Clinical Operations Program Associate Director
Clinical Operations Program Associate Director
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Job Description
Job Description Summary
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.Job Description
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 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Skills Desired
Budget Management Clinical Trials Negotiation People Management Process Improvements Project Planning Vendor Management Waterfall ModelRequired Experience:
Director
Employment Type
Full-Time
