Careers at Palvella Therapeutics

Job Title: Director, Commercial Operations
Location: Field-Based or HQ; Travel Required
Company: Palvella Therapeutics
Function: Commercial
FLSA Status: Exempt
Reports To: SVP Sales

Position Summary:

The Director, Commercial Operations serves as a critical operational backbone for the commercial organization by partnering cross-functionally to ensure that all customer-facing field teams, including the Sales organization, Patient Access Market Access, and Field Marketers, are equipped with the systems, data, processes, and support infrastructure necessary to operate with excellence in a competitive and highly regulated marketplace.

This role requires a rare blend of strategic thinking and hands-on execution. The ideal candidate thrives in ambiguity, excels at translating commercial strategy into operational action, and brings deep expertise in CRM platforms, field reporting, cross-functional coordination, and commercial analytics. As a growing company, this role will evolve rapidly and offers significant opportunity for career advancement.

Key Responsibilities:

Field Operations Support—Sales Team

• Serve as the primary operational point of contact for the full sales organization.
• Manage and optimize CRM system (Veeva) configuration, data integrity, and user adoption across the field sales team.
• Design and maintain territory alignments, call plans, and sample management workflows in close collaboration with Sales leadership.
• Support incentive compensation (IC) program administration, working with Finance and HR to ensure accurate, timely payouts and quota-setting processes.
• Build and maintain sales force effectiveness (SFE) dashboards and reporting tools that enable leadership to monitor performance in real time.

Field Operations Support—Patient Access & Reimbursement Team

• Provide dedicated operational support to the Patient Access field team, Patient Access Liaisons, and Hub/specialty pharmacy partners.
• Track and report on access metrics including prior authorization approval rates, time-to-therapy, and hub case status to identify bottlenecks and improve the patient journey.
• Manage vendor relationships for hub services, specialty pharmacy networks, and co-pay/patient assistance program providers.

CRM, Systems & Data Infrastructure

• Own day-to-day administration and continuous improvement of the commercial CRM platform (Veeva preferred), including user access, field configurations, validation rules, and integrations.
• Manage data governance standards across all commercial systems, ensuring data accuracy, completeness, and compliance with company and regulatory policies.
• Partner with IT and data vendors to implement new tools, system integrations, and process automation that improve field team productivity.
• Maintain master data management (MDM) for customer (HCP/HCO) records, territory hierarchy, and organizational rosters.

Reporting, Analytics & Business Insights

• Develop and distribute regular commercial performance reports and dashboards for senior leadership, including weekly/monthly KPI readouts across all field teams.
• Support quarterly business reviews (QBRs) with data compilation, slide preparation, and performance narrative.
• Leverage syndicated data sources (e.g., IQVIA, Symphony Health, Specialty Pharmacy data) to enrich commercial analytics and provide actionable insights.
• Produce ad hoc analyses as requested by the SVP Sales, Chief Commercial Officer, or other senior stakeholders.

Cross-Functional Collaboration & Compliance

• Act as a liaison between the commercial field teams and internal functions including Marketing, Medical Affairs, Market Access, Finance, Legal, Compliance, and Human Resources.
• Ensure all commercial operations activities adhere to relevant regulatory requirements, including FDA promotional guidelines, HIPAA, Sunshine Act (Open Payments), and company-specific SOPs.
• Support onboarding of new field personnel with system access provisioning, training coordination, and equipment/materials setup.

