Clinical Science Manager Jobs in Raleigh, NC (NOW HIRING)

Summary

Precision BioSciences is advancing PBGENE-DMD, a first-in-class ARCUS gene editing therapy that directly corrects the dystrophin gene. Following our recent FDA Fast Track designation, we are accelerating the mission to deliver this transformative treatment to patients with Duchenne Muscular Dystrophy (DMD).

To support this milestone, we are seeking a Clinical Science Liaison (CSL). This newly created, field-based role will interface on an ongoing basis with Clinical Operations, Medical Affairs, and Patient Advocacy, serving as the primary external representative to clinical trial sites, investigators, and the advocacy community for the FUNCTION-DMD program.

Essential Duties and Responsibilities

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position. This list contains the major duties and requirements of the job and is not all-inclusive. Incumbent(s) may be expected to perform role-related duties other than those contained in this document.

1. Clinical Site Management & Training

• Serve as a primary scientific interface site-level contact for investigators and site medical staff within responsible geography, liaising with Clinical Operations, the CRO and the Medical Monitor who maintain primary contacts for site operations, monitoring and clinical trial issue resolution
• Be the local expert on PBGENE-DMD, the clinical trial protocol, and the process for administering drugs
• Lead site-level training on protocol procedures and staff support
• Thoroughly understand the patient journey in the trial at the clinical site and work with and through the staff to facilitate improvements at the site that will help the patient and family continue in the trial
• Meet with all staff who will be assessing patients to ensure consistency with assessments; Ensure training of new staff members
• Educate staff about PBGENE-DMD; Train fellows & residents that cycle through the clinical site.
• Support biopsy training coordination alongside Clinical Operations
• Support site-level understanding of protocol and data to be collected for the trial; Note: Data quality and input are the responsibility of Clinical Operations and Data Management
• Support site staff understanding of protocol amendments to ensure all appropriate changes developed by Clinical Operations, the Medical Monitor and Clinical Development are implemented at the site
• Triage scientific and protocol-related questions directing safety, eligibility, dosing, patient-specific, and/or medical judgement questions to the Precision Medical Monitor and/or Clinical Development
• Provide frequent updates to Clinical team to support ongoing recruitment
• Bring Precision personnel to the site as needed to facilitate the relationship at all levels
• Be onsite during each administration of PBGENE-DMD during Phase1/2

2. Scientific Exchange & Medical Affairs

• Have keen awareness of competing trials underway at the site and help site level decision-makers and parents understand the rationale for choosing a gene editing approach
• Provide literature summaries and interpret external data trends for internal teams
• Gather and relay investigator scientific feedback to Clinical Development leadership
• Provide background on standard-of-care shifts in the DMD treatment landscape
• Support Data and Safety Monitoring Board (DSMB) meeting preparation as needed
• Translate complex ARCUS gene editing science into accessible language for non-scientific audiences
• Articulate Precision’s differentiation versus AAV gene therapy and exon-skipping approaches
• Attend scientific and medical conferences to represent Precision BioSciences

3. Patient Advocacy & Community Engagement

• Partner with Clinical Development, Clinical Operations, Program Management and Corporate Communications team to support compliant scientific education for advocacy organizations and patient communities
• Support the presentation of the PBGENE-DMD program to advocacy groups at all levels: National (PPMD, CureDuchenne), Regional, Local, and International
• Understand role of IRB in approving patient-facing materials and ensure that local approval is sought where needed
• Work with clinical and corporate functions to develop and customize patient-facing materials for trial sites and advocacy audiences;
• Build high-trust partnerships with DMD family communities and advocacy organizations

4. Investigator Engagement & Pipeline Development

• Support investigator engagement and relationship management alongside Clinical Development leadership; Earn direct access to the investigator
• Partner with the MD and program team to identify and pipeline future investigators for program expansion
• Identify barriers encountered by patient families related to temporary housing/living arrangements and communicate with Clinical Operations for resolution with Greenfire when issues are encountered. Serve toas the local contact where necessary to ensure resolution

Qualifications

The requirements listed below are representative of the knowledge, skill, and/or ability required to perform this job successfully.

Required:

• Bachelor’s degree (or equivalent) and 7+ years of total experience in clinical research, medical affairs, patient advocacy, or clinical practice within biotech, pharma, and/or clinical trial site(s), or equivalent combination of education and experience
• Direct experience in pediatric rare disease or neuromuscular therapeutic areas
• Demonstrated experience managing clinical trial site relationships
• Track record of engagement with patient advocacy organizations
• Strong scientific communication skills; ability to translate complex data for diverse audiences
• Willingness to travel up to 60–70% at peak

Preferred

• Prior experience in a Clinical Science Liaison, Medical Science Liaison, Clinical Trial Liaison, or equivalent field-based role
• Advanced degree (PharmD, PhD, NP/PA, or equivalent) in a relevant scientific discipline
• Direct DMD / Duchenne Muscular Dystrophy experience
• Existing relationships at target DMD trial sites
• Gene therapy or gene editing clinical program experience
• Site activation experience at DMD Centers of Excellence
• Nurse Practitioner background with neuromuscular or rare disease site experience
• Familiarity with DMD advocacy landscape (PPMD, CureDuchenne, MDA)
• Experience with small molecule DMD therapies

Travel Requirements

• This position requires 60%+ travel at peak to clinical sites, conferences, patient advocacy events

Location

• This is a field-based, remote role that will function remotely in accordance with company guidelines.

Precision BioSciences, Inc. (Nasdaq: DTIL), is a clinical stage biotechnology company dedicated to improving life (DTIL) with its novel and proprietary ARCUS® genome editing platform. This isn’t just a statement supporting the products that we’re developing – it’s a statement that speaks to our collective desire to do our part in improving the lives of those around us. ARCUS is a highly specific and versatile genome editing platform designed with therapeutic safety, delivery, and control in mind. Using ARCUS, Precision is developing in vivo gene correction therapies for genetic diseases. Our team includes pioneers in genome editing, leaders in business, and a full staff of talented and committed people who are excited to be a part of medical and scientific breakthroughs. For additional information, please visit www. precisionbiosciences.com

Precision BioSciences actively fosters an inclusive environment to ensure we attract and retain the best talent; we value diversity of life experiences and perspectives; and we encourage innovation in pursuit of our mission. We provide equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws. Precision BioSciences complies with applicable state and local laws governing non-discrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including, but not limited to, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.