Executive Director, Medical Affairs - LatAm
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.
This position will provide scientific and medical support for the Latin American region and develop and lead the regional medical strategy and associated tactics. The individual will represent BioMarin professionally as the medical and scientific expert, and build collaborative relationships with internal and external stakeholders. The individual may manage operations and/or CROs employed by BioMarin for investigator and company sponsored studies of marketed products in domestic markets. This individual will contribute to the generation and refinement of BioMarin initiatives and deliverables and provide scientific review for materials produced. Responsibilities will also include strategic publication planning and providing scientific and medical training to internal and external customers in the region.
This Senior Medical Director position is a leadership role with substantial strategic input, for this role the individual will have regional product responsibility with a focus on shaping and defining the strategy and tactics required to support medical affairs product pipeline, launch and post-marketing commitments. Key product responsibilities include cross-functional leadership, strategic alignment with commercial business partners on product launch strategy and execution, scientific message development and product scientific materials review, KOL relationship management and medical monitoring of post-approval commitments. There will also be close collaboration with Regulatory Affairs on filing of new indications and maintenance of licenses.
- Responsible for direct management of Medical Affairs projects and personnel within the Latin American Region.
- Establish a rapport with the physicians and key opinion leaders by providing information on a variety of programs and services.
- Provide strategic direction to the team on KOL development in Latin America.
- Provide medical support in the filing of BioMarin products registration, including but not limited to activities such as pre-filing consultation meeting, strategic planning of filing, etc., Provide timely medical review and approval of promotional pieces and sales training materials.
- Responsible for the medical direction in product labeling and other registration and labeling related topics.
- Work hand-in-hand with the regional marketing team in various medical and marketing initiatives.
- Strategically plan and execute various patient and physician programs.
- Work with outside stakeholders such as NGOs, patient advocacy groups and other patient organizations.
- Work closely with the Core Product Teams, Market Timing Team and other task force to ensure timely and accurate information is provided on Latin America for future product planning.
- Work with the clinical team on coordination of trials in Latin America.
- Assist in the preparation of presentations/manuscripts.
- Develop strong productive relationships with cross functional team members to foster development of medically accurate, innovative, high quality communications that support company strategies
- Responsible for providing medical input into development, execution and interpretation of Phase I, II, III and IV clinical protocols. This includes review of draft IST protocols, reports and manuscripts.
- Oversee clinical registries and evaluate safety issues associated with products and promotional activities for BioMarin products in accordance with respected regulatory requirements.
- Assist in critically evaluating study results in statistical and final reports and ongoing reviews with study investigators, resolving problems arising in the course of clinical investigations and preparing reports to the management and medical community.
- Responsible for representing BioMarin at scientific, clinical and business development meetings.
- Direct medical writing activities associated with Medical Affairs to ensure accurate execution of product dossiers, product related slide decks, standard response letters, FAQs as well as corporate abstracts, posters, oral presentation and manuscripts when appropriate.
- Promote effective communication between internal and external groups regarding Medical Affairs initiatives.
- Act as a key member of the ISTRC and Latin American PRB committees.
- Serve as medical and technical resource for clinical issues raised by internal and external collaborators, investigators, consultants, patients and contract resources.
- Interact in collaborations with strategic partners with various registration authorities in Latin America.
- Strategic planning and execution on publications generated from Latin America.
- Analyze and interpret medical literature to compose comprehensive, balanced, medically accurate documents that can be used to respond to unsolicited requests from external customers concerning the use of BioMarin’s products.
- Support early disease training across the region and in collaboration with the Medical Affairs learning and development department develop content and modules for training
The Senior Medical Director must seek to effectively lead the regional Medical Sciences activities and support the global product strategy, make impeccable decisions, and ensure the success of the business. To achieve these ends, the Senior Medical Director should:
- Be a highly capable communicator to audiences of all types and sizes, modeling open and clear communication across functions and teams
- Have a clear vision for the future of the business based on a big picture understanding of company strategy, and be able to effectively articulate this vision to others
- Prioritize career development by inspiring and motivating others while proactively acknowledging the progress, growth and success of individuals and teams
- Demonstrate mastery of the medical and scientific knowledge for key BioMarin therapeutic areas
- Be capable of making sound business decision considering corporate and product strategies and market realities
- Be able to prioritize, establish and maintain key relationships with influential Key Opinion Leaders, HCPs and other industry thought leaders
BioMarin offers comprehensive career development programming, including guidance, targeted training opportunities, and mentorship programming. A career development pathway for Medical Affairs has been defined and is available to employees of BioMarin
The Senior Medical Director will manage multiple levels of direct reports
EDUCATION AND EXPERIENCE
- MD with country licensure or fellowship required
- 8 or more years of relevant experience in clinical science, medical affairs, and/or drug development
- 5 or more years of line management experience preferred
- Significant understanding of the health care system in the covered countries is a must
- Strategic view and market mobilization at medical scenario
- Team management, organization and leadership skills
- Ability to react to rapidly changing priorities and effectively manage changes to collaborate with business strategy and execution plans
- Adept conceptual thinker with strong analytical and problem-solving skills
- Able to lead initiatives, advocate for programs and the ability to present compelling supporting facts and back-up data
- Excellent communication ability, both verbal and written (both, Portuguese and English and desirable Spanish), at all levels
- The ability and desire to interact with multidisciplinary teams
- Manage and adhere to all corporate policies and practices
WORK ENVIRONMENT / TRAVEL
The employee will be required to travel 50-60% of the time and this may occasionally include weekends.
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.