Referso Jobs

Associate Director, Device Regulatory Affairs

Lifelancer · Posted Nov 11, 2026

Open

Remote, United States
Remote
Full-time · Director
$160K–$220K per year
10+ years

Associate Director, Device Regulatory Affairs

Lifelancer · Posted Nov 11, 2026

Open

Remote, United States
Remote
Full-time · Director
$160K–$220K per year
10+ years

Senior Director, Clinical Safety Physician

Avalyn Pharma · Posted Nov 5, 2026

Open

Remote, United States
Remote
Full-time · Senior
$310K–$350K per year
10+ years

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Provides medical leadership and oversight of drug safety across Avalyn’s portfolio of inhaled antifibrotic investigational products.

Compensation

$310,000—$350,000 USD

Responsibilities

Provide medical leadership and oversight of safety across Avalyn’s clinical-stage investigational products
Perform medical review and assessment of serious adverse events, adverse events of special interest, deaths, discontinuations due to adverse events, and other medically significant events
Review case narratives and ensure appropriate follow-up of medically important information
Apply clinical judgment to distinguish drug-related safety findings from manifestations of the underlying disease
Identify, evaluate, and escalate potentially important safety findings

Requirements

MD or DO required; board certification or equivalent clinical specialty qualification preferred
Nice to have: board certification
Nice to have: experience in pulmonary diseases
Nice to have: experience in rare diseases or inhaled therapeutics
Nice to have: Phase 2/3 development experience

Skills

clinical safety pharmacovigilance

Senior Director, Regulatory Strategy Program Lead

Rapport Therapeutics · Posted Nov 5, 2026

Open

Boston, Massachusetts, United States
Hybrid
Full-time · Director
$275K–$300K per year
12+ years

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The regulatory lead for RAP-219 and Bipolar Mania trials, shaping the path from science to treatment through regulatory strategy, planning, and health authority interactions.

Compensation

we expect the hiring range for the role to be $275,000 to $300,000.

Responsibilities

Lead regulatory strategy for RAP-219, guiding development from early clinical trials through global filings.
Lead regulatory strategy for our bipolar mania trials, partnering with cross-functional teams.
Translate strategy into action through hands-on regulatory planning, document development, and submission preparation.
Shape program decisions across Clinical, CMC, Nonclinical, and Clinical Pharmacology.
Prepare for and lead health authority interactions, including FDA meetings.

Requirements

Bachelor’s degree in a life science or related discipline
Nice to have: neurology
Nice to have: psychiatry
Nice to have: small molecules

Skills

regulatory strategy pharmaceutical industry biotech industry global drug development

Vice President, Clinical Science & Clinical Development

Celldex Therapeutics · Posted Nov 5, 2026

Open

Hampton, New Jersey, United States
Vp
$401K–$494K per year
10+ years

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Senior medical and scientific leader overseeing clinical development programs from early to late-stage, providing strategic leadership, regulatory strategy, and organizational development within Celldex's Clinical organization.

Compensation

The expected base salary for this position is: $401269.00 to $493561.00. We are committed to compensating employees equitably based on several factors including experience, education, licensure/certifications, skill level, location of the position, and availability of similar talent in a competitive market. Subject to eligibility and applicable plan terms, compensation includes base salary, annual discretionary bonus, long term incentive, 401(K) plan with employer contribution, health care and other insurance benefits (for employee and family), paid holidays, vacation, and sick days.

Responsibilities

Provide senior medical and scientific leadership for clinical development programs
Oversee creation of integrated clinical development plans
Translate scientific insights into development strategies
Provide strategic guidance on indication selection and trial design
Partner with Chief Medical Officer on portfolio strategy

Requirements

MD required
Nice to have: board certification in allergy, immunology, dermatology

Skills

clinical development regulatory submissions FDA interactions

Senior Director/Executive Director, Biostatistics

Nkarta, Inc. · Posted Nov 1, 2026

Open

South San Francisco, California, United States
Full-time · Manager
$300K–$360K per year
8+ years

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Lead the biostatistics strategy for the NKX019 autoimmune program and serve as statistician of record across all indications, studies and health-authority interactions.

Compensation

$300,000—$360,000 USD

Responsibilities

Lead biostatistics strategy for NKX019 autoimmune program
Author and own statistical analysis plans, estimand frameworks, analysis populations and TFL specifications
Independently perform complex analyses and review deliverables
Design potential pivotal studies and adaptive designs
Translate Phase 1/2 dataset into quantitative case for decisions

Requirements

PhD in Biostatistics or Statistics
Nice to have: B cell-directed therapies
Nice to have: new patient-reported outcome instrument development
Nice to have: cell or gene therapy
Nice to have: dose-escalation designs

Skills

clinical-trial biostatistics statistical analysis advanced statistical methods SAS R

Associate Director, Device Regulatory Affairs

Associate Director, Device Regulatory Affairs

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Senior Director, Clinical Safety Physician

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Senior Director, Regulatory Strategy Program Lead

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Vice President, Clinical Science & Clinical Development

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Senior Director/Executive Director, Biostatistics

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FDA interactions jobs

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