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) and the Global Study Teams (GSTs), working cross functionally in a matrix environment with other CPT & GST members, Site Management & Monitoring teams, field-based liaisons, and site personnel. The CDS supports and works closely with the assigned Clinical Development physicians and the Global Clinical Development Lead with deliverables necessary for effective and efficient Clinical Development Plan design and execution.

Accountabilities include clinical and scientific support for the development and implementation of clinical program strategies, design, planning & delivery of clinical trials, clinical data review, medical monitoring activities, interpretation of results, reporting and activities required for worldwide registration of the product (e.g. clinical input to NDA/BLA). The CDS may lead cross functional teams, e.g. in the design of a clinical study or lead specific workstreams related to the development program.

The CDS may also provide expert input or lead functional process improvement initiatives and provide contributions to cross asset or cross therapy area working groups depending on the level of experience.

As a key member of the clinical team, this position requires strong collaborative communication skills, including the ability to engage with and influence a diverse range of stakeholders both within and external to Alexion. The individual will operate according to the highest ethical standards in compliance with internal SOPs, local regulations, laws and 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), document discussions and actions .

• Clinical and scientific contribution to the development of Clinical Development Plans, Clinical Study Design Concepts and Clinical Study Protocols, including engaging with relevant internal and external stakeholders.

• Preparation and review of clinical study related documents, potentially across several 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.

• Prepare Clinical Development materials and presentations for Governance review.

• Lead the update and review process for documents owned by Clinical Development, e.g. in relation to Protocol Amendments and Admin Change Letters, overseeing the necessary rounds of reviews, obtaining signatures, and uploading to the TMF.

• Serve as the main Clinical Development team point of contact for communication with sites and global and local study team members.

• Participate in Investigator Meeting planning and execution.

• Participate and contribute in Medical Monitoring activities, clean, analyze and review safety and efficacy data to establish the presence or absence of trends and follow up as appropriate.

• Contribute to developing presentations and present protocol and trial data to internal stakeholders (e.g., CRA's, study subteams) and external stakeholders (e.g. vendors) as required.

• Responsible for documenting relevant discussions, decisions, communication with sites and timely uploading to the TMF.

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

• Maintaining 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

• May provide support 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 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

• 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.

We wouldpreferfor you to have:

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

• Previous Hospital experience as a study coordinator or in a similar role in the past is a plus

• Advanced knowledge of the assigned therapy area

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