Associate Director, Clinical Operations

Description

Mozart Therapeutics is focused on developing disease-modifying therapies for autoimmune and inflammatory diseases that work by targeting a novel regulatory CD8 T regulatory cell network. The company is headquartered in Seattle, WA. The company is seeking a highly motivated and experienced individual who can work in a dynamic start-up environment to perform bench research to support small pre-clinical and non-clinical teams for the discovery and development of therapeutic candidates in inflammatory and autoimmune disease. 

We are seeking an Associate Director, Clinical Operations, reporting to our Chief Medical Officer. You will be responsible for managing the overall operation of clinical studies including project planning, budget, resource management and contract research organization management.  

You are: collaborative | a critical and creative thinker | solution-oriented | an invested mentor

ESSENTIAL DUTIES & RESPONSIBILITIES:

• Works with departmental leadership to establish strategic plans and objectives. 
• Helps establish departmental methods, techniques, and standards for projects, programs, and people. 
• Leads and manages clinical operations for one or more clinical trials.
• Contributes to the writing and review of clinical documents such as protocols, informed consent forms, investigator brochures, monitoring plans, and clinical study reports. 
• Selects and oversees CROs and ensures adequate oversight and timely input to ensure the study is executed according to the agreed project plan. Analyzes CRO performance trends and resolves or escalates accordingly.
• Builds and maintains study timelines, tracks milestones, and monitors overall operational performance metrics through the life of the study. 
• Recommends and implements innovative processes to improve clinical trial management to meet program needs.
• Identifies and/or anticipates risks and develops mitigation plans across trials within the development program, and escalates issues to senior management as necessary.
• May develop and manage clinical study budget and ensure clinical studies are executed within projected budget, on time, and with highest quality. 
• Oversees internal, contract, and/or CRO clinical trials staff and provides oversight and guidance to study teams.
• Effectively works with cross functional colleagues to ensure plans for clinical studies are in line with program and corporate goals.
• Writes and/or reviews clinical operations SOPs and related quality documents including, but not limited to, training, tools, templates, CRO manuals, and vendor oversight plans.
• Ensures clinical trials maintain an inspection readiness state throughout the lifecycle of the trial.
• Ensures that the conduct of clinical trials is in compliance with ICH, GCP and applicable regulatory requirements and that reported trial data are accurate, complete and verifiable from source documentation.

Requirements

KNOWLEDGE, SKILLS, AND ABILITIES:

• Strong working knowledge of the international conference on harmonization (ICH) and good clinical practice (GCP) guidelines and other applicable regulatory guidelines required.
• A comprehensive understanding of and experience in clinical trial operations is required, including initiation procedures, clinical monitoring functions, drug safety reporting, data flow from external sites to internal processing/review/query resolution, data analysis and study report generation.
• Able to recognize need(s), find solutions and take initiative to address in pro-active manner.
• Excellent interpersonal and professional skills are mandatory. 
• Strong organizational and time management skills. Excellent oral and written communication skills. 
• Able to create and project timelines in MS Project, SmartSheet, or similar platform. 
• Excellent critical thinking and scientific acumen, with a demonstrated ability to analyze, interpret, and clearly communicate (orally and in writing) complex clinical trial and regulatory strategy.
• A strong team player with a passion for science and helping discover and develop novel therapies for unmet medical needs.

EDUCATION AND EXPERIENCE:

• Bachelor’s degree (or equivalent) in a relevant scientific field, with advanced degree or nursing degree preferred, and 8 years of biotech/pharmaceutical clinical trial experience, with an extensive portion supporting oncology and/or immuno-oncology programs.
• Minimum of 5 years of management experience, including experience managing the work of other clinical, contract and CRO staff. 
• Phase 1–3 experience with at least 6 years managing clinical trials, including global studies.  
• Experience in autoimmune disease preferred (eg: gastrointestinal indications)

PHYSICAL REQUIREMENTS/WORK ENVIRONMENT:

This position requires up to 20% domestic travel and may include limited international travel.

This position primarily works in an office environment. It requires frequent sitting, standing, and walking. Daily use of a computer and other computing and digital devices is required. May stand for extended periods when facilitating meetings or walking in the facilities. This position periodically requires work before or after normal working hours (8am – 5pm) during the work week and on weekends. 

The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods. Reasonable accommodations may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described.

Mozart Therapeutics is an innovative, fast paced, collaborative culture looking to hire individuals who are seeking to make a significant contribution to advancing and developing novel immune modulators that target a subset of T lymphocytes to improve clinical outcomes in patients with autoimmune diseases. We are a well-funded privately held biopharmaceutical company founded in 2020. 

We offer our employees competitive compensation including annual performance bonuses and stock option grants. The pay range for the Associate Director, Clinical Operations position is $134,537 min – $206,063 max per year. The pay wage range shown is based on the job posting’s primary location. Actual compensation packages are based on a wide array of factors, including but not limited to skill set, experience, certifications, and location, in addition to internal equity and alignment with market data.  Benefits, including paid vacation, paid sick leave, paid holidays, and paid time off between Dec 25 and Jan 1, medical, dental and vision insurance, life insurance, 401(k) with company matching and stock options. All benefits are non-contractual and may be amended, terminated, or enhanced as Mozart Therapeutics deems necessary. We are an equal opportunity employer.

Salary : $206,063