GSK
Clinical Development Director - Nephrology
Competitive salary and benefits
Job Function:
Medical and Clinical
Job Type:
Location:
Stevenage
Based:
Closing date:
ABOUT THE ROLE
Job Description
Site Name:
UK - Hertfordshire - Stevenage
- UK – London – New Oxford Street
Posted Date:
Nov 11, 2024
Role Requirements:
Must be based in a UK GSK site for a minimum of 2 days per week.
Position:
Clinical Development Director - Nephrology
Role Overview:
The Clinical Development Director - Nephrology will provide clinical and scientific insights to the Nephrology franchise, including emerging indications and adjacencies. The role involves working within project teams to plan and assure the delivery of clinical research and development activities. Collaboration with research members to define the best clinical indication for a target and integrating inputs from various disciplines (scientific, clinical, commercial, regulatory) is essential.
Key Responsibilities:
Clinical Development:
- Design and lead clinical development protocols/studies/programs in Nephrology across all phases of development.
- Develop clinical development strategies, including study Ph1-2/3 design.
- Provide clinical expert input into regulatory documentation and lead regulatory interactions from a clinical perspective.
- Work with Research Unit members to define prioritized clinical indications for early targets.
- Integrate inputs from across disciplines to contribute to the Medicine Profile, Target Validation, Translational Plans, Candidate Selection, clinical development plan, and integrated evidence plan.
- Design and deliver early clinical development plans demonstrating proof of mechanism, potential efficacy, and safety profiles.
- Lead the integrated evidence planning to address the needs of regulators, payors, and patients.
Regulatory and Safety:
- Provide clinical input into presentations and supporting documentation for governance bodies.
- Escalate clinical safety incidents to the Immunology Clinical Research and Early Programs Head and GSK Pharmacovigilance.
- Address clinical questions at meetings with regulatory authorities/ethics committees.
- Ensure regulatory reporting requirements, including Development Safety Update Reports (DSURs) and IB updates.
- Incorporate patient perspectives in the design and conduct of clinical studies.
- Ensure medical governance across the project to maintain scientific integrity and overall safety of study subjects.
Leadership and Collaboration:
- Lead the clinical team (CT) and Integrated Evidence Team (IET).
- Engage external academic and clinical experts to enhance the quality and delivery of clinical programs/studies.
- Mentor and coach other members of Clinical Research and Early Programs Immunology.
- Provide input into disease area strategy and execute this strategy based on expertise.
- Play a leadership role in medical governance initiatives in R&D, discovery/development policy, processes, or guidelines.
- Network externally with academia/pharma and bring expertise back to GSK.
- Anticipate, communicate, and suggest solutions on trends/events outside GSK that affect business direction.
Experience and Skills:
Experience in drug development and/or translational medicine, preferably with industry experience.
- Ability to work across multiple projects and be independently accountable for own projects.
- Leadership experience in medical governance initiatives and professional networks.
- Command of the drug discovery and development process to influence a culture of continuous improvement.
This role offers an opportunity to contribute significantly to the Nephrology franchise at GSK, working with a diverse team to advance clinical research and development.
REQUIREMENTS
Basic Qualifications:
We are looking for professionals with the following required skills to achieve our goals:
Primary medical qualification (i.e., medical degree) and a clinical medical specialty qualification.
- Significant proven clinical or scientific expertise in nephrology.
- Industry or academic experience in translational medicine and early/late phase drug development.
- Experience in setting and executing scientific strategy, while being mindful of overall goals.
- Understanding and knowledge of early/late drug development and translational sciences.
Preferred Qualifications:
Please note the following skills are not necessary but preferred. If you do not have them, please still apply:
Primary medical qualification (i.e., medical degree) and PhD with a clinical medical specialty qualification (e.g., fellowship) in nephrology.
- Experience in working with relevant regulatory bodies and professionals in early/late-stage discovery and development.
- Project Management:
- Demonstrates the discipline of risk-based planning, organizing, and managing resources to bring about the successful completion of specific project goals and objectives in accordance with defined quality and time-based metrics.
ABOUT THE COMPANY
Uniting Science, Technology, and Talent to Get Ahead of Disease Together
GSK is a global biopharma company with a special purpose: to unite science, technology, and talent to get ahead of disease together. Our goal is to positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns, all while creating an organisation where people can thrive.
Our Mission:
Prevent and Treat Disease: We offer vaccines, specialty, and general medicines.
- Focus Areas: We concentrate on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas:
- Infectious diseases
- HIV
- Respiratory/immunology
- Oncology
Our People:
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel:
Inspired
- Encouraged
- Challenged to be the best they can be
- Welcome, valued, and included
- Able to keep growing and look after their wellbeing
Join Us:
If you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
Equal Opportunity Employer:
We are open to all talent. In the US, we adhere to Affirmative Action principles, ensuring that all qualified applicants receive equal consideration for employment without regard to:
Neurodiversity
- Race/ethnicity
- Colour
- National origin
- Religion
- Gender
- Pregnancy
- Marital status
- Sexual orientation
- Gender identity/expression
- Age
- Disability
- Genetic information
- Military service
- Covered/protected veteran status
- Any other federal, state, or local protected class (*US only)
Agile Working Culture:
We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore the opportunities with our hiring team.
Adjustments and Support:
Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities, contact us at:
- Phone: 0808 234 4391
Please note, if your enquiry does not relate to adjustments, we will not be able to support you through these channels. However, we have created a UK Recruitment FAQ guide. Click the link and scroll to the Careers Section where you will find answers to multiple questions we receive.
Personal Information:
As you apply, we will ask you to share some personal information, which is entirely voluntary. This information helps us consider a diverse pool of qualified candidates and understand how well we are doing against our inclusion and diversity ambitions. We would appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information, and we will treat your information confidentially.
HOW TO APPLY
