TurlockRecruiter
the smart solution for Turlock jobs

Medical Director, Clinical Science, Gene Therapy for Hemophilia A

Company: BioMarin Pharmaceutical
Location: San Rafael
Posted on: May 16, 2019

Job Description:

BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.

BioMarin's Research & Development group is responsible for everything from research and discovery to post-market clinical development. Research & Development 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 rare diseases. Come join our team and make a meaningful impact on patients' lives.

As a vital member of the valoctocogene roxaparvovec (previously known as BMN 270) Clinical Science (CLS) team, the Medical Director is responsible for the medical and scientific integrity during study planning and execution and is accountable for the day-to-day CLS medical monitoring deliverables. Key responsibilities, as delegated by the Clinical Development Team Lead, include:


  • Provide medical and scientific input into the clinical development program
  • Provide CLS input in all stages of the clinical trial, from start-up to close-out
  • Monitor patient eligibility, safety, and data and initiate appropriate action, as needed
  • Represent CLS as a member of the Study Execution Team (SET)
  • Ensure detail-oriented contributions are of high-quality and in compliance with regulatory requirements

    RESPONSIBILITIES

    • Medical and Scientific Oversight


      • Act as the medical and scientific subject matter expert, and primary contact, for the assigned clinical study, which includes being readily available to advise on study-related medical questions or problems during the conduct of the study
      • Initiate and provide the medical and scientific input into and review of: protocols, protocol amendments; case report forms; adverse events (AEs); clinical study reports (CSRs); data management and statistical tables and listings; audit reports; and regulatory submissions
      • Facilitate the review and approval of all study-related CLS deliverables and content


        • Clinical Study Planning and Execution


          • Act as study scientific and medical subject matter expert and main point of contact for Principal Investigators (PIs) and sites to assess patient eligibility, discuss safety concerns, provide scientific/medical rational, and manage ongoing protocol issues
          • Ensure protocols are followed and participate in development of protocol amendments
          • Provide medical leadership to sites by developing or participating in training, answering investigator questions about the protocol and the medical management of subject emergencies
          • Respond to site and Health Authority questions about the protocol
          • Attend and present at Investigator Meetings, as needed
          • Conduct medical review, assessment, and interpretation of clinical and safety data to ensure that the data are complete, accurate, and presented with the appropriate medical interpretation
          • Review and analyze serious AEs, safety, and efficacy trends
          • Contribute to and review CSR writing (e.g., review final tables/listings/graphs, work with the medical writer to review & revise CSR document, draft discussion and conclusions, participate in comment resolution meetings)
          • Present study updates and topline results to CLS leadership, as needed
          • Recommend and develop Key Opinion Leader (KOL) and Advisory Panel networks, as appropriate
          • Provide representation at regulatory meetings, as needed


            • Clinical Governance / Team Membership and Leadership


              • Act as the primary point of contact between SET and CLS to ensure appropriate dissemination of information and communication (including functional managers and other relevant individuals)
              • Proactively identify and communicate potential risks and mitigations relevant to CLS deliverables
              • Contribute to development and maintenance of study-specific plansthat are the responsibility of CLS

                EDUCATION AND EXPERIENCE

                • MD or MD, PhD with country licensure or fellowship required
                • Medical specialty in hematology and experience in hemophilia and/or gene therapy desirable; sub-specialty experience in clinical trials, molecular medicine, data analysis also desirable
                • At least 2 years of relevant experience in CLS, medical affairs, and/or drug development; 2-5 years' clinical trial experience after fellowship in academia is acceptable as well

                  We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

Keywords: BioMarin Pharmaceutical, Turlock , Medical Director, Clinical Science, Gene Therapy for Hemophilia A, Executive , San Rafael, California

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Executive Jobs


Program Estimating Manager
Description: Responsibilities:Serve as a leader and technical expert in estimating and manage a team of senior estimators.Thoroughly understand the principles of estimating. Understand the relationships between the (more...)
Company: WSP Global
Location: Sacramento
Posted on: 05/22/2019

Program manager
Description: Program Manager needs: Minimum of two 2 years of real-world Scrum coaching experience, guiding at least two 2 organizations through
Company: Global Channel Management, Inc.
Location: Roseville
Posted on: 05/22/2019

Psychiatric Medical Director
Description: Psychiatric-Mental Health opening in Yuba City, California. This and other physician jobs brought to you by DocCafe.com
Company: FCSpsy
Location: Yuba City
Posted on: 05/22/2019


Office Manager II - Block Advisors
Description: Office Manager II - Block Advisors Seeking retail office managers eager to advance their career by accelerating our seasonal business and a leading dynamic team of tax advisor professionals to deliver (more...)
Company: H&R BLOCK
Location: Sacramento
Posted on: 05/22/2019

DIRECTOR OF MARKETING - Consumer Packaged Goods (CPG) Marketing Experienced
Description: DIRECTOR OF MARKETING - Consumer Packaged Goods CPG Marketing Experienced Rapid Brands Sacramento, CA Office After appearing on ABCs hit show Shark Tank, Rapid Ramen, now Rapid Brands has grown to (more...)
Company: Rapid Brands Inc.
Location: Sacramento
Posted on: 05/22/2019

Northern California Service Division Safety Manager
Description: We are looking for a Northern California Service Division Safety Manager to join our Sacramento, CA office br br ACCO Engineered Systems has been annually recognized by a national industry magazine (more...)
Company: Acco Engineered Systems
Location: Sacramento
Posted on: 05/22/2019

Traffic Manager
Description: Job Summary: Deploys commercial advertising - configuring, monitoring, analyzing, and optimizing online and stream ad campaigns, utilizing emerging technology, applying campaign strategy, and providing (more...)
Company: iHeart Media
Location: Sacramento
Posted on: 05/22/2019

Hospice Case Manager - RN
Description: Sunbelt is seeking for a qualified and professional Hospice Case Manager - RN in Carmichael, CA. The assignment will be
Company: Sunbelt Staffing
Location: Carmichael
Posted on: 05/22/2019

SAFETY AND OCCUPATIONAL HEALTH MANAGER
Description: SAFETY AND OCCUPATIONAL HEALTH MANAGER Department of the ArmyArmy National Guard UnitsOverview--------- Open closing dates05/17/2019 to 05/24/2019- (more...)
Company: Army National Guard Units
Location: Sacramento
Posted on: 05/22/2019

Manager, Environmental Services
Description: Crothall Healthcare is a Compass One Company that provides specialized, high-quality, innovative, and responsive support services exclusively to the healthcare industry. Crothall serves many of the Top (more...)
Company: Compass Group USA Inc
Location: Sacramento
Posted on: 05/22/2019

Log In or Create An Account

Get the latest California jobs by following @recnetCA on Twitter!

Turlock RSS job feeds