Alexion Pharmaceuticals Associate Director, Clinical Development Scientist in Boston, Massachusetts
Some opportunities happen only once in a lifetime - like a job where you have the chance to change lives. At Alexion, people living with rare and devastating diseases are our Guiding Star. We are driven to continuously innovate and create meaningful value in all we do to help patients and families fully live their best lives. We value the uniqueness and diversity of our employees and recognize that nurturing the diverse perspectives and strengths of our people translates into innovative breakthroughs for patients.
This is what you will do:
The Associate Director, Clinical Development Scientist (CDS) may lead a cross functional team in the design and execution of a clinical study and may provide input into the global clinical development plans and strategy for a therapeutic area. The job holder supports assigned clinical development physician(s) and the therapeutic area head with deliverables necessary for effective and efficient clinical development plan design and execution and therapeutic area strategy.
You will be responsible for
Lead a team in preparation of clinical study related documents including protocols, charters, statistical summary reports, meeting presentations, publications, and clinical sections of regulatory documents (may manage several studies in parallel).
Lead a study team to design a clinical protocol, including engaging with relevant internal and external stakeholders; responsible for preparing materials and protocol defense presentation for C-PRC review. Represent the clinical study team at the clinical subteam.
May supervise and develop clinical development scientists and/or fellows; Lead a team in preparation of clinical study related documents including protocols, charters, statistical summary reports, meeting presentations, publications, and clinical sections of regulatory documents
Participate in Investigator meeting planning and execution and/or on-site initiation meetings
Lead the execution of clinical trials; Monitor, clean, analyze and review safety and efficacy data to establish the presence or absence of trends and follow up as appropriate.
Lead a team in study execution, including country and site selection, site training and start-up and data monitoring; expertise in data analysis and presentation required. Depending upon specific expertise in translational science, may lead a translational sub team of the clinical team.
Liaise with other functions to design external expert consultations, contribute to the development of study concepts and designs, protocols and study essential documents. Engage with clinical investigators on clinical studies to enable quality clinical execution, analyze and interpret clinical data, and collaborate with the broader team to define clinical and therapeutic area strategy. Engage with investigators, site staff, CROs, and site monitors to maintain enthusiasm and support enrollment for ongoing clinical studies. Where appropriate, serve as the SME for identification, translation, inclusion, implementation and reporting related to liquid, tissutal and/or imaging endpoints.
Lead the execution of clinical trials and associated data collection activities, providing guidance to the clinical study team related to:
country and site feasibility assessments and selection
site training and oversight
ongoing data monitoring
Maintain awareness of internal and external developments (scientific, clinical, competitive, and regulatory) that could impact the development plan, including attendance at major scientific conferences, participation in competitive intelligence activities, and periodic literature review Critically evaluate available information about diseases of interest to the therapeutic area and the competitive landscape and synthesize information succinctly to support dissemination and incorporation into clinical development programs, asset plans and therapeutic area strategy
Help to determine appropriate advisory boards experts
Provide support for business development activities, such as due diligence and research collaborations
May serve as the Translational Science lead for one or more programs
You will need to have:
Understanding of general (and specific) therapeutic principles
Knowledge in the principles of clinical research methodology, statistics, data analysis and interpretation
Familiar with scientific literature searches and weighing of quality peer reviewed data
Ability to clearly communicate to internal and external stakeholders orally and in writing
For those assigned to clinical endpoint support, e.g., imaging, experience in at least one meaningful modality, e.g., ultrasound, computerized tomography, magnetic resonance, positron emission tomography
Specific therapeutic area experience
Basics of strategic vs. tactical thinking
Experience in interacting with varying levels of internal/external management and/or academicians and/or clinicians and/or scientists, etc.
Strong business acumen; including in-depth knowledge of the multidisciplinary functions involved in a company’s drug development process, e.g., clinical operations, biostatistics, regulatory, commercial operations, etc. and can proactively integrate multiple perspectives into the clinical development process for best end-results
5+ years of industry experience in clinical development is preferred
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.
Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases and devastating conditions through the discovery, development and commercialization of life-changing medicines. Headquartered in Boston, Massachusetts, Alexion has offices around the globe and serves patients in more than 50 countries. Further information about Alexion can be found at: www.alexion.com.
Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, parental status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact accommodations@Alexion.com. Alexion participates in E-Verify.
As a leading employer in our industry, Alexion offers a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more.
AstraZeneca completed its acquisition of Alexion, marking the creation of Alexion, AstraZeneca Rare Disease. If you're interested in career opportunities with AstraZeneca, click here (https://careers.astrazeneca.com/) .