Job Description

Who We Are

Avenzo Therapeutics, Inc. (“ Avenzo ”) is an early-stage biotechnology company focused on developing the next generation of oncology therapies for patients. The company was co-founded in 2022 by Drs. Athena Countouriotis and Mohammad Hirmand (former CEO and CMO of Turning Point Therapeutics, respectively). With a proven track record in building and scaling biotech companies, our experienced management team is passionate about and committed to building a pipeline of potential best-in-class targeted oncology programs. The company is headquartered in San Diego, California.

Position Summary

Reporting to the Vice President, Clinical Development the Senior Director, Pharmacovigilance (PV) will be responsible for the pharmacovigilance and risk management of assigned investigational and/or marketed oncology products. This individual will be responsible for the identification of safety signals, signal investigation, and the proactive management of the benefit-risk profile for assigned products. They will work effectively with key stakeholders and business partners on strategy and tactical safety issues, and keep senior management informed of evolving safety profiles, plans, and execution issues.

Essential Job Functions and Responsibilities

• Expert knowledge of safety, including any emerging safety concerns and risk/benefit profile for responsible compounds
• Accountable for safety signal detection activities for assigned products and discuss safety signals as needed
• Oversight of day-to-day safety monitoring activities and safety operations of clinical trials for the assigned product
• Provide PV subject matter expertise on clinical development teams and other cross-functional forums throughout the company.
• Facilitate internal cross-functional Safety Management Committee and/or other safety governance/review meetings; including coordinating materials, data outputs and presentation, agenda and minutes.
• Provide safety reports for assigned products are triaged, processed, and submitted/distributed as required per global requirements and applicable SOPs
• Perform individual case safety report assessments for clinical trial safety reports, including a review of Analysis of Similar Events, as applicable
• Communicate with partner companies, vendors, and internal groups regarding the processing and timely exchange of safety reports and ensuring compliance with partner pharmacovigilance agreements
• Contribute to the development and review of clinical, regulatory, and scientific documents, including clinical study protocols, informed consent forms, study plans, clinical study reports, manuscripts/journal articles, scientific abstracts/posters, case report forms, statistical analysis plans, and/or other documents as needed
• Develop training materials and conduct training on PV related content, including presentations
• Participate in developing PV organizational strategy, processes, SOPs, goals, and objectives and assist with the implementation and training to support department goals and initiatives

Qualifications

• PhD or MD required in advanced medical or life sciences or a related area degree preferred with 10+ years of experience in the pharmaceutical or biotechnology industry or an equivalent combination of academic and industry experience.
• Immuno-oncology therapeutic area experience or equivalent required
• Advanced working knowledge of safety & pharmacovigilance regulations and guidelines
• Demonstrated knowledge of global PV regulatory environment with working knowledge of international regulations including but not limited to FDA, EU, GVP, and ICH guidelines and regulations about clinical development and post-marketing safety environments
• Working knowledge of industry-standard safety databases (ARGUS and ARISg) and other electronic data capture systems
• Experience reviewing cumulative safety data with the ability to interpret, synthesize, and communicate complex clinical /pharmaceutical information and safety data
• Experience in the preparation and authoring of pre- and post-aggregate safety reports
• Thorough understanding of the drug development process and context applicable to safety surveillance activities
• 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
• Ability to travel as needed

Physical Demands and Work Environment

Physical Demands:

• Constant or continuous use of a computer keyboard, monitor and mouse to perform a variety of tasks
• Constant or frequent sitting, standing or walking
• May lift and/or move objects of various weights

Work Environment:

• Hybrid; on-site requirement Monday through Wednesday each week
• Noise level in the work environment is usually moderate
• Fast-paced, time sensitive environment with frequently changing priorities
• Handle multiple projects simultaneously

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

What We Offer

• Competitive salary and discretionary bonus plan plus equity
• Medical, dental and vision insurance with 100% employer paid premiums for the employee coverage and 80% for family coverage
• Employer-funded Health Savings Account
• Flexible Spending Accounts
• Group Life and AD&D insurance
• Voluntary Life and AD&D insurance
• Short-and Long-Term disability
• 401(k) retirement plan
• Critical Illness and Accident insurance
• Time off, including 10 paid holidays, winter closure, PTO and sick time

A reasonable estimate of the base salary range for this role is $276,500 – 300,000 and $324,700 – 335,000 for an MD. The final salary offered to a successful candidate will be dependent on several factors such as experience, education, skills and competencies.

Avenzo Therapeutics is an equal opportunity employer that does not discriminate on the basis of actual or perceived race, color, national origin, ancestry, sex, gender, sex stereotype, gender identity, gender expression, transgender, sexual orientation, pregnancy, childbirth, breastfeeding or related medical condition, religious creed, physical disability, mental disability, age, medical condition, marital status, registered domestic partner status, military or veteran status, genetic information or characteristics, or any other characteristic protected by federal, state or local law. Avenzo Therapeutics also prohibits discrimination, harassment, disrespectful or unprofessional conduct based on the perception that anyone has any of those characteristics or is associated with a person who has or is perceived as having any of those characteristics.

Notice to Search Firms/Third Party Agencies: Avenzo Therapeutics does not accept unsolicited resumes from recruiters or employment agencies without an executed search agreement in place.

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