Medical Director, Medical Affairs, ALS

Overview

The Medical Director will be responsible for developing and overseeing the execution of Medical Affairs programs in the US that support pre‑approval, marketed, and late development products and compounds with a focus on ALS, rare disease.

This individual will play an integral role in supporting the Medical Affairs team, as well as appropriate cross‑functional initiatives such as providing clinical and disease state expertise and product (compound) knowledge to support evidence generation. The Medical Director will serve on the promotional and non‑promotional program review committees, offer medical input upon request to assist in the development of promotional materials, and on other internal activities leveraging their scientific and clinical expertise as well as their knowledge of best practices in Medical Affairs. This role will report directly into the Executive Medical Director, Medical Affairs.

Responsibilities

• In collaboration with the VP Medical Affairs and Executive Medical Director, propose strategic medical affairs plans to support programs in the US for pre‑approval, marketed, and late development products and compounds with a focus on rare diseases
• Assist in creating Medical and Scientific programs that are scientifically and clinically sound, meet the needs of the medical and patient communities or other constituencies, and be executed in compliance with applicable laws, regulations, and company policies.
• Plan and oversee approved or required activities including but not limited to Scientific Communications, Life Cycle Management activities, and other programs to apply medical input.
• Assist in developing and managing relationships of US Key Opinion Leaders (KOLs).
• Represent Medical Affairs on promotional and non‑promotional medical‑legal‑regulatory review (PMRC) committees; and provide content expertise on other internal initiatives or work groups, as needed.
• Develop and maintain excellent working relationships with both US and global Clinical Development, Marketing, and Regulatory functions, ensuring seamless communications and provision of up to date scientifically accurate clinical information to external and internal sources.
• Maintain scientific, clinical, and therapeutic expertise in the company’s immediate areas such as ALS.
• Represent Medical Affairs Rare Disease and Shionogi Inc. by speaking at medical meetings, meetings with national or regional managed care accounts, scientific organizations, and conferences.
• Represent Medical Affairs Rare Diseases and Shionogi Inc. in external settings such as medical congresses and company‑sponsored scientific advisory meetings.
• Lead the Medical Plan development in collaboration with other medical cross‑functional partners.
• Completes all company‑based and job‑related training as assigned by Shionogi Inc. within the required timeline.
• Additional duties as assigned by Shionogi Inc. management.

Qualifications

• MD/DO, PharmD or PhD level in biologic sciences with specialty training related to job function, and experience in Rare Diseases
• Minimum of 7+ years’ experience within the pharmaceutical industry including 3 years in an in‑house Medical Affairs role with demonstrated ability to mentor/develop staff.
• Ability to develop/maintain credible relationships with top tier KOL experts; existing network of relationships in Neurology or Rare Diseases is preferred.
• Willing to be flexible regarding specific product responsibilities.
• Strategic thinker who can clearly anticipate future needs/trends and develop and drive appropriate tactical plans to capitalize on that vision.
• Demonstrated knowledge of regulations governing promotional activities coupled with sense of ethics, integrity and commitment to patients/customers.
• Highly developed interpersonal, influencing and leadership skills.

Competencies

• Polished presentation, instructional and oral/written communication skills; adept at conveying scientific information in simple terms.
• Excellent planning and organizational skills, demonstrated independently as well as within cross‑functional teams.
• Proven ability to effectively manage relationships with cross‑functional teams in a matrix organization and with external groups; demonstrates strong customer service orientation. Proven supervisory skills are preferred.
• Organized and skilled at managing multiple projects to timeline and budget
• Self‑starter, hard‑working and independent.
• Maintains optimism and energy in the face of change and adversity; proven ability to collaborate and problem solve.

Other Requirements

• Must be able to travel 30%–40% domestically and internationally for business and project meetings as required.
• Must live a commutable distance to our US Corporate Headquarters in Florham Park, NJ. Hybrid office presence required 50% per month, at least 2–3 days per week (when not traveling)

Additional Information

The base salary range for this full‑time position is $230,000 - $280,000. Individual pay is determined by several factors, which include but are not limited to: job‑related skills, experience, and relevant education or training. The range does not include the comprehensive benefits, bonus, long‑term incentive, applicable allowances, or any additional compensation that may be associated with this role.

EEO

Shionogi Inc. is an equal opportunity employer supporting individuals with disabilities and veterans. All qualified applicants will receive equal consideration for employment opportunities based on valid job requirements without regard to race, color, religion, sex (including pregnancy), marital status, national origin, age, ancestry, citizenship, disability, genetic information, status as a disabled veteran, a recently separated veteran, Active Duty Wartime or Campaign Badge Veterans, and Armed Forces Service Medal Veterans, or any other characteristic protected by applicable law. It is the policy of Shionogi Inc. to undertake affirmative action for protected veterans and individuals with disabilities in compliance with all federal, state, and local requirements to recruit a diverse pool of protected veteran and individuals with disabilities applicants and to ensure that our employment practices are, in fact, non‑discriminatory.

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