Director Clinical Operations

SciPro; United States; On-site; USD 165,000 - 195,000; Full time

Job summary

A rapidly growing biotech firm is seeking a Director of Clinical Operations to drive their innovative biologics pipeline. This role is pivotal in overseeing clinical trials, managing timelines, and collaborating with CRO partners. The ideal candidate will have extensive experience in clinical operations, particularly in Phases 1 and 2, and a strong background in immunology. Join a dynamic team that values flexibility and strategic thinking in a fast-paced environment, contributing to groundbreaking treatments for autoimmune conditions.

Benefits

Medical Insurance

Vision Insurance

401(k)

Disability Insurance

Qualifications

• 5+ years of clinical operations experience in biotech.
• Experience in leading clinical programs in Phases 1 & 2.

Responsibilities

• Lead planning and execution of clinical studies, ensuring alignment with targets.
• Collaborate with CROs on contract negotiations and vendor selection.

Skills

Clinical Operations

Program Leadership

Project Coordination

Site Management

Study Start-up

Global Trial Experience

Immunology & Inflammation Knowledge

Education

Bachelor's or Master's in Life Sciences or Healthcare

Job description

This rapidly growing biotech with a focus on developing innovative biologics to treat autoimmuneindications is actively seeking a Director of Clinical Operations to support their expanding clinical pipeline. This company currently has one early phase clinical asset as well as a strong pipeline moving towards the clinic. Due to the pipeline expanding, they require a strong clinical operations leader to join the team and help progress these assets.

This role will report to the C-suite and will play a key strategic role in designing and executing the company's clinical trials.

Qualifications:

• Bachelors or Masters degree in a life sciences or healthcare field with 5+ years of clinical operations experience and program leadership.
• Experienced in leading clinical programs in Phases 1 & 2 including study start-up, site management and monitoring, and project coordination.
• Previous experience working with in a biotechnology setting is preferred and someone who enjoys wearing multiple hats, working in fast paced environments, and maintains a flexible mindset.
• Global trial experience (specifically with Europe) is ideal.
• Past experience with clinical programs focused on Immunology & Inflammation indications and biologics are pluses.

Responsibilities:

• Responsible for leading the planning, executing, and managing assigned clinical studies, including timelines, deliverables, recruitment strategies, and performance metrics, while ensuring alignment with established targets.
• Work collaboratively with CRO partners and do things such as lead RFI/RFP processes, contract negotiations, and vendor/CRO selection, oversee vendor and site activities.
• Develop and manage study budgets, financial reporting, and reconciliation while contributing to the creation and oversight of critical clinical study documents, such as protocols, monitoring plans, and recruitment strategies.
• Present relevant strategies and study results to wider team and external partners.

Seniority level

• Seniority level

  Director

Employment type

• Employment type

  Full-time

Job function

• Job function

  Science, Project Management, and Research

• Industries

  Biotechnology Research, Pharmaceutical Manufacturing, and Research Services

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Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

Disability insurance

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