PURPOSE OF THE ROLE
management of the safety profile of Merck Serono products,
allowing efficient risk management, proactive risk minimization
measures, contribution to ongoing evaluation of benefit-risk, and
sustained high level compliance with worldwide regulations,
requires effective medical, technical and scientific expertise in
safety data collection, evaluation, interpretation and
The overall goal of the Director of Global Drug Safety Science
(GDSS) is to provide GDS and other Merck Serono staff with
state-of-the-art safety thinking and methodology for safety
decision-making. This includes, but is not limited to, safety
biomarkers, organ-specific toxicities, translational safety,
modeling and simulation, safety biostatistics, pharmacogenetics,
and strategies for alternative sources/databases for safety data
collection. This is achieved through internal and external
networks leading to the development and maintenance of an
internal knowledge base with access to relevant experts. This
will add value through enhanced signal anticipation and
evaluation, leading to safety decision-making earlier in clinical
development with better focused target indications and
populations, including opportunities for personalized healthcare.
The GDSS Director interfaces with the Global Drug Safety
Operations (GDSO) and Global Drug Safety Medicine (GDSM) groups
to develop a shared understanding of opportunities for innovation
and to ensure that the current and future needs of these GDS
customers are met.
The GDSS Director contributes to the safety strategy for the
product portfolio as the Scientific Secretary for the GDS Peer
Review and Challenge Board.
KEY TASKS & RESPONSIBILITIES
You ensure access
to an internal and external network of experts to achieve:
implementation and management of formal panels of internal
cross-functional knowledge for specific organ-toxicity questions
(hepatic, renal, haematological, immunological, pulmonary
development of safety biomarker knowledge and technology to
clinical development safety decision-making through enhanced
anticipation and evaluation.
simulation and modeling techniques to help inform safety
safety biostatistical methodology for safety data analysis
future sources of safety information, including electronic
databases, social media etc, and planning to incorporate
sources into our
safety data acquisition and management.
of pharmacogenetics/pharmacogenomics into safety strategies
interface between pre-clinical and clinical development to
data into safety strategies for early phase clinical
affiliation with appropriate external consortia and
GDS staff are aware of emerging techniques, expertise and
- You manage the Epidemiology Team within GDS.
- You ensure that
related to the value-added potential from safety science.
budget planning and control, according to agreed targets.
Interfaces with other Departments/Functions:
groups (GDSM, GDSO, GDS Regions).
Medical Information and Communication, MASC, Corporate
GPU, Business Units, pre-clinical and toxicology, DMPK.
Teams, Clinical Development Teams, Project Teams,
areas identified in
- External experts, panels and consortia related to the different
the scope of
with both clinical and industry (5 to 10 years) experience,
clinical development and pharmacovigilance experience
development, signal detection and evaluation, experience of
and leading teams in development activities).
experience in handling safety issues related to known target
hepatic, renal, hematological) and good understanding in the
therapeutic areas of the Company (oncology, neurodegenerative
external profile in pharmacovigilance, therapeutic or
networks (e.g. speaker at professional conferences and
on external policy-making or educational groups).
knowledge of developments in healthcare technology and
knowledge of product development process and experience of
external scientific societies and/or Industry-Agency
PROFESSIONAL & TECHNICAL SKILLS
- Strong team working experience.
- Successful managerial experience for positions with related
and written professional English a must. Any other EU