Senior Director, Medical & Scientific Affairs

DEPARTMENT: Medical Affairs

REPORTS TO: Vice President, Medical & Scientific Affairs

SUMMARY: The Senior Director, Medical & Scientific Affairs serves as a strategic partner to the VP of Medical & Scientific Affairs, and functions as the key scientific and medical expert for the company’s therapeutic areas of interest, and investigational and commercial products to ensure their full scientific value is realized. As a leader in the organization, the Senior Director, Medical & Scientific Affairs participates in the development of the overall medical and scientific strategy that drives core medical activities including headquarter- and field-based interactions with healthcare professionals, generation of scientific and clinical data, and dissemination of medical communications used to advance the understanding of Emalex’s programs. The Senior Director, Medical & Scientific Affairs engages external medical experts in the scientific community to advance Emalex’s clinical understanding of relevant disease areas and provides strategic medical input to support core commercial strategies. The Senior Director, Medical & Scientific Affairs is also a member of the Medical, Legal, Regulatory (MLR), Medical Education grants (MEG), and Investigator Sponsored Studies (ISS) grant submissions review committees.

DUTIES AND RESPONSIBILITIES:

• Build and maintain effective professional relationships with external medical experts and healthcare practitioners to engage in scientific dialogue and exchange of clinical information in support of Emalex’s assets and the Medical Affairs strategy; conduct Medical Advisory Boards as needed
• Collaborate with Clinical Development, Regulatory Affairs, and other internal stakeholders to effectively integrate investigational products and/or new uses into the commercial marketplace with scientific accuracy and integrity
• Establish appropriate strategic partnerships with national centers of excellence and patient advocacy groups in support of Emalex’s assets
• Lead efforts to mine existing data from company sponsored studies and collaborate with Clinical Development and other cross-functional partners to design and implement post-registrational studies including Phase IV studies
• Create external presentations, medical information documents, and scientific publications with a high level of scientific accuracy and integrity; deliver scientific presentations to healthcare organizations and other external audiences
• Support the development of the annual Publications Plan; deliver timely, impactful medical communications (abstracts, posters/presentations, manuscripts) in support of Emalex’s scientific areas of focus
• Lead US medical congress planning activities to engage in evidence-based education and share medical communications related to Emalex sponsored scientific data at national and international meetings
• Participate in the review and approval of materials submitted to Medical, Legal, Regulatory review committee, to ensure alignment with the Medical Affairs strategy
• Participate in the review and approval of independent research submitted through the Investigator Sponsor Studies program to ensure alignment with the Medical Affairs strategy.
• Participate in the review and approval of medical education grant submissions to ensure alignment with the Medical Affairs strategy
• Provide scientific support for the development of compliant promotional materials
• Conduct the scientific training of members of the promotional speaker’s bureau
• Create training materials and conduct scientific/medical training of Medical Affairs colleagues and cross-functional business partners including sales representatives
• Assist in the evaluation of new potential assets or acquisitions in collaboration with the business development department

SUPERVISORY RESPONSIBILITIES:

• This job has no current supervisory responsibilities, potential for future supervisory responsibilities.

QUALIFICATIONS:

• Medical Doctorate (MD, DO) degree; other scientific doctorate level degree (PhD or PharmD) with extensive therapeutic area expertise and relevant experience (e.g., neurology, neuroscience, Tourette Syndrome, or movement disorders) may be considered
• 7+ years prior pharmaceutical/biotech industry experience including a minimum of 5 years in Medical Affairs
• Excellent oral and written English communication skills.
• Proven record of being a successful medical leader with demonstrated ability to work cross-functionally