Senior Director, Medical Affairs Strategy (Rare Disease)

Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, a diverse pipeline of early- to late-stage assets, and in-house advanced technology capabilities, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website https://www.us.sumitomo-pharma.com or follow us on LinkedIn.

Job Overview

The Sr. Director, Medical Strategy (Rare Disease) will be a key member of the Medical Affairs team reporting to the Executive Director, Medical Affairs Strategy.   The job is responsible for strategic direction and management for RETHYMIC (allogeneic processed thymus tissue–agdc), indicated for immune reconstitution in pediatric patients with congenital athymia.   RETHYMIC is the first and only FDA-approved tissue-based treatment for congenital athymia, engineered to help children develop an immune system sufficient to fight infections.

The role will provide set Medical Strategy for both internal company programs and external facing HCP and Payer interactions. The Sr. Director of Medical Affairs develops and maintains professional relationships with key physicians and other health care providers to conduct external scientific information exchange, gain clinical and scientific insights, and help identify unmet medical needs.  The job requires conducting peer to peer conversations regarding clinical immunology and give presentations on congenital athymia, an ultra-rare indication, working across multiple specialist types in a complex care setting.   

This job will effectively lead and communicate with cross-functional team members to share and gain insights that help SMPA meet the unmet medical needs of this ultra-rare disease community.  The role will also collaborate closely with Commercial leadership and advance patient advocacy efforts to ensure that Medical Affairs activities align with patient focused programs.

Job Duties and Responsibilities

• Develops and aligns medical affairs strategic plans with brand strategic imperatives that support impactful insights, data generation, and data communication plans to support education and awareness to HCP stakeholders and healthcare payers.
• Leads the creation and execution of evidence generation plans to enhance the value of RETHYMIC in a real-world setting, including continuation of product registry and Natural History Study. 
• Collaborates with Scientific Communication in the development and implementation of detailed scientific Publication Plans, Medical Advisory Boards, and Patient Advisory Boards upon review and approval of Legal and Compliance process.
• Critically evaluates information gained from published studies, and HCP interactions to develop key insights that deepen our understanding of the market’s needs and opinions of external stakeholders and therefore contribute to enhancement of scientific messages, plans, and strategy.
• Develops and sustains relationships with key HCPs to support compliant exchange of scientific and medical information including Advisory Boards and presentations at national and international meetings.
• Represents the Medical Affairs department on the RETHYMIC lifecycle team to provide medical affairs input to Clinical Research and Clinical Operation’s needs.
• Assesses and approves long-term Medical Education programming or Medical Affairs Sponsorships with Advocacy and Medical Education Groups
• Provides input into the development of Areas of Interest supporting research and presents research concepts to internal Review Committee for Investigator Initiated Study (IIS) concepts and research protocols.
• Leads internal and external training on congenital athymia disease state and label education to ensure consistent information about RETHYMIC.
• Engages with appropriate Market Access stakeholders to understand the state of healthcare policies and guidelines as they relate to clinical practices and reimbursement of RETHYMIC at a local, state, regional, federal, and national level.
• Presents data on RETHYMIC and educate to scientific experts including physicians, academic institutions, researchers, and allied health care professionals.
• Provides detailed and compliant medical review and approval of external resources, communications, and publications – ensuring medical accuracy, relevance, and fair-balance (in both Promotional Review Committee and Scientific Medical Review Committee)
• Reviews and approves custom responses to unsolicited request for medical information associated with RETHYMIC for congenital athymia.
• Serves as a subject matter expert in immunology and communicate current and emerging medical and scientific information on RETHYMIC for Medical Affairs programs.
• Attends relevant Immunology medical and scientific conferences to support speakers and presenters, ensure the success of medical communication goals, and participate in the collection and reporting of competitive intelligence within company guidelines.
• Develops and oversees Medical Affairs annual operating budget.
• Manages direct reports (if assigned).
• Ensures that all interactions and activities in the US adhere to corporate and healthcare compliance guidance in all activities, including those related to clinical trials, scientific interactions with internal and external groups, and responses to unsolicited requests for medical/scientific information.
• Ability to travel (domestic and some international) to attend scientific congresses, participate in internal meetings, and meet key stakeholders in the development of Medical Affairs activities - up to 25% travel.

Key Core Competencies

• Excellent verbal and written communication skills, as the position will interface with key opinion leaders and a wide range of internal employees.
• Ability to effectively communicate, collaborate and deliver excellent work in a fast-paced, and rapidly changing dynamic company.
• Must have excellent interpersonal skills, with experience in conflict management and relationship building.
• Ability to analyze complex issues critically and develop realistic and accomplishable plans and solutions, familiarity with the use and measurement of Key Performance Indicators.
• One-Team attitude with the capability to work cross-functionally with peer, and other colleagues, as appropriate.
• Capable of translating brand goals and objectives into actionable medical and scientific strategies.
• Proven track record of detailed, medically accurate, and scientifically relevant writing and review skills in line with compliance requirements.
• Experience representing a broad range of stakeholders in the development and communication of medical activities and plans.

Education and Experience

• Advanced degree in medical science (MD, PharmD, PhD); MD with relevant specialization (pediatrics, genetics, inborn errors of metabolism, immunology or similar) preferred.
• Biotech or pharmaceutical industry clinical research experience related to the design and/or conduct of clinical studies.
• 8+ years of relevant Medical Affairs work experience in biotech or pharmaceutical industry, or equivalent professional clinical experience the field of rare diseases (genetic diseases, biologic therapies, pediatric population experience strongly encouraged)
• Experience leading in a matrix team environment is considered a plus.
• Strong computer skills (Microsoft Office, etc.), knowledge of database management (Veeva Vault, etc.), and other enterprise platforms required for business.

The base salary range for this role is $ 274,800 to $343,500.    Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state.  Our robust time-off policy includes unlimited paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter.  Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law.

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Confidential Data: All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential.

Compliance :Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards.

Mental/Physical Requirements: Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.

Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) and Affirmative Action employer

Sumitomo Pharma America (SMPA) is committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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