Director of Global Drug Safety Science (m/f)
Merck - Darmstadt

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PURPOSE OF THE ROLE

The continuous
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
communication.

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

Functional Tasks:
You ensure access

to an internal and external network of experts to achieve:
  • The
implementation and management of formal panels of internal
experts to

provide
cross-functional knowledge for specific organ-toxicity questions
and

decision-making
(hepatic, renal, haematological, immunological, pulmonary
etc.).

  • Input to the
development of safety biomarker knowledge and technology to
add

value to
clinical development safety decision-making through enhanced
safety

signal
anticipation and evaluation.

  • Incorporation of
simulation and modeling techniques to help inform safety

knowledge in
clinical development.

  • State-of-the-art
safety biostatistical methodology for safety data analysis
and

interpretation.

  • Understanding of
future sources of safety information, including electronic
health

records, claims
databases, social media etc, and planning to incorporate
these

sources into our
safety data acquisition and management.

  • Implementation
of pharmacogenetics/pharmacogenomics into safety strategies

and
decision-making.

  • An effective
interface between pre-clinical and clinical development to
translate

pre-clinical
data into safety strategies for early phase clinical
development.

  • Membership or
affiliation with appropriate external consortia and
policy-forming

or educational
groups.

Managerial Tasks:
  • You manage the Epidemiology Team within GDS.
  • You ensure that
GDS staff are aware of emerging techniques, expertise and

knowledge
related to the value-added potential from safety science.

  • You ensure
budget planning and control, according to agreed targets.

MAIN INTERFACES

Interfaces with other Departments/Functions:
  • Internal GDS
groups (GDSM, GDSO, GDS Regions).

  • GCDC, GRA, GCO,
Medical Information and Communication, MASC, Corporate

Communication,
GPU, Business Units, pre-clinical and toxicology, DMPK.

  • Global Product
Teams, Clinical Development Teams, Project Teams,

Submission
Teams.

External Interfaces:
  • External experts, panels and consortia related to the different
areas identified in

the scope of
safety science.

Qualifications

EDUCATION

  • MD required,
with both clinical and industry (5 to 10 years) experience,
preferably

including both
clinical development and pharmacovigilance experience
(including

early phase
development, signal detection and evaluation, experience of
benefit-

risk evaluation,
and leading teams in development activities).

  • First-hand
experience in handling safety issues related to known target
organ

toxicities (e.g.
hepatic, renal, hematological) and good understanding in the

strategic
therapeutic areas of the Company (oncology, neurodegenerative

diseases and
rheumatology).

  • Recognized
external profile in pharmacovigilance, therapeutic or
clinical

development
networks (e.g. speaker at professional conferences and
workshops,

representation
on external policy-making or educational groups).

  • Working
knowledge of developments in healthcare technology and
science.

  • Excellent
knowledge of product development process and experience of
cross-

functional team
work.

  • Membership in
external scientific societies and/or Industry-Agency
partnerships

is
appreciated.

PROFESSIONAL & TECHNICAL SKILLS

  • Strong team working experience.
  • Successful managerial experience for positions with related
responsibilities.

  • Fluent spoken
and written professional English a must. Any other EU
language

appreciated.

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