Sunovion Director, Medical Affairs in Marlborough, Massachusetts
This position focuses on providing strategic medical direction and oversight of tactical execution of Medical Affairs activities for our therapeutic products in late phase development and approved for marketing in US of products. This is a key position that will report to the Executive Medical Director, Therapeutic Products.
Job ID: 6477BR
Department: Medical Affairs
Location: Marlborough, MA
Job Type: Full-time
Summary of Responsibilities: This position focuses on providing strategic medical direction and oversight of tactical execution of Medical Affairs activities for our therapeutic products in late phase development and approved for marketing in US of products. This is a key position that will report to the Executive Medical Director, Therapeutic Products.
Essential Functions: The Director of Medical Affairs is responsible for all Medical Affairs activities related to therapeutic products during late stages of clinical development and after regulatory approval in US and will work under the supervision and guidance of the Senior/Executive Medical Director, Medical Affairs.
These responsibilities include, but are not limited to:
•Medical Affairs Life Cycle Management for individual products; preparation and management of Phase IV clinical trials, including protocol development, interaction with and supervision of CRO activity and medical supervision of clinical trials and results interpretation in collaboration with respective Clinical Development and Clinical Operations team; support and coordination of strategy for pharmacoeconomic and other outcomes-based research with HEOR team.
•Collaborative development and execution of comprehensive Scientific Communications and Publications plan for the brand(s) including preparation and submission of abstracts, presentation of posters and oral reports at scientific congresses and development of primary and secondary manuscripts in timely and efficient manner.
•Review and compliant management of initiation of investigator-initiated trial proposals, CME proposals and other grant applications.
•Medical review of promotional materials (PMRC).
•Medical review of non-promotional materials (MSRC).
•Development of medical strategy for MSL teams, including creation of proactive and reactive MSL materials for use in the field and education of MSLs on respective topics.
•Review and approval of brand specific materials developed by Medical Information (SRLs, FAQs, AMCP Dossier, responses to ad hoc requests for information and presentations, etc.).
•Prepare medical materials for Sales Force training and executing related training activities.
•Collaborate with the Brand Marketing team to ensure alignment on overall business strategy and the medical affairs team within a matrix environment that may utilize outside contractors; previous experience working in a collaborative environment with commercial colleagues is needed.
•Maintain fiscal responsibility for Medical Affairs activities related to brand(s), develop and manage budget.
Minimum Education Requirements: PhD
Experience Required: 5 - 7 Years
Knowledge & Skills (General and Technical): Education level and/or relevant experience(s):
MD, DO, PhD, PharmD or equivalent
Experience required: 5-7 years
•The good working knowledge of US drug development, regulatory requirements, and prior experience in dealing with the FDA, including DDMAC is preferred, but not required.
•Industry experience in the development of pharmaceuticals, and especially prior Medical Affairs experience, is needed.
•Specialty training and clinical experience in neurology and Parkinsons’ Disease would be highly desirable in a candidate.
•Experience in development of compounds in other therapeutic areas and at earlier developmental stages is a plus.
Other Requirements (Licenses, Certifications, Specialized Training, Physical or Mental Abilities Required): •Strong communication skills, both written and oral, including presentation and scientific writing ability, are essential.
•Scientific reasoning, ability to interpret scientific data, and basic understanding of statistics are mandatory.
•Sense of urgency to meet agreed upon timelines and obtain results is essential.
•Excellent leadership and people management skills will be important considerations in candidate selection.
•Working knowledge of MS application software (Word, PowerPoint, Outlook, and Excel) is necessary.
Confidential Data: All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential.
Compliance: Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sunovion are carried out with the "best" industry practices and the highest ethical standards.
Mental/Physical Requirements: Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a computer for extended periods of time.
Sunovion Pharmaceuticals Inc. is an Equal Employment Opportunity (EEO) and Affirmative Action employer
Sunovion is committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.