---
title: 'Vice President, Head of Clinical Development – Allergy & Urticaria at ARS Pharmaceuticals Operations, Inc.'
canonical: 'https://feeny.ai/job/vice-president-head-of-clinical-development-allergy-urticaria-ars-zzck71twqas5'
type: 'job'
last_seen: '2026-09-14'
---

# Vice President, Head of Clinical Development – Allergy & Urticaria at ARS Pharmaceuticals Operations, Inc.

- **Company:** ARS Pharmaceuticals Operations, Inc.
- **Location:** San Diego California, United States
- **Work type:** remote
- **Posted:** 2026-08-28
- **Last confirmed live:** 2026-09-14
- **Apply:** https://job-boards.greenhouse.io/arspharmaceuticalsoperationsinc/jobs/5393124008

## Job description

ARS Pharmaceuticals is a fast-growing, innovative company dedicated to transforming the treatment of severe allergic reactions with neffy®, the first and only FDA-approved needle-free epinephrine product. If you’re motivated to make a meaningful impact, this is your opportunity to join a collaborative, entrepreneurial, and inclusive culture.

## JOB SUMMARY

The Vice President, Head of Clinical Development – Allergy & Urticaria is responsible for clinical strategy and execution across ARS Pharma’s allergy and urticaria portfolio, including chronic spontaneous urticaria (CSU) and related immunology-mediated conditions. This role owns clinical trial design and program execution from early-phase proof-of-concept through global registration and serves as the organization’s senior authority on the allergy/urticaria therapeutic area and its evolving regulatory landscape. The VP translates enterprise medical and evidence strategy into actionable, scientifically rigorous clinical development plans.

The VP partners closely with Medical Affairs, Regulatory Affairs, Development, Technical Operations, Biometrics & Data Management, Clinical Operations, Pharmacovigilance/Safety, and Commercial/Market Access to build integrated development plans that support successful global registration and market adoption. The VP will play a critical role in building out ARS Pharma’s clinical development function and team as the allergy and urticaria portfolio scales.

## ESSENTIAL JOB DUTIES & RESPONSIBILITIES

- Own clinical strategy and execution for the allergy and urticaria portfolio, ensuring development plans reflect the latest science, competitive landscape, and unmet patient needs.
- Lead the design, execution, and oversight of clinical development programs for allergy and urticaria assets, from IND-enabling studies through Phase 3 registration trials.
- Lead trial design across the portfolio, including study population, endpoints, comparators, and statistical approach, in partnership with Biometrics and the C-Suite
- Translate enterprise medical and evidence strategy into detailed clinical development plans, study designs, timelines, and risk/benefit tradeoffs.
- Author and oversee clinical protocols, investigator brochures, statistical analysis plans, clinical study reports, and other core clinical documents in partnership with Biometrics and Medical Writing.
- Serve as the senior clinical development representative in interactions with FDA, EMA, and other health authorities, including IND/CTA submissions, End-of-Phase meetings, and Type B/C meetings.
- Provide medical monitoring oversight and clinical data interpretation across ongoing studies, ensuring subject safety and data integrity.
- Partner with Clinical Operations and CRO partners to ensure trials are executed on time, on budget, and to GCP/ICH standards; oversee site selection, enrollment strategy, and vendor management.
- Chair or co-chair internal safety review committees and support benefit-risk decisions and post-market clinical surveillance in partnership with Pharmacovigilance, Regulatory, and Quality.
- Contribute clinical development expertise to early- and mid-stage protocol design for pipeline expansion and business development opportunities in allergy, urticaria, and related immunology-mediated conditions.
- Partner with Medical Affairs and HEOR/RWE colleagues to ensure clinical development plans generate evidence that supports adoption, guideline inclusion, and payer/reimbursement narratives.
- Engage key opinion leaders (KOLs), investigators, and scientific advisory boards to inform trial design and endpoint selection (e.g., UAS7, CU-Q2oL, itch/hive severity scores).
- Represent clinical development in board meetings, investor updates, and partner/licensing discussions as needed.
- Build, lead, and mentor a growing clinical development team (medical directors, clinical scientists, medical monitors), fostering a culture of scientific rigor, compliance, and collaboration.