Qualifications:

Required

• Bachelor’s degree required; degree in Life Sciences, Business, Public Health, or a related field preferred.
• Minimum of 5–8 years of progressive experience in commercial operations, sales operations, or a related function within the pharmaceutical or biotechnology industry.
• Direct experience supporting multiple field-based commercial teams (e.g., Sales, Patient Access, TLLs/Field Marketing, or MSLs).
• Proficiency in CRM platform administration and optimization, with Veeva CRM strongly preferred.
• Strong working knowledge of specialty pharmaceutical commercial models, including specialty pharmacy distribution, hub services, and reimbursement support programs.
• Demonstrated analytical capabilities, including experience with BI/reporting tools (e.g., Tableau, Power BI, Excel) and commercial data sources (e.g., IQVIA, Symphony Health).
• Excellent organizational skills with the ability to manage multiple concurrent priorities in a fast-paced, resource-constrained environment.
• Proven ability to work effectively with cross-functional stakeholders at all levels of the organization.
• Strong understanding of pharmaceutical compliance requirements, including PhRMA Code, OIG guidelines, and Sunshine Act (Open Payments).
• Bachelor’s degree required; degree in Life Sciences, Business, Public Health, or a related field preferred.
• Minimum of 5–8 years of progressive experience in commercial operations, sales operations, or a related function within the pharmaceutical or biotechnology industry.
• Direct experience supporting multiple field-based commercial teams (e.g., Sales, Patient Access, TLLs/Field Marketing, or MSLs).
• Proficiency in CRM platform administration and optimization, with Veeva CRM strongly preferred.
• Strong working knowledge of specialty pharmaceutical commercial models, including specialty pharmacy distribution, hub services, and reimbursement support programs.
• Demonstrated analytical capabilities, including experience with BI/reporting tools (e.g., Tableau, Power BI, Excel) and commercial data sources (e.g., IQVIA, Symphony Health).
• Excellent organizational skills with the ability to manage multiple concurrent priorities in a fast-paced, resource-constrained environment.
• Proven ability to work effectively with cross-functional stakeholders at all levels of the organization.
• Strong understanding of pharmaceutical compliance requirements, including PhRMA Code, OIG guidelines, and Sunshine Act (Open Payments).

Preferred

• Experience at a commercial-stage specialty biotech or rare disease company.
• Familiarity with incentive compensation design and administration.
• Experience with launch preparation and commercialization activities in a publicly traded biotech setting.
• Exposure to Market Access analytics, including payer mix, pull-through, and formulary reporting.

Working Conditions & Travel:

• Position may be based at company headquarters or remote/field-based
• Travel of approximately 20–35% expected, including attendance at national sales meetings, regional field rides, and key commercial events.

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Job Title: Associate Director, Quality Assurance
Location: Wayne, PA / In-Person
Company: Palvella Therapeutics

Position Summary:

The Associate Director, Quality Assurance plays a critical role in supporting the development, implementation, and continuous improvement of the Quality Management System (QMS) at Palvella Therapeutics. This position ensures that quality assurance activities are conducted in accordance with applicable regulatory requirements and internal quality standards, supporting the company’s clinical-stage programs through potential commercialization.

This role is responsible for executing and overseeing core QA functions including document control, deviation and CAPA management, internal and external audit support, and regulatory compliance activities. The Associate Director, QA will collaborate cross-functionally with Clinical Operations, Regulatory Affairs, CMC, and contract manufacturing organizations (CMOs) to maintain a state of inspection readiness and support the company’s NDA submission goals.

This position requires a detail-oriented quality professional with strong working knowledge of GMP/GCP regulations and hands-on experience in a clinical-stage or early commercial pharmaceutical environment. The Associate Director will work under the strategic direction of the VP, QA/QC while independently driving execution of quality programs and serving as a subject matter expert (SME) on QA matters.

Key Responsibilities:

