BioMarin Pharmaceutical
Senior Director, US Medical Lead, Growth Related Conditions
BioMarin Pharmaceutical, San Rafael, California, United States, 94911
OVERVIEW: BioMarin US Medical Affairs For more than two decades, going our own way has led to countless breakthroughs, bettering the lives of those suffering from rare genetic diseases. In 1997 we were founded to make a big difference in small patient populations. Now we seek to make an even greater impact by applying the same science-driven, patient-forward approach that propelled our last 25 years of drug development to larger genetic disorders, as well as genetic subsets of more common conditions. Through our unparalleled expertise in genetics and molecular biology, we will continue to develop targeted therapies that address the root cause of the conditions we seek to treat. Applying our knowledge to make a transformative impact is not just a calling, but an obligation to those who will benefit most. The end goal has always been better lives and now we can reach more. And the more people we reach, the more our impact can grow. We transform lives through genetic discovery. Our Culture Our desire to make a positive impact on our patients extends to our employees and BioMarin is committed to fostering an inclusive environment where every person feels seen, valued, and heard - so employees can thrive in all areas of their lives, in and outside of work. We seek to provide an open, flexible, and friendly work environment to empower people and to provide them with the ability to develop their long-term careers. Ultimately, we want to be an organization where people enjoy coming to work and take pride in our efforts to help patients. 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 or best-in-class therapeutics that provide meaningful advances to patients. Come join our team and make a meaningful impact on patients' lives. Global Medical Affairs (GMAF) is a department within BioMarin's Worldwide R&D organization. GMAF's purpose is to drive BioMarin's scientific strategy to improve access and health outcomes for patients BIOMARIN US MEDICAL AFFAIRS US Medical Mission: To accelerate the integration of our medicine in standard of care. Develop and execute patient-centric, insights-driven medical strategies to improve healthcare outcomes and the appropriate use of our medicines through scientific engagement, education, and evidence generation. SUMMARY DESCRIPTION This position is embedded in the US Medical Affairs organization and is responsible for medical leadership for BioMarin's growth-related conditions medicines and programs. This responsibility includes leadership and direction across US medical team to ensure strategic alignment and integration at the global level of regionally driven priorities. This individual will interface externally with healthcare professionals, clinical investigators, regulatory agencies amongst others as well as with cross-functional internal BioMarin teams providing medical insights to drive scientific strategy within integrated brand plans and to inform clinical development and life cycle plans related to this therapeutic area. This individual will be the scientific reference point at the US level, representing the department and the company at key internal and external activities and events in relation to the therapeutic area. KEY RESPONSIBILITIES: Medical Lead - US Medical
Lead US medical strategic planning, prioritization, and execution oversight of Growth Conditions medical activities. Assign and align functionally and cross-functionally on objectives, deliverables, roles & responsibilitiesPartnering with cross-functional BioMarin teams (including marketing, market access, clinical development and others) in the development and execution of integrated VOXZOGO brand and launch strategies, robust LCM and pipeline development plansEnsuring timely GMAF leadership team awareness and alignment on key program needs and opportunities and ensure representation of GMAF aligned position in internal and external forums and processesProviding medical input into development, execution, and interpretation of clinical protocols. This includes review of draft independent research protocols, reports, and manuscripts; oversight of clinical registries and other post-marketing commitment; support evaluation of safety issues in collaboration with Medical Monitors and other teams; review of study results in study reportsDevelop high-performing US medical Growth related Conditions team of direct reports and matrix partners.Direct interaction with investigators, KOLs and the research community to support company initiatives. Responsible for representing BioMarin at scientific, clinical, and business development meetings. Promote effective communication between internal and external groups regarding Medical Affairs initiativesResponsible for partnering in the cross-functional development of key scientific and medical narrative for core data documents, publications, and communications, including identification of data gaps and proactive resolutionDrive strategic congress planning for Achondroplasia key congresses and align cross-functionally on objectives, key messages and plans at key US conferencesEnsure compliance with policies, SOPs, Code of Business Conduct and Corporate Social Responsibility, as well as relevant legislation and regulationsPersonal Qualities
Ability to work proactively and effectively, with exceptional creative problem-solving skills and self-motivation.Ability to lead a cross-functional teams within a matrix type organizational structureAbility and agility to develop and maintain scientific and clinical knowledge and expertise to a level required as subject matter expert in growth related consitionsDevelop, retain and motivate direct reports (medical directors) and integration with matrix team with clear delineation of accountabilitiesAbility to promote effective communication between internal and external groups. Collaborative and flexible in personal interactions at all levels of the companyAble to thrive in an ambiguous and demanding environment, with high capacity for effective relationship building and teamworkFlexibility and adaptability. Sensitivity to a multicultural environmentExcellent written and oral communication skills. Able to convince, inspire and motivate people with a variety of backgroundsSolid business acumen with high scientific inquisitivenessWillingness to travel approx. 20-40% of the time, including internationallyEDUCATION AND EXPERIENCE
Advanced Degree (M.D. / Ph.D. / PharmD) in Medicine and/or a medical sciences fieldVery strong industry experience, especially in Medical Affairs ( 7 years)Experience in pediatric endocrinology preferredUnderstand US Healthcare compliance landscape. Knowledgeable of current GCP guidelines and compliance rules. Clinical trial and publication experience is desirableDemonstrate excellent medical affairs skills and ideally have working knowledge in the therapy areaExperience in Skeletal Dysplasia highly desirable, either in pharmaceutical/clinical research or a clinical environmentExperience in rare diseases or genetic medicine highly desirableNote: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.
