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Senior Director, Head of (Oversight) Monitoring

Remote

 

About Apogee Therapeutics
Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally.
Apogee Therapeutics, Inc. is a biotechnology company seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need. Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. We seek to reshape the current standard of care for inflammatory and immune diseases because we believe people living with these diseases deserve the best possible treatment, and we refuse to stop at “good enough.”
We are a fast-paced company committed to building an exceptional company culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless. 
If this sounds like you, keep reading!

 

Role Summary

We are seeking an experienced and dynamic Senior Director, Head of Monitoring, to lead and grow an in-house oversight monitoring team for Apogee-sponsored clinical trials. This key leadership role will be responsible for overseeing the clinical research organization (CRO) monitoring and site activities, with a strong focus on fostering relationships with investigative sites and ensuring Apogee is recognized as the "Sponsor of Choice."  This role will support the in-house monitoring team across all Apogee studies and ensure consistency in oversight monitoring across the company through oversight monitoring SOPs, process, templates and training.    

As a critical member of the Clinical Operations Leadership Team, the Senior Director will be accountable for line and performance management of the oversight monitoring team. 

Key Responsibilities

  • Provide leadership, strategic oversight, and guidance to the Apogee clinical monitoring team across all programs to ensure company objectives are met.
  • Accountable for strategic CRA resource planning across the Apogee portfolio as well as the oversight of all CRA line management.
  • Accountable for developing company-wide oversight monitoring strategies and framework to align with company goals and regulatory requirements and ensure consistency in oversight monitoring efforts across all programs and therapeutic areas.
  • Responsible for the overall monitoring plans to ensure that third party vendors are monitoring according to Apogee expectations.
  • Collaborate cross-functionally to integrate oversight monitoring processes into the overall study operations.
  • Compile, assess, and communicate risks and optionality to support informed decision making for company monitoring strategy.
  • Serve as an escalation point for clinical monitoring issues with CRO partners and vendors.
  • Ensure that issues found during oversight visits are reported and actioned upon.

Ideal Candidate

  • Bachelor's degree in a scientific or healthcare-related field
  • At least 18 years of clinical research experience, including at least 5 years leading monitoring departments, coupled with demonstrated ability to grow and develop a department
  • Minimum of 10 years line management experience
  • Biotech industry/start-up experience strongly preferred
  • Significant knowledge of pharmaceutical industry, drug development and regulatory processes
  • Deep understanding of clinical monitoring and clinical oversight activities
  • Strong project management skills with high sense of urgency, ability to collaborate and influence effectively cross-functionally
  • Proven ability to effectively execute clinical trials within designated program budgets, timelines and compliance guidelines
  • Excellent communication skills with an ability to present to a variety of stakeholders and tailor message accordingly
  • Experience working in a fast-paced and dynamic environment
  • Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless
  • This position requires up to 30% travel

The anticipated salary range for candidates for this role will be $245,000-$285,000 / year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.

 

What We Offer
  • A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless
  • Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly
  • Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
  • Flexible PTO
  • Two, one-week company-wide shutdowns each year
  • Commitment to growing you professionally and providing access to resources to further your development
  • Apogee offers regular all team, in-person meetings to build relationships and problem solve
 
E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster.
 
Apogee Therapeutics is proud to be an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.
 
To review our privacy policy, click here

 

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