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