Key responsibilities
* initiate medical affairs activities including data generation and dissemination strategy; develop global medical affairs strategy; deliver medical functional plan and brand plan; ensure area and affiliate execution.
* design, analyze, interpret, and report scientific content of protocols, investigator brochures, clinical study reports, and regulatory submissions and responses.
* oversight of medical affairs-led clinical studies; monitor study integrity; interpret and communicate accumulating safety and efficacy data; provide in-house clinical expertise; coordinate scientific activities with internal stakeholders and leadership.
* participate in design and execution of clinical trial safety; resolve safety issues; perform safety monitoring; review and assess all adverse events (aes) and serious adverse events (saes).
* serve as clinical interface; solicit leader input; partner with medical affairs, commercial, and other functions to integrate cross-functional perspectives into clinical development plans and protocols.
* support scientifically accurate marketing materials, medical education programs, advisories, and symposia; support review/approval/execution/communication of sponsored or supported clinical research activities.
* coordinate scientific/medical activities with internal stakeholders (commercial, market access, heor, clinical operations, clinical development, regulatory); serve as interface for key regulatory discussions.
* provide therapeutic area/disease-specific education to investigators, clinical monitors, and global project team members; stay current with conferences/literature as a therapeutic resource.
* ensure budgets, timelines, and compliance requirements are factored into scientific activities.
* understand and comply with regulatory requirements related to clinical studies and global drug development.
qualifications
* scientific director: phd or pharmd (additional post-doctorate experience highly preferred); typically 10–15 years pharmaceutical industry/related; 7–10 years medical affairs with global medical affairs experience highly preferred.
* senior medical director: md or equivalent (do or non-us equivalent); relevant specialty in academic/hospital environment preferred; residency and/or fellowship preferred; minimum 2 years clinical trial or medical affairs experience (5 years preferred).
* substantial therapeutic area understanding (direct multiple myeloma expertise highly preferred).
* knowledge of clinical trial methodology, data analysis/interpretation, regulatory requirements, and protocol development.
* proven leadership in cross-functional global teams; ability to support global business strategy.
* excellent oral and written english communication skills.
work location/schedule
ideally based in mettawa, il or florham park, nj (other u.s. sites may be considered); hybrid schedule with 3 days/week onsite.
benefits
* paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) to eligible employees.
* eligible for short-term incentive programs.
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