• Quality Management System (QMS) Execution: Support the development, maintenance, and continuous improvement of the company’s QMS. Ensure SOPs, policies, and quality documents are current, controlled, and aligned with regulatory expectations.
• Regulatory Compliance: Ensure QA operations comply with applicable regulations and guidelines (e.g., FDA 21 CFR Parts 210/211/312, GMP, GCP, ICH). Monitor regulatory developments and assess impact on quality systems and procedures.
• Document Control & Change Control: Oversee the document control system, including the creation, review, approval, and retirement of SOPs, forms, and controlled documents. Manage change control processes to ensure changes are evaluated, documented, and implemented appropriately.
• Deviation & CAPA Management: Lead the investigation of deviations, out-of-specification (OOS) results, and quality events. Develop and track corrective and preventive actions (CAPAs) to ensure timely resolution and sustained effectiveness.
• Batch Record Review & Product Release Support: Review executed batch records, laboratory data, and associated documentation for completeness and compliance. Support disposition decisions and product release activities in collaboration with QC.
• Audit & Inspection Readiness: Conduct and support internal audits and qualify supplier/vendor audits. Assist in the preparation for and management of external regulatory inspections (e.g., FDA PAI, BIMO). Maintain ongoing inspection readiness posture.
• Supplier & CMO Quality Oversight: Support qualification and ongoing oversight of contract manufacturers, testing laboratories, and other external partners. Maintain quality agreements and monitor vendor performance against quality requirements.
• Training Program Support: Assist in developing and delivering GMP/GCP training programs for internal staff and external partners. Ensure training records are maintained and that personnel are current with applicable quality requirements.
• Quality Metrics & Reporting: Track and report on key quality metrics, including CAPA status, deviation trends, audit findings, and document control performance. Provide regular updates to the VP, QA/QC and contribute to quality management reviews.
• NDA Submission Support: Contribute QA expertise to the preparation of regulatory submissions, including NDA sections related to quality systems, CMC, and GMP compliance. Support compilation and review of quality data packages.
• Cross-Functional Collaboration: Partner with Regulatory Affairs, Clinical Operations, CMC, and Manufacturing to integrate quality requirements across the product development lifecycle. Serve as a quality resource and SME for cross-functional project teams.

Qualifications:

• A Bachelor’s degree in Pharmaceutical Sciences, Chemistry, Biology, Engineering, or a related scientific field is required.
• Minimum of 7 years of experience in pharmaceutical quality assurance, with at least 2–3 years in a senior or lead QA role.
• Demonstrated experience supporting QA activities in a clinical-stage or commercial pharmaceutical or biopharmaceutical environment.
• Solid working knowledge of GMP, GCP, FDA, ICH, and applicable regulatory guidelines.
• Proven track record in deviation investigation, CAPA management, document control, and audit execution.
• Experience with rare disease or specialty pharmaceutical programs is a plus.
• Strong attention to detail and ability to manage multiple priorities in a fast-paced, resource-constrained environment.
• Excellent written and verbal communication skills, with ability to clearly articulate quality requirements and findings to cross-functional stakeholders.
• Analytical and critical-thinking skills, with the ability to assess risk and recommend pragmatic quality solutions.
• Experience with electronic quality management systems (eQMS) and document management platforms.
• Ability to work independently while maintaining alignment with senior leadership and organizational goals.
• Collaborative team player with the ability to influence without authority.

Preferred Qualifications:

• An advanced degree (Master’s or PhD) in a related field is preferred.
• Familiarity with NDA preparation, regulatory submissions, or FDA inspection support is strongly preferred.
• Certification in Quality Assurance (e.g., ASQ Certified Quality Auditor, Certified Quality Engineer) or GMP-related certifications.
• Lean Six Sigma or other continuous improvement certifications are a plus.

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Job Title: Medical Science Liaison
Location: Field-Based
Company: Palvella Therapeutics

A Message from the Palvella Leadership Team

Position Summary:

Palvella Therapeutics (NASDAQ: PVLA) is a clinical-stage biopharmaceutical company developing innovative therapies for serious, rare skin and vascular conditions that currently have no FDA-approved therapies. With a pipeline of potentially first-in-disease assets and a clear path toward commercialization, Palvella offers a unique opportunity to join at a pivotal moment, helping bring meaningful therapies to patients with significant unmet medical needs.

At the core of Palvella’s innovation is its patented QTORIN™ platform, which is designed to deliver therapies directly to affected tissue while minimizing systemic exposure. The platform supports the development of topical therapies that penetrate deep into the layers of the skin, reflecting Palvella’s commitment to pairing scientific precision with real-world applicability for patients and clinicians.

