- Leading Early-Global Project Team Leads
- Optimize program management and oversight of research projects through eGPT leads in Research moving from lead candidate identification to IND filing. The leader will contribute to research portfolio management by collaborating with Research and Project Management functions.
- Providing central oversight of early Global Project Team leads and ensuring research efforts are launched at the appropriate time to meet IND filing milestones for the late stage Research projects
- Leading Translational Research
- Launch translational research efforts in a timely manner from target selection onwards to ensure on time availability of biomarker plans and bench-to-bed translational strategies for development programs:
- Provide scientific leadership in areas of biomarker discovery, development and translational research collaborating with multiple cross-functional teams across R&D
- Collaborate across R&D functions to develop scientifically rigorous translational and biomarker strategies ahead of clinical development milestones that are based on AstraZeneca's 5R framework to assess proof of mechanism, demonstrate early signs of efficacy, support patient selection and generate an understanding of the variability in patient response.
- Accountable for delivering the biomarker section of exploratory endpoints in CDP and clinical study protocols.
- Collaborate with key stakeholders in R&D on companion diagnostics strategy to champion diagnostic development during the early clinical development.
- Support scientific input and review of all translational research aspects of clinical and regulatory documents, including but not limited to development plans, study protocols, clinical study reports, and regulatory submissions.
- Foster external/academic collaboration on translational research to enrich and refine prognostic, diagnostic and predictive biomarkers and potential companion diagnostic opportunities
- Have a dotted line into the head of Development, Regualtory, and Safety, joining key DRS leadership team meetings and:
- Collaborate with Clinical Development leaders (Clinical Pharmacology, Immunogenicity Sciences and Early Clinical Development leaders) to implement the continuum of translational strategies from pre-IND to post-IND stage.
- Contribute to key development milestones with optimal data package in timely fashion by nurturing and facilitating a collaborative culture across R&D.
- Ensure the department achieves the highest levels of Scientific Excellence
- Expand and continuously improve our technologies, processes and platforms
- Hire, train and develop scientists, clinicians and subject matter experts to ensure the success of Alexion programs
- Identify new technologies, processes and platforms that will enable Alexion to conduct its internal research with ever improving quality, speed and productivity
- Drive the behaviors and values identified as critical to Alexion's success and the Research group in particular
- Serve as an active member of the Alexion Research and Product Development leadership team that is accountable for executing strategies to achieve vision and goals
- Provide advice, mentoring and support to the cross-functional/matrix Research teams as needed
- Development and execution of a strategy and business plan for the Translational Sciences team that supports the Alexion vision and strategy as a whole
- Ph.
- Demonstrated track record of success in the discovery and development of new therapeutics ideally in the area of rare diseases. Management experience, preferably in industry. Responsibilities would have included strategic, and technical oversight of the drug development process in some capacity.
- 15 years of experience in drug discovery and early development
- The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.
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Vice President, Head of Translational Sciences - Boston, United States - Alexion Pharmaceuticals, Inc.
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Description
This is what you will do:
The Head of Translational Science will be responsible for driving growth and expansion of the translational sciences team.
The leader will enable agile Translational Science support for complement and beyond-complement portfolio in each of the Alexion therapeutic areas of interest (rare hematology, nephrology, neurology, musculoskeletal, cardio and metabolic diseases).
This leader will ensure scientific leadership in developing and executing biomarker plans, collaboration across R&D and implementation of bench-to-bedside translation strategies.
The leader will also build translational research capabilities, supporting the efforts to create strong data driven program justifications using AstraZeneca's 5R development principles (right target, right tissue, right patient, right safety, right commercial potential.) The leader will be responsible for instituting consolidated oversight for late-stage research projects, ensuring close collaboration on key deliverables across R&D and building bridges on translational research initiatives and topics across business units within AstraZeneca.
The leader will be a key member of the Research Steering Committee (responsible for governing the research portfolio), rare Early Stage Product Committee (rESPC) and business development committee for the rare disease business unit.
Participation in these key governance teams offers the leader a voice in decisions that drive the success of the overall enterprise.
With a dotted-line into the Head of Development, Regulatory, and Safety (DRS), this role will also be responsible for supporting the connection and collaboration between Research and DRS and be accountable for implementing translational strategies throughout drug development at Alexion.
You will be responsible for:
Functional leadership of all the groups responsible for leading late stage research projects under 1) early global project team leads (eGPTLs) and 2) translational research group, including:
Additionally, the Head of Translational Sciences will:
You will need to have:
This role has an expectation of working in the office 3 days a week.
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines.
In-person working give us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.Vaccination status
AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.
We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.
We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
Working at AlexionThe Highest Standards
By operating with the highest standards of ethics and integrity, we aspire to live up to the expectations of patients, physicians, and ourselves, and to earn trust in our communities.
We encourage diversity of backgrounds and ideas.
We genuinely care for and respect each other, working together as a high-performing team to deliver extraordinary results while embracing different perspectives.
DedicationThe dedication and passion of our employees enable us to stay focused on what matters most.
We push ourselves to achieve the highest level of medical innovation, and to redefine what it means to live with a rare disease.
AstraZeneca embraces diversity and equality of opportunity.We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.
We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.