Medical Director, (Global/PKU)Location San Rafael, California Apply
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.
OVERVIEW: BioMarin Global Medical Affairs Medical Sciences
BioMarin Global Medical Affairs (GMAF) offers scientific and clinical expertise to post-marketing products through the direction and planning of medical communications, support of education and research, liaising with the medical community, response to incoming inquiries about Medical Affairs products and trials, and leadership of the execution of Medical Affairs trials.
Within BioMarin GMAF, 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.
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
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
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
· 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 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
It is expected that the Medical Director has the experience and knowledge required to demonstrate an advanced of the communication and collaboration competency, as well as advanced skills in strategic thinking and planning, medical and scientific knowledge and external stakeholder engagement. The individual in this role will be required to:
· Develop and deliver well organized and effective presentations and distill complex issues and topics into simple terms to drive dissemination up and down the organization and with external parties
· Show interest in the needs, expectations and circumstances of external partners and internal stakeholders to deepen relationships
· Lead the development and implementation of strategic plans that link task to strategy achievement
· Demonstrates comprehensive knowledge of relevant therapeutic areas and disease conditions
BioMarin offers comprehensive career development programming, including guidance, targeted training opportunities, and mentorship programming. A career development pathway for GMAF has been defined and is available to employees of BioMarin.
EDUCATION AND EXPERIENCE
· MD with country licensure or fellowship required; BS in life or health sciences
· 2 or more years of relevant experience in clinical science, medical affairs, and/or drug development
WORK ENVIRONMENT / PHYSICAL DEMANDS / TRAVEL
The employee may frequently be required to sit and talk or hear. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and taste or smell. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities by this job include close vision, depth perception and ability to adjust focus.
The employee will be required to travel 40-50% travel requirement and may include weekends
Internal: Market Planning, Commercial / Market Access, Commercial Marketing, Clinical Operations, Communications, Regulatory Affairs, Regulatory Patient Engagement, Study Management, Medical Information, Legal / Compliance, Corporate Communications, Pharmacovigilance, Biometrics, DSQ, Business Operations
External: Key Opinion Leaders, Health Care Practitioners, Advisory Boards