Clinical Development Director - Nephrology, London

Clinical Development Director – Nephrology, London

Client:

GSK

Location:

London, United Kingdom

Job Category:

Other

EU work permit required:

Yes

Job Reference:

af562ae5980f

Job Description:

Please note this role requires to be based in a UK GSK site for a minimum of 2 days per week.

Are you a Nephrology Physician looking to partner with world renowned experts – bringing cutting edge science and technology to aid in the development of novel treatments for patients? This Director role in our Respiratory & Immunology Research Unit (RIRU) may be of interest.

A Clinical Development Director – Nephrology is sought to provide clinical and scientific insights to the Nephrology franchise including emerging indications and adjacencies. You will work within project teams to plan and assure delivery of clinical research and development activities. You will work closely with research members to define the best clinical indication for a target and integrate inputs from across disciplines (scientific, clinical, commercial, regulatory) to contribute to the Early Medicine Profile, Target Validation plans, and Candidate Selection.

The responsibilities of the Clinical Development Director – Nephrology include (but are not limited to):

1. Designing and leading clinical development protocols/studies/programs in Nephrology across all phases of development.
2. Providing clinical expert input into regulatory documentation and leading regulatory interactions.
3. Working closely with Research Unit members to define prioritized clinical indications and integrate inputs from across disciplines.
4. Design and delivery of an early clinical development plan that effectively demonstrates proof of mechanism, potential efficacy, and a safety profile.
5. Leading the integrated evidence planning to address the needs of regulators, payors, and patients.
6. Participating/leading the clinical team and Integrated Evidence Team.
7. Engaging external academic and clinical experts to enhance quality and delivery of clinical programs/studies.
8. Providing clinical input into presentations and supporting documentation.
9. Accountability for escalation of clinical safety incidents.
10. Clinical input to regulatory documentation to support the desired indication.
11. Responsibility for addressing clinical questions at meetings with regulatory authorities/ethics committees.
12. Accountability for regulatory reporting requirements.
13. Accountable for incorporating patient perspective in the design and conduct of clinical studies.
14. Medical Governance across the project to ensure scientific integrity and overall safety of the study subjects.
15. Providing medical monitoring and oversight of the safety of study participants.

Leadership

Experience in drug development and/or translational medicine, preferably with industry experience.

You will be expected to work across multiple projects and be independently accountable for your own projects.

Provide input into disease area strategy and be capable of executing this strategy based on your own expertise and that gained from your network.

Play a leadership role in medical governance initiatives in R&D.

Mentoring and coaching other members of Clinical Research and Early Programs Immunology.

External networking with academia/pharma, bringing expertise back to GSK.

Why you?

Basic Qualifications:

1. Primary medical qualification and a clinical medical specialty qualification.
2. Significant proven clinical or scientific expertise in nephrology.
3. Industry or Academic experience in translational medicine and early/late phase drug development.
4. Understanding and knowledge of early/late drug development and translational sciences.

Preferred Qualifications:

Please note the following skills are not necessary, just preferred:

1. Primary medical qualification and PhD with a clinical medical specialty qualification in nephrology.
2. Experience in working with relevant regulatory bodies.
3. Project Management experience.

Why GSK?

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people.

Our success absolutely depends on our people. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be.

As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles.

We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

Please note that if you are NOT a passport holder of the country for the vacancy you might need a work permit.

Bank or payment details should not be provided when applying for a job.

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