Medical Director, Mood & Pipeline – US Medical Affairs
About The Position
This role is a key member of the Medical Director, Mood & Pipeline – US Medical Affairs reports to the TA Lead within the broader US Medical Affairs organization. This Medical Director, Mood & Pipeline – US Medical Affairs owns the overarching medical portfolio strategy across the Mood therapeutic area, with primary accountability for new indications, pipeline and emerging assets, portfolio-level data dissemination and congress strategy, and competitive intelligence. The role works closely with the other Neuroscience Medical Directors and Associate Directors, as well as partners in US and Global Medical Affairs, Real World Value & Evidence (RWV&E), Epidemiology, R&D, Biostatistics, and US and Global Commercial teams, to shape and drive strategy for the Mood portfolio and pipeline, ensuring alignment with business objectives and regulatory standards. If you are a strategic thinker with a passion to advance clinical science and improve the lives of patients living with mood disorders, this is your opportunity to make a difference.
Requirements
- MD, DO, PhD, PharmD or NP degree required, (PhD Preferred)
- At least 8 years of combined industry, academic, clinical research or clinical practice experience, of which at least 3 years in the pharmaceutical industry with accountability for the timely execution of key deliverables.
- Neuroscience, psychiatry and/or mood-disorder therapeutic-area expertise is essential.
- Familiarity with clinical trial design and clinical data interpretation is important; prior R&D or clinical-development experience is a plus but not required for this role.
- Excellent analytical and strategic-thinking aptitude, scientific writing proficiency, and strong organizational, written and verbal communication skills, including impactful scientific oral presentations.
- The ability to work in a matrix environment, collaborating effectively with many cross-functional partners and leading cross-functional teams, is essential.
Nice To Haves
- Analytical Reasoning
- Business Requirements Analysis
- Clinical Research and Regulations
- Clinical Trials Operations
- Communication
- Developing Others
- Digital Culture
- Digital Literacy
- Healthcare Trends
- Inclusive Leadership
- Leadership
- Medical Affairs
- Medical Communications
- Medical Compliance
- Product Strategies
- Stakeholder Analysis
- Strategic Thinking
- Workflow Analysis
Responsibilities
- Lead the overarching medical portfolio and pipeline strategy across the Mood therapeutic area, including new-indication and label-expansion strategy for approved and pipeline assets.
- Provide medical leadership for new products and emerging assets in the Mood space, partnering with R&D and Global Medical Affairs from early development through launch.
- Own the portfolio-level data dissemination plan and congress strategy, ensuring a coherent scientific narrative across assets.
- Provide US medical input into Research & Development (R&D), including input into the design of R&D clinical trials, presentations and publications.
- Serve as the mechanism and emerging-science lead for the portfolio, and maintain ongoing competitive and scientific landscape surveillance (competitive intelligence) to inform strategy.
- Contribute as US MAF representative to supported lifecycle and new-indication studies including Phase IIIb/IV trials, post-marketing requirement studies, registries, real-world evidence, and investigator-initiated or collaborative studies leading study design, protocol development, analysis-plan development, and overall trial leadership.
- Contribute to the preparation of regulatory submissions and interactions with FDA, and help ensure regulatory post-marketing commitments are satisfied with cost-effective, efficient and scientifically rigorous methods.
- Collaborate with external investigators and thought leaders; develop credible relationships with key opinion leaders, medical societies and patient advocacy organizations across the mood and psychiatry community.
- Partner with the Spravato Medical Director to ensure future indications are supported.
- Take on special projects as needed
Benefits
- medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance
- consolidated retirement plan (pension) and savings plan (401(k))
- long-term incentive program
- Vacation – up to 120 hours per calendar year
- Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year
- Holiday pay, including Floating Holidays – up to 13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
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What This Job Offers
Job Type
Full-time
Career Level
Senior
