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.