- Collaborating on, or lead where appropriate, the preparation of clinical study related documents including protocols, charters, statistical summary reports, meeting presentations, publications, and clinical sections of regulatory documents.
- Liaising with other functions to enable quality clinical study execution; Provide input to the study team for country and site feasibility assessments
- Collaborating with the clinical study team in site identification and selection and provide assistance with study start-up activities; Participate in the development of clinical study protocol concept sheets and protocols, study operations manuals, and other study essential documents.
- Participating in Investigator meeting planning and execution and/or on-site initiation meetings.
- Monitoring, cleaning, analyzing, and reviewing safety and efficacy data to establish the presence or absence of trends and follow up as appropriate.
- Supporting the design and execution of key elements of the Clinical Development Plan (clinical study or studies) and associated data collection activities, within a therapeutic area. Serve as the medical expert for clinical study team.
- Liaising with other functions to arrange external expert consultations, contribute to the development of study concepts, protocol designs, 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 the clinical strategy. Support CRAs/CROs on study protocol and related questions and serves as point of contact for managing/answering questions relating to trial procedures. Finally, engage with investigators, site staff, CROs, and site monitors to maintain enthusiasm and support enrollment for ongoing clinical studies.
- Reviewing and synthesizing scientific literature and competitive intelligence to support study and program strategy
- 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.
- Supporting development of publications arising from studies and other relevant initiatives.
- Providing support for business development activities, such as due diligence and research collaborations.
- Where appropriate, serve as the SME for identification, translation, inclusion, implementation, and reporting related to liquid, tissue and/or imaging endpoints
- MD or equivalent with specialty training in ophthalmology, OD with PhD also considered
- Previous history designing and executing clinical trials
- Safety medical monitoring and reporting experience
- Protocol development experience
- Regulatory experience
- Basic statistical knowledge
- Excellent written / oral communication skills
- Ability to think strategically
- Willingness to take on new responsibilities
- Interest in career progression and ability to take on additional responsibilities
- 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.
- Specific therapeutic area experience in retinal disease
- Minimum 2+ years of experience supporting industry-sponsored clinical trials in the biopharmaceutical industry or 5+ years of experience in an academic or clinical research setting.
- Knowledge in the principles of clinical research methodology, statistics, data analysis and interpretation
- Ability to clearly communicate to internal and external stakeholders orally and in writing
Associate Medical Director, Clinical Development Sciences - Barcelona, España - Alexion Pharmaceuticals
Descripción
This is what you will do:
The Associate Medical Director provides input into a clinical study protocol and supports a clinical study team. The job holder supports assigned clinical development physician(s) and the therapeutic area head with deliverables necessary for effective and efficient clinical study design and execution. Assists in the preparation of study protocols and study execution. May also perform medical monitoring for one or more studies.
You will be responsible for:
You will need to have:
We would prefer for you to have:
Date Posted
09-Apr-2024Closing Date
28-Jul-2024Alexion 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 E-Verify.