Director-Medical Affairs - USA

Who We Are
JCR Pharmaceuticals Co., Ltd. is a fully integrated specialty Biopharmaceutical company focusing on the treatment of rare diseases including growth hormone deficiency, anemia, graft-versus-host disease, Fabry Disease and Mucopolysaccharidosis Type II. Founded in 1975 and headquartered in Ashiya, Hyogo prefecture, JCR has around 900 employees, with biomanufacturing sites and research centers in Kobe (Japan), and overseas subsidiaries in San Diego (USA), Leiden (Netherlands), and Sao Paulo (Brazil).
What We Do
For many years JCR has been developing a technology (J-Brain Cargo®) to transport biotherapeutics across the blood-brain-barrier to address neurologic symptoms in children affected with rare genetic diseases (lysosomal storage diseases). In 2021, JCR was the first company to successfully submit the first molecule based on this technology (IZCARGO®) to regulatory approval for the treatment of MPS II (Hunter Syndrome) in Japan. The molecule is currently in global phase 3 clinical development to bring this innovation to patients across the world. Helping these individuals fulfill some of their hopes and dreams through the medicines we develop gives us a deep sense of purpose.
Applying this technology, JCR has built an industry-leading development portfolio of 16 potentially game-changing programs in lysosomal storage diseases, all of them addressing a unique unmet medical need. While three programs are currently in clinical trials, several others are expected to enter the clinic in the next years. JCR Pharmaceuticals has therefore rapidly expanded its international clinical development capabilities and built regulatory affairs knowledge in all regions where we conduct clinical trials.
Job Summary
The Director of Medical Affairs for USA is responsible for the development and implementation of a US focused medical affairs strategy/Medical plan that includes programs designed to integrate and address the strategic interests of clinical, scientific, and business stakeholders across all JCR Therapeutic Areas/indications within the region. This individual is also responsible for aligning the US Medical Affairs strategy with the corporate Medical Affairs strategy. This will also involve responsibility for developing and managing the medical affairs budget for the US.
This individual is responsible for building and developing programs that deliver clinical results and optimize patients’ long-term health outcomes. This involves building and managing both internal and external working relationships.
The focus of the role will include but will not be limited to: building and maintaining relationships with Key Opinion Leaders (KOLs) in the US; guiding and positioning the disease(s) and the available treatments; facilitating the development and execution of investigator initiated research studies; guide other activities such as medical plan; publication planning; establishing KOL advisory boards; establishing, managing and developing training programs.
This individual is also accountable for ensuring that the programs/activities associated with the medical affairs function are conducted in accordance with applicable regulatory requirements.
Essential Functions (Primary duties and responsibilities expected to be performed) include:

• Establishes and manages an efficient Medical Affairs function within the US. Collaborates with the Head of Global Medical Affairs and the global and regional representatives of the clinical and regulatory functions to develop an integrated Medical Affairs strategy for the US that aligns with and supports the global Medical Affairs strategy and associated departmental initiatives. Develops, implements, and manages a KOL strategy that supports JCR’s clinical development objectives and is perceived by KOLs as providing lasting mutual value. Directly responsible for establishing and managing relationships with KOLs and similar, external key stakeholders (e.g. academic institutions with a relevant medical/scientific community). Responsible for development and management of peer-level KOL/key stakeholder relationships. In cooperation with Patient Advocacy and Clinical, may represent JCR at patient advocacy group meetings or other professional medical and advisory organizations. In collaboration with the Clinical development teams, provides medical oversight for the scientific aspects of JCR and satellite symposia, workshops, and other meetings, including speaker contacts and post-conference publications. In partnership with the Clinical development teams, develops and executes a medical publication strategy. Contributes to the development of JCR’s US-focused communications strategy and ensures that communications incorporate key medical messaging. Ensures that communications are reviewed and that they are medically correct. Organizes, oversees, and performs the medical review/approval for promotional materials in the US when applicable. Provides medical support to US FDA-focused regulatory, labeling and market access activities. Ensures the highest standards are applied to associated medical governance activities. Ensures that US-based medical affairs activities are conducted in compliance with appropriate safety, environmental, financial, legal, and regulatory requirements.
  

Knowledge/Skills/Abilities Required

• An M.D. degree and a minimum of 10-15 years of experience in medical affairs roles at a biotechnology or pharmaceutical company, at least 5 of which were spent in a regional medical affairs management position. Experience required in orphan diseases.
• Demonstrated ability to think strategically while also retaining responsibility for the hands-on execution of the associated programs. Experience developing and managing a local budget. Direct management of, and hands-on involvement in full life cycle medical/clinical research and medical education activities for marketed biotechnology or pharmaceutical products. Demonstrated ability to apply medical/clinical expertise to the development of a regional medical affairs function that advances the company’s clinical development objectives. Deep understanding of the clinical trials process with demonstrated ability to design and implement programs and initiatives to achieve specific strategic objectives. Experience evaluating and approving proposals for investigator-initiated studies, ensuring that they are aligned with the company’s strategy. Demonstrated ability to critically interpret the impact of new research findings on current medical thinking. Ability to leverage this data to build and foster disease management frameworks. Track record of success working in a matrixed environment. Team-oriented with outstanding interpersonal skills and the ability to work collaboratively, effectively, and cross-functionally. Superb oral and written communication skills as demonstrated by the ability to present complex medical information to professional and lay audiences. Ability to interact effectively with patients, families, and patient advocates. Deep understanding of the US healthcare landscape and its implications on clinical, regulatory, and other strategies for the compound. This includes a sound understanding of a KOL-driven specialty care environment.
  

Special Knowledge Or Skills Preferred But Not Mandatory

• Prior experience with Early Access Programs. Experience in one or more of the following therapeutic areas: inborn errors of metabolism, lysosomal storage diseases, genetic disorders, neuromuscular and metabolic disorders. Language skills: second language desirable.
  

Travel Requirements
25-50%; the position is based in the US and the headquarter of JCR USA is based in San Diego. For the right candidate we will consider a hybrid position working remotely and 3 days in the office every 4-6 weeks.
Reporting Relationships
The position reports to Head of Global Medical Affairs & works closely with the GM USA with a reporting line to JCR USA for administrative purposes.