Senior Clinical Trial Manager / Clinical Trial Manager

Employer
Nkarta Inc
Location
South San Francisco, CA, United States
Posted
Oct 08, 2020
Ref
25450
Hotbed
Biotech Bay
Required Education
Masters Degree/MBA
Position Type
Full time
S enior Clinical Trial Manager / Clinical Trial Manager

Founded at the birthplace of biotechnology, Nkarta's mission is to discover, develop and deliver novel off-the-shelf (e.g. allogeneic) natural killer (NK) cell therapies that profoundly impact patients' outcomes and survival . The company is based on the proprietary, robust and well-characterized NK cell expansion technology pioneered by Dr. Dario Campana. Nkarta is focused on leveraging the inherent power of NK cells to identify and kill abnormal cells and recruit adaptive immune effectors to generate responses that are deep and durable.

Nkarta combines its NK cell expansion and cryopreservation platform with proprietary cell engineering technologies to generate an abundant supply of NK cells, engineer enhanced NK cell recognition of tumor targets, and improve persistence for sustained activity in the body for the treatment of cancer.

Founded in 2015, Nkarta became a public company (Nasdaq symbol NKTX) in 2020. Our development pipeline of engineered NK cell therapy candidates consists of two co-lead programs, NKX101 and NKX019. The IND for NKX101 for the treatment of relapsed or refractory AML and higher-risk MDS was accepted by the FDA in July 2020. We expect to begin dosing patients in this study by the end of 2020. As we broaden the development of NKX101, we also plan to initiate studies in solid tumors. Our second co-lead program, NKX019, is designed to target B cell lymphomas. We plan to file our IND for NKX019 with the FDA in early 2021. In addition, we recently completed the construction of a GMP compliant clinical manufacturing facility in our South San Francisco location designed to produce viral vector and supply our initial clinical trials.

Position Title S enior Clinical Trial Manager / Clinical Trial Manager

Location South San Francisco, CA

Reports to SeniorDirector, Clinical Operations

Position Summary

This role manages early development/first-in-human clinical studies of cellular immunotherapy products from Nkarta's deep pipeline. The lead cell therapy candidate is in the pre-IND stage and is on track for clinical studies in early 2020 in multiple solid tumor and hematologic malignancy indications.

The Senior Clinical Trial Manager / Clinical Trial Manager (Sr. CTM/CTM) works closely with the head of clinical operations and the rest of clinical and leadership team to ensure successful execution of clinical trials. The role manages operational activities of assigned clinical programs, oversees internal and external staff for the timely and quality implementation and execution of clinical trials. Partnership with key internal and external stakeholders to ensure continuous harmonized operations of clinical operations activities is critical. Works closely with investigative site personnel, CROs, and other study vendors. Ensures conduct of clinical trial activities in accordance with Standard Operating Procedures and all applicable regulations governing the conduct of clinical trials.

Key Responsibilities

Manages defined aspects of clinical trials to ensure trials are completed on time and in compliance with Code of Federal Regulations (CFR), ICH/GCP guidelines and company SOPs.

Coordinates activities within various phases of clinical studies (i.e. study planning, site qualification and selection, monitoring, data review and cleaning, closeout, etc.).

Maintains study timelines including identifying and communicating trial issues that will impact budget, resources and/or timelines.

Handles day-to-day interaction with CROs in the execution of ongoing clinical trials. Coordinate CRO relationships and manage performance.

Assists in selection, management and oversight of other external vendors (e.g. CROs, clinical labs, etc.).

Participates in development essential study documents (study protocol, ICF, Case Report Forms, Clinical Study Reports, etc.), as appropriate.

Develops, reviews/approves clinical study plans, manuals, presentations, other study documents (country/site specific ICF's, site facing documents and tracking tools), assists with user acceptance testing, sample and product tracking, and other activities as needed.

Helps identify and recruits clinical investigators. Builds and maintains great working relationships with KOLs and PIs. Trains investigators and investigative site staff.

Conducts oversight monitoring activities as needed.

Participates with in-house data review.

Assists with external vendor partner management. Includes review of invoices for accuracy compared to vendor contract. Coordinates and participates the development of technical specifications for vendors (e.g. scope of work, review and approval of specifications, procedural manuals, etc.).

Handles other duties and responsibilities to support successful execution of assigned clinical programs.

Assists in creating and implementing departmental procedures in compliance with industry standards and regulatory requirements.

Contributes to wider organizational goals and/or activities as assigned.

Position Requirements

3-5+ year's industry drug development experience.

1-3+ years' experience in the management and execution of a clinical trial at a trial sponsor or CRO.

History of success in managing different clinical trial vendors.

Experience with international oncology/hematology trials.

Cell and/or gene therapy experience is preferred.

Previous on-site monitoring experience is preferred.

Thorough knowledge and understanding of FDA and ICH Guidelines, Good Clinical Practices (GCP), medical terminology, and clinical trials.

Strong computer skills including MS Office (Word, Excel, Outlook, Project).

Ability to handle multiple tasks and deadlines.

Excellent planning and organizational skills.

Ability to think critically and demonstrated troubleshooting and problem-solving skills.

Excellent written and oral communication skills, including presentation skills.

Ability to develop and maintain excellent working relationships with both internal colleagues and external contacts, including key thought leaders, and investigators.

Able and willing to travel domestically and internationally.

Must be self-motivating, prioritize and manage a large volume of work, and show attention to detail.

Flexible and solution focused.

Maintains a high level of professional expertise through familiarity with scientific literature, product portfolio and the competitive landscape.

Embodies the Nkarta culture of empowerment, diversity, and inclusion.

Education / Background

Bachelor of Science degree in a biomedical or related clinical field.

Work Environment / Physical Demands

The common requirements of an office environment (computers, computer screens, workstations, etc.) apply for this position. Airplane and car travel are a requirement for this role.

Working at Nkarta

The 50+ team members at our South San Francisco, California primary location describe working at Nkarta, along with opportunities for improvement, in some of the following ways:

"Work is interesting - lots of projects in the pipeline (so I don't have to worry about the one project failing). Leadership is open, straight forward."

"Smart, capable, nice people. People I work with day to day are enjoyable."

"Employee-centric."

"I like that the company is open minded with a (people) -(looking for) a set of skills that can grow (as opposed to thinking you have to have exactly what's in a job spec now) Things that broaden their (employees) skills and growth."

"Like any startup there are fires to put out; feel confident we have the people to control those fires."

"Diverse people from different backgrounds."

To learn more about our work at Nkarta and the career opportunities that will drive us forward to serve patients, please visit the company's website at https://www.nkartatx.com