovative opportunities.

In the Respiratory Immunology and Inflammation Research Unit (RIIRU) our enduring purpose is to leverage immune science to address underlying organ dysfunction and disease. We are trailblazing a pipeline of medicines to dramatically improve how we cure and care for patients. We are a diverse team of industry-leading experts who channel our passion for scientific exploration into true value for patients and GSK. We drive the end-to-end R&D journey fueling early discovery and our mid-stage pipeline while also advancing our late-stage medicines to launch. We are combining field-leading data sets capabilities and methods with decades of knowledge to transform our success in how we innovate new medicines.

Working model:

This role is hybrid. You will be on-site at one of the posted locations at least two days per week. Remote work is available on other days.

Position Summary

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

• Support alignment of translational and clinical plans and study designs with project strategies to ensure quality design and execution of the CDP. Develop sections of core regulatory documents.

• Generate the data and evidence required to determine a targets potential efficacy safety profile key areas of differentiation and route to becoming a medicine with value to patients in the shortest possible timeframe.

• Define and deliver the clinical pillars of the translational table.

• Deliver clinical development and study timelines and endpoints including pharmacology mechanism and clinical efficacy endpoints enabling key decision points and Go/No Go criteria for the CDP

• Establish and maintain relationships with program counterparts in Biology Translational Sciences Commercial Regulatory Clinical Operations Market Access Medical Affairs and Statistics.

• Contribute to the implementation and embedding of strategic initiatives and various organizational initiatives in Clinical Development.

Clinical Development Strategy and Study & Program Design

• Provide effective support and oversight of R&D evidence generation strategy plan and activities to ensure patient safety and on-time in-full study delivery. Contribute to the study team discussions on indication planning and incorporate input from across disciplines (scientific clinical commercial regulatory stats etc.) to contribute to vital deliverables including early medicine profile target validation translational plans candidate selection.

• Design clinical development plans study protocols and associated documents across all phases of development reflecting internal and external stakeholder input (e.g. patients evidence generation regulators payors pharmacovigilance).

• Bring clinical expertise to regulatory interactions and documents including briefing documents presentations addressing questions and responses for assigned studies and programs.

• Provide medical monitoring and oversight of the safety of study participants on behalf of the Sponsor during the study together with Pharmacovigilance Physician.

• Accountable for medical governance across the project to ensure scientific integrity and overall safety of the study subjects across the study.

Clinical Leadership

• Contribute to leading the Clinical Matrix Team (CMT) for a program. Serves as a clinical point of contact both internally and externally for an indication of an asset or for a clinical study. Represents the CMT at Early/Medicine Development Teams or clinical study at CMT.

• Serve as the Clinical point of contact for an investigational agent (early development) or clinical study for internal and external stakeholders including regulatory agencies key opinion leaders and clinical investigators and with the relevant internal review boards (e.g. Technical Review or Governance) and/or Protocol Review Board.

• Assist with clinical evaluation of business development opportunities

• Stay abreast of advancements in research clinical trial methodologies competitive environment and regulatory space in the relevant disease area to maintain GSKs competitive edge.

• Identify and highlights transformational opportunities; where projects can offer highly significant benefit to patients in ways not possible with existing approaches.

• Gather and supports the integration of inputs from across disciplines (scientific clinical commercial regulatory) to contribute to clinical components of the Medicine Profile (MP).

• Consistently contribute to solving study and overall clinical development challenges.

• Demonstrate ability to influence others at project departmental and inter-departmental levels as appropriate

Creating Innovative Scientific and Technical Solutions

• Embrace challenge as an opportunity for creativity and use new learning and digital tools to create innovative approaches to science and technical solutions.

• Promote an environment for others to generate ideas for improvement and proactively drives innovation beyond taking advantage of opportunities that arise.

Influencing and Inspiring Others and Managing Conflict

• Consistently achieves desired outcomes through strong influencing skills including understanding others perspectives building trust tailoring communications depending on the audience and using persuasive arguments to gain support.

• Able to consistently inspire others by setting a positive example communicating a compelling vision and creating an environment where team members feel valued and motivated.

• Manage conflicts effectively and independently negotiating mutually acceptable solutions.

Enterprise Mindset Strategic Thinking and Navigating Ambiguity

• Demonstrate enterprise mindset with effective collaboration across the matrix able to integrate cross-functional knowledge into decision-making processes and balance team objectives with the wider business goals.

• Analyses interprets and critically evaluates data information and digital content to interpret complex information anticipate obstacles and identify potential solutions.

• Demonstrate flexibility and adaptability in changing environments able to analyze incomplete information identify potential risks and implications and make informed decisions.

Why You

Basic Qualifications:
We are seeking professionals with the following required skills and qualifications to help us achieve our goals

• Bachelors degree in life sciences medicine pharmacy or a related field.

• Experience in clinical development clinical operations or clinical science roles with a focus on kidney disease.

• Knowledge of and experience in the execution of clinical and/or translational studies.

• Experience and understanding of clinical development from early stage through to regulatory submission including study design protocol authoring and data review/interpretation.

• Knowledge of GCP ICH and global regulatory guidelines.

• Experience authoring or contributing to clinical study proposals protocols Investigators Brochures informed consent forms clinical study reports and regulatory submissions.

• Demonstrated ability to operate effectively within cross-functional matrix teams and contribute to clinical decision-making.

• Proven track record of working with investigators site staff external experts CROs and vendors.

Preferred Qualifications:

If you have the following characteristics it would be a plus

• Advanced degree ( PhD PharmD) in life sciences or a related discipline

• Knowledge of kidney disease research priorities public health needs competitor landscape clinical practice trends and treatment guidelines evolution preferred

• Experience presenting or preparing materials for Protocol Review Boards governance meetings or scientific forums.

• Knowledge of regulatory requirements to support registration including experience contributing to IND EoP2 scientific advice pre-NDA/BLA NDA/MAA or AdCom submissions.

Skills

Analytical Thinking Business Acumen Change Management Clinical Research Clinical Trial Designs Communication Decision Making Fostering Collaboration Influencing Without Authority Leadership Matrix Leadership Mentorship People Management Risk Management Strategic Thinking

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 $189750 to $316250. If you are based in another US location the annual base salary range is $172500 to $287500. The US salary ranges take into account a number of factors including work location within the US market the candidates skills experience education level and the market rate for the 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.

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

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 were 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.

If you require an accommodation or other assistance to apply for a job at GSK please contact the appropriate Recruitment Staff by emailing us at -

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.

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 GSKs 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 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 GSKs compliance to all federal and state US Transparency requirements. For more information please visit the Centers for Medicare and Medicaid Services (CMS) website at Experience:

Director