The Clinical Operations Program Associate Director (COPaD) is accountable for the oversight, coordination and development of early modeling viability assessments, global feasibility assessments, recruitment projections, and allocation strategies for assigned trials and programs.

#LI-Hybrid

Location : Basel, Switzerland

Responsibilities include but not limited to:

• ​Leading and conduct the end-to-end feasibility process in collaboration with the country feasibility managers, clinical trial team and medical teams
• Analyze various data sources, including clinical trial data, historical performance, publications, epidemiology, clinical trial and commercial landscape, etc.
• Provide modeling and viability analysis to support early recruitment projections and clinical trial planning
• Provide feedback on study design based on available data and feasibility insights
• Propose optimal country and site allocation, including associated risks and opportunities in alignment with the global program strategy
• Acts as the point of contact for assigned program and trial feasibilities, leading the multidisciplinary feasibility teams to develop, validate and refine allocation strategy, including timelines, scenarios, and risk mitigation plans.
• Identify and resolve events in the indication landscape that represent operational risks for the execution of clinical trials within the given indication/program.
• Lead integration of regional and local indication strategies within global execution plans.
• Partner closely with the country feasibility team to align on the end-to-end quality of feasibility product
• Is responsible for the creation and maintenance of patient enrollment forecast, at study levels
• Ensures alignment of feasibility and allocation strategy and seamless start up planning with COPH, Study Start-Up Lead and feasibility teams, in collaboration with teams/associates responsible for regional feasibility.
• Improve and develop tools and processes for modelling and viability assessments, feasibilities, recruitment projections, etc.

Minimum Requirements:

• Bachelors in life science/healthcare required; Advanced degree or equivalent education/degree in life sciences/ healthcare preferred (PhD/MD/ PharmD/ Masters).
• ≥ 5 years of pharmaceutical clinical drug development experience recommended (with ≥3 years in planning/execution global clinical trials recommended)
• Strong understanding of all aspects of clinical drug development with particular emphasis on clinical trial design, trial execution, and strong knowledge about the feasibility and allocation process of a program and/or study.
• Possess strong, resourceful research skills to locate unusual information and have capacity to develop a deep domain specific knowledge base.
• Understand the Clinical Trial matrixed process from research through post marketing phase IV, health authority guidelines, country challenges as well as sources for therapeutic area data.

Desirable requirements:

• Demonstrated ability to collaborate across partner functions in a matrix environment, without direct reports, but able to coordinate the activities of others.
• Demonstrated experience in feasibility for global clinical trials.
• Has had success in identifying, proactively flagging, and resolving risks; experience with strategic scenario planning and management.
• Communicates effectively with leaders in a local/regional/global matrixed environment.
• Proven ability on strategic planning and managing operational challenges at global, regional, or country level.
• Good project management capabilities with demonstrated ability to problem solve and mediate complex issues.
• Strong ability to understand analytical data insights with proven ability to communicate background details and rationale.
• Thorough knowledge of the international aspects of drug development process, the international standards (GCP/ICH), health authority regulations, and clinical development process.
• Good understanding of global competitive landscape and implications on clinical development.
• Strong leadership and negotiation skills.
• Demonstrated strong presentation and diplomacy skills.

Commitment to Diversity and Inclusion

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Accessibility and Accommodations

Novartis is committed to working with and providing reasonable accommodation to all individuals. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to receive more detailed information about the essential functions of a position, please send an e-mail to inclusion.switzerland@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

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