Astellas Pharma Senior Director, Translational Medicine (Mitobridge) in Cambridge, Massachusetts
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.
The Translational Medicine Senior Director works strategically across the entire spectrum of drug development to implement discovery, translational and clinical research that support our therapeutic programs. This involves close partnership with internal team leaders and external partners from the earliest stage of target identification through to approval and life cycle management. This role is the pivotal bridge between Drug Discovery Research at Mitobridge, development project teams, M&D and Patient Centricity. This role is essential to increase the pace and success rates of proof-of concept clinical trials, leading to focused investment on high value clinical assets.
Essential Job Responsibilities:
- Reporting to the President, the Senior Director of Translational medicine will be part of the Company's leadership team. He/she will build and lead the Company's scientific vision and strategy, which includes scouting and curating cutting-edge biology-based platforms with a focus on delivering differentiated products that can address unmet medical needs.
- The Senior Director identifies opportunities to improve and expand overall R&D vision, strategy, capabilities by bringing innovative solutions to solve new drug development challenges. Internal partners include Drug Discovery Research (all sites and specialties), 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.
- Establish and lead the overall Translational Medicine effort, integrating development and prioritization of therapeutic hypotheses, preclinical research, toxicology and biomarker assay development, with clinical strategies including pharmacology, regulatory and medical to design and efficiently complete first in human and proof of concept (POC) trials.
- Communicate and lead an updated drug discovery strategy and roadmap with a particular emphasis on leveraging translational sciences to improve proficiency in completing POC clinical trials that support Go/NoGo decisions for specific therapeutic hypotheses. Support a team of direct reports, secondment scientists, external KOLs and/or CRO partners.
- Ensures late stage preclinical (e.g., IND enabling) and clinical study (e.g., therapeutic hypothesis and specific patient population) deliverables are met according to specified timelines, budgets, quality and resources, working in close collaboration with internal and external stakeholders including project teams, research organizations, regulatory authorities and other stakeholders.
- 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 endpoints
- Provides 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. Authors, edits, reviews and approves study reports and regulatory submissions from Pre-IND submission through early phase clinical trials, linking preclinical, PK, PD, efficacy, toxicology and clinical development
- Anticipate the evolution of medical treatment and other drug development in critical disease areas. Incorporate strategies for patient characterization/ precision medicine to differentiate and add value to Astellas assets. Support back translation, so that clinical results drive further discovery efforts Presentation of programs at internal and external meetings and conferences.
- Represent Astellas externally as an innovative drug developer, strengthen reputation for agility in testing new ideas and attract new partnerships and assets that bring value to Astellas platforms and pipeline.
- Manage external collaborations with a global network of scientific, clinical and translational advisors. Establish and maintain clinical Translational bioassays capability through combination of internal assets and external CROs to complete research supporting clinical trial objectives.
- Facilitate the establishment and maintenance of effective collaborations with academic institutions and patient foundations.
- Develop and manage yearly budget for the department and ensure appropriate alignment to agreed portfolio. Participate and represent area of expertise in the Company's Mid-term Business Planning process.
- Liaise effectively with parent company and other internal stakeholder groups/personnel to advance the Company's R&D pipeline and promote a highly collaborative operating culture.
- Perform other duties as directed.
- PhD or MD with 10+ years of industry experience in start-up, biotechnology, or global pharmaceutical companies
- A strong biomedicinal background enables a biology-based approach that is foundational to modern medicine.
- The position requires strategic thinking and technical expertise in varied areas of research, medicine and drug development.
- Translational medicine skills and experience at successfully leading drug programs from concept to clinical POC and approval are essential. Capable to manage external collaborations with a global network of scientific, clinical and translational advisors.
- Strong collaborative skills that cross the scientific disciplines involved in both R&D, along with a willingness to cross those boundaries.
- 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.
- At least 5 years experience as head of R&D function
- late stage clinical development, e.g., drug approval, NDA, sNDAs, accelerated approval, rare diseases (orphan designation), global product development
- clinical and biomarker strategies to develop and differentiate products in market, to patients, prescribers, regulators and payors.
- Highly 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.
- Record of successful support of multiple, complex, global translational medicine clinical projects and related deliverables.
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled
Category Research and Development