Associate Medical Director, Clinical Development
Associate Medical Director, Clinical Development
Location: Barcelona, Spain.
Reports to: Senior Medical Director,
This is what you will do:
The Associate Medical Director, Clinical Development 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:
- country and site feasibility assessments and selection
- site training and oversight
- patient recruitment
- 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:
- M.D. or equivalent degree
- Clinical experience 2+ years in ophthalmology or nuerology
- 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:
- Preferred: Advanced knowledge of the assigned therapy area is desired
- 5+ years of industry experience in clinical development is preferred
Alexion 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 accommodations@Alexion.com. Alexion participates in E-Verify.