Medical Director, Early Clinical Development at Denali Therapeutics

South San Francisco, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, PharmaceuticalsIndustries

Requirements

MD or MD-PhD; formal training in neurology is strongly preferred. Subspecialty experience in Alzheimer’s or Parkinson’s disease is ideal
2 years of industry experience in neurology or comparable clinical trial experience in an academic setting
Proven ability to lead cross-functional teams in a biopharmaceutical environment
Demonstrated experience in CDP planning and execution for neurological indications, including FIH and other clinical studies
Strong understanding of biomarker-driven strategies, clinical pharmacology, and quantitative pharmacology
Effective cross-disciplinary collaboration skills
Excellent written and verbal communication skills, with strong presentation capabilities
Track record in people management and mentorship
Experience interacting with regulatory agencies

Responsibilities

Provide clinical leadership on one or more programs, including the development and execution of Clinical Development Plans (CDPs)
Oversee clinical science aspects of trial design, execution, interpretation, and reporting, with a focus on safety, pharmacodynamics, and efficacy
Present clinical strategies and progress to Denali leadership
Collaborate cross-functionally with translational, regulatory, statistical, clinical pharmacology, and safety teams to ensure integrated, data-driven development plans
Lead the creation of clinical documents, including study protocols, investigator brochures, clinical study reports, and regulatory submissions
Conduct and supervise medical monitoring and safety reporting throughout trials
Provide medical oversight for adverse event (AE) and serious adverse event (SAE) assessments and follow-up
Partner with Discovery to evaluate and prioritize preclinical targets, offering clinical insights into feasibility and strategy
Mentor and manage clinical science team members
Collaborate with academic and clinical experts to strengthen Denali’s scientific leadership
Represent Denali and its programs in both internal and external forums
Champion a culture of compliance, ethics, patient-centricity, and scientific rigor

Skills

Key technologies and capabilities for this role

Clinical DevelopmentNeurodegenerative DiseasesAlzheimer’s DiseaseParkinson’s DiseaseFirst-in-Human TrialsEarly-Stage TrialsTranslational MedicineBiomarker-Driven DevelopmentNeurologyClinical Strategy

Questions & Answers

Common questions about this position

What experience is required for the Medical Director role?

The ideal candidate will have experience in Alzheimer’s and/or Parkinson’s disease drug development, including first-in-human (FIH) and early-stage trials, along with a strong background in neurology and clinical development.

What are the main responsibilities of this position?

Key responsibilities include providing clinical leadership on programs, overseeing trial design and execution, collaborating cross-functionally, leading clinical documents and regulatory submissions, medical monitoring, and mentoring team members.

Is this a remote position or does it require onsite work?

This information is not specified in the job description.

What is the salary or compensation for this role?

This information is not specified in the job description.

What makes a strong candidate for this Medical Director position?

A strong candidate is a physician-scientist with experience in Alzheimer’s and/or Parkinson’s drug development, including FIH and early-stage trials, and a background in neurology, ready to provide clinical leadership and collaborate cross-functionally.

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.

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