Senior Director Global Medical Affairs Inborn Errors of Metabolism

Remote

Full time

R12809

The Senior Director, Inborn Errors of Metabolism, Global Medical Affairs (GMA) is a critical contributor and member of the Global Medical Affairs Leadership Team, reporting to the head of Global Medical Affairs. Maintains key accountability for all GMA roles dedicated to the Inborn Errors of Metabolism team, including medical strategy and field medical. Will lead launch preparation in a rare disease space, where urgency is required. Works cross-functionally with both US and global counterparts in commercial, market access, payer value, early development, clinical development and others to create and execute strategic asset plans. Leads the strategic generation of scientific data and the consistent and accurate scientific communication about Otsuka’s inborn errors of metabolism product in the US and globally.

If you have passion for helping patients in difficult to treat conditions and love the excitement of launching a new medicine, we would like to speak to you about this exciting opportunity.

Job Description

• Drive launch strategy and launch preparation activities for all medical affairs deliverables

• Oversees global medical affairs planning and activities in cross-functional collaboration with other US and global functions, while working closely with medical excellence and operations

• Develop and drive the strategic vision for assigned asset (s), as well as contribute to the TrPP (target reimbursable product profile)

• Responsible for annual data gap analysis to develop and evolve the product data generation plan for inborn errors of metabolism asset through its lifecycle

• Responsible for the global evidence generation review process to harmonize the global Phase IIIB and IV programs, including Investigator Sponsored Studies and non-interventional studies

• Oversee core content development, in collaboration with the communication strategy lead

• Oversees communication strategy plans inborn error of metabolism asset in collaboration with the communication strategy lead, including creating the Global Publication Plans

• Acts as a driving force in the public dissemination of product related data

• Ensures that both US and regional offices/affiliates (Europe, Canada, and International) are properly cognizant of all product related data and organizes coordination of medical activities across all regions

• Oversees development of manuscripts, presentations, symposiums and posters

• Serves as a therapeutic area thought leader and interacts with experts in the field to obtain feedback on clinical aspects of US and global products and new data generation, interpretation and dissemination

• Provides input into regulatory documents, including product labeling

• Establishes SOPs and sets standards to ensure that the medical function operates effectively and efficiently and that all medical communications are accurate and of high quality

• Ensures compliance with all relevant Corporate Policies (CO) and Standard Operating Procedures (SOPs).

Qualifications

Required:

MD, PhD or PharmD with exceptional leadership experience in the Medical Affairs area

• Minimum of 10 years of experience in Medical Affairs

• At least 5-7 years of demonstrated supervisory experience with the ability to lead and motivate others

• Previous experience launching new medicines, preferably in rare disease

• Requires extensive understanding of the company's products, clinical development, commercialization strategy, the competition, and the pharmaceutical industry in general.

• Proven track record of leading and developing high-performing team

• Solid statistical knowledge with a demonstrated ability to interpret study findings and communicate appropriately.

• Skilled in managing change and influencing people

• Excellent communication and interpersonal skills and ability to influence in a matrixed environment

• Ability to travel up to 30-40% of time both domestically and internationally, based on business need

• Experience or expertise in rare diseases is highly preferred

Competencies

Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.

Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.

Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.

Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.

Respectful Collaboration - Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals.

Empowered Development - Play an active role in professional development as a business imperative.

Minimum $230,720.00 - Maximum $345,000.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate’s job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.

Application Deadline : This will be posted for a minimum of 5 business days.

Company benefits: Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.

Come discover more about Otsuka and our benefit offerings; .

Disclaimer:

This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.

If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting View email address on click.appcast.io .

Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: “Otsuka–people creating new products for better health worldwide.” In the U.S., Otsuka is comprised of two companies, Otsuka America Pharmaceutical, Inc., and Otsuka Pharmaceutical Development & Commercialization, Inc., that share a deep commitment to the development and commercialization of innovative products in the spaces of neuroscience, nephrology, and digital medicine.

Driven by our purpose to defy limitation, so that others can too, we have an unwavering belief in doing more and transcending expectations. In going above and beyond—under any circumstances—for patients, families, providers, and for each other. It’s this deep-rooted dedication that drives us to uncover answers to complex, underserved medical needs, so that patients can push past the limitations of their disease and achieve more than they thought was possible each and every day.

OPDC and OAPI are indirect subsidiaries of Otsuka Pharmaceutical Company, Ltd., which is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 34,400 people worldwide and had consolidated sales of approximately USD 14.2 billion in 2023.

We invite you to explore our open positions for an opportunity to join our 2,200 colleagues in the U.S. whose passion for our mission and pride in our company have earned us certification as a Great Place to Work by the Great Place to Work Institute.