Medical Scientific Director
The Medical Scientific Director is accountable for the day-to-day oversight of numerous BioMarin-sponsored and collaborative studies across a therapeutic area, ensuring consistency of approach, conduct, monitoring, analysis, and reporting of studies within oneor more programs. The Medical Scientific Director will work in partnership with Real World Evidence (RWE)/Epidemiology, Global Medical Leads, Data Sciences and 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 Director is part of the Integrated Evidence function comprised of subject matter experts in evidence planning, observational 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 medical practice on appropriate use and long-term safety and effectiveness of BioMarin products to drive clinical adoption.
Key Responsibilities
- Executes evidence generation activities (non-interventional, 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 Country Medical Leads, RWE Lead, and HEOR to understand key global and local (key market) needs and opportunities in order to develop strategic study pull through and dissemination plans
- Collaborates closely with operational strategic partners to ensure successful implementation of GMAF-led studies; identifies issues in a timely manner, leads implementation of complex solutions, and/or escalates as appropriate
- 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
- Leads the development of 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
- Designs secondary data analysis plans of BioMarin clinical and real-world data to support program strategy
- Ensures adequate medical monitoring oversight of assigned studies (where relevant) 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, and inspection readiness activities
- Presents results of assigned studies to internal and external stakeholders, including at scientific conferences, and other relevant forums.
- 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 for assigned programs.
- Participates in initiatives to enhance or drive efficiency in study implementation
Desired Experience
- PharmD/PhD/MD with at least 5 years experience conducting observational and Phase IIIb/IV studies within Clinical Development and/or Medical Affairs; MS/MPH with 10+ years similar experience
- Experience in delivering a portfolio of protocols and ensuring they meet strategic program objectives
- Experience responding to regulatory agency, IRB/Ethics Committee questions regarding study designs and protocol conduct
Skills
- Proven track record of working with cross-functional partners to ensure successful end-to-end delivery of studies in support of product Integrated Evidence Plans.
- Track record of delivering high quality novel observational and Phase IIIb/IV studies
- Works effectively in a cross-functional matrix settings to shape the study strategy for one or more assigned projects
- Awareness of novel prospective observational and interventional study designs
- Understanding of statistical and data analysis, research methods and design
- Experience in 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.
- Strong scientific writing and document development
Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned. Equal Opportunity Employer/Veterans/Disabled An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Medical Scientific Director
The Medical Scientific Director is accountable for the day-to-day oversight of numerous BioMarin-sponsored and collaborative studies across a therapeutic area, ensuring consistency of approach, conduct, monitoring, analysis, and reporting of studies within oneor more programs. The Medical Scientific Director will work in partnership with Real World Evidence (RWE)/Epidemiology, Global Medical Leads, Data Sciences and 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 Director is part of the Integrated Evidence function comprised of subject matter experts in evidence planning, observational 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 medical practice on appropriate use and long-term safety and effectiveness of BioMarin products to drive clinical adoption.
Key Responsibilities
- Executes evidence generation activities (non-interventional, 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 Country Medical Leads, RWE Lead, and HEOR to understand key global and local (key market) needs and opportunities in order to develop strategic study pull through and dissemination plans
- Collaborates closely with operational strategic partners to ensure successful implementation of GMAF-led studies; identifies issues in a timely manner, leads implementation of complex solutions, and/or escalates as appropriate
- 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
- Leads the development of 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
- Designs secondary data analysis plans of BioMarin clinical and real-world data to support program strategy
- Ensures adequate medical monitoring oversight of assigned studies (where relevant) 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, and inspection readiness activities
- Presents results of assigned studies to internal and external stakeholders, including at scientific conferences, and other relevant forums.
- 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 for assigned programs.
- Participates in initiatives to enhance or drive efficiency in study implementation
Desired Experience
- PharmD/PhD/MD with at least 5 years experience conducting observational and Phase IIIb/IV studies within Clinical Development and/or Medical Affairs; MS/MPH with 10+ years similar experience
- Experience in delivering a portfolio of protocols and ensuring they meet strategic program objectives
- Experience responding to regulatory agency, IRB/Ethics Committee questions regarding study designs and protocol conduct
Skills
- Proven track record of working with cross-functional partners to ensure successful end-to-end delivery of studies in support of product Integrated Evidence Plans.
- Track record of delivering high quality novel observational and Phase IIIb/IV studies
- Works effectively in a cross-functional matrix settings to shape the study strategy for one or more assigned projects
- Awareness of novel prospective observational and interventional study designs
- Understanding of statistical and data analysis, research methods and design
- Experience in 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.
- Strong scientific writing and document development
Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned. Equal Opportunity Employer/Veterans/Disabled An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
