Company Overview

This company manufactures and supplies researchers with biologics.

Position Title: Dir./Sr. Dir./VP of Clinical Operations — JO-2206-5788

Territory: Various

Therapeutic Area: Women's Health

This individual manages and oversees all of the Company’s clinical operations.

This leader is self-directed, dynamic, and willing to roll up their sleeves in order to ensure the highest quality of work output. This role works closely with internal teammates and vendors/partners to ensure all activities and deliverables are completed to implement contracted services on time and within the budget and the scope of the contract.

The leader plays a critical role in driving efforts to rapidly introduce the Company’s new, innovative technology to new markets.

Essential Duties and Responsibilities

• Provide leadership, strategic oversight, and guidance of Clinical Operations to ensure quality, timeline, resources, and budget goals are met.
• Represent all aspects of Clinical Operations and provide updates as required to the Executive Committee, Project Teams, Board of Directors, and other key internal stakeholders.
• Ensure the effective and constructive integration of clinical operations knowledge and expertise into all applicable Clinical Development activities; interact and collaborate with other department heads as appropriate.
• Lead and mentor Clinical Operations staff to support successful internal training and its implementation, and serve as an advocate for the professional development of Clinical Operations staff.
• Keep abreast of competitive regulatory and clinical practices and utilize this knowledge during the ongoing development and adjustment of plans.
• Manage Stakeholder expectations/influence and ensure successful delivery of the operation project.
• Prepare project plan to manage schedule, cost (budget), and scope of the operation project.
• Monitor the daily execution of the project and manage any deviations from the project plan.
• Perform risk management and formulate strategies to mitigate risks to projects.
• Drive, manage, and coordinate numerous projects within possible constraints of human and financial resources and changing priorities to ensure the successful completion of projects.
• Promote standards and best practices for implementations and manage multiple implementations simultaneously.
• Comfortable multi-tasking in a fast-paced small company environment and able to adjust workload based upon changing priorities.
• Excellent team player; willingness and ability to fill functional gaps in a small organization.

Qualifications (Education & Experience)

• Minimum degree requirements of a bachelor’s degree (BA, BS) in a scientific or health field.
• A minimum of 10 years of experience with expertise in the areas of clinical operations development and strategic planning.
• Expertise in clinical operations – demonstrated ability to effectively manage projects and people. Proactive problem-solving abilities and follow-through.
• Ability to work independently to achieve objectives and work on more than one project simultaneously.
• Collaborative and team-oriented.
• Demonstrates strong problem-solving, communication, and leadership skills.
• Excellent organizational skills, ability to manage multiple tasks, and meticulous attention to detail.
• Excellent oral, written, and presentation skills-able to explain complex concepts clearly to a variety of audiences
• Ability to manage successful meetings (preparation, facilitation, and follow-up).
• Knowledge of, and exposure to, Regulatory, Clinical, Medical Affairs, Market Access, Marketing, and Sales.
• Computer literacy required (MS Word, MS Excel, MS PowerPoint, and MS Project) care discipline with an advanced degree preferred.
• A clinical degree is highly desired, although relevant work experience without a clinical degree may be sufficient.
• PMP Certification preferred.
• This is a fully remote, full-time position with up to 50% travel. Must have the ability to work a flexible schedule, including some nights and weekends.

Since 2009, TriNet Pharma has evolved into one of healthcare’s largest and most respected agencies for recruiting and placing permanent and contract Medical Affairs, Clinical Affairs, Regulatory Affairs, and Medical Communications professionals in life sciences companies in the United States and around the world.