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Senior Director, Translational Medicine (Mitobridge)

Company: Astellas Pharma
Location: Somerville
Posted on: January 12, 2021

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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