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Sr / Medical Director, PKU, Global Medical Sciences, Global Medical Affairs

Location San Rafael, California
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.

Within BioMarin Global Medical Affairs, the Medical Sciences group is responsible for being the subject matter experts on commercial product scientific and medical knowledge, setting the Medical Affairs product strategy and leading global Medical Affairs activities for each BioMarin product progressing from pipeline status through product launch to post approval status. This includes collaborating with cross-functional stakeholder to define product strategy, developing and communicating key scientific messages to stakeholders in preparation for a commercial product launch; leading efforts to develop additional scientific evidence to support commercial product viability; and acting as the critical link between BioMarin and the external health care practitioners using BioMarin products by supporting scientism and medical knowledge dissemination.

 SUMMARY DESCRIPTION

 The Medical Director is responsible for supporting Global Medical Sciences activities for an assigned product from pipeline through post approval status to support, and in alignment with Medical Sciences Global Medical Product Lead (GML) and Product Global Medical Plan.  Key product responsibilities include, but are not limited to, alignment with commercial business partners, Global Medical plan development, product launch execution, promotional or scientific materials review and approval, KOL relationship management and medical monitoring of  post-approval commitments

KEY RESPONSIBILITIES:

 Responsibilities may include, but are not limited to:

Provide Medical Affairs Global Medical Product Support for PKU franchise in support of the Global Medical Lead (GML):

 Product Strategy & Planning:

  •  Support the develop and implementation of the Global Medical Plans and medical activities in coordination with the Global Medical Lead (GML), Medical Affairs, Commercial and Regulatory colleagues
  • Ensure adherence to regulatory and clinical practice guidelines in supporting development and marketing of BioMarin compounds
  • Act as a point of contact and product and disease area expert for all product or disease area related issues

 Scientific Messaging and product marketing materials

  • Contribution in the creation of a scientific messaging platform and related promotional materials, response letters
  • Drive relevant publications on diagnostics, disease management and treatment guidelines and attend quarterly publication meetings
  • Review Medical Information request fulfillment, standard response documents and FAQs with sign-off responsibility where regulations require
  • Conduct medical review of promotional material to ensure maximum effectiveness while adhering to the company's ethical standards and relevant Codes of Practice for the region
  • Participate in, and contribute perspectives to scientific messaging discussions

 Global &/or Local Market key relationship and access development

  • Communicate with commercial teams on a regular basis to ensure appropriate medical/scientific support for marketing and sales initiatives
  • Participate in develop, management and maintenance of  KOL relationships in close collaboration with other MDs or MSL teams
  • Organize, attend, and if required, chair advisory boards 

Product Launch

  •  Develop launch plans in collaboration with Medical Affairs and Commercial colleagues and execute on the GMAF tactical launch activities in support of global product launch
  • Post Marketing – Registries, IR, observational
  • Support PMC/PMRs and studies falling under the GMAF scope in collaboration with the GML, study management lead when required; Assist study management team in medical review and input in Medical Affairs-run studies as assigned. Act as Medical Monitor for PMC/PMRs as needed.
  • Attend and conduct investigator meetings, as needed in alignment with Global Medical Plan objectives
  • Participate BioMarin Independent Research Program reviews as assigned 

Product and Disease Training and Education

  • Assist in the training of new medical affairs and commercial recruits by presenting the scientific disease and product related data and present at sales conferences, meetings, etc. to develop high level of medical knowledge within sales force 

EDUCATION AND EXPERIENCE:

  • MD with county licensure or fellowship required
  • Relevant experience in pharmaceutical/biotech or related industries.
    • 5+ years of Industry experience in Global Medical Affairs (Sr. Medical Director)
    • 2+ years of Industry experience in Global Medical Affairs (Medical Director)
  • Experience in clinical science and drug development is desirable
  • Outstanding leadership, presentation, written and oral communication skills required
  • Collaborative and flexible in interactions at all levels within the company, and with external collaborators
  • Ability to work proactively and effectively, with exceptional creative problem-solving skills
  • Excellent strategic planning, organizational, analytical and communication skills
  • Knowledgeable and current in GCP guidelines in US and Europe; regulatory filing experience would be advantageous
  • Be well connected within the medical and scientific community and have a proven successful track record
  • Experience in one/more of the following therapeutic areas would be considered advantageous: metabolic disease, genetics, immunology
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.

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San Rafael

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We treat rare diseases, and that gives us rare opportunities. Chris Brodeur, Director, Corporate Compliance
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