Global Clinical Program Lead

Job title:

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 ResponsibilitiesProgram 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.