Senior Director, Translational Medicine (Mitobridge)
Company: Astellas Pharma
Location: Somerville
Posted on: January 12, 2021
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Job Description:
Developing innovative therapies is one of the most challenging,
most essential and personally rewarding fields in science. This is
the most exciting time to be a part of Astellas, a company with a
uniquely collaborative and patient-focused culture.There's
something special about working at Astellas. It's reflected in our
focus on the people we serve, the way we treat each other and the
results we achieve together as a company.Astellas is announcing a
Senior Director, Translational Medicine (Mitobridge) opportunity at
their Mitobridge site in Cambridge, MA.At Mitobridge, we are
passionate about developing novel therapeutics that improve
mitochondrial function to treat devastating human diseases.
Mitochondrial dysfunction is increasingly linked to disease
pathologies and we believe that 'normalizing' mitochondrial
function can ameliorate or reverse disease states.Purpose:The
Translational Medicine Senior Director works strategically across
Drug Discovery Research (Research) and Medical & Development
(Development) with a focus on generating and exploring
unprecedented therapeutic hypotheses. This involves close
partnership with project teams and external partners from the
earliest stage of target identification through approvals (the main
emphasis will be from pre-candidate through human POC). This role
is the pivotal bridge between Drug Discovery Research at
Mitobridge, Medical & Development and Patient Centricity. The main
objective will be increasing the pace and success rates of POC
clinical trials, leading to high value products in areas of unmet
medical need.Essential Job Responsibilities:As a Member of the
Company's leadership team, contribute to culture, vision, strategy,
goals, budgetsLead the overall Translational Medicine effort and by
working with project teams generate and explore unprecedented
therapeutic hypotheses. This will include devising preclinical and
clinical strategies with a focus on regulatory and medical
approaches to efficiently complete first in human and proof of
concept (POC) trials.Work closely with internal partners including
Drug Discovery Research, Regulatory, Medical & Development and
Business Development, while external interactions span basic and
medical disease experts, global regulatory agencies, patient
advocacy organizations and research foundations, as well as
academic innovators and venture capital companies.Identify KOLs and
lead consultations (individually and via SABs) to define
translation medicine plan and the minimal preclinical package to
support development and also clinical experts to develop POC trials
and endpointsProvide guidance to project teams for identifying
targets, drug candidates and research strategies with a
translational path that enables learning and decision making in
early clinical development.Contribute to scouting and curating
cutting-edge biology-based platforms with a focus on delivering
differentiated products that can address unmet medical
needs.Represent Astellas externally strengthening reputation for
agility in testing new ideas and attract new partnerships and
assets that bring value to Astellas platforms and pipeline. Present
programs at internal and external meetings and conferences.Authors,
edits, reviews and approves study reports and regulatory
submissions from Pre-IND submission through early phase clinical
trials, linking preclinical, PK, PK/PD, efficacy, toxicology and
clinical development.Qualifications:RequiredPhD or MD with 10 years
of industry experience in start-up, biotechnology, or global
pharmaceutical companiesStrong biomedical R&D
backgroundStrategic thinking and technical expertise in varied
areas of research, medicine and drug developmentTranslational
medicine skills and experience, including successfully leading drug
development program(s) from concept to clinical POCStrong
collaborative skills that cross the scientific disciplines involved
in both R&D, along with a willingness to cross those
boundaries.Capable to manage external collaborations with a global
network of scientific, clinical and translational
advisors.Challenges the status quo, identifies and sponsors
transformational change projects that cross Astellas functions and
business units. Champions innovation and strategic capability
building across therapeutic/functional areas, conceptualizing and
creating new work and business opportunities. Develops a culture of
research based on cutting edge methods and practices to create best
in class teams and increased business growth. Pioneers
identification of new or emerging partners and establishes
strategic partnerships to create a win-win
situation.PreferredExperience with late stage clinical development,
e.g., drug approval, NDA, sNDAs, accelerated approval, rare
diseases (orphan designation), global product developmentHighly
developed mastery of the planning, control and monitoring of
complex and highly visible drug development projects and activities
with a minimum of ten years- experience in pharmacology and
translational medicine within the pharmaceutical
industry.Demonstrated scientific and business acumen and the
ability to influence senior leaders and stakeholders and lead
complex partnership and alliance activities.LI-JA1Equal Opportunity
Employer Minorities/Women/Protected Veterans/DisabledCategory
Research and Development
Keywords: Astellas Pharma, Somerville , Senior Director, Translational Medicine (Mitobridge), Executive , Somerville, Massachusetts
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