Medical Director, Clinical Development
Amylyx PharmaceuticalsSalary not specified
Full Time
Expert & Leadership (9+ years)
Sr Director, Clinical Development at Tarsus Pharamceuticals
Irvine, California, United States
Not SpecifiedCompensation
Senior (5 to 8 years)Experience Level
Full TimeJob Type
UnknownVisa
PharmaceuticalsIndustries
Requirements
- Advanced clinical/science degree
- Experience in clinical development
- Leadership experience
- Expertise in infectious disease
- Experience with regulatory documents (INDs, Protocols, IBs)
- Experience with clinical data review
- Experience with cross-functional team leadership
- Experience with Health Authority interactions
- Experience with cooperative groups/alliance partners
Responsibilities
- Provides strategic leadership and oversight for clinical development programs
- Shapes and drives the development of strategic clinical initiatives
- Oversees and interprets clinical data at the portfolio level
- Demonstrates hands-on leadership in all aspects of clinical development
- Leads clinical development efforts in infectious disease
- Responsible for effective and efficient execution of the CDP
- Attends and contributes to meetings with Health Authorities (HAs)
- Represents Tarsus with cooperative groups/alliance partners and key opinion leaders
- Serves as Program Team Leader for critical programs
- Drives cross-functional alignment and integration of strategy, timelines, budgets, and value creation
- Communicates key updates, risks, and opportunities to executive leadership
- Anticipates and mitigates program risks and identifies strategic opportunities
- Details Go/No Go criteria and scenario planning
- Builds organizational capability and fosters a culture of scientific rigor, operational excellence and innovation
Skills
Key technologies and capabilities for this role
Questions & Answers
Common questions about this position
What is the salary range for the Sr Director, Clinical Development role?
This information is not specified in the job description.
Is this Sr Director, Clinical Development position remote or does it require office presence?
This information is not specified in the job description.
What key skills and expertise are required for the Sr Director, Clinical Development role?
The role requires deep therapeutic area and clinical development expertise, particularly in infectious disease with a focus on prevention strategies, hands-on leadership in clinical development, and ability to lead multidisciplinary cross-functional teams.
What is the team structure like for this Sr Director, Clinical Development position?
The role involves serving as Program Team Lead (PTL), managing one or more programs by leading multidisciplinary/cross-functional teams from relevant expert functions.
What makes a strong candidate for the Sr Director, Clinical Development role?
A strong candidate will have experience aligning with career goals, deep expertise in clinical development and infectious disease, and skills that match the hands-on leadership and strategic contributions needed, as discussed with your manager and HRBP before applying.
Tarsus Pharamceuticals
Develops treatments for eye care diseases
About Tarsus Pharamceuticals
Tarsus Pharmaceuticals develops treatments for diseases that lack effective solutions, focusing mainly on eye care and infectious diseases. Their key product, XDEMVY, is an FDA-approved eye drop solution used to treat Demodex Blepharitis, a condition affecting the eyelids. The company is also working on other potential treatments for conditions such as Lyme Disease Prevention, Meibomian Gland Disease, and Rosacea. Tarsus differentiates itself from competitors by concentrating on specific medical needs and maintaining a strong pipeline of future products. Their goal is to provide effective treatments for patients suffering from these conditions while ensuring compliance with regulations and ethical standards.
Irvine, CaliforniaHeadquarters
2017Year Founded
$58.4MTotal Funding
IPOCompany Stage
Biotechnology, HealthcareIndustries
201-500Employees
Benefits
Health Insurance
Dental Insurance
Vision Insurance
Paid Vacation
Hybrid Work Options
Professional Development Budget
Risks
Increased competition in ophthalmic treatments challenges Tarsus's market position.
Potential clinical trial delays could affect Tarsus's product pipeline.
Supply chain constraints may hinder XDEMVY's production and distribution.
Differentiation
Tarsus focuses on high unmet needs in ophthalmic and infectious diseases.
Their lead product, XDEMVY, is FDA-approved for Demodex blepharitis treatment.
Tarsus's pipeline includes innovative treatments for Lyme disease and Rosacea.
Upsides
Growing awareness of Demodex blepharitis expands market for Tarsus's XDEMVY.
Telemedicine rise offers new marketing opportunities for Tarsus's products.
FDA's focus on unmet needs may expedite Tarsus's pipeline approvals.
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