Palvella’s lead product candidate, QTORIN™ rapamycin, is being evaluated in clinical programs for microcystic lymphatic malformations (mLM) and cutaneous venous malformations (cVM). With a potential first commercial launch anticipated in early 2027 in mLM, this is a pivotal time to join Palvella, contribute to building its first commercial organization, and make a direct impact on patients, families, and the broader rare skin disease community.

The company is gearing up for what will be a transformational year in 2026 by adding a number of leaders to the management team in preparation for commercialization in early 2027.

The Executive Team

You’ll be joining a passionate, agile, and deeply experienced leadership team, including:

• Wes Kaupinen, Founder and Chief Executive Officer
• Jeff Martini, Ph.D., Chief Scientific Officer
• Matthew Korenberg, Chief Financial Officer
• Ashley Kline, Chief Commercial Officer
• Kathy Goin, Chief Operating Officer
• David Osborne, Ph.D., Chief Innovation Officer

You will report directly to Vimal Patel, Senior Vice President, Medical Affairs

The Role: Medical Science Liaison / Senior Medical Science Liaison

The Medical Science Liaison (MSL) / Senior Medical Science Liaison (Senior MSL) is a field-based medical professional responsible for delivering high-quality, non-promotional scientific exchange and supporting clinical development activities across Palvella’s rare disease portfolio.

The level (MSL vs. Senior MSL) will be determined based on experience, therapeutic expertise, and demonstrated field impact. Both roles are hands-on, externally focused, and deeply connected to the science.

Key Highlights

The successful candidate is scientifically rigorous, externally credible, and deeply patient-focused. He or she will be motivated by advancing meaningful scientific dialogue in areas of high unmet need and by building trusted partnerships within the rare dermatology and vascularanomaly community. This individual will play a visible role in shaping Palvella’s Medical Affairs presence during a pivotal stage of late-stage development and pre-commercial readiness.

• Deliver high-quality, balanced scientific exchange to dermatologists, vascular anomaly specialists, geneticists, and clinical investigators across assigned territory.
• Establish and maintain trusted, long-term relationships with key opinion leaders, academic centers, and vascular anomaly clinics.
• Communicate complex disease biology, mTOR pathway science, and QTORIN™ clinical data with clarity and scientific rigor.
• Support ongoing and planned clinical programs in microcystic lymphatic malformations, cutaneous venous malformations, and other rare dermatologic conditions.
• Generate and share actionable field insights to inform Medical Affairs strategy, clinical development planning, and future launch readiness.
• Partner cross-functionally with Clinical Development, Regulatory, and Commercial colleagues to ensure aligned and compliant scientific engagement.
• Represent Palvella at key dermatology, rare disease, and vascular anomaly congresses and educational forums.
• Contribute to the development and refinement of medical materials, FAQs, and educational content.
• Maintain deep, current knowledge of mTOR biology and emerging data in rare dermatologic and vascular disorders.
• Play a visible role in building a high-performing, collaborative Medical Affairs organization during a pivotal stage of company growth.

Location & Work Model

This is a field-based, externally focused role with significant travel (approximately 60–70%) to support scientific engagement with key opinion leaders, investigators, and academic centers across the assigned territory. The MSL will operate remotely within the United States while maintaining strong alignment with cross-functional partners.

Palvella’s headquarters is located in suburban Philadelphia (Wayne, PA), and periodic travel to headquarters and national congresses will be expected.

