Associate Director, Medical Information and Review

About the Role

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. The role includes managing Medical Review personnel to ensure the medical and scientific accuracy of promotional and non-promotional materials. As necessary, this individual may support broader activities within Global Medical Affairs, adhering to departmental SOPs, corporate policy, and legal and regulatory requirements.

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.
  • Oversees the third-party contact center, including:
    • Compliance with workflow procedures and standards.
    • Handling inquiries requiring escalation or customization.
    • Conducting quality review of medical information cases and responses to ensure consistency and accuracy.
    • Providing new hire or ongoing therapeutic area/product training, as applicable.
  • Performs 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.
  • Leads medical information launch planning and execution for new products and indication expansion.
  • Ensures all medical information activities comply with applicable laws, regulations, and industry standards (e.g., PhRMA, FDA, EMA).
  • Participates in internal audits and regulatory health authority inspections as needed.
  • Provides conference support, including staffing the medical information booth and covering scientific sessions.
  • Implements medical information best practices.
  • Supports various operational initiatives, including development and maintenance of SOPs, training modules, database/system enhancements, and identification of new innovative opportunities for dissemination of medical information.
• Medical Review Process (25%):
  • Oversees personnel tasked with ensuring medical accuracy of Deciphera’s advertising, promotional, and scientific materials as part of the Promotional Material Review Committee (PMRC) and Medical Material Review Committee (MMRC), in collaboration with Medical Affairs Medical Directors.
  • Ensures the team provides 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.
• Other duties and responsibilities as assigned.

Requirements

• 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 using regulatory labels, 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.
• Strong team player with the ability to effectively collaborate with cross-functional teams.
• Ability to travel to meetings/conferences (domestic and international) approximately 20% of the time.

Preferred Qualifications

• 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.

Pay

The base salary pay range for this role is $167,000 - $230,000. Actual compensation packages will depend on various factors, including depth of experience, education, skillset, overall performance, and/or location.

Benefits

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