KNOWLEDGE, SKILLS, & ABILITIES:

- Experience presenting clinical data and development strategy to regulatory agencies, scientific advisory boards, and investigator/KOL audiences.
- Experience advising the executive leadership team on clinical development strategy, trial design, and risk/benefit tradeoffs.
- In-depth knowledge of the allergy and urticaria therapeutic area — disease biology, standard of care, competitive pipeline, endpoints, biomarkers, and patient-reported outcome measures.
- Current knowledge of the FDA, EMA, and global regulatory landscape for allergy and urticaria (and biologics/immunology programs generally), including relevant guidance documents and precedent approvals.
- Demonstrated expertise in clinical trial design, including study population, endpoint selection, comparator strategy, and adaptive/innovative trial methodologies.
- Experience managing global, multi-site clinical trials, including work with CROs and central labs.
- Demonstrated ability to operate effectively in a hands-on, fast-paced environment with limited infrastructure and evolving organizational needs.

## EDUCATION AND EXPERIENCE

- MD, MD/PhD, or PharmD required (MD preferred); Board Certification in Allergy/Immunology, Dermatology, or a related specialty a plus, with 12+ years of progressive clinical development leadership in the biotechnology or pharmaceutical industry.
- Significant hands-on clinical development experience in allergy, urticaria (including chronic spontaneous urticaria), or related immunology-mediated therapeutic areas.
- Demonstrated success leading clinical programs from IND through registration (BLA/NDA), including direct authorship of protocols and regulatory submissions.
- Executive presence and ability to partner effectively with the C-Suite, and cross-functional leaders across Regulatory, Biometrics, Clinical Operations, Pharmacovigilance, and Commercial in a publicly traded environment.
- U.S.-based; ability to travel domestically and internationally for key internal and partner meetings (up to 20–30%).

At ARS, we are proud to offer a highly competitive compensation & benefits package.

The base salary range for this position is $325,000 to $400,000 and may be eligible for performance-based incentive compensation.  Actual pay rates are determined by considering multiple factors including qualifications, relevance of experience, education & credentials, subject matter expertise, and other job-related factors permitted by law.

This position is also eligible for Equity, 401k matching, and our excellent benefits package including 100% employer paid Medical, Dental & Vision for employees. View the full package here: [ARS Careers Page](https://www.ars-pharma.com/careers)

ARS Pharmaceuticals believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. ARS Pharmaceuticals is also committed to providing reasonable accommodation to qualified individuals so that an individual can perform their job-related duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at careers@ars-pharma.com

The position will be posted until a final candidate is selected for the requisition or the requisition has a sufficient number of applications.

## About ARS Pharmaceuticals Operations, Inc.

## Company Overview
- **One-liner**: ARS Pharmaceuticals develops needle-free, patient-friendly emergency treatments for severe allergic reactions (anaphylaxis), with its FDA-approved neffy® (epinephrine nasal spray).
- **Entity Type**: Public (NASDAQ: SPRY, IPO November 2022)
- **Headquarters**: San Diego, California, United States
- **Founded**: 2015
- **Founders**: Richard Lowenthal, M.S., MSEL (President & CEO) and Sarina Tanimoto, M.D., M.B.A. (Chief Medical Officer)

## Core Business
- Primary industry/industries: Pharmaceutical manufacturing, biotechnology, allergy therapeutics.
- Target customers: Patients and caregivers at risk of type 1 allergic reactions (food, medications, insect bites) and the healthcare professionals who prescribe epinephrine.
- Mission or purpose statement: To develop safe and effective treatments that are needle-free, easy to carry, simple to administer, and help eliminate the anxiety and hesitation associated with using an injectable device. [linkedin.com](https://www.linkedin.com/company/arspharmaceuticals)

