Scientific Director / Senior Medical Director, Multiple …, San Francisco Caballúa

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 General 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. #J-18808-Ljbffr Postúlate en Kit Empleo: kitempleo.com.mx/empleo/5uk4ai