Senior Director of Biostatistics at Orchard Therapeutics leading statistical innovation for clinical drug development. Overseeing a high - performing Biostatistics team and collaborating with regulatory agencies.
About the role
- Associate Director managing regional expert input and medical education programs across Europe for a global healthcare leader. Ensuring compliance and effective stakeholder collaboration in the medical affairs sector.
Responsibilities
- Organizes and executes compliant regionally initiated programs, ensuring adherence to company and country policy and regulations
- Is responsible for multiple therapeutic areas (TAs) requiring in-depth knowledge and understanding of franchises’ key priorities
- Partners with all referenced stakeholders to plan, design, enable, and oversee programs for the region and franchise
- Oversees the conflict-of-interest screening, contracting, program execution and close-out, and ensures that all compliance metrics are met
- Manages execution of some programs onsite determined by priorities and capacity in agreement with stakeholders and manager
- Provides oversight of budgets across multiple franchises, aligning business and scientific objectives with the region priorities
- Administers budget in accordance with the Company’s established financial guidelines and financial stewardship principles
- Provides oversight of vendors/agencies involved in the planning and execution of programs
- Ensures that all processes, systems, and operational elements comply with internal policy, industry standards, country regulations, and compliance metrics
- Informs guidance, standard operating procedures (SOPs), and standards across region, tailoring as required by region
- Acts as a consultant to business groups and stakeholders, advising how to achieve strategic and compliant expert engagement programs
- Fully understands and can articulate priorities of both regional and HQ initiatives to maximize opportunities
- Leads training with stakeholders on policy, processes, and execution for expert input and medical education activities
- Participates as key stakeholder in regional strategic initiatives
- Serves as audit point with respect to any remediation activities required by GEMS (within specific region)
Requirements
- Minimum BA/BS in science, business, healthcare, or related field
- 4-6 years of experience in medical affairs, sales and marketing, scientific leader/medical meeting management, or related area
- Strong compliance knowledge, including knowledge of industry compliance rules and requirements.
- Advanced project management skills to oversee the execution of a high volume of regional advisory boards, Expert Input Forum (EIF) meetings, and medical education programs
- Effective communication skills and ability to frequently and effectively communicate with internal stakeholders, scientific leaders, agencies, and vendors
- Business, financial, and scientific acumen to understand and help inform marketing, medical strategy, and life cycle management of ALL franchises
- Strong leadership skills to facilitate, moderate, or lead planning discussions at all levels of the organization, including senior leadership levels
- Ability to provide solutions that ensure full compliance with all Company policies and all applicable laws, regulations, and codes of conduct
- Prudent judgment skills necessary for management and oversight of programs
- Ability to work collaboratively in a regional environment, which includes applying the local cultural consideration/sensitivities when dealing with employees, scientific leaders, delegates, attendees, and vendors from a multitude of countries
- Willingness to travel (primarily within region) approximately 35%-40% of time
Benefits
- Flexible Work Arrangements
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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