## Products & Services
- **neffy® (epinephrine nasal spray)**: The first and only FDA-approved needle-free epinephrine product for the emergency treatment of allergic reactions (anaphylaxis). It is also approved in Canada. ARS Pharma positions it as a convenient, portable alternative to auto-injectors like EpiPen. [ars-pharma.com](https://ars-pharma.com/)

## Market Standing
- **Valuation/Market Cap**: ~$803.5M (as of 2026). [linkedin.com](https://www.linkedin.com/company/arspharmaceuticals)
- **Key Metric**: Annual Revenue of **$84.3M** (latest reported). [linkedin.com](https://www.linkedin.com/company/arspharmaceuticals)
- **Notable Investors/Partners**: Lead investors include Deerfield (Series C, 2018), SR One (Series D, 2021). Post-IPO debt financing (2025) and a $100M debt round (2025). [linkedin.com](https://www.linkedin.com/company/arspharmaceuticals)
- **Growth Signals**: Employee headcount grew **23.2% YoY** to 142 people. The company’s share of the epinephrine market is expanding, backed by a dedicated commercial launch of neffy. Post-IPO, the company acquired Silverback Therapeutics (2022). [linkedin.com](https://www.linkedin.com/company/arspharmaceuticals)

## Competitive Advantages
- **First‑mover in needle‑free epinephrine**: neffy is the only FDA‑approved intranasal epinephrine, offering a clear compliance and usability advantage over injectables (needle‑free, no fear of needles, easier to carry).
- **Strong IP and formulation expertise**: Proprietary intranasal delivery system backed by clinical data and regulatory approvals.
- **Patient/caregiver centricity**: The product directly addresses hesitation and anxiety around injections, which historically leads to under‑treatment or delayed treatment during anaphylaxis.

## Strategic Focus
- **Commercial execution**: Scaling the launch of neffy in the U.S. and expanding into Canadian and international markets.
- **Market education**: Converting physicians and patients from injectable epinephrine to the needle‑free alternative.
- **Expanding indications**: Potential label expansions or new formulations for broader allergic reaction settings.

## Why Work Here
- **Culture**: Collaborative, entrepreneurial, and patient‑driven. The company describes itself as inclusive and innovative, focused on improving patient lives. [ars-pharma.com/careers](https://ars-pharma.com/careers/)
- **Work model**: Most positions are eligible for remote or flexible hybrid schedules.
- **Benefits**: ARS pays 100% of medical, dental, and vision premiums for employees and 80% for dependents. Includes a 401(k) with 5% match, Employee Stock Purchase Plan (15% discount), 15 days Flexible Time Off, 8 days sick leave, 8 paid holidays plus 3 floating holidays, wellness program, and various voluntary coverages (pet insurance, legalShield, critical illness). [ars-pharma.com/careers](https://ars-pharma.com/careers/)
- **Growth**: Rapidly expanding commercial-stage biotech with a recent approval and active hiring across sales, medical science liaison, and corporate functions.

## Sources
1. [ars-pharma.com](https://ars-pharma.com/)
2. [ir.ars-pharma.com/investor-relations](https://ir.ars-pharma.com/investor-relations)
3. [ars-pharma.com/careers](https://ars-pharma.com/careers/)
4. [ars-pharma.com/leadership](https://ars-pharma.com/leadership/)
5. [linkedin.com/company/arspharmaceuticals](https://www.linkedin.com/company/arspharmaceuticals)

## Other roles at ARS Pharmaceuticals Operations, Inc.

- [Senior Director / Executive Director, Medical Affairs](https://feeny.ai/job/senior-director-executive-director-medical-affairs-ars-pharmaceuticals-34etv33b1bs6) — United States
- [Medical Science Liaison - West](https://feeny.ai/job/medical-science-liaison-west-ars-pharmaceuticals-operations-inc-united-states-kp9vr2phwvvk) — United States