Medical Director, Clinical Development, Immunology
Company: Biogen Idec
Location: Somerville
Posted on: January 12, 2021
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Job Description:
Job DescriptionThe position of Medical Director, Clinical
Development sits in the Immunology emerging therapeutic area --- a
component of the Clinical Development Organization. The new Medical
Director will support one or more development programs involving
products in Lupus or other autoimmune disease. They will work in
close collaboration with the Medical Director and cross-functional
clinical study teams and provide clinical science support for
assigned programs in immunology. The initial focus will be in
leading designing clinical development protocol and clinical trial
in late development. Activities include direct responsibility for
advancing high priority clinical programs through clinical study
design, protocol development and study conduct.The Medical Director
has the following responsibilities: Will report to a more senior
member of the immunology-rheumatology clinical team who has direct
responsibility for the overall research strategy and clinical and
scientific development activities.Will lead conceptualization and
development of clinical trials in conjunction with multiple
functions, including development from inception of trials in new
indications.Drive development of clinical development plans and
protocols for clinical studies; May serve on one or more study
management teams as a clinical development functional area leader,
participating in all aspects of trial execution as required,
including presenting at clinical study investigator meetings,
monitoring and reviewing incoming safety &efficacy data,
engaging with study physicians, reviewing final data outputs and
other activities as needed.Provide ongoing medical expertise and
medical oversight of clinical trials, including eligibility
evaluation and toxicity management, in conjunction with external
and internal partners.Prepare and/or provide input to clinical
study related and other regulatory documents (e.g. CSRs, IBs,
PIS/ICFs, SAPs, Data Management Plans, IND, briefing books);Provide
clinical scientific input to business development (e.g. due
diligence);Provide medical leadership for programs that integrate
the individual---s knowledge in in basic science, drug development,
and medical practice with input from the medical community around
the world.Develop and deliver presentations to internal and
external stakeholders.Elaborate and integrate the scientific and
clinical rationales, regulatory requirements to support buidling a
solid Clinical Development Plan (CDP), including appropriately
aggressive clinical development timelines, incorporating key
decision points and Go/No Go criteria for each CDP.Must ensure
adherence to all requirements of good study conduct and standards
of Good Clinical Practice.May interface with key medical experts
and represent the team at medical congresses and
conferences.LI-NM1QualificationsBiogen is excited to expand the
immunology space and add depth to their Clinical Development Team.
The ideal candidate will have the following mix of professional and
personal characteristics:MD/MD-PhD with Immunology-Rheumatology
training, ideally with a clinical background in Lupus.Five (5)
years of experience including clinical research in academia and
progressive responsibilities in drug development in industry
(clinical trial experience mandatory). Industry experience in
immunology, specifically Lupus strongly preferred.Capacity and
willingness to work effectively across disease areas.Demonstrated
leadership and team building skills as well as the ability to
perform effectively in a dynamic environment.Ability to compile and
present development plans, study designs, analyses of data in
forums consisting of individuals representing a variety of
functions (eg, both with and without scientific
backgrounds).Excellent communication skills (oral and written) and
excellent organizational skills.The ability to lead directly and by
influence, including strong problem solving, conflict resolution,
and analytical skills. Must be able to work with minimal
supervision.Ability to represent the department on project teams,
committees and at external meetings.Able to work collaboratively in
a multi-disciplinary team setting and employ a team approach to
decision-making.Ability to balance multiple competing demands and
meet aggressive timelines.Scrupulous attention to detail, clear
ability to think critically, establish and maintain rapid
timelines, and persistent commitment to ensuring a high level of
quality.Ability to travel domestically and internationally to
company, scientific, regulatory, investigator, and other meetings
(20%-30% potential travel, within current COVID-19
regulation).Additional InformationThe position of Medical Director
Clinical Development sits in the Immunology emerging therapeutic
area --- a component of the Clinical Development Organization. The
new Medical Director will support one or more development programs
involving products in Lupus or other autoimmune disease. They will
work in close collaboration with the Medical Director and
cross-functional clinical study teams and provide clinical science
support for assigned programs in immunology. The initial focus will
be in leading designing clinical development protocol and clinical
trial in late development. Activities include direct responsibility
for advancing high priority clinical programs through clinical
study design, protocol development and study conduct.Location is
flexible to Cambridge MA, Maidenhead UK, or Baar
Switzerland.SummaryType: Full-timeFunction: Other
Keywords: Biogen Idec, Somerville , Medical Director, Clinical Development, Immunology, Executive , Somerville, Massachusetts
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