Medical Director Clinical Development- Nephrology

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.
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Our approach to R&D

We are seeking an experienced Medical Director Clinical Development- Nephrology to join GSK’s Respiratory, Immunology & Inflammation Research Unit. In addition to providing clinical and scientific leadership to clinical and translational studies or programs for asset-level projects, you will contribute to the assessment of potential mechanisms and targets, target validation programs, life-cycle expansion and innovative clinical development opportunities. You will work cross-functionally to develop and execute clinical development plans (CDPs) and contribute to above-project development of foundational and real-world data, and translational and biomarker capabilities, within a department that prioritizes understanding mechanism and unmet need alongside innovative clinical development, helping us deliver differentiated medicines that change the course of disease and improve patients’ lives.

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.

PLEASE NOTE: This career opportunity requires an on-site office presence (minimum of two days a week) at one of GSK’s US (PA or MA) or UK (Stevenage or London HQ) sites.

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 target’s 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

• Accountable for 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.

• Actively leads the end-to-end clinical development strategy for an early program and may contribute to later stages.

• Serve as the primary 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 GSK’s 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.

Skills

Clinical Development, Communication, Drug Regulatory Affairs, Evidence Based Decision Making, Good Clinical Practice (GCP), Influencing Without Authority, Learning Agility, People Management, Project Management, Scientific Presentations, 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 $222,750 to $371,250. • If you are based in another US location, the annual base salary range is $202,500 to $337,500. 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.

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 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.

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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.

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