FolsomRecruiter
the smart solution for Folsom 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, Folsom , 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


Director of Operations, Janitorial Division
Description: Crossroads is seeking a Director of Operations for the Janitorial Services Division to oversee the Janitorial operations in California, Texas and Seattle. This position is responsible for planning, directing (more...)
Company: Crossroads Diversified Services
Location: Sacramento
Posted on: 05/26/2019

Homebased Sales Manager Position
Description: Our growing health benefits company is seeking at home representatives. Must be self-motivated and driven. We provide you
Company: Benefits Company
Location: Roseville
Posted on: 05/26/2019

IBWAVE Certified DAS Project Manager
Description: Estimating Responsibilities include: Responsible for bidding process start to finish Identify projects to bid and consult with Owner
Company: Walker Telecomm, Inc.
Location: Sacramento
Posted on: 05/26/2019


Construction Project Manager (Type I Construction Experienced)
Description: Construction Project Manager Type I Construction Experienced Sacramento, CA Prestigious Construction General Contractor specializing in Hospitality, Multifamily, Commercial, Restaurant, Bar Nightclub (more...)
Company: TJG Civil Engineers and Land Planners
Location: Roseville
Posted on: 05/26/2019

Nurse Shift Manager
Description: Overview br Dignity Health Mercy General Hospital has been serving the Sacramento community for more than 100 years. Founded by the Sisters of Mercy, Mercy General has been at its current site in the (more...)
Company: Mercy General Hospital
Location: Sacramento
Posted on: 05/26/2019

Product Manager, Clinical Genetics
Description: About Us Novogene, headquartered in Beijing with branches in Hong Kong, the U.S., and the U.K., is a leading genomics solution provider with cutting edge bioinformatics expertise and the largest Illumina-based (more...)
Company: Novogene Corporation
Location: Sacramento
Posted on: 05/26/2019

Land Development Civil Engineer Project Manager - Roseville CA
Description: Land Development Civil Engineer Project Manager Roseville, CA Office Civil Engineering Land Development Residential Subdivisions and Commercial Site Development Design Open Position: Land Development (more...)
Company: TJG Civil Engineers and Land Planners
Location: Roseville
Posted on: 05/26/2019

Sr. Construction Project Manager - Sacramento, CA
Description: Position: Senior Construction Project Manager Ground up Commercial, Mixed-Use, and Multi-Family Building Construction Location: Sacramento, CA Minimum Years of Construction Experience Required: 10 years (more...)
Company: Johnson Construction Management
Location: Elk Grove
Posted on: 05/26/2019

Manager of Nursing
Description: Overview br Dignity Health Woodland Memorial Hospital is Yolo County's largest health care provider, serving the community since 1905. Woodland Memorial Hospital is a 108-bed acute care facility offering (more...)
Company: Woodland Healthcare
Location: Woodland
Posted on: 05/26/2019

Product Manager, Clinical Genetics
Description: About Us Novogene, headquartered in Beijing with branches in Hong Kong, the U.S., and the U.K., is a leading genomics solution provider with cutting edge bioinformatics expertise and the largest Illumina-based (more...)
Company: Novogene Corporation
Location: Sacramento
Posted on: 05/26/2019

Log In or Create An Account

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

Folsom RSS job feeds