Global Clinical Program Lead

hace 7 meses

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, Marketing, Market Companies and Business Development.
• In this role a person is responsible for the continues benefit risk evaluation of one or more clinical assets, providing overall clinical/medical leadership including clinical development strategy and oversees the appropriate implementation of clinical development plan for the project(s) assigned.
• The GCPL has accountability for the clinical deliverables to time and quality for the corresponding project. Main responsibilities are in early or late-stage development projects but assignments across development stages are possible.
• This position demands strong analysis/synthesis and communication skills, with a good level of autonomy.

Tasks & Responsibilities

• Responsible for defining the clinical development strategy, milestones and resources required to meet development decision points/Target Product Profile (TPP), Target Product Claims (TPC) and target labelling, in collaboration with the cross functional teams.

• Plan and implement Phase 2 and 3 studies
• Plan and implement dose finding and pivotal studies enabling regulatory approval

• As a core member of the Global Project team provides clinical/medical leadership within internal cross functional teams for the assigned assets, as well as joint clinical/cross functional teams in case of development/market partnership.

• Global Clinical Development representative at internal meetings and Committees, and primary contact for Global Medical Affairs, Market Access, and Marketing to define the needs and clinical differentiation strategy.

• Provides clinical/medical guidance to the Clinical Study Teams to ensure alignment of clinical trials conduct and planning in line with the overall development strategy.

• Single point accountable lead for the design, delivery and interpretation of clinical studies results ensuring the ethical and scientific integrity of the plans, studies, and products in compliance with GCP.

• Review and approves (when applicable) key clinical trial documents (e.g., protocol, SAP, CSR).

• Responsible for data review of ongoing studies and continuous benefit/risk evaluation

• Ensure internal and external peer review of study/program design.

• Analyze and present clinical trial results when required (internal / external Committees)

• Responsible for clinical/medical overview/content of the study synopsis, protocol, amendments, CSRs, ICF, CRF, protocol deviation decisions and other clinical documents (e.g., IB, briefing package for regulatory authorities, responses to Health Authorities for registration purposes and clinical studies approvals, ISE, ISS, publication).

• Leads scientific meetings/Advisory boards, with subject matter experts/key opinion leaders to ensure robust clinical development plan and study designs to maximize product value and data generation.

• 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.

• Leads/support study specific committees (ie. IDMC, steering committee, adjudication committee) 

• Ensure 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.

• Leads/Chairs the Strategic Clinical Teams.

Education & Experience

• Medical degree. Specialty in dermatology is a plus.

• Advanced Degree (PhD or master’s degree in Pharmaceutical Medicine) is valuable.

• Demonstrated clinical research expertise in Dermatology/Immunology preferred but not required.

• At least 3 years of Pharmaceutical Industry experience in drug development.

• Demonstrates understanding of methodology in the design, conduct, review and 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.

Skills & Competencies

• 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.

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.

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