Ideal Candidate Snapshot

• Advanced scientific degree (PharmD, MD, PhD, NP, PA, or equivalent) with strong foundational knowledge in dermatology, rare disease, immunology, vascular anomalies, or related therapeutic areas.
• 3–5+ years of experience in Medical Affairs or as a field-based MSL (level determined by experience), preferably supporting clinical-stage or pre-launch assets.
• Demonstrated ability to engage in high-level, evidence-based scientific exchange with dermatologists, academic investigators, and multidisciplinary specialty clinics.
• Experience working with or strong interest in rare disease populations, complex care models, and academic medical centers.
• Proven track record of building credible, trusted external relationships while maintaining compliance and scientific integrity.
• Strong ability to distill complex clinical and mechanistic data into clear, impactful dialogue tailored to diverse stakeholders.
• Collaborative mindset with experience partnering cross-functionally across Clinical Development, Regulatory, and Commercial teams.

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Job Title: Senior Director, R&D Quality
Department: Quality Assurance & Quality Control
Company: Palvella Therapeutics
Location: Wayne, PA
Reports To: Vice President, Quality Assurance & Quality Control

About Palvella

Palvella Therapeutics is a clinical-stage biopharmaceutical company on a mission to develop and deliver the first FDA-approved therapies for serious, rare genetic skin diseases that have long been overlooked. Our lead program, QTORIN™ rapamycin (PTX-022), has earned Breakthrough Therapy, Orphan Drug, and Fast Track designations. With the Phase 3 SELVA trial in microcystic lymphatic malformations now complete, we are actively preparing our first New Drug Application submission — and the pre-approval and BIMO inspections that come with it.

We operate a lean, focused model while directing a network of best-in-class partners across manufacturing, testing, and distribution. That structure means real ownership, broad scope, and the rare chance to build quality infrastructure from the ground up rather than inherit it — and to see the direct line between your work and a therapy reaching patients who have had no other options.

The Opportunity

This is a build-and-lead role for a senior quality professional who wants their next move to be a step up, not a step sideways. As Senior Director, R&D Quality, you will own quality oversight across Palvella’s entire research and development ecosystem — Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), and Good Laboratory Practice (GLP) — and architect the R&D quality systems that will carry the company through its first NDA submission and BIMO inspection and into commercialization. With our pivotal trial complete and the NDA in active preparation, you will join at a defining inflection point and play a leading role in making Palvella inspection ready.

The role is structured intentionally as a succession path. You will partner closely with the VP, QA & QC, leading the R&D quality function while developing the breadth — including GMP/CMC and commercial quality readiness — to step into broader enterprise quality leadership as the company grows toward and beyond approval. If you have deep R&D quality expertise and the ambition to expand it across the full product lifecycle, this role is designed to get you there

Key Responsibilities

Clinical Quality Oversight (GCP)—Primary Focus

• Lead risk-based GCP quality oversight of Palvella’s clinical program, including quality oversight of completed pivotal trial activities through database lock, study closeout, and clinical study reporting, as well as any subsequent studies, ensuring compliance with ICH-GCP, applicable regulations, and protocol.
• Provide direct GCP quality oversight of Palvella’s sponsor-conducted clinical studies, including clinical operations activities performed in-house — site selection and management, monitoring, informed consent, the trial master file, and source data and data integrity at the point of conduct.
• Provide quality oversight of CROs, central labs, and clinical vendors where engaged, ensuring effective sponsor oversight and clear, consistent quality expectations across both in-house and partner-conducted activities.
• Quality review and approval of key clinical quality documents, plans, and controlled procedures.
• Evaluate and escalate potential serious breaches, scientific misconduct, and data integrity concerns; lead root cause analysis and ensure timely, effective CAPA.
• Partner with Clinical Operations, and Regulatory Affairs to embed quality by design into study conduct and documentation.

BIMO & Inspection Readiness and Management—Critical Priority

• Own end-to-end BIMO (Bioresearch Monitoring) inspection readiness in support of the NDA, establishing and executing a BIMO readiness program that prepares Palvella’s in-house clinical operations, sponsor oversight records, CROs, clinical sites, and supporting functions for FDA inspection.
• Lead inspection-readiness assessments, mock inspections, and remediation across R&D, ensuring the trial master file, sponsor oversight documentation, and quality records are complete, accurate, and inspection-ready.
• Serve as a primary liaison and inspection host for FDA BIMO and other Health Authority inspections (e.g., EMA), managing inspection logistics, front/backroom operations, and the coordination of timely, well-controlled responses to observations.
• Build the internal capability and training so the organization remains inspection-ready on an ongoing basis, not only at submission.

