Associate Director, Clinical Operations

About N-Power Medicine

Position Overview

NPM is looking for an exceptional Associate Director, Clinical Operations with an appetite for hands-on development of clinical study management processes and study execution. As an Associate Director, Clinical Operations at NPM, you will collaborate closely with the Senior Director, Pharma Delivery Operations to play a pivotal role in establishing clinical study management necessary to drive NPM's critical applications in clinical trials and community oncology.

You will work collaboratively with cross-functional teams, including Clinical Science, Compliance, Network Operations, Quantitative Science, and Pharma Delivery Operations to develop processes that support the efficient and effective conduct of clinical studies at our Network Partner sites, from planning to close out.

Role Objectives and Responsibilities

Lead and oversee the strategic planning, implementation and execution of clinical trials and external control arms across multiple programs in accordance with project timelines, budget, and quality standards

Develop and manage comprehensive program project plans, including but not limited to, study protocols, clinical trial budgets, timelines, enrollment and risk mitigation strategies

Collaborate cross functionally with internal teams, including Clinical Science, Compliance, Network Operations, Quantitative Science, and Pharma Delivery Operations to ensure alignment on clinical trial objectives and milestones

Provide operational expertise and strategic input into the development of Clinical Development Plans (CDP), supporting the overall clinical strategy for the program

Serve as the point of contact for clinical suppliers, overseeing their performance and ensuring adherence to contractual agreements, timelines and quality standards

Ensure compliance with regulatory requirements, ICH-GCP requirements, and company SOPs throughout all stages of clinical trial conduct

Oversee the collection, analysis and interpretation of clinical trial data, working closely with Clinical Science, and Quantitative Science teams to ensure data accuracy and integrity

Oversee the eTMF, ongoing quality review and final reconciliation of study documents including review of site regulatory documents/packages

Oversee the development and execution of NPM’s biospecimen and imaging programs

Contribution to the development of clinical trial management best practice processes and SOPs

Education, Experience, Behavioral Competencies, & Skills

Bachelor's degree required; advanced degree in business, life sciences, or related field preferred

8 - 10 years of experience in clinical operations, delivery/program management, or client operations within biotechnology, healthcare, life sciences, or oncology clinical research

Expertise in global regulatory and compliance requirements for clinical research, including but not limited to US CRF and ICH GCP

Experience working with EDC, CTMS, CTFM, and eTMF systems preferred

Ability to manage multiple competing priorities and adapt to changes

Strong communication, interpersonal, and problem solving skills

Able to engage in strategic business discussions and craft executive-level communications and materials.

Must be comfortable working in a fast-paced environment

Travel Requirements

Pay Information

The expected salary range for this position is $175,000 and $195,000. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. N-Power Medicine (NPM) offers equity at hire as well as a discretionary annual bonus which may be available based on Company performance. This position is eligible for company benefits.

More About Us:

We are a mission-driven, well-funded, rapidly growing company, eager to attract passionate professionals offering a highly attractive compensation package with a balanced and flexible work environment, competitive industry benefits as well as a 401K plan and other great company “perks.”

We are an Equal Opportunity Employer and value diversity at our company. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.

Applicants must be currently authorized to work in the U.S. on a full-time basis. The Company will not sponsor applicants for work visas