Clinical Development Director- Nephrology
About the role
This role will temporarily be based at Stevenage. However, the Company plans to relocate its offices to Cambridge. The location of this role will therefore subsequently change to Cambridge in accordance with timelines to be set by the Company. The relocation is currently proposed to take effect by early 2029.
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.
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.
Qualifications
- Advanced degree (e.g. MS, PhD, PharmD) in life sciences or a related discipline (preferred).
- 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 (preferred).
- Knowledge of regulatory requirements to support registration, including experience contributing to IND, EoP2, scientific advice, pre-NDA/BLA, NDA/MAA, or AdCom submissions (preferred).
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
Benefits
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.