Lead, Medical Scientific Directors (Senior Director)
The Lead, Medical Scientific Directors, reporting into the Head, Evidence Planning and Strategy, is a newly created role that will establish and build a team of Medical Scientific Directors responsible for scientific leadership and implementation of integrated, end-to-end observational and Phase 3b/IV studies to fill key evidence gaps in product Integrated Evidence Plans across the pipeline.
This team is accountable for the day-to-day oversight of numerous BioMarin-sponsored and collaborative studies across a therapeutic area, ensure consistency of approach, conduct, monitoring, analysis, and reporting within one or more programs. The Lead will work in partnership with Real World Evidence (RWE)/Epidemiology, Global Medical Leads, Global Study Operations to develop practical study strategies and ensure optimal hands-on study operations and execution support for Medical Affairs-led studies from cross functional partners.
The Medical Scientific Directors are part of the Evidence Planning and Strategy Function comprised of subject matter experts in evidence planning, study design and data interpretation. The function works to drive excellence in evidence planning and implement novel study design approaches to generate robust evidence to enhance understanding of unmet medical need; support patient and endpoint selection for Clinical studies; and inform clinical practice on appropriate use and long term safety and effectiveness of Biomarin products.
Study Strategy and Implementation
- Designs and executes evidence generation activities (non-interventional, pragmatic, low-interventional and interventional Phase IIIb/IV studies) that will fill priority evidence gaps identified in product Integrated Evidence Plans (IEPs).
- Collaborates closely and builds alliances with Global and Regional Medical Leads, RWE/Epidemiology, and HEOR to understand key global and regional (key market) needs and opportunities in order to develop strategic study plans
- Main point of contact with operational strategic partners to ensure successful implementation of the full portfolio of Medical Affairs-led studies; identifies issues in a timely manner, leads implementation of complex solutions, and/or escalates as appropriate
- Reviews and provides scientific input into the development of study concepts, protocols and protocol amendments, statistical analysis plans, data review plans, and responses to regulatory agency questions regarding scientific aspects of study protocols
- Reviews and provides scientific input into annual, interim and periodic study reports for Medical Affairs-led studies, including coordination of SME input, data interpretation and presentation, and ensuring that regulatory agency questions (where relevant) have been adequately addressed
- Influences management/senior staff decisions regarding study strategy and is viewed as a Subject Matter Expert on scientific decisions impacting a program
- Ensures adequate medical monitoring oversight of portfolio of Medical Affairs-led studies including monitoring and arbitration on subject eligibility, quality of safety and study data, development and review of ICFs, CRFs, TLGs, accurate AE and concomitant medication coding, study reports, and inspection readiness activities
- Participates in program program-wide Medical Affairs and cross-functional asset teams; contributes to discussions to ensure consistency across assigned studies.
Quality, Compliance and Process improvement
- Champions process enhancements and solutions for complex issues and collaborates cross-functionally to develop/implement controlled documents for protocol and study report development, study monitoring plans
- Coordinates Medical Affairs input in preparation of regulatory submissions, responses to regulatory queries, IRB/Ethics Committee questions, and in preparation for program regulatory inspections and audits.
- Identifies internal and external best practices, trends, developments, or alternative approaches with regard to evidence planning and study implementation
- Line management of Medical Scientific Directors; review work, develop staff, ensure appropriate succession planning, and provide ongoing feedback. Responsible for short- and long-term resource planning, priority setting, and filling of resource and skill gaps to address the needs of the program(s).
- Define team role, responsibilities, and remit within the Evidence Planning and Integration function as well as the broader Medical Affairs and Worldwide Development Organization
- BA/BS or Master’s level degree in life sciences or health related field with 15+ years experience with increasing responsibilities, complexity and accountabilities within the biopharmaceutical industry or, PharmD/PhD/MD 8+ years
- Minimum 8 years clinical and/or medical affairs experience conducting observational and Phase IIIb/IV studies within the biopharmaceutical industry
- Has independently authored protocol concept documents, study protocols, plans, data review, review/development of statistical analysis plans and outputs, and study reports
- Experience in translating strategic evidence plans into scientific concepts in multiple protocols and ensuring they meet strategic program objectives
- Prior role in a global function, leading operational and/or strategic study teams; medical monitoring experience or oversight of Medical Monitors
- Experience responding to regulatory agency, IRB/Ethics Committee questions regarding study designs and protocol conduct
- Track record for attracting and developing talent and optimizing team performance in direct and matrixed leadership roles.
- Subject matter expertise in a global competitive environment for executing medical affairs programs/studies; rare disease experience desirable
- Novel prospective observational and interventional study designs
- Understanding of statistical and data analysis, research methods and design
- Study monitoring
- Advanced knowledge of the clinical research process and Good Clinical/Pharmacoepidemiology Practice standards and requirements relating to conducting research and disseminating of scientific information.
- Scientific writing and document development
In terms of the performance and personal competencies required for the position, we would highlight the following:
Developing and coaching teams
- Leader that can motivate and engage teams at all levels providing vision and clear communication on expectations to achieve meaningful outcomes and create business impact.
- Actively represents and encourages open, honest, and clear communication across teams and functions; ability to message at all levels
- Holds teams accountable for deliverables by creating a shared sense of ownership for success; encourages risk identification and mitigation strategies
- Naturally connects and builds strong relationships with others, demonstrating strong emotional intelligence and an ability to communicate clearly and persuasively.
- An ability to inspire trust and followership in others through compelling influence, powerful charisma, passion in his/her beliefs, and active drive.
- Creates a sense of purpose/meaning for the team that generates followership beyond his/her own personality and engages others to the greater purpose for the
organization as a whole.
- The ability to create and articulate an inspiring vision for the organization, not only for the areas they are directly responsible for, but the enterprise as a whole.
- The inclination to seek and analyze data from a variety of sources to support decisions and to align others with the organization's overall strategy.
Executing for Results
- The ability to set clear and challenging goals while committing the organization to improved performance, tenacious and accountable in driving results.
- Comfortable with ambiguity and uncertainty; the ability to adapt nimbly and lead others through complex situations.
- A leader who is viewed by others as having a high degree of integrity and forethought in his/her approach to making decisions; the ability to act in a transparent and consistent manner while always taking into account what is best for the organization
This role can be based in the US or Europe.
BioMarin is looking for an experienced Scientific leader with deep experience in the biopharma industry, who can work with cross-functional partners to ensure successful end-to-end delivery of Medical Affairs-led studies in support of product Integrated Evidence Plans. This is a leader who has ideally had experience in both Clinical Development and Medical Affairs and a track record of delivering high quality novel observational and Phase IIIb/IV studies. With a strategic mindset, this candidate will play a critical role in establishing a new team of Medical Scientific Directors that will drive and shape evidence strategy for marketed products, thereby experience in peri and post launch study execution is required.