In the U.S., the salary range for this position is $ 214,200 to $ 321,200 per year, which factors in various geographic regions. The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors. A discretionary bonus and/or long-term incentive units may be provided as part of the compensation package, in addition to the full range of medical, financial, and/or other benefits, dependent on the level and position offered.
Lead US medical strategic planning, prioritization, and execution oversight of Growth Conditions medical activities. Assign and align functionally and cross-functionally on objectives, deliverables, roles & responsibilitiesPartnering with cross-functional BioMarin teams (including marketing, market access, clinical development and others) in the development and execution of integrated VOXZOGO brand and launch strategies, robust LCM and pipeline development plansEnsuring timely GMAF leadership team awareness and alignment on key program needs and opportunities and ensure representation of GMAF aligned position in internal and external forums and processesProviding medical input into development, execution, and interpretation of clinical protocols. This includes review of draft independent research protocols, reports, and manuscripts; oversight of clinical registries and other post-marketing commitment; support evaluation of safety issues in collaboration with Medical Monitors and other teams; review of study results in study reportsDevelop high-performing US medical Growth related Conditions team of direct reports and matrix partners.Direct interaction with investigators, KOLs and the research community to support company initiatives. Responsible for representing BioMarin at scientific, clinical, and business development meetings. Promote effective communication between internal and external groups regarding Medical Affairs initiativesResponsible for partnering in the cross-functional development of key scientific and medical narrative for core data documents, publications, and communications, including identification of data gaps and proactive resolutionDrive strategic congress planning for Achondroplasia key congresses and align cross-functionally on objectives, key messages and plans at key US conferencesEnsure compliance with policies, SOPs, Code of Business Conduct and Corporate Social Responsibility, as well as relevant legislation and regulationsPersonal Qualities
Ability to work proactively and effectively, with exceptional creative problem-solving skills and self-motivation.Ability to lead a cross-functional teams within a matrix type organizational structureAbility and agility to develop and maintain scientific and clinical knowledge and expertise to a level required as subject matter expert in growth related consitionsDevelop, retain and motivate direct reports (medical directors) and integration with matrix team with clear delineation of accountabilitiesAbility to promote effective communication between internal and external groups. Collaborative and flexible in personal interactions at all levels of the companyAble to thrive in an ambiguous and demanding environment, with high capacity for effective relationship building and teamworkFlexibility and adaptability. Sensitivity to a multicultural environmentExcellent written and oral communication skills. Able to convince, inspire and motivate people with a variety of backgroundsSolid business acumen with high scientific inquisitivenessWillingness to travel approx. 20-40% of the time, including internationallyEDUCATION AND EXPERIENCE
Advanced Degree (M.D. / Ph.D. / PharmD) in Medicine and/or a medical sciences fieldVery strong industry experience, especially in Medical Affairs ( 7 years)Experience in pediatric endocrinology preferredUnderstand US Healthcare compliance landscape. Knowledgeable of current GCP guidelines and compliance rules. Clinical trial and publication experience is desirableDemonstrate excellent medical affairs skills and ideally have working knowledge in the therapy areaExperience in Skeletal Dysplasia highly desirable, either in pharmaceutical/clinical research or a clinical environmentExperience in rare diseases or genetic medicine highly desirableNote: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.
In the U.S., the salary range for this position is $ 214,200 to $ 321,200 per year, which factors in various geographic regions. The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors. A discretionary bonus and/or long-term incentive units may be provided as part of the compensation package, in addition to the full range of medical, financial, and/or other benefits, dependent on the level and position offered.