Associate Director, Clinical Development Scientist (Alexion)

Alexion has over 3,000 talented colleagues dedicated to serving people living with rare diseases in more than 50 countries around the world. Our global headquarters are based in Boston, Massachusetts and our EMEA headquarters are in Zürich, Switzerland and Barcelona, Spain. We also have a Research Center of Excellence in New Haven, Connecticut, global supply chain and operations headquarters in Ireland, as well as local and regional operations in countries around the world, including Poland.

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:

• Leading 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).

• Leading 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 sub team.

• 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 

• Participating in Investigator meeting planning and execution and/or on-site initiation meetings

• Leading 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.

• Leading 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.

• Liaising 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.

• Leading the execution of clinical trials and associated data collection activities, providing guidance to the clinical study team related to:-site training and oversight ;patient recruitment ;country and site feasibility assessments and selection ; ongoing data monitoring ; study closeout

• 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 

• Helping to determine appropriate advisory boards experts

• Providing 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

• 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 would prefer for you to have:

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

• Preferred: Advanced knowledge of the assigned therapy area is desired

• 5+ years of industry experience in clinical development is preferred

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 authorisation and employment eligibility verification requirements.