Vice President Clinical Operations

Zentalis Pharmaceuticals

California

On-site

USD 273,000 - 357,000

Full time

14 days+

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Benefits offered by this job

Medical insurance

Vision insurance

401(k)

Job summary

Zentalis Pharmaceuticals is seeking a Vice President of Clinical Operations to lead and manage clinical trial operations. This strategic role includes overseeing trial deliverables, ensuring compliance with regulatory standards, and contributing to clinical development strategies. Candidates should have substantial experience in oncology trials and effective leadership skills.

Qualifications

Minimum of 10 years clinical operations experience in pharmaceutical or biotech.
Demonstrated experience in leading global late-stage oncology trials.
Ability to interface with top-level Executives and lead clinical trials.

Responsibilities

Lead Clinical Operations team to ensure operational trial deliverables are met.
Drive studies in accordance with ICH/GCP, ISO and applicable FDA regulations.
Build strong relationships with internal stakeholders to execute trials effectively.

Skills

Leadership

Analytical thinking

Problem-solving

Interpersonal skills

Time management

Education

Bachelor’s Degree in life sciences/healthcare

Advanced degree preferred

Tools

Electronic Data Capture

Trial Master File Systems

Microsoft Office Suite

MS Project

Microsoft Excel

Microsoft PowerPoint

Job description

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Zentalis Pharmaceuticals provided pay range

This range is provided by Zentalis Pharmaceuticals. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$273,000.00/yr - $357,000.00/yr

Vice President, Clinical Operations

COMPANY OVERVIEW:

Zentalis Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing azenosertib (ZN-c3), a potentially first-in-class and best-in-class WEE1 inhibitor for patients with Cyclin E1+ platinum-resistant ovarian cancer (PROC). Azenosertib is being evaluated as a monotherapy and in combination across multiple tumor types in clinical trials and has broad franchise potential. In clinical trials, azenosertib has been well tolerated and has demonstrated anti-tumor activity as a single agent across multiple tumor types. The Company is also leveraging its extensive experience and capabilities to translate its science to advance research on additional areas of opportunity for azenosertib outside PROC.

POSITION SUMMARY:

Reporting to the Chief Medical Officer, the Vice President Clinical Operations will be responsible for leading and driving clinical trial operations. This role oversees and leads the Clinical Operations team to ensure all operational trial deliverables across programs are completed according to timelines, budget, operational procedures, quality standards, SOPs and business guidelines.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Provide functional leadership including hiring, training, staff assignments, coaching, mentoring and performance management in a matrix environment
Lead all aspects of study progress from planning to close-out to assure adherence to intended timelines and achievement of study goals
Drive studies in accordance with appropriate quality standards including ICH/GCP, ISO and applicable FDA/global regulations
Provide strategies to support data dissemination to meet the needs for market registrations by authorities, reimbursement clinical and product marketing and further drug development
Develop infrastructure build for regulated clinical trial programs; including inspection readiness
Provide strategic and tactical input into integrated clinical development strategy and timelines
Develop clinical operations strategy including risk management and contingency planning
Build strong and highly collaborative relationships with key internal stakeholders to facilitate the planning and execution of clinical trials
Guide the clinical operations execution activities of all clinical trials in the assigned area and ensure all clinical trials are executed per key metrics (timelines, budget, operational and quality standards [ICH/GCP/SOPs])
Maintain procedures to verify the accuracy and timeliness of trial information in all trial databases and tracking systems
Other projects as deemed appropriate.

KNOWLEDGE/SKILLS/ABILITIES REQUIRED:

Bachelor’s Degree in life sciences/healthcare is required. Advanced degree is preferred in scientific or health care field or related subject matter and a minimum of 10 years of clinical operations experience in a pharmaceutical or biotech setting
Successful track record leading global late-stage oncology trials is required, experience with late-stage trials in gynecological malignancies preferred
Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines
Strong leadership, collaborative and interpersonal skills
Experience interfacing with top-level Executives
Excellent computer skills (Microsoft Office Suite, Project, Visio, Electronic Data Capture and Trial Master File Systems)
Experience working independently and in a team environment, being flexible and adapting in a changing environment
Ability to travel occasionally
Demonstrated managerial and leadership skills in a dynamic environment running multiple clinical trials
Demonstrated experience and commitment toward leading an organization focused on clinical investigation, clinical operations, drug safety, adverse reaction reporting, medical communications and medical services
Ability to multi-task/ prioritize and time management of daily activities
Intermediate to advanced software skills (e.g., Microsoft Excel, PowerPoint, MS Project)
Demonstrates high level of accuracy and effective oral and written communication skills
Flexibility within a rapidly changing environment
Excellent ability to work in a goal and team-oriented setting
Well-developed organizational skills

Seniority level