Clinical Development Director- Nephrology

GSK•Waltham, MA

4d•Hybrid

About The Position

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 development. In 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.

Requirements

Bachelor’s 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, Investigator’s 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.

Nice To Haves

Advanced degree (e.g. MS, 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.

Responsibilities

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.
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.
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 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
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.
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.
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.