Pharmacovigilance Quality Oversight (GVP)

• Provide quality oversight of pharmacovigilance activities, including AE/SAE handling, safety reporting, and oversight of PV vendors and safety data exchange.
• Ensure PV quality systems, including audit coverage and inspection readiness, support compliant safety surveillance across clinical and expanded access settings.

Nonclinical Quality Oversight (GLP)

• Provide GLP quality oversight of nonclinical and toxicology studies and the CROs conducting them, ensuring data integrity and compliance to support regulatory submissions.

R&D Quality Systems & QMS Build-Out

• Design, build, and mature Palvella’s R&D quality management system — procedural document hierarchy, SOPs/WIs, document control, and templates — appropriate to a lean organization that conducts clinical studies in-house while relying on outsourced manufacturing, testing, and distribution partners.
• Establish and own R&D quality processes including deviation/CAPA management, quality risk management, and quality metrics, reporting, and escalation.
• Develop and lead GxP and inspection-readiness training and learning management programs that ensure consistent, compliant, audit-ready organization.
• Drive continuous improvement, identifying and leading process improvement initiatives across the R&D quality landscape.
• Partner with VP QA & QC to design, build, and implement a best-in-class, fit-for-size, life-cycle quality system capable of supporting a robust pipeline and strong commercial presence.

Audit & Submission Readiness

• Establish and execute a risk-based audit program covering CROs, PV, GLP, and other R&D vendors, prioritized by NDA and BIMO impact.
• Support quality deliverables for Palvella’s first NDA submission and ensure R&D quality systems and records withstand pre-approval and BIMO inspection scrutiny.

Quality Leadership & Strategy

• Serve as a member of the quality leadership team, helping set strategic direction for quality objectives and influencing how quality operates across the company.
• Partner cross-functionally with Clinical Operations, Regulatory Affairs, Medical Affairs, and external partners to advance compliant, efficient operations.
• Build, mentor, and develop quality staff as the function scales.

Qualifications

Required

• Bachelor’s degree in life sciences or related discipline; equivalent professional experience will be considered.
• 15+ years of progressive experience in pharmaceutical/biotech quality, with significant depth in R&D and GxP quality management.
• Demonstrated leadership of GCP quality oversight of clinical trials — including sponsor-conducted, in-house clinical operations as well as oversight of CROs and vendors — with working knowledge across GVP and GLP.
• Proven record building or substantially maturing quality management systems and procedural document programs.
• Direct experience leading inspection readiness and hosting/managing FDA inspections, with direct BIMO inspection readiness and/or management experience strongly preferred.
• Strong command of quality risk management, root cause analysis, and CAPA/deviation processes.
• Excellent leadership, cross-functional influence, and written and verbal communication skills.

Preferred

• Experience providing quality oversight of sponsor-conducted (in-house) clinical operations, in addition to vendor/CRO oversight, in a lean clinical-stage organization.
• Direct experience supporting an NDA/MAA submission and leading BIMO and pre-approval inspection readiness through to a successful inspection outcome.
• Experience with expanded access / compassionate use programs.
• Lean Six Sigma or comparable process-improvement certification.
• Appetite to broaden into GMP/CMC and commercial quality as part of a defined growth path.

What We Offer

• A clearly defined succession path to broader enterprise quality leadership.
• The chance to build, not just maintain — meaningful ownership in a high-impact, lean organization.
• Direct, leading involvement in a company’s first NDA and BIMO inspection — a career-defining milestone.
• A mission with real human stake: first-in-class therapies for patients with rare diseases and few or no options.
• A collaborative, expert team based near Philadelphia’s life sciences corridor.

Palvella Therapeutics is an equal opportunity employer.

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