Global Clinical Program Lead

hace 3 meses

Sant Feliu de Llobregat, España Almirall A tiempo completo

**Date**:1 Oct 2024

**Location**: SFEL - R&D SANT FELIU DE LLOBR, ES, ES - Spain

**Company**:Almirall

**Mission**:

- Accountable for the continuous benefit risk evaluation of one or more clinical assets, providing overall clinical/medical leadership including clinical development strategy and oversees the appropriate implementation of a clinical development plan for the project(s) assigned.
- Accountable for delivering clinical results on time and with high quality for the assigned project. While the primary responsibilities lie in early or late-stage development projects, assignments may span across different development stages.
- Serves as a primary source of clinical/medical accountability and oversight for the assigned clinical studies

**Tasks and Responsibilities**:
Program level responsibility:

- Core member of the Global Project Team and is leads the Strategic Clinical Team within Global Clinical Development
- Accountable for defining the Clinical Development Plan including clinical development strategy, defining study concept documents
- Accountable for the medical and scientific content of the Target Product Profile (TPP), and project-related documents (e.g., Investigator’s Brochure (IB), Safety Strategy document, Biomarker strategy, briefing packages for regulatory authorities, responses to questions from regulatory authorities, publications).
- Accountable for data review of ongoing studies and continuous benefit/risk evaluation

Study level responsibility:

- Accountable for review and approval of critical study documents (eg. Protocol, CSR )
- Core member of Clinical Study Teams within Global Clinical Development. The GCPL Provides medical input and support to the study team for a given clinical development trial in line within defined clinical development strategy, Target Product Profile (TPP) and target labelling, in collaboration with the cross functional teams.
- Accountable for the delivery and interpretation of clinical studiy results
- Once clinical study results are available, responsible for data analysis, and developing content proposals for publications

Interactions:

- Acts as GCD representative in collaboration with cross-functional teams with other R&D and non-R&D departments such as Regulatory and Patient Safety, Disease Biology, Global Market Access and Pricing, Medical affairs, Marketing, Market Companies and Business Development
- Global Clinical Development representative at the meetings with Health Authorities (HA) and other external stakeholders’ meetings (e.g., external scientific forums, investigators meetings), in consultation with Early or Late-Stage Global Clinical Development Director.
- Ensures clinical review/oversight of potential due diligences during evaluation of external opportunities (External Innovation and Licensing department), presenting and defending conclusions to appropriate decision-making Committees, in consultation with Early or Late-Stage Global Clinical Development Director.

**Education**:

- Medical degree. Specialty in dermatology is a plus.
- Advanced Degree (PhD or master’s degree in Pharmaceutical Medicine) is valuable.

**Experience**:

- Demonstrated clinical research expertise in Dermatology/Immunology preferred but not required.
- At least 5 years of Pharmaceutical Industry experience in drug development.
- Demonstrates a thorough understanding of methodology in the design, conduct, review, interpretation, and presentation of clinical research.
- Significant hands-on clinical drug development experience and scientific credibility. Experience in early-stage or late-stage development preferred.
- Fluency in English (written and spoken), Proficiency with MS Office.

**Specific Knowledge**:

- Ability to communicate information and lead presentations in scientific and clinical settings.
- Data analysis, communication, and high presentations skills in team settings and in formal presentations to leadership Committees both internally and externally.
- Strategic leadership skills with the ability to influence others and drive consensus building.
- Proven teamwork and collaboration skills.
- Analytical and problem-solving mindset.

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