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.
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. BioMarin has an active legacy and soon-to-be approved product portfolio as well as an exciting, cutting edge Discovery and Research program. Medical Affairs has a pivotal strategic leadership role in scientific and business development of therapeutics that make substantial positive impact on patient lives in rare diseases.
This position will provide scientific and medical planning and support for the Asia Pacific region. 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. The position requires drug development acumen and seasoned people management influencing across functions and regions. He/She will be part of the GMAF leadership Team, making important decisions on direction, execution and successful implementation of critical organizational objectives. Key product responsibilities include cross-functional leadership, strategic alignment with commercial business partners, product launch strategy and execution, scientific message development and product scientific materials review, KOL relationship management and medical monitoring of post-approval commitments.
- *KEY RESPONSIBILITIES**
- Responsible for direct management of Medical Affairs strategy, medical plans, projects and personnel within the APAC Region.
- Provide oversight, coaching and management of direct reports within APAC Medical Affairs team.
- Establish a rapport with the physicians and key opinion leaders by providing information and a variety of programs and services.
- Provide strategic direction to the team on KOL development in Asia Pacific.
- 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 APAC for future product planning.
- Work with the clinical team on coordination of trials in Asia Pacific.
- 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 within APAC.
- 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 APAC 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 Asia Pacific.
- Strategic planning and execution on publications generated from Asia Pacific.
- 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.
- *REQUIRED COMPETENCIES**
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
- *PEOPLE MANAGEMENT**
The Senior Medical Director will manage multiple 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
- 3 or more years of line management experience preferred
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.
Location: Remote - Anywhere
Skills required for this job: