Global Development Lead, Internal Medicine, Sr. Director (MD)
$274.5kScorpion Therapeutics
Responsibilities Lead cross‑functional clinical development teams for assigned Internal Medicine/portfolio assets; design, execute, and interpret studies supporting worldwide regulatory submissions. Create and gain endorsement for the Clinical Development Plan and associated protocol design documents. Negotiate clinical program tradeoffs and milestones; ensure delivery in line with timelines and budget. Develop comprehensive global clinical development plans (including China/Japan) and pediatric investigation plan/study plan with trial clinicians to ensure feasibility and optimized execution. Provide product/program input for target product profiles; develop clinical development enabling strategies (digital/innovation and patient engagement). Partner with trial clinicians on governance reviews; provide therapy area/indication expertise for clinical data review (CRF design, signal interpretation, adverse event contextualization). Support trial‑level statistical analysis planning, TLF/Table/List/Figure development, and database releases with statistics/programming. Develop submission deliverables (IAP, IARP, submission TLFs) including SCE and SCS; review/approve submission‑level safety narrative plan. Support product label development/maintenance. Provide regulatory submission support (DSUR, PBRER) including disclosure deliverables and product defense. Engage external stakeholders (e.g., advisory boards, steering committees, DMC, adjudication committees, patients/advocates). Ensure compliance with internal SOPs and external regulatory standards; review IIR proposals. Qualifications MD or DO. Background in chronic weight management, endocrinology, or internal medicine with Phase1–3 clinical development and translational medicine experience. 8+ years relevant clinical research and development experience (academia and/or biopharma). Extensive knowledge of clinical development, global/regional regulation, ICH/GCP, and adverse event management. Demonstrated clinical/medical, administrative, and project management; strong written/verbal communication. Demonstrated experience managing/training large clinical development teams; experience designing/launching large teams preferred. Skills/Leadership Ability to influence cross‑functional matrix teams; persuasive effective staff leader. Strong influencing, conflict management, team building, accountability, and ability to drive in uncertainty. Benefits Annual base salary range: $274,500–$457,500; bonus target 25% of base; participation in long‑term incentive plan. 401(k) with Pfizer matching; retirement savings contribution; paid vacation/holidays/personal days; paid caregiver/parental and medical leave; medical/dental/vision coverage. Application/Logistics Up to 30% travel; hybrid role (on‑site ~2.5 days/week). Relocation support may be available (based on business needs/eligibility). #J-18808-Ljbffr Scorpion Therapeutics
$274.5k
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