Alexion Pharmaceuticals Clinical Development Scientist in Boston, Massachusetts
The Clinical Development Scientist (CDS) provides 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. The successful candidate will 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 onclinical studies to enable quality clinical execution, analyze and interpret clinical data, and collaborate with the broader team to define clinical and therapeutic area strategy. Depending upon specific expertise, the CDS may hold the role of subject matter expert in specific fields such as liquid and tissue biomarker or imaging endpoints.
Job Duties & Responsibilities
Accountable for supporting the design and execution of clinical trials and associated data collection activities, within a therapeutic area
- Collaborate on, or lead where appropriate, the preparation of clinical study related documents including protocols, charters, statistical summary reports, meeting presentations, publications, and clinical sections of regulatory documents.
- Provide input to the study team for country and site feasibility assesments
Collaborate with the clinical study team in site identification and selection, and provide assistance with study start-up activities,
Participate in the development of clinical study protocol concept sheets and protocols, study operations manuals, and other study essential documents.
Support CRAs/CROs on study protocol and related questions and serves as point of contact for managing/answering questions relating to trial procedures.
Participate in Investigator meeting planning and execution and/or on-site initiation meetings
Monitor, clean, analyze and review safety and efficacy data to establish the presence or absence of trends and follow up as appropriate.
Engage with investigators, site staff, CROs, and site monitors to maintain enthusiasm and support enrollment for ongoing clinical studies.
Review and synthesize scientific literature and competitive intelligence to support study and program strategy
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
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.
Help determine appropriate advisory boards experts
Support development ofpublications arising from studies and other relevant initiatives.
Provide support for business development activities, such as due diligence and research collaborations.
Where appropriate, serve as the SME for identification, translation, inclusion, implementation and reporting related to liquid, tissutal and/or imaging endpoints.
Advanced scientific degree (M.S., Ph.D., Pharm D., MPH or similar degree) required, with 2 years of experiencesupporting industry-sponsored clinical trials in the biopharmaceutical industry or equivalent experience in an academic or clinical research setting
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
Project management skills: can prioritize multiple tasks and goals to ensure the timely, on-target and within-budget accomplishment of such by using appropriate software based tools
Some opportunities happen only once in a lifetime - like a job where you have the extraordinary opportunity to change lives. At Alexion, such opportunities arise through our unwavering mission to serve patients and families affected by rare diseases. These patients are our guiding star, and we act with integrity, urgency, and discipline because we know their lives are at stake.
Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases through the discovery, development and commercialization of life-changing therapies. As the global leader in complement biology and inhibition for more than 20 years, Alexion has developed and commercializes the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), and anti-acetylcholine receptor (AchR) antibody-positive generalized myasthenia gravis (gMG). Alexion also has two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare metabolic disorders, hypophosphatasia (HPP) and lysosomal acid lipase deficiency (LAL-D). In addition, the company is developing two late-stage therapies, a second complement inhibitor and a copper-binding agent for Wilson disease. Alexion focuses its research efforts on novel molecules and targets in the complement cascade and its development efforts on the core therapeutic areas of hematology, nephrology, neurology, and metabolic disorders. Alexion has been named to the Forbes list of the World's Most Innovative Companies seven years in a row and is headquartered in Boston, Massachusetts' Innovation District. The company also has offices around the globe and serves patients in more than 50 countries.
Alexion's aspiration is to be the most rewarding place to work, where people are empowered to make a difference and where diversity of backgrounds and ideas is encouraged. We are looking for talented individuals who share our passion and commitment to change the lives of patients with rare diseases. We hope you will consider joining our team. Further information about Alexion can be found at: www.alexion.com.
As a leading employer in our industry, Alexion is proud to offer 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.