Senior Medical Director, Clinical Science

Kyowa Kirin is a global specialty pharmaceutical company backed by more than 70 years of breakthrough life science innovation, dedicated to discovering and advancing treatments for diseases in which unmet need is greatest. Based in Japan with worldwide operations, we work across the continuum from drug discovery to commercialization, guided by our commitment to patients and their families.
Our research teams, located in California and around the world, are focused on developing the next generation of antibody, cell, and gene therapies, with particular emphasis on bone and mineral disorders, hemato-oncology, and rare diseases. We accelerate development through collaborations with industry, academia, patients, and healthcare providers, and since 2018 we have introduced four new therapies serving patients with progressive illnesses often in need of new therapeutic alternatives.
Our culture is grounded in our values: Commitment to Life, Integrity, Innovation, and Teamwork/Wa, and brought to life through the Kabegoe Principles, which define the behaviors and actions that guide how we work together to deliver meaningful impact for patients.
We’re proud of the progress we’ve made and mindful of the countless individuals still waiting for their own breakthroughs. A commitment to making people smile unites our efforts. Learn more at www. kkna. kyowakirin. com.
Summary:
The Senior Medical Director, Clinical Science is a vital position in our growing global organization. As part of the Development Strategy & Science group, this position is a key member of multi-disciplinary project teams responsible for the achievement of milestones (e. g., IND, FIH, POC, EOP2, NDA) for development programs. In this role, the position will dive deeply into the underlying science, as a subject matter expert in the field. She/he will play an active role in the creation of regulatory documents (e. g., BB, IND), study protocols, and clinical development plans. The position will be responsible for establishing and maintaining KOL relationships.
Essential Functions:

• Serve as subject matter expert for internal project teams, providing guidance from clinical perspective.

• Create written material for clinical sections of key regulatory submissions; interface with regulatory authorities in each country to provide support for regulatory submissions and ensure compliance with local regulatory requirements and standards throughout the course of clinical trials.

• Contribute to the formulation of clinical development strategies, in collaboration with related functions, and create clinical development plans, accordingly.

• Actively contribute to the formulation of clinical trial protocols with sufficient feasibility and high probability of success based on expertise in the disease area.

• Provide input from the clinical perspective to the formulation of Target Product Profiles.

• Analyze safety and efficacy findings from clinical studies; participate in inter-disciplinary team meetings, as required

• Support required safety evaluations for clinical studies, e. g. SAE assessment, as needed.

• Perform close oversight of work performed by external medical monitors involved in group’s clinical studies

• Maintain knowledge of scientific developments in field and activities of competitors.

• Create and maintain good relationships with KOLs and clinical investigators; identify physicians with potential to serve as strong investigators for clinical studies.

• Attend relevant scientific meetings to strengthen competency in field and to gain awareness of research activities underway.

• Lead and author the publications and meeting presentations of clinical trials and review articles in cooperation with Medical Writing.

• Support business development, as needed, in due diligence efforts of new in-licensing opportunities (or other topics)

• Perform other duties, as required.

• A minimum of 10 years of pharmaceutical industry experience with a minimum of five (5) years in clinical development; significant comparable experience outside of pharmaceutical industry may be considered.

• Significant experience and ability to work effectively with external partners, including physicians and vendors.

• Advanced specialty training in Endocrinology greatly preferred.

• Strong scientific background with good understanding of drug development process

• Good leadership skills, highly motivated, great attention to detail, ability to work in complex and changing situations, excellent problem-solving skills.

• Broad level of interpersonal skills and flexibility; cultural sensitivity and ability to develop consensus within matrix structure of a multinational organization.

• Excellent written and oral communication skills

• Good project management skills; able to organize and prioritize multiple activities.

• Proficient in MS Office Suite, relevant software applications, using templates, and other electronic formats.

• Ability to think analytically (strategically and tactically) and simultaneously consider scientific, medical, and business aspects of projects.