Senior Director Physician – Renal SKG Lead

The clinical Renal Safety Knowledge Group (SKG) Lead manages a diverse range of activities related to monitoring,

diagnosis, and mitigation of drug/biological-induced renal toxicity in a matrix environment. The role holder inspires,

manages, and leads cutting edge projects to better understand and characterise drug/biological-induced renal toxicity on a

global basis. The Renal SKG Lead will be influencing the shaping of the organisation by providing strategic direction and

applying a full understanding of global issues related to drug/biological-induced renal toxicity. The role leads efforts related

to renal safety within the broader AZ organization.

Responsible:

Acts as an expert involved in the design, conduct, monitoring, data interpretation and reporting of potential clinical

safety signals related to renal toxicity which arise during the conduct of clinical trials.

Manages global research projects for state-of-the-art detection, management, and mitigation of clinical safety signals

related to renal toxicities

Ensures the research projects related to drug-induced renal toxicity adhere to Good Clinical Practice and regulatory

requirements.

Acts as renowned expert in own field to provide expert scientific and medical input to Global Patient Safety activities,

with special focus on cross-project and cross-TA activities of a scientific nature

Leads and endorses the development of scientific methods applied to a wide range of safety data related to drug-

induced drug/biological induced renal toxicity

Promotes safety sciences and clinical safety across projects and therapeutic areas
Provides support, as needed, for discussions with internal governance and international regulatory bodies
Contributes to improved understanding and prevention of drug/biological-induced renal toxicity issues across functions

within the company and across Pharmaceutical Companies and Regulatory Authorities.

Contributes to the implementation of the Global Patient Safety strategy, and to the successful implementation of the

global working model for Clinical Safety.

Leads the drug/biological-induced renal toxicity biomarker development and collaborates with the Preclinical SKG lead

on preclinical strategies

Essentials:

Medical practitioner with at least 5 years drug development experience.
Specialised in Nephrology or related specialty (board certified)
Regulatory Agency interactions (authoring briefing documents / regulatory responses / label discussions)
Leading cross-functional teams
Broad knowledge of drug development and global regulatory requirements with regards to renal-specific safety evaluation, safety reporting and risk management strategies
Influencing skills, excellent verbal and written communication skills
Capable of conceptual thinking and strategic vision with respect to renal toxicity
Ability to identify and mitigate against renal toxicity risks.
Ability to establish causality in cases of renal injury.
Ability to define best practices in renal safety.

Desirable:

At least 2 years of patient safety experience
Setting up internal and external collaborations (e.g. safety consortia) to promote organ safety

· Demonstrated experience in adopting new technology (biomarkers, etc.) ·Strategic thinking and influencing with respect to renal safety