Associate Director, Medical Affairs Operations at Denali Therapeutics

South San Francisco, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

BiotechnologyIndustries

Requirements

BA or BS in Health Sciences or related discipline, PhD/MD/MBA is a plus
At or near 7 years of biotechnology operations experience with preferred experience in Medical Affairs operations
Strong aptitude and interest in science, drug development process and commercialization pathways

Responsibilities

Contribute to the development and implementation of medical strategies, plans, and initiatives to support product lifecycle management and address unmet medical needs
Contribute to the development and execution of medical plans, ensuring alignment with overall company objectives and regulatory requirements
Develop and implement processes, tools, and training to enhance operational effectiveness within Medical Affairs
Establish governance frameworks and ensure alignment with internal policies and external regulations
Partner with cross-functional teams (Compliance, Legal, Commercial, Advocacy, R&D) to drive medical strategy execution and optimize workflows
Lead metrics tracking, reporting, and continuous improvement initiatives across Medical Affairs
Support digital innovation and system integration for Medical Affairs functions
Lead operational planning and execution of medical congresses, symposia, and scientific meetings
Collaborate across functions beyond Medical Affairs to include Commercial, Patient Advocacy, Market Access, etc., to oversee logistics for Denali’s participation, including pre and post-congress internal meetings, exhibit booths, scientific presentations, and investigator meetings
Partner with cross-functional teams (Field Medical, Commercial, Market Access, Regulatory) to ensure compliant presence and impactful engagement at congresses
Manage vendors and agencies supporting congress logistics, ensuring adherence to budgets, timelines, and compliance standards
Track and report metrics related to congress participation, insights, and scientific impact
Lead the management and oversight of independent medical education grants, investigator-initiated studies, sponsorships, exhibits, and charitable donations
Ensure grant processes adhere to internal policies and external compliance requirements
Collaborate with Medical Affairs leadership to assess funding priorities and make recommendations
Work with multiple functional stakeholders to ensure contracts are executed and paid in a timely manner, which will include tracking the process and reporting on data

Skills

Congress Planning

Grants Operations

Publications Planning

Medical Information

Process Development

Training Programs

Governance Frameworks

Medical Strategy

Product Lifecycle Management

Operational Efficiency

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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