Senior Scientist, Clinical Pharmacology at Denali Therapeutics

South San Francisco, California, United States

Apply Now

Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, Pharmaceuticals, Neurodegenerative DiseasesIndustries

Requirements

PhD or PharmD in Pharmaceutical Sciences, Pharmacokinetics, Pharmacology, or related scientific discipline with 5+ years experience in Clinical Pharmacology and drug development (may include relevant postdoctoral experience)
Proficiency in quantitative PK/PD data analysis tools (e.g., Phoenix WinNonlin, population PK analysis, exposure-response analysis, and/or PBPK modeling)
Experience in developing Clinical Pharmacology and M&S strategies, with biotherapeutics experience preferred
Strong analytical and communication skills for presenting complex PK/PD data
Proven ability to collaborate effectively on cross-functional teams
Background in neuroscience indications and/or oligonucleotide drug development preferred

Responsibilities

Develop Clinical Pharmacology and M&S strategies for multiple biotherapeutics and small molecule programs from pre-IND through late-stage clinical studies, including pivotal Phase 2/3 trials and NDA/MAA/BLA submissions
Develop clinical study designs and write study protocols, amendments, and reports that meet regulatory standards and project timelines with minimal supervision
Conduct hands-on pharmacokinetic (PK) and pharmacodynamic (PD) data analysis using advanced tools and methodologies to support clinical decision-making
Analyze, interpret, and communicate PK/PD data to project teams, senior leadership, and regulatory authorities
Author and review sections of regulatory submissions, including IND/CTA and NDA/MAA/BLA filings

Skills

Clinical Pharmacology

Modeling and Simulation

Pharmacokinetics

Pharmacodynamics

PK/PD Analysis

Study Design

Protocol Writing

Regulatory Submissions

NDA

MAA

BLA

Biotherapeutics

Small Molecules

Denali Therapeutics

Develops treatments for neurodegenerative diseases

About Denali Therapeutics

Denali Therapeutics focuses on finding and developing treatments for neurodegenerative diseases like Alzheimer's, Parkinson's, and ALS, which involve the gradual loss of nerve cells and can lead to serious physical and mental challenges. The company uses scientific research to understand the biological pathways that lead to these diseases, aiming to create drugs that target specific molecules in the body to treat them. Denali stands out from its competitors by combining its own research efforts with partnerships with other biotech firms and pharmaceutical companies, allowing it to share risks and access new technologies. The goal of Denali Therapeutics is to create effective treatments that improve the lives of patients suffering from these debilitating conditions.

South San Francisco, CaliforniaHeadquarters

2015Year Founded

$337.5MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

201-500Employees

Risks

Failure in ALS trials raises concerns about pipeline efficacy.

Increased competition in ALS treatment could impact market share.

Discontinuation of programs due to toxicities highlights potential development challenges.

Differentiation

Denali focuses on neurodegenerative diseases like Alzheimer's, Parkinson's, and ALS.

The company employs a science-driven approach to translational medicine and clinical development.

Denali leverages partnerships to access new technologies and spread financial risk.

Upsides

Denali's $500 million financing strengthens its financial position for pipeline advancement.

Partnership with Biogen could accelerate Parkinson's treatment development.

Focus on blood-brain barrier technology shows promise in treating lysosomal storage diseases.

Land your dream remote job 3x faster with AI

Try Jobo Free