Senior Medical Director

Simulations Plus is a leading provider of biosimulation, simulation-enabled performance and intelligence solutions, and medical communications to the biopharma industry. Our biosimulation solutions integrate artificial intelligence/machine learning, physiologically based pharmacokinetics, physiologically based biopharmaceutics, quantitative systems pharmacology/toxicology, and population PK/PD modeling.  

We also deliver simulation-enabled performance and intelligence solutions alongside medical communications support for clinical and commercial drug development. Our cutting-edge technology is licensed and utilized by leading pharmaceutical, biotechnology, and regulatory agencies worldwide. 

Leadership truly cares about maintaining a positive culture and employee well-being. We offer fully remote work, flexible schedules, and generous vacation policy along with affordable health coverage, stock options, annual bonuses, and more! 

The Senior Medical Director will write and develop medical/scientific materials for education, insights gathering, and training; includes development of materials such as presentations, enduring materials, and digital content. The role is responsible for the accuracy of the content development from conception to completion.  

Business Unit: Medical Communications (MC)

Internal Grade: 16

Direct Reports: No

Status: Exempt

Location: Remote 

Job Responsibilities: 

• Serve as the medical/scientific content strategy and execution lead for client projects to develop promotional and non-promotional materials such as slide decks, case studies, meeting summaries, white papers, training modules, discussion guides, surveys, etc. 
• Plan and execute medical strategy and engagement for clients
• Provide strategic insights and clinically relevant perspective to clients
• Develop deep understanding of disease states, market dynamics, and current medical and/or regulatory issues related to various products 
• Serve as the subject matter and therapeutic expert lead: conducting background research utilizing the medical/scientific literature, treatment guidelines, market research results, and other sources
• Serve as an internal disease-area scientific and research expert to support cross-functional strategies and other scientific communication deliverables
• Gather, organize, interpret, and present information in a manner appropriate for the target audience
• Establish strong relationships and collaborate with physician opinion leaders and client representatives including marketing directors, legal, regulatory, and medical teams
• Attend client meetings and medical conferences to provide on-site medical/scientific content support 
• Review and provide oversight in content developed by fellow medical writers to ensure quality control on content and context
• Collaborate with internal teams to plan, execute, and deliver on client projects
• Participate in discussions regarding the creation of departmental SOPs addressing processes and procedures necessary to achieve organizational objectives
• Ownership of the scientific accuracy and integrity of materials developed
• Produce high quality output while managing competing deadlines, shifting priorities, and working within the projected budget
• Other duties as assigned 

Qualifications: 

• 8+ years medical director, writer or related experience
• Experience with materials requiring medical/regulatory/legal (MRL) reviews required 
• General knowledge of medical sciences, healthcare delivery, and the pharmaceutical/biotechnology industry
• Oncology/Hematology/ Immunology experience strongly preferred
• Understand regulations governing the biotechnology and pharmaceutical industries
• Excellent verbal and written communication skills
• Strong presentation skills
• Maintain an objective and professional attitude
• Excellent interpersonal skills and effectively collaborate with a multifunctional team 
• Self-directed and work well under pressure
• Excellent organizational and time management skills
• Strong attention to detail
• Ability to work in a fast-paced, collaborative environment
• Accept constructive criticism well
• Strong computer and software skills
• Some travel up to 25% required for client meetings and conferences 

Education: 

• Bachelor’s Degree in life sciences or related field 
• PhD or MS in life sciences or MD/PharmD preferred 

Find out more about how amazing it is to work at Simulations Plus by visiting www.simulations-plus.com/career-center and apply today!