Primary Objective of Position

The Director of Medical Information and Communications is a vital member of the Medical Affairs team who is responsible for the planning, development, and implementation of medical content and communications for healthcare professionals using various channels, including digital, to support patient care. This role leads and manages capabilities related to medical information, product access, medical review, digital communications, and insight gathering. This highly strategic role will collaborate cross-functionally with Commercial, Clinical Development, Pharmacovigilance, Compliance, Quality Assurance, and the broader Medical Affairs team.

Major Duties/Responsibilities

• Oversee Puma’s Medical Information capabilities and call center, ensuring quality written responses to medical information inquiries and providing scientific oversight for the development of Standard Response Letters (SRLs)

• Ensure Puma’s Medical Information database is comprehensive, up-to-date, and easily accessible for responding to medical inquiries, and collaborate with other teams to obtain necessary product information and updates

• Monitor updates to treatment guidelines and clinical pathways and lead the development of dossiers and submissions to guidelines and compendia

• Oversee Puma’s medical review activities for promotional and medical materials, ensuring accurate and timely reviews, and providing strategic oversight in collaboration with the Head of Medical Affairs and the Medical Director

• Partner on the development of proactive and reactive Medical Affairs communications, including digital, that are consistent with messaging and approved lexicon

• Drive forward-thinking digital innovation to promote efficiencies and facilitate engaging scientific exchange

• Provide managerial support for medical insight generation, synthesis, and translation into medical strategy

• Survey the medical literature for relevant new data in disease states of interest to ensure that medical materials are medically accurate and clinically impactful

• Develop and maintain relationships with national and regional medical and scientific thought leaders and centers of excellence

• Support training for the Sales Team on Medical Information processes

• Become an oncology subject matter expert and internal liaison for marketed and pipeline products

• Provide oversight of vendors engaged in the aforementioned activities

• Provide coverage for Medical Affairs booths at US medical congresses and as needed, support medical booth materials and logistics

• Provide input and participate in decisions that affect the budget, functional capabilities, and operations of Medical Affairs

• Responsible for implementing a continuous improvement approach to existing and new procedures and ensuring that all SOPs/policies are up to date

• Stay informed of changes in regulations and adjust processes and practices accordingly

Skills & Abilities

• Knowledge of regulatory guidelines related to medical information, Scientific Information on Unapproved Uses (SIUU), and safety reporting

• Excellent communication and interpersonal skills, with the ability to effectively interact with a wide range of internal and external stakeholders

• The ability to positively influence stakeholders in a team environment for greater outcomes

• Detail-oriented with strong organizational and problem-solving abilities

• Proficient in using medical information and publication databases and other relevant software tools

Education & Professional Experience

Required:

• Advanced degree in a scientific or medical discipline (PharmD, MD, PhD)

• 7+ years of experience in medical information, medical affairs operations, field medical, market access, or a related field within the biotech or pharmaceutical industry

• Oncology experience

• Experience with the development of materials for internal and external customers, preferably experience developing standard response letters (SRLs) and medical review of materials by MLR (Medical Legal Regulatory)

Preferred:

• Direct leadership experience is preferred as well as leading in a matrix environment

Physical Demands

The physical demands of the office are normally associated with extended amounts of time sitting and using office equipment, including a computer, keyboard and mouse, which can cause muscle strain. While performing the duties of this job, the employee is frequently required to stand, walk and sit. Periodic light lifting of supplies and materials may apply.

Travel (including air) may be required up to 25%. This may include carrying a laptop, lifting luggage and possibly long flight times.

Compensation Range

The base compensation range for this position is $225k - $250k per year, higher compensation may be available for someone with advanced skills and/or experience.