Jobs · Healthcare · California

Senior Medical Director South San Francisco, CA

BioSpace · South San Francisco, CA · 1 wk ago
HybridHealthcare$338k–$413k/yrFull-time

About the role

Maze Therapeutics is seeking a Senior Medical Director to join our Clinical Sciences team. This role will be pivotal in driving the clinical development programs for game-changing therapies, focusing on a small molecule targeting SLC6A19.

Responsibilities

  • Lead the design, execution, and analysis of clinical trials for the SLC6A19 program and other early-stage clinical assets at Maze
  • Author and review clinical-regulatory documents, including protocols and amendments, informed consents, study reports, and SAPs
  • Prepare and deliver scientific presentations and other communication materials for internal and external stakeholders, including investigators and other Maze collaborators
  • Engage with scientific thought leaders and patient advocacy groups to gain insights to inform clinical development plans and build awareness and enthusiasm for the Maze pipeline assets
  • Partner with Clinical Development Operations to identify and select study investigators and sites and build strong professional relationships with study investigators
  • Partner with Clinical Development Operations to identify, select, and oversee vendors and CROs to support program needs
  • Develop and integrate timelines and budgets for clinical activities with overall company timelines and goals, in close coordination with project management, CMC, nonclinical development, regulatory affairs, and other stakeholders

Requirements

  • MD with 6+ years of drug development industry experience
  • Board eligibility/certification and clinical experience in internal medicine and/or pediatrics. Additional clinical or research experience in nephrology or cardiometabolic diseases is preferred
  • Experience as a clinical study medical monitor
  • Experience with the preparation and submission of scientific publications, study protocols, Investigator Brochures, and other clinical-regulatory documents
  • Experience in the planning and oversight of early-stage and/or registration-enabling clinical development programs including CRO and site selection and relationship building with investigators/site study staff, patient advocacy groups, and other third parties
  • Demonstrated knowledge and experience in the design and conduct of clinical trials and clinical data analysis and interpretation, particularly Phase 2 trials
  • Experience leading a cross-functional study team
  • Exceptional organizational, analytical, and communication skills, enabling you to translate corporate objectives into actionable plans that consistently deliver high-quality data on time and within budget
  • A positive and enthusiastic disposition, adaptability to changing environments, and unwavering personal and ethical standards in pursuit of corporate goals
  • Willingness to travel domestically and internationally (up to 20%) for vendor visits, industry conferences, regulatory meetings, advisory boards, and other essential gatherings

Qualifications

  • Doctorate/PHD/MD

Skills

  • Strong leadership and collaboration skills
  • Excellent communication and presentation skills
  • Ability to manage multiple projects simultaneously
  • Knowledge of clinical trial design and execution
  • Experience with regulatory submissions and document preparation
  • Strong organizational and analytical skills

Benefits

  • Competitive medical, dental, and vision insurance
  • Mental health offerings
  • Equity incentive plan
  • 401(k) program with employer match
  • Bargain holiday and PTO policy

Pay

The expected annual salary range for employees located in the San Francisco Bay Area is $337,500 - 412,500.

Schedule

This position is full-time.

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