Associate Director, Medical Information and Review

Role Summary

The Associate Director, Medical Information and Review works closely with the Head of Global Medical Affairs Excellence to lead a high performing team responsible for medical information and medical review activities across Deciphera’s portfolio. This individual is responsible for providing high-quality, timely, balanced and up-to-date medical and scientific information to internal and external customers, globally.

Key Responsibilities

• Management of the Medical Information function - 75%
• Responsible for the creation, review, and approval of standard response letters (SRLs), FAQs, and other scientific materials
• Ensures scientific accuracy, compliance, and alignment with product labeling and regulatory requirements
• Oversight of the third-party contact center as it relates to: Compliance with workflow procedures and standards; Inquiries requiring escalation or customization; Conducting quality review of medical information cases and responses to ensure consistency and accuracy; New hire or ongoing therapeutic area/product training, as applicable
• Perform critical analysis of medical inquiry trends to identify key insights, develop evidence-based conclusions, and provide actionable recommendations that inform Global Medical Affairs strategic plans
• Lead medical information launch planning and execution for new products and indication expansion
• Ensure all medical information activities comply with applicable laws, regulations, and industry standards (e.g., PhRMA, FDA, EMA)
• Participate in internal audits and regulatory health authority inspections as needed
• Provide conference support including staffing the medical information booth and covering scientific sessions as needed
• Implementation of medical information best practices
• Supports various operational initiatives including development and maintenance of SOPs; training modules; database/system enhancements; identification of new innovative opportunities for dissemination of medical information.
• Medical Review Process - 25%
• Oversee personnel tasked with ensuring medical accuracy of Deciphera’s advertising, promotional and scientific materials as part of Promotional Material Review Committee (PMRC) and Medical Material Review Committee (MMRC), in collaboration with the Medical Affairs Medical Directors
• Ensure team is providing fact-checking of data points and verification that all claims and statements are adequately supported by appropriate references and properly cited in materials submitted to the PMRC/MMRC in a timely manner

Qualifications

• Required Qualifications
• Advanced scientific degree in pharmacy (PharmD) or related science (PhD) with 5+ years of experience or MS with 10+ years of experience
• Deep understanding of regulatory and compliance frameworks (FDA, EMA, OIG, PhRMA)
• Understands the process for developing medical information response documents through the use of regulatory label, published medical literature, clinical study reports, posters, and abstracts
• Excellent written, verbal, and interpersonal communication skills
• Detail-oriented and self-motivated to drive for results
• Must be a strong team player with the ability to effectively collaborate with cross-functional team
• Able to travel to meetings / conferences (domestic and international) approximately 20% of the time
• Preferred Capabilities
• Prior experience working with medical information systems/databases (e.g., Salesforce) or promotional/medical review systems (e.g., Veeva PromoMats)
• Adept at learning new software / applications
• Training or past experience in rare disease or oncology therapeutic areas
• Experience working on product launches
• Working knowledge of US, European, and international regulatory requirements, guidelines, and compliance standards applicable to medical information operations

Additional Information

• Competitive salary and annual bonus
• Comprehensive benefits package including medical, dental, vision insurance, 401(k) retirement plan with company match, and more
• Generous parental leave and family planning benefits
• Outstanding culture and opportunities for personal and professional growth

Equal Employment Opportunity Information

Deciphera is committed to equal employment opportunity and values diversity. To ensure that we comply with reporting requirements, we invite you complete the confidential survey at the end of this application. Providing this information is optional. It will not be accessible or used in the hiring process, and has no effect on your opportunity for employment. This information will also be treated confidentially. We are committed to make all hiring decisions and other employment decisions on a non-discriminatory basis.