Position: Head of Clinical Pharmacology
Hiring Manager: Chief Medical Officer
Location: Boston area preferred; Remote US considered (with East Coast time zone)
Travel: up to 20%; domestic and international
Founded in 2019, the Pyxis Oncology team has been charting a course to develop therapeutics for difficult-to-treat cancers. Our motivated and passionate team is laser-focused on the clinical development of our lead therapeutic candidate, micvotabart pelidotin (MICVO), a first-in-concept antibody-drug conjugate (ADC) that targets Extracellular Domain B (EDB+FN), which leverages a unique non-cellular mechanism to drive anti-tumor activity. EDB+FN is a splice variant of fibronectin – one of the key structural components of the tumor matrix – and is a compelling target for cancer therapeutics as the physiological expression of EDB+FN is very low in healthy adult tissues while found to be highly expressed in a variety of solid tumor tissues. Unlike conventional ADCs, which bind to the tumor cell surface antigens, MICVO uniquely targets EDB+FN within the tumor extracellular matrix, ultimately destabilizing the barrier that protects, feeds, and provides structure to the tumor, in addition to killing tumor cells directly.
In a preliminary Phase 1 dose escalation study (n=80) across nine different solid tumor types, we observed the strongest tumor regression response with MICVO in recurrent and metastatic head and neck squamous cell cancer (R/M HNSCC). In six heavily pretreated HPV-positive and HPV-negative efficacy evaluable patients who had received a median of four prior lines of therapy with R/M HNSCC, MICVO achieved a 50% ORR, confirmed by RECIST 1.1 including one complete response and a DCR of 100%. In early 2025, the U.S. Food and Drug Administration granted Fast Track Designation to MICVO for the monotherapy of adult patients with R/M HNSCC whose disease progressed following treatment with platinum-based chemotherapy and an anti-PD-1 antibody.
HNSCC is one of the most common cancers, and it is estimated that there will be approximately one million new cases of HNSCC worldwide annually by 2030. Based on the significant need for durable therapies in this patient population and the strength of the preliminary data in our monotherapy dose escalation study, we are actively advancing MICVO as a monotherapy and in combination with anti-PD-1 therapy to offer a potential differentiated, HPV-agnostic option for R/M HNSCC across multiple lines of treatment. As part of our “pipeline in a pill” strategy, we are also assessing opportunities for further signal-finding in tumor indications that demonstrated tumor regression in the Phase 1 study.
With strong partnerships in place – including a Clinical Trial Collaboration Agreement with Merck to study MICVO combination with Merck’s KEYTRUDA® (pembrolizumab) – join us as we rapidly advance our mission to improve the lives of people with difficult-to-treat cancers.
Position Summary:
The Head of Clinical Pharmacology will lead and manage all aspects of the clinical pharmacology function by providing guidance on dosage and trial design while delivering high-quality interpretation of clinical pharmacology data to advance Pyxis Oncology’s (‘PYXS’ or ‘Company’) MICVO and other programs. This hands-on clinical pharmacology leader will play a key role on the leadership team, will be expected to provide proactive and strategic engagement of the clinical pharmacology function, while also driving deliberate translational and clinical activities that support organizational goals.
Responsibilities:
- Provide recommendations for clinical dosage and relevant dosing algorithms to the broader clinical and development teams as well as contribute to dose-exposure response and dose selection for first-in-human trials.
- Work cross-functionally with the R&D team to drive programs into the clinic by applying an in-depth understanding of preclinical data and how programs translate into the clinic.
- Lead all clinical pharmacology activities and act as a representative on programs by providing all clinical pharmacology components to clinical plans.
- Operate as a key member of the clinical leadership team to define strategy of lead programs.
- Deliver high-quality evaluation and interpretation of clinical pharmacology data (PK, PD, PK/PD, dose, concentration/response relationships, etc.)
- Contribute to authoring and reviewing of necessary regulatory documents such as INDs, NDAs, and BLAs in addition to serving as the clinical pharmacology representative in all regulatory interactions.
- Manage all outsourcing activities as it relates to clinical pharmacology such as vendor management, vendor selection, protocol design/implementation, etc.
- Performs other related duties and/or ad hoc projects as required or as assigned by manager.
- Demonstrate PYXS core values: be of service, be clever, be gutsy, be tenacious, and be you.
Education and Experience:
- PhD in Pharmaceutical Sciences, Pharmacology, Pharmacometrics, or related field with 15+ years of industry experience in biotechnology, pharmaceutical, CRO, or biopharmaceutical setting; oncology experience is strongly preferred.
- Demonstrated understanding of Clinical Pharmacology and Pharmacometrics shown by extensive experience in designing and executing clinical pharmacology studies with the ability to make data-driven decisions based on preclinical and clinical information.
- Experienced in authoring and reviewing necessary protocol and regulatory documents such as CTAs, INDs, NDAs, etc.
- 5+ years of management experience is required for this position.
- Experience in designing clinical pharmacology with biologic modalities; Antibody-Drug Conjugates (ADCs) is a plus.
Qualifications:
- Ability to work cross-functionally with internal and external teams such as preclinical R&D, clinical development, clinical operations, etc.
- Leadership capability and willingness to maintain a level of hands-on responsibility for a portion of the portfolio while leading the function.
- Strong and effective communication skills; must be able and willing to proactively communicate cross-functionally as well as with leadership and board level members.
- Eligible to work in the United States without sponsorship.
The starting full-time annual base salary for this position is estimated to range between $310,000 to $365,000 (USD). The final compensation package offered to a successful candidate will consider a number of factors including but not limited to prior experience, relevant expertise, education, skills, qualifications and certifications, business needs, and market conditions.
Pyxis Oncology also provides eligible employees a comprehensive and competitive total rewards package including but not limited to a discretionary annual bonus (related to company and individual performance), equity, health insurance (including medical, dental, and vision), company paid life and disability insurance, unlimited vacation with paid holidays, 401(k) plan with company match, a flexible work model, and paid parental leave.
