Clinical Development Scientist

This is what you will do:

The Global Clinical Development Scientist(CDS)is an important part of the Clinical Project Team (CPT) andtheGlobal Study Teams(GSTs),working cross functionally in a matrix environment with other CPT & GST members, Site Management & Monitoringteams, field-based liaisons, and site personnel.TheCDSsupportsandworksclosely with theassignedClinicalDevelopmentphysiciansandtheGlobalClinical Development Leadwith deliverables necessary for effective and efficientClinicalDevelopmentPlandesign and execution.

Accountabilities include clinicaland scientificsupport for the development and implementation of clinical program strategies,design, planning&deliveryof clinical trials, clinical data review,medical monitoring activities,interpretation of results, reporting and activitiesrequiredfor worldwide registration of the product (e.g.clinical input to NDA/BLA).TheCDSmay leadcrossfunctional teams,e.g.in the design of a clinical studyorleadspecific workstreamsrelated to the development program.

TheCDSmay also provide expert input or lead functional process improvement initiatives and provide contributions to cross asset or crosstherapyarea working groups depending on the level of experience.

As a key member of the clinical team, this positionrequiresstrong collaborative communication skills, including the ability to engage with and influence a diverse range of stakeholders both within and external to Alexion. The individual willoperateaccording to the highest ethical standards in compliance with internal SOPs, local regulations,lawsand adhere to Good Clinical Practice and regulatory requirements.

Depending upon experience level, the role will mentor the development of less experienced members of the clinical team.

Responsibilities include:

• Lead and manage the Clinical Sub Team (one of three mandatory GPT sub teams), documentdiscussions andactions.

• Clinical and scientific contributionto thedevelopmentofClinical Development Plans, Clinical Study Design ConceptsandClinicalStudy Protocols, including engaging with relevant internal and external stakeholders.

• Preparationand reviewof clinical study related documents, potentiallyacrossseveral studies in parallel,e.g.design concept,protocols,admin change letters,informed consent forms,charters, summary reports, meeting presentations, publications, and clinical sections of regulatory documents.

• PrepareClinical Developmentmaterials and presentationsfor Governance review. 

• Lead theupdate andreview process for documentsowned by ClinicalDevelopment,e.g.in relation to Protocol Amendments and Admin Change Letters,overseeing the necessary rounds of reviews, obtaining signatures, and uploading to theTMF.

• Serve as the mainClinical Developmentteampoint of contact for communication with sites andglobal and localstudy team members.

• Participate in InvestigatorMeetingplanning and execution.

• Participate and contributeinMedicalMonitoring activities, clean, analyze and review safety and efficacy data toestablishthe presence or absence of trends and follow up asappropriate.

• Contribute to developing presentations and present protocol and trial data to internal stakeholders (e.g., CRA’s, studysubteams) and external stakeholders (e.g.vendors) asrequired.

• Responsible for documentingrelevant discussions,decisions,communication withsitesandtimelyuploading to theTMF.

• May supervise and develop clinical development scientists and/or fellows

• Maintainingawareness 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 

• May providesupport for business development activities, such as due diligence and research collaborations

You will need to have:

• Understanding of general (and specific) therapeutic principles 

• Knowledge in the principles of clinical researchmethodology, statistics, dataanalysisand 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 businessacumen;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

• The duties of this role aregenerally conductedin 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.

We wouldpreferfor you to have:

• Advanced scientific degree (M.S., Ph.D., Pharm D.,MPHor similar degree) 

• PreviousHospitalexperience as a study coordinator or in a similar role in the pastis a plus

• Advanced knowledge of the assigned therapy area

• 5+ years of industry experience in clinical development(previousexpericein clinical operational or clinical development is plus)