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Job Description
Job ID:
COMPANY OVERVIEW
This company uses cutting edge science to discover, develop,
manufacture and market therapies for the treatment of
serious diseases with a focus on neurodegenerative
disorders. They are the world’s oldest independent
biotechnology company and a Fortune 500 company with more
than $4 billion in revenues. Patients worldwide benefit from
their products.
This company has a product pipeline that is one of the most
robust in the industry, with 15 programs in in development,
seven of which are Phase III programs. The company’s core
therapeutic areas include neurology, immunology, and
hemophilia. This robust and diverse pipeline is a testament
to the dedication, inspiration and hard work of scientists
who strive to create meaningful therapeutic advancements for
patients.
POSITION OVERVIEW
The Associate Director, Epidemiology is a newly created role
reporting to the Senior Director, Epidemiology. The Senior
Director was hired three and a half years ago to build a
core epidemiology group within the Safety organization. In
the past, there had been pieces of epidemiology expertise
housed within the team but never as an official function.
The talented individual that we seek will be part of this
crucial team and will assist with the continued building and
integration of the epidemiology group into a major asset for
the Safety organization, as well as one that will have
significant ability for impact in the company.
This team consists of 6 talented, PhD level epidemiologists
who have already made substantial progress integrating the
function. It is a fun time to join the company as they have
a robust pipeline of compounds. At this time, there are more
than 20 programs in the clinic, including several in late
stage development.
The new Associate Director will have a high level of
visibility both internally within the group and throughout
the company. Because the epidemiology group is relatively
new, the Associate Director will work with the Senior
Director to provide strategic insight for the growth of
epidemiologic studies, primarily for the clinical
development programs in the neurology and immunology areas;
which includes daclizumab for relapsing forms of MS and an
antisense investigational drug for SMA. In addition, they
may also contribute to other clinical development and
post-marketing programs.
Overall, the primary purpose of the role and, ultimately the
team is to provide high-level epidemiologic support
(conceptual, methodological and statistical) to the
activities of the Safety organization. In addition,
responsibilities will include supporting existing
post-marketing registries/observational studies; design and
conduct of observational studies to support the clinical
trial and post-marketing safety physicians; identification
of opportunities for, and support of, signal detection,
pharmacovigilance, and risk management activities.
The ideal candidates will have the following mix of personal
and professional characteristics:
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PhD, Dr. PH or ScD in epidemiology
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3-5 years relevant pharmacoepidemiology experience,
including 3 years in a pharmaceutical company or CRO
(relevant research experience includes research in the
areas of pharmacoepidemiology, patient-reported outcomes
research or health-related quality of life research)
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Experience in the neurology, immunology or hemophilia
therapeutic area is a plus
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Experience in risk management and signal detection
required
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Expertise in the design, conduct, analysis,
interpretation and communication of observational
studies
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Strong epidemiologic analytical skills demonstrated by
expertise in epidemiologic analyses using SAS, SPSS and
or STATA
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Understanding of the pharmaceutical industry in general
and specific to epidemiology.
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Working knowledge of guidance's, and legal and
regulatory principles applicable to safety surveillance
and pharmacoepidemiology
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Experience designing and conducting data base studies
(i.e. GPRD, IHCIS) for data mining or epidemiologic
research
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Ability to resourcefully provide estimates of incidence
and prevalence of health conditions, disease progression
and disease-specific risk factors
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Experience with questionnaire and CRF design (including
PRO/HRQoL)
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Understanding of PSURs/PRs, pharmacovigilance, and Risk
Management plans
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Close attention to detail as required when working in a
Safety organization
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Ability to work in a multi-disciplinary team setting and
employ a team approach to decision making
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Excellent communication skills, both oral and written
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