Sr. Study Manager, Global Study Operations (Also open in UK) - BioMarin Pharmaceutical
San Rafael, CA 94901
About the Job
DescriptionWho We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health.Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need
We enlist the best of the best – people with the right technical expertise and a relentless drive to solve real problems – and create an environment that empowers our teams to pursue bold, innovative science
With this distinctive approach to drug discovery, we’ve produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options
Our Culture From research and discovery to post-market clinical development, our WWRD engine involves all bench and clinical research and the associated groups that support those endeavors
Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with genetic diseases
The BioMarin Global Study Operations (GSO) function is tasked with providing strategic direction on the feasibility, design, and conduct of clinical studies and drives the delivery of high-quality data to support the registration and approval of clinical development assets
The function achieves this through the development and operationalization of Clinical Development Plans, study planning and delivery, cross-functional leadership of Study Execution Teams, operational trial expertise, and vendor management and oversight.Role SummaryFor assigned study(ies), the Sr
Study Manager (SM) is accountable for day-to-day Global Study Operations study execution and related deliverables and is the primary point of contact within GSO for a study
Key responsibilities include managing risks, issues and opportunities that impact timeline, quality, and budget, overseeing the GSO study team, vendors and CRO, as well as collaborating with cross-functional representatives to execute on study deliverables
The Sr
SM may be assigned to and is responsible for managing complex early-stage studies, late-stage, pivotal registration, or post approval studies, which requires a greater depth of study execution experience
The Sr
SM plays a greater role in supporting the Program Lead (PL) and/or Program Director (PD) in program wide activities, engaging with leadership, and leading Study Execution Team (SET) activities.Within the role the candidate is expected to show and have proficiency and experience in the following competencies: Core: Decision Making, Strategic Thinking, and Problem Solving Influence and Organizational Awareness People Management Agility and Proactivity Leadership Communication and CollaborationTechnical Data Analysis and Interpretation Study Management and Execution Compliance and Quality Drug Development and Study Design Product and Therapeutic Area Knowledge Responsibilities include but are not limited to: Overall study execution oversight Provide leadership, guidance, and direction to GSO staff assigned to studies Facilitate cross-functional Study Execution Team (SET) meetings Collaborate with cross-functional study members to drive and execute on study deliverables, documents, and plans Proactively identify, manage, and communicate cross functional study issues, risks and mitigations in a timely manner Provide regular study quality and progress updates to key stakeholders as needed Monitor and act upon study metrics; review trend-identification and analysis and provide targeted follow up where appropriate Collaborate with other Study Managers to ensure consistency and maintenance of the various study plans within a program Collaborate with People and Process Managers of the Study Specialist staff to support team member productivity and career growth Other responsibilities Include:Contribute to the Study protocol and Informed Consent Form (ICF) developmentManagement of Study TimelineManagement of CRO and Vendors Management of Study Lifecycle (start-up, enrollment, maintenance and close-out)Oversight of Drug / Investigational Product (IP) processManagement of Study Budget Oversight of Feasibility, Recruitment and EnrollmentOversight of Study Outcome and Data Deliverables Lead or participate in program or study-specific projects that have a wider impact Collaborate with study managers/cross-functional team members to implement department process change and efficiencies Education & Experience: BA/BS/BSc 7 years’ work experience in life sciences or medically related field, including 4 years of biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical, or CRO Experience in oversight of external vendors (e.g., CROs, central labs, imaging vendors, etc.)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.
We enlist the best of the best – people with the right technical expertise and a relentless drive to solve real problems – and create an environment that empowers our teams to pursue bold, innovative science
With this distinctive approach to drug discovery, we’ve produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options
Our Culture From research and discovery to post-market clinical development, our WWRD engine involves all bench and clinical research and the associated groups that support those endeavors
Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with genetic diseases
The BioMarin Global Study Operations (GSO) function is tasked with providing strategic direction on the feasibility, design, and conduct of clinical studies and drives the delivery of high-quality data to support the registration and approval of clinical development assets
The function achieves this through the development and operationalization of Clinical Development Plans, study planning and delivery, cross-functional leadership of Study Execution Teams, operational trial expertise, and vendor management and oversight.Role SummaryFor assigned study(ies), the Sr
Study Manager (SM) is accountable for day-to-day Global Study Operations study execution and related deliverables and is the primary point of contact within GSO for a study
Key responsibilities include managing risks, issues and opportunities that impact timeline, quality, and budget, overseeing the GSO study team, vendors and CRO, as well as collaborating with cross-functional representatives to execute on study deliverables
The Sr
SM may be assigned to and is responsible for managing complex early-stage studies, late-stage, pivotal registration, or post approval studies, which requires a greater depth of study execution experience
The Sr
SM plays a greater role in supporting the Program Lead (PL) and/or Program Director (PD) in program wide activities, engaging with leadership, and leading Study Execution Team (SET) activities.Within the role the candidate is expected to show and have proficiency and experience in the following competencies: Core: Decision Making, Strategic Thinking, and Problem Solving Influence and Organizational Awareness People Management Agility and Proactivity Leadership Communication and CollaborationTechnical Data Analysis and Interpretation Study Management and Execution Compliance and Quality Drug Development and Study Design Product and Therapeutic Area Knowledge Responsibilities include but are not limited to: Overall study execution oversight Provide leadership, guidance, and direction to GSO staff assigned to studies Facilitate cross-functional Study Execution Team (SET) meetings Collaborate with cross-functional study members to drive and execute on study deliverables, documents, and plans Proactively identify, manage, and communicate cross functional study issues, risks and mitigations in a timely manner Provide regular study quality and progress updates to key stakeholders as needed Monitor and act upon study metrics; review trend-identification and analysis and provide targeted follow up where appropriate Collaborate with other Study Managers to ensure consistency and maintenance of the various study plans within a program Collaborate with People and Process Managers of the Study Specialist staff to support team member productivity and career growth Other responsibilities Include:Contribute to the Study protocol and Informed Consent Form (ICF) developmentManagement of Study TimelineManagement of CRO and Vendors Management of Study Lifecycle (start-up, enrollment, maintenance and close-out)Oversight of Drug / Investigational Product (IP) processManagement of Study Budget Oversight of Feasibility, Recruitment and EnrollmentOversight of Study Outcome and Data Deliverables Lead or participate in program or study-specific projects that have a wider impact Collaborate with study managers/cross-functional team members to implement department process change and efficiencies Education & Experience: BA/BS/BSc 7 years’ work experience in life sciences or medically related field, including 4 years of biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical, or CRO Experience in oversight of external vendors (e.g., CROs, central labs, imaging vendors, etc.)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.
Source : BioMarin Pharmaceutical