BerkeleyRecruiter
the smart solution for Berkeley 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, Berkeley , 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


Restaurant Manager
Description: Be a part of something revolutionary At sweetgreen, we believe in quality ingredients - and not just for our food. Our Assistant Coaches Assistant Managers lead our team members, They are our most (more...)
Company: Sweetgreen
Location: Sunnyvale
Posted on: 05/28/2019

Maternal Child Health Nurse Director
Description: An excellent opportunity for Nurse Director of Maternal Child Health is now available in the Central California Medical Center. br The Maternal Child Health Nurse Director will oversee labor and delivery, (more...)
Company: Nurse Management
Location: Turlock
Posted on: 05/28/2019

Search Engineering Manager
Description: Let companies apply to you, not the other way around. Sign up with Hired to get access to thousands of companies currently hiring search engineering managers and developers. Want to work for a company (more...)
Company: Hired
Location: San Rafael
Posted on: 05/28/2019


Engineering Manager. - Oakland
Description: Let companies apply to you, not the other way around. Sign up with Hired to get access to thousands of companies currently hiring Engineering Managers. Are you an Engineering Manager Engineering Managers (more...)
Company: Hired
Location: Oakland
Posted on: 05/28/2019

Global Employee Communications Manager
Description: It's fun to work in a company where people truly BELIEVE in what they're doing br br We're committed to bringing passion and customer focus to the business. br br The Role br br The Global (more...)
Company: Proofpoint
Location: Sunnyvale
Posted on: 05/28/2019

Business Development Manager, Rack Solutions
Description: Summary: SuperMicro Computer is looking for a Business Development Manager, Rack Solutions. In this role, you will be responsible for managing existing customer relationships while developing new ones, (more...)
Company: Super Micro Computer, Inc.
Location: San Jose
Posted on: 05/28/2019

Senior Software Engineering Manager
Description: Castlight's Engineering team is searching for a Senior Software Engineering Manager who has strong technical skills. The candidate should be able to ensure that their team is delivering well-engineered (more...)
Company: Castlight Health
Location: Sunnyvale
Posted on: 05/28/2019

Solid Waste Manager
Description: SOLID WASTE MANAGER br
Company: Stockton, CA Area Jobs
Location: Stockton
Posted on: 05/28/2019

Engineering Manager. - Sunnyvale
Description: Let companies apply to you, not the other way around. Sign up with Hired to get access to thousands of companies currently hiring Engineering Managers. Are you an Engineering Manager Engineering Managers (more...)
Company: Hired
Location: Sunnyvale
Posted on: 05/28/2019

Senior or Principal Level Manager/ Environmental Scientist / Geologist/ Hydrogeologist /Engineer
Description: Farallon Consulting, L.L.C. has a full-time opening for a Senior or Principal Level Manager/ Environmental Scientist / Geologist/ Hydrogeologist /Engineer in its Oakland, California office. Senior or (more...)
Company: Farallon Consulting, L.L.C.
Location: Oakland
Posted on: 05/28/2019

Log In or Create An Account

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

Berkeley RSS job feeds