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 a Director, Global Clinical Operations (Dir, GCO), who will be accountable for the strategic operational management, tactical planning, and execution of global clinical trial programs (Phases I-III). This individual will be a key leader within Clinical Operations, driving the success of their assigned clinical trials and teams. They will lead the collaborative partnership of the cross-functional matrix team. The individual will be responsible for ensuring adherence to GCPs, SOPs and all regulatory agency guidelines, as well as study operational planning and execution. A key focus will be the oversight of and partnership with CROs and other 3rd party vendors to ensure study milestones and deliverables are achieved according to agreed quality standards and timelines and that the quality of data is suitable for regulatory submission/inspections.

Key Responsibilities 

  • Serve as the central point of contact and contributes expertise for clinical trial execution on assigned protocols and/or programs
  • Provide leadership to a growing clinical operations department
  • Identify critical path items and evaluate variances to propose and oversee the implementation of proactive contingency plans, when necessary
  • May lead the Clinical Trial Team (CTT)
  • Create and support implementation of Clinical Operations processes, platforms and/or systems
  • Work cross-functionally to establish and ensure clinical program timelines and goals are met and risks are appropriately escalated to the Clinical management team
  • Serve as the central point of contact and contribute expertise for clinical trial execution on assigned protocols
  • May be responsible for participating/presenting at Investigator Meetings, SIVs and other meetings
  • Accountable for program level clinical operations budget forecasting, accrual management and quarterly review, ensuring tight control between study forecasts and actuals
  • Review and approve contracts, work orders and invoices prior to submission for executive approval

Ideal Candidate 

  • BA/BS in life sciences or equivalent
  • Minimum12 years of clinical research experience, including at least 5 years leading global projects from inception to completion, coupled with demonstrated ability to hold team and CRO members accountable to tight timelines and budgets
  • Minimum of 4 years line management experience
  • Experience building a Clinical Operations Department in a growing company
  • Experience working in a Functional Service Provider (FSP) model
  • Experience managing a clinical program from Phase 1 to Phase 2 (and eventually into Phase 3)
  • Leader with growth mindset, willing to learn from as well as mentor others
  • Ability to build and lead high-functioning teams, both within clinical operations and cross-functionally
  • Strong communication skills with ability to develop relationships and present to a variety of stakeholders and tailor message accordingly
  • Able to distill complex matters into a clear business case and roadmap for execution
  • 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
  • Work comfortably in a fast-paced, dynamic work environment
  • Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless

OTHER REQUIREMENTS

  • Ability and willingness to travel up to 20%

The anticipated salary range for candidates for this role will be $215,000-$235,000/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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