Senior/Executive Director, Clin Development

About the role

Avenzo Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing next-generation oncology therapies. This position is responsible for providing critical input into the strategy, development, management, and implementation of clinical studies.

Responsibilities

• Lead the development of clinical study protocols, protocol amendments, study guides, protocol training materials, and other clinical study-related documents based on the global development plan
• Manage clinical proof of concept, pivotal studies, and regulatory submissions
• Provide practical and overarching strategic guidance for preclinical and clinical programs, ensuring that the design, implementation, and conduct of the company’s clinical studies
• Deliver unambiguous data and information that allows for clear decision-making and advancement of its developmental efforts
• Identify clinical trial sites; work closely with and support Clinical Operations in site relationship activities as required
• Contribute to operational aspects of study conduct and patient enrollment efforts, including participation in site training, initiation and activation, and subsequent site engagement activities
• Maintain focus on robust study conduct and quality data generation
• Demonstrate the ability to develop unique and innovative clinical strategies to significantly shorten the development cycle in the face of an evolving regulatory landscape
• Lead the clinical development of assigned development programs and represent the program to executive leadership and study team members
• Support the recruitment/screening/selection of investigators in collaboration with Clinical Operations; ensure that Good Clinical Practices (GCPs) are followed
• Author clinical reports upon completion or termination of studies
• Accountable for preparing clinical portions of protocols, investigator brochures, medical reports, efficacy and safety summaries, scientific rationales, and benefit/risk ratios
• Contribute to Health Authority interactions and the development of regulatory documents
• Attend and present at investigator meetings and site initiation visits as applicable
• Take initiatives with investigator and KOL engagement

Requirements

• MD required, advanced medical or life sciences or a related area degree preferred with 12+ years of experience in the life sciences industry or an equivalent combination of academic and industry experience
• Oncology solid tumor clinical development experience is required 10+ years of experience in clinical development
• Proven track record of leading clinical development programs from early-phase trials through regulatory submissions
• Strategic leadership skills with the ability to inspire, mentor and manage cross-functional teams
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with internal and external stakeholders
• Strong analytical and problem-solving abilities, with a strategic mindset

Preferred Qualifications

• Strategic leadership skills with the ability to inspire, mentor and manage cross-functional teams
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with internal and external stakeholders
• Strong analytical and problem-solving abilities, with a strategic mindset

Benefits

• Group healthcare plans that offer medical, dental, vision, and basic life and AD&D insurance
• Short-term and long-term disability insurance, flexible spending accounts, health savings accounts, and voluntary insurance programs, including voluntary life, AD&D accident, and critical illness
• 401(k) plan
• Accrual of 10 hours of paid vacation time every month and accrual of 1 hour of paid sick leave for every 30 hours worked
• 17 paid holidays each calendar year, including a winter closure, subject to applicable Company policies
• Annual discretionary bonus and an equity award