Associate Medical Director, PKU - North America Medical Sciences, Global Medical AffairsLocation 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.
BioMarin Global Medical Affairs Medical Sciences
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.
Global Medical Affairs (GMAF) is an expert scientific and medical function that develops and maintains non-promotional, evidence-based, transparent and balanced scientific and educational programs and resources in support of BioMarin’s products and disease states of interest. We do this by assuring safe and appropriate product use, support of continuous scientific exchange and through ongoing and new data generation.
Within BioMarin Medical Affairs, the Medical Sciences group, consisting of MDs and MSLs, is responsible for being the subject matter experts on 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 stakeholders 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 scientific and medical knowledge dissemination.
The Associate Medical Director position is a regional role within Medical Affairs Medical Sciences focusing on supporting Medical Sciences activities across all products in an assigned geographic area within a global region (e.g., EUMEA or LATAM). A key element of this position will be to maintains a local presence in assigned countries and execute key responsibilities, including, but not limited to, the development of an area Medical Plan, collaborating with Commercial colleagues, managing relationships with influential area KOLs/HCPs, gathering and sharing field intelligence that may impact Regional and Global product strategies, providing medical expertise and support to stakeholders, and ensuring marketing and communication compliance with local codes
Responsibilities may include, but are not limited to:
Provide assigned Geographic Area Medical Leadership for one or more post-marketing or pre-launch products:
Product Strategy & Planning
- Develop an Area Medical Plan in coordination with Regional and Global Medical Sciences leadership, Commercial Area Director/Country Manager and other relevant stakeholders
- Establish a close collaboration with the local Commercial Area Director/Country Manager and the local commercial team to align on medical plan and marketing tactics
- Act as local product and disease area expert (this includes keeping up to date on all new literature as well as new fields of scientific relevance) across all marketed products in the assigned geographic area
- Ensure adherence to country specific regulatory and clinical practice guidelines in supporting development and marketing of BioMarin compounds
Scientific Messaging and product marketing materials
- In collaboration with Medical Information, conduct review Medical Information request fulfillment, standard response documents and FAQs in local language with sign-off responsibility where regulations require
- Conduct Medical review of regional promotional material to ensure maximum effectiveness in local areas while adhering the company's ethical standards and relevant Codes of Practice in the respective geographic area
- Review and approve medical marketing materials in compliance with local country regulations
Local Market key relationship field intelligence, and access development
- Develop, manage and maintain relationships with investigators, KOLs and the research community to support company initiatives; collaborate with Regional and Global Medical Sciences leadership and commercial on the identification and management of relationships
- Recognize and share with Regional and Global Medical Sciences leadership, Commercial any key information received in field meetings (with KOLs, Investigators, other HCPs) that is critical to Medical or Product strategy such as adverse events, safety issues, product feedback or other field intelligence
- Gather competitive intelligence and clinical insights from the field and provide to BioMarin Commercial competitive intelligence function and Global and Regional Medical Product Leadership as appropriate
- Support the organization of, attend and, if required, chair local area advisory boards
- In collaboration with Regional Medical Product leadership, prepare for, attend and present at payer and regulatory meeting
- Support the Regional Medical Product leadership on the execution of local Medical Sciences tactical product launch activities in countries within the assigned area
Post Marketing – Registries, IR, observational
- Attend investigator meetings (where applicable)
- Oversee and support BioMarin Independent Research Program in the area (act as key BioMarin contact for sites)
- In collaboration with Regional Medical Product leadership, provide area medical / scientific expertise and support to the local product registration activities
- Assist the training of new commercial recruits by presenting the scientific disease and product related data and present at sales conferences, area meetings, etc. to develop high level of medical knowledge within sales force
EDUCATION AND EXPERIENCE
- MD with county 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