Associate Director Clinical Development Scientist

The Associate Director Clinical Development Scientist (CDS) may lead a cross functional team in the design and 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 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 CPRC 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 and/or onsite initiation meetings

• Lead the 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 including country and site selection site training and startup 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 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 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

  • patient recruitment

  • ongoing data monitoring

  • study closeout

• 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

• PhD

• 5 years of industry experience in clinical development

• 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 indepth knowledge of the multidisciplinary functions involved in a companys 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 endresults

The annual base pay for this position ranges from $138736.00 $208104.00 Annual. Hourly and salaried nonexempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors including market location jobrelated knowledge skills and experience. In addition our positions offer a shortterm incentive bonus opportunity; eligibility to participate in our equitybased longterm incentive program (salaried roles) to receive a retirement contribution (hourly roles) and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program 401(k) plan; paid vacation and holidays; paid leaves; and health benefits including medical prescription drug dental and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired employee will be in an atwill position and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time including for reasons related to individual performance Company or individual department/team performance and market factors.

Date Posted

29Apr2025

Closing Date

13May2025Alexion 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 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 Alexion participates in EVerify.