Clinical Scientist

Santa Monica

Neogene Therapeutics is a pre-clinical stage biotechnology company aiming to change the treatment paradigm for solid cancers. Our mission is to provide cancer patients with T cell therapies targeting mutated proteins called neo-antigens, which are present on cancer cells as a consequence of DNA mutations. Neogene is developing novel technologies to enable the engineering of ‘designer T cells’ with neo-antigen specificities that display an optimized ability to seek and destroy cancer cells.

Neogene is seeking a Clinical Scientist to join our Clinical Development team and work in an exciting new area of cell therapy at Neogene Therapeutics. This role is based out of Santa Monica, CA and reports directly to the Vice President of Clinical Development.

The Clinical Scientist drives and participates in the development of clinical strategies for assigned clinical protocol(s) and is responsible for leading, developing and ensuring effective and efficient execution of the Clinical Development Plan (CDP). The Clinical Scientist is expected to perform their responsibilities independently and provide managerial duties.

Responsibilities include, but are not limited to:

Is a standing member of the Clinical Science Team and/or an ad hoc member of the Project Team and relevant sub-teams, and as such, presents and helps cross-functional team members synthesize/contextualize clinical data to facilitate discussion.
Effectively represents Clinical Science (CS) on Project Teams of assigned clinical trial/program and ensures cross-functional integration, coordination and alignment to enable effective and efficient CDP execution, including regular review and analysis of protocol violations, authoring of study start-up documents required from Clinical Science, partnering with Data Management for case report form (CRF) design and instructions for use, review of all study documents requiring clinical expertise as identified by the Project Team, and communication of milestone timelines to enable preparation of high quality data summaries to support regulatory and clinical documentation and/or team deliverables.
Trains study site personnel on protocol execution.
Contributes to clinical documentation of study execution including management of regulated documents, notes of clinical decisions, and study conduct that are considered permanent record.
Authors and/or reviews the clinical sections of any regulatory documents supporting Neogene’s clinical trials in collaboration with the Clinical Team Leader and the Medical Writer.
May consult or be the Medical Monitor as the primary point of contact to address or properly triage inquiries from site, CRO personnel, and site monitors regarding the study protocol, informed consent, and patient-specific questions.
Responsible for the review, finalization, and update of information/data entered into clinical trials registry (clinicaltrials.gov).
Participates in the development of the CDP, as needed.
Assists with Clinical Science due diligence activities for in-licensing and development opportunities.
Partners with Data Management to develop novel electronic CRF and instructions for their use, the Data Quality Review Plan, and resolution of all clinical queries to sites.
May participate in Health Authority interactions, as well as interactions with site IRBs/Ethics Committees and/or review committees.
May mentor and/or train new Clinical Scientists.
Contributes to scientific abstracts for submission to national and international scientific conferences.
Contributes to publications for peer-reviewed journals.
Collaborates with Clinical Team Leader to create, review, and/or present clinical slides for internal meetings and external forums.
Collaborates with biostatistics to develop and QC data tables, listings, and figures and develops data-driven study-specific analyses, as appropriate.
Collaborates with Safety Science to identify and track any potential safety events within a given trial and/or across trials for assigned program(s.)
Conducts medical data reviews.
Provides Clinical Science input to proposed revisions of SOPs and Guidance documents.
Supports Clinical Development departmental goals and initiatives.

Requirements:

Candidates for this position should hold the following qualifications, have the following experience, and be able to demonstrate the following abilities to be considered as a suitable applicant. Please note that except where specified as “preferred,” all points listed below are considered minimum requirements.

Proven abilities to perform CS responsibilities independently and with limited guidance. Has demonstrated, through experience, abilities to competently manage most CS deliverables associated with assigned clinical studies.
Has impeccable ethics.
Outstanding attention to detail.
Strong business acumen; has knowledge of the multidisciplinary functions involved in a company’s drug development process, e.g., clinical operations, biostatistics, regulatory, etc. and can proactively integrate multiple perspectives into the clinical development process for best end-results.
Excellent leadership and project management skills: can prioritize multiple tasks and goals and deliver them in a timely, on-target and high-quality manner within budget guidance.
Excellent interpersonal, verbal communication and influencing skills: can influence without authority and has proven experience building and cultivating relationships with key partners and stakeholders, both internally and externally.
Strong written communication skills.
Strong experience building and cultivating relationships with key partners and stakeholders, both internally and externally.
Strong presentation skills: effective at summarizing and presenting the key considerations and decision-points.
Confident and competent when interacting with varying levels of internal/external management, key opinion leaders, etc.; stays focused and on-point, can raise problems or challenges in a productive and mature manner.
Excellent teamwork and negotiation skills knows how to complete deliverables by working effectively with others internally and externally; can effectively drive discussions and decisions toward desired end-results.
Proven track record of effective decision-making makes good business decisions and exercises sound judgment. Consistently and effectively identifies and addresses important factors affecting clinical trial design and execution.
For the Lead CS: Aptitude or proven ability to manage others (can lead and motivate direct reports, prioritize, and oversee their work through to successful outcomes, and support their career development efforts.)
Ability to travel globally (<10%; variable based on project assignment.)

Education and Experience

Advanced clinical/science degree required (MD, PharmD, PhD, MSN, MPH, etc.).
6 + years pharma/biotech industry experience or demonstrates relevant equivalent clinical or laboratory research experience.
A minimum of 4 years experience with clinical trials.
2 + years relevant oncology therapeutic area experience.
Experienced working in complex matrixed settings.
Experienced authoring full clinical trial protocols and/or study results and conclusions.
In-depth understanding of Phase 1-2 drug development.
Experienced working with the principles and techniques of data analysis, interpretation, and assessment of clinical relevance.
Well-versed in medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMEA and other relevant guidelines and regulations
Strong computer skills.
Preferred: Comprehensive understanding of adoptive T cell product and their safety profiles
Preferred: Experience publishing clinical trial results in peer-reviewed journals

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