Director of Medical Affairs

Nature and Scope

The Director of Medical Affairs works with the Head of Medical Affairs in the activities associated with the development and commercialization of new products, if any, and the support of existing products.  The incumbent will be responsible for the medical strategy and execution of medical affairs activities. In conjunction with the Head of Medical Affairs, the Director will provide medical expertise to the various Marketing and Sales Departments, as needed. 

Essential Duties and Responsibilities

Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.

• Provide leadership, management and strategic direction to medical affairs teams/members: HEOR evidence generation, medical information, and medical affairs managers.
• Act as a Medical/Scientific advisor regarding approved products and marketed unapproved products, as assigned by the Head of Medical affairs.
• Under the guidance of Head of Medical affairs, build the Medical Affairs strategic and tactical plan, in partnership with other internal stakeholders.
• Provide strategic input and direction for all HEOR Evidence generation activities in the pre-launch, launch, and post launch space including HEOR research projects and related publications, budget impact model, and dossier.
• Provide medical and scientific support to internal stakeholders and assist in the training of the Marketing and Sales departments as needed.
• Review medical information responses and provide guidance on standardized response letters (SRLs), FAQs, SOPs, dossiers, etc.
• Manage and provide input and direction for promotion, medical, and regulatory review (PMR).
• Oversee medical training and onboarding.
• Assist the Head of Medical Affairs with focused assignments for design, execution, and summary findings of Scientific Advisory Boards and Phase IV studies.
• Identify, contact, develop and maintain relationships with key opinion leaders, advocacy organizations, and professional societies.
• Develop and coordinate relationships with External Research Foundations.
• Contribute to, and support execution of the lifecycle management activities for the company’s commercialized indications/assets.
• Provide input into the creation of marketing materials and ensure data is accurately and effectively communicated.  Reviews and approves marketing materials for accuracy and fair balance.
• Assist other Medical Affairs managers, when required, with various projects and responsibilities.
• Participate in special Regional and National projects e.g., team meetings, training, etc.
• Perform any other tasks/duties as assigned by management.

Education Requirements and Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.

• M.D, PharmD, or Ph.D. in Biology, Biochemistry, Bioinformatics, Analytical Chemistry, Chemical Engineering, or related field required.
• Minimum 8 years of pharmaceutical industry experience with minimum 4-5 years of Medical Affairs experience required.
• Minimum of 10 years of progressive leadership in the Pharmaceutical industry with demonstrated ability leading, coaching and developing staff members required.
• Scientific background and solid understanding of the pre-clinical and clinical development processes.
• Demonstrated understanding of legal, regulatory and compliance policies
• Excellent oral and written English communication skills.
• Basic Statistical knowledge with a demonstrated ability to interpret study findings and communicate appropriately.
• Requires extensive understanding of the company's products, commercialization strategy, the competition, and the pharmaceutical industry in general.
• Ability to prioritize and perform multiple tasks simultaneously.
• Ability to make decisions independently and with appropriate input.
• Ability to take feedback constructively and consider the viewpoints of others.
• Ability to work well in a matrix environment, particularly with Clinical Research & Development, Project Management, Regulatory Affairs, and Commercial organizations
• Flexibility in adapting to multiple therapeutic areas interchangeably.
• Strong computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook).
• Willingness to do what it takes to “get the job done properly.”
• This position requires up to 20% annual travel (primarily domestic with some international travel on an as needed basis)

Expected Salary Range:

$183,100 - $225,000

The salary range displayed is the  minimum and maximum annual salary range of compensation for the role that the employer in good faith believes to be accurate at the time of the posting of an advertisement for the role.  Actual compensation for the role will be based on a number of different factors including but not limited to the candidate’s qualifications, education, knowledge, skills and experience.

American Regent also offers a competitive total rewards package which includes healthcare, life insurance, profit sharing, paid time off, matching 401k as well as a wide

range of other benefits.

American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.

Applicants have rights under Federal Employment Laws.

• FMLA poster: https://www.dol.gov/whd/regs/compliance/posters/fmlaen.pdf
• Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov)
• Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf

American Regent Inc. endeavors to make https://americanregent.com/Careers accessible to any and all users.  If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email hrtalentacquisition@americanregent.com.