Clinical Development Physician

hace 4 semanas

Girona, España Almirall A tiempo completo

Mission

Clinical Development Physician is an important part of Global Study Teams within Global Clinical Development. Provides medical input and support to the study team for a given clinical development project in line within defined clinical development strategy, Target Product Profile (TPP) and target labelling, in collaboration with the cross functional teams and under supervision of a Global Clinical Program Lead (GCPL) or a line manager. Serves as a primary source of clinical/medical accountability and oversight for the clinical study/ies.

Tasks and Responsibilities

Supports the GCPL and Clinical Development Scientist (CDS) in designing clinical development plans and clinical studies. Supports clinical study synopsis, study protocol, study protocol amendments elaboration in collaboration with GCPLs and CDS. Supports GCPL and CDS in review of the scientific content of the study protocol, amendments, CSRs, ICF, CRF, as well as scientific/clinical content of key internal or external project related documents (eg. IB, briefing package for regulatory authorities, ISE, ISS, publication). Provides medical support to the Clinical Study Team to address questions raised by Ethics Committees as well as questions coming form the investigators in preparation and during the study/ies conduct. Leads medical data review, including eligibility review and safety data review. Provides medical support for the protocol deviation review. Partners with CDS and Clinical Operations to support clinical study/ies delivery (enrollment status, eligibility criteria and adjudication for protocol violation, evaluate need for study protocol amendment/s) Once clinical study/ies results are available, support the GCPL and CDS in data analysis, data review and content proposals for the publications. Core member of the Clinical Study Team

Education

Medical degree. 

Experience

1-3 years of experience Industry experience in drug development is a plus

Specific Knowledge

Specialty in dermatology or immunology is a plus Fluency in English (written and spoken) Proficiency with MS Office.

Values

Care: we listen & empathize, we value diverse perspectives & backgrounds and we help each other succeed. Courage: we challenge the status quo, we take full ownership and we learn from our success & failures Innovation: we put the patient and customer at the center, we create novel solutions and we empower entrepreneurial mindsets. Simplicity: we act decisively and avoid over-analysis, we understand why before we act and we are agile & keep things simple.

  • Intern / Becario/a Clinical Study Physician 1

    hace 2 semanas

    Girona, España Almirall A tiempo completo

    Mission We are seeking a dedicated and enthusiastic trainee to support our Pharma Plant Services Operative team in the field of biological products. This is an exciting opportunity to gain hands-on experience and develop your skills in a dynamic and fast-paced environment. Tasks and Responsibilities In collaboration with Clinical Lead, Clinical...

  • Global Clinical Program Lead

    hace 1 semana

    Girona, España Almirall A tiempo completo

    Mission • The Global Clinical Program Lead (GCPL) is a core member of the Global Project Team and is leading the Strategic Clinical Team within Global Clinical Development, working cross functionally with other R&D and non-R&D departments such as Regulatory and Patient Safety, Disease Biology, Global Market Access and Pricing, Medical affairs,...

  • Senior Statistician

    hace 6 días

    Girona, España Almirall A tiempo completo

    Mission The Senior Statistician will be responsible of the design and statistics of clinical trials and clinical development projects within Almirall. The Senior Statistician will partner with senior scientists in clinical (Global Development and Global Medical Affairs), safety, regulatory, market access and research on clinical development projects,...

  • Intern Becario/a Preclinical Safety

    hace 4 semanas

    Girona, España Almirall A tiempo completo

    Mission The Preclinical Safety Team is helping Almirall R&D to identify drugs with an acceptable safety profile in humans that is appropriate for the intended population (e.g. therapeutic indication). How • Guide Drug Discovery on selection of the best targets and compounds regarding safety. • Guide Drug Development on the safe progression of...

  • ADME & DMPK Senior Scientist

    hace 1 semana

    Girona, España Almirall A tiempo completo

    Mission Be a member of R&D project teams to provide expert ADME&DMPK support across a project lifecycle in a multidisciplinary environment with special focus between the early stages of drug discovery through candidate nomination and early clinical development.  Ensure that ADME profiling, PK/PD, M&S, human dose predictions or other related...

  • ADME & DMPK Senior Scientist

    hace 3 semanas

    Girona, España Almirall A tiempo completo

    Mission Be a member of R&D project teams to provide expert ADME&DMPK support across a project lifecycle in a multidisciplinary environment with special focus between the early stages of drug discovery through candidate nomination and early clinical development.  Ensure that ADME profiling, PK/PD, M&S, human dose predictions or other related...

  • Patient Safety Senior Director

    hace 4 semanas

    Girona, España Almirall A tiempo completo

    Mission The director of patient safety at Almirall is accountable for: Establishing and maintain a Global/Corporate Pharmacovigilance system that protects patients and users of Almirall medical solutions. Acting as the EU Qualified Person for Pharmacovigilance (QPPV) and UK QPPV. Ensures an adequate safety profile of investigational medicinal...