Director Physician, Hepatic SKG expert
Company: AstraZeneca
Location: Montgomery Village
Posted on: June 26, 2025
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Job Description:
The Clinical expert in the Hepatic Safety Knowledge Group (SKG)
manages a diverse range of activities related to monitoring,
diagnosis, and mitigation of drug/biological-induced hepatic
toxicity in a matrix environment. The role holder leads or
contributes to cutting edge drug/biological-induced liver toxicity
projects on a global basis. The Clinical expert in the Hepatic SKG
will be influencing the shaping of the organisation by inputting
into strategic direction and applying a full understanding of
global issues related to drug/biological-induced liver toxicity.
The role impacts the entire function and the broader AZ
organization. Responsible for acting as an expert involved in the
design, conduct, monitoring, data interpretation and reporting of
individual clinical trials. Ensures projects adhere to Good
Clinical Practice and regulatory requirements. Will be responsible
for contributing to the development of the functional strategy or
act as renowned expert in own field. Main Duties and
Responsibilities: Acts as an expert involved in the design,
conduct, monitoring, data interpretation and reporting of potential
clinical safety signals related to liver toxicity which arise
during the conduct of clinical trials. Contributes to scientific
research around drug-induced liver injury, having a strong presence
at internal and external conferences, and delivering key scientific
publications Contributes to global collaborative research projects
for state-of-the-art detection, management, and mitigation of
clinical safety signals related to liver toxicities Ensures the
research projects related to drug-induced organ toxicity adhere to
Good Clinical Practice and regulatory requirements. Acts as
renowned expert in liver safety to provide expert scientific and
medical input to Patient Safety activities, with special focus on
cross-project and cross-TA activities of a scientific nature Leads
or contributes to the development of scientific methods applied to
a wide range of safety data related to drug-induced drug/biological
induced liver toxicity Works with relevant stakeholders to enhance
visualisation and presentation of liver safety data Provides
support, as needed, for discussions with internal governance and
international regulatory bodies Leads or contributes to key cross-
industry activities around drug-induced liver injury research, such
as research consortia Contributes to improved understanding and
prevention of drug/biological-induced liver toxicity issues across
functions within the company and across Pharmaceutical Companies
and Regulatory Authorities. Lead initiatives to increase
cross-company knowledge of drug-induced liver injury through
training and other activities Works as part of a cross functional
team in drug/biological-induced organ toxicity biomarker
development and preclinical strategies Promotes safety sciences and
clinical safety across projects and therapeutic areas Essential
Requirements: Medical degree with strong clinical experience in
hepatology Specialty training and/or board certification in a
relevant speciality (e.g., hepatic medicine/hepatic surgery) > 3
years of clinical development/patient safety experience in
industry, or other relevant experience Experience in leading or
contributing to relevant development programmes (e.g., those in
liver disease, or developing products with liver safety signals)
Experience working with regulatory agencies, preparing regulatory
documents and overseeing submissions. Highly developed levels of
conceptual thought and strategic vision to manage the highest level
of risk. Ability to balance business and clinical research
objectives A thorough knowledge of the pharmaceutical industry,
especially clinical research, safety and global regulatory
requirements and practices governing expedited and periodic safety
reporting, signal generation, safety evaluation and risk management
activities Proven high quality scientific track record Excellent
verbal and written communication skills Experience in leading of
cross-functional teams Broad knowledge of drug development
Desirable Requirements: Extensive general medical knowledge and
academic/research experience Experience of being a member of a
company Hepatic Safety expert group (or similar), assessing liver
cases for causality across a range of products Experience in safety
data analytics and visualisation of liver safety data (such as
through Spotfire or R analytics programmes) including experience of
hepatotoxicity signal detection. Demonstrated capability to lead
implementation of new technology and/or working routines within a
complex organization. Drug development / patient safety experience
across therapeutic areas, including liver diseases or Oncology
Proven ability in leading in a cross- industry project or consortia
Publications in safety-related scientific research Strong
team-working skills and an ability to work collaboratively in a
global pharmaceutical environment Strategic thinking Strategic
influencing Date Posted 13-Jun-2025 Closing Date 30-Jul-2025Our
mission is to build an inclusive and equitable environment. We want
people to feel they belong at AstraZeneca and Alexion, starting
with our recruitment process. We welcome and consider applications
from all qualified candidates, regardless of characteristics. We
offer reasonable adjustments/accommodations to help all candidates
to perform at their best.
Keywords: AstraZeneca, Frederick , Director Physician, Hepatic SKG expert, Science, Research & Development , Montgomery Village, Maryland
