Senior Director Global Medical Affairs Inborn Errors of Metabolism

Remote

Full time

R12809

• 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).

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

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.