You oversee the feasibility process for clinical trials, analyzing data and providing insights to optimize study design and site allocation while managing risks and ensuring quality across teams.
Anforderungen
- •Bachelor's in life science/healthcare required
- •Advanced degree in life sciences preferred
- •At least 5 years in drug development recommended
- •At least 3 years in global clinical trials recommended
- •Strong understanding of clinical drug development
- •Strong research skills for unusual information
- •Understanding of Clinical Trial matrixed process
Deine Aufgaben
- •Lead the end-to-end feasibility process.
- •Analyze clinical trial and historical data.
- •Provide modeling for recruitment projections.
- •Give feedback on study design insights.
- •Propose optimal country and site allocation.
- •Act as point of contact for feasibility.
- •Identify operational risks in clinical trials.
- •Integrate regional strategies into global plans.
- •Align with country feasibility team on quality.
- •Create and maintain patient enrollment forecasts.
- •Ensure alignment of feasibility and startup planning.
- •Develop tools for modeling and viability assessments.
Original Beschreibung
# Clinical Operations Program Associate Director
**Basel (City)** | **Full time**
**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.
**Skills Desired**
Budget Management, Clinical Trials, Negotiation, People Management, Process Improvements, Project Planning, Vendor Management, Waterfall Model