Associate Medical Director

JR Spain; Barcelona; Presencial; EUR 70.000 - 120.000; Jornada completa

Descripción de la vacante

JR Spain is looking for an Associate Medical Director in Barcelona to oversee clinical study protocols and ensure effective trial execution. This role entails collaborating on study documents, monitoring clinical data, and engaging with various stakeholders. Ideal candidates hold an MD, have a history of clinical trials, and possess strong strategic communication skills.

Formación

• Experience designing and executing clinical trials.
• Basic statistical knowledge.
• Willingness to take on new responsibilities.

Responsabilidades

• Collaborating on clinical study documents and protocols.
• Monitoring and analyzing safety and efficacy data.
• Engaging with clinical investigators to support study execution.

Conocimientos

Excellent written and oral communication

Strategic thinking

Safety medical monitoring

Regulatory experience

Educación

MD or equivalent

Descripción del empleo

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Some opportunities happen only once in a lifetime - like a job where you have the chance to change lives. At Alexion, people living with rare and devastating diseases are our Guiding Star. We are driven to continuously innovate and create meaningful value in all we do to help patients and families fully live their best lives. We value the uniqueness and diversity of our employees and recognize that nurturing the diverse perspectives and strengths of our people translates into innovative breakthroughs for patients.**Clinical Development Sciences, Associate Medical Director****Location**:Barcelona, ES**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**:- 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**You will need to have**:- MD or equivalent- 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.**We would prefer for you to have**:- Board Certification- Advanced knowledge of the assigned therapy area is desired, with the capability to interpret, discuss and represent trial or program level data.- Minimum 2+ years of experience supporting industry-sponsored clinical trials in the biopharmaceutical industry or equivalent experience in an academic or clinical research setting