Director / Senior Director of Clinical Science

NGM Bio

South San Francisco, CA, US
  • Job Type: Full-Time
  • Function: Clinical Research
  • Post Date: 04/13/2021
  • Website: ngmbio.com
  • Company Address: 630 Gateway Blvd, South San Francisco, CA, 94080-7014

About NGM Bio

NGM Bio is a research-driven, clinical-stage biopharmaceutical company with a passion to improve the lives of those struggling with serious diseases. Our expertise in drug discovery and translational development, coupled with the significant resources from our partnership with Merck, is driving development of transformational medicines that dramatically improve human health.

Job Description

NGM Biopharmaceuticals, Inc. is a biopharmaceutical company dedicated to discovering and developing the next generation of medicines for the treatment of serious diseases.  Our experienced scientific team has joined forces with an impressive group of industry professionals, Nobel Laureates and other distinguished researchers to build a company where innovation and cutting-edge science has provided the foundation for a robust drug discovery engine that has a track record of generating one new IND candidate per year.  NGM’s current pipeline of clinical-stage programs consists of five drug candidates targeting liver and metabolic diseases, retinal diseases and cancer.  The most advanced drug candidate, aldafermin (NGM282), is in Phase 2b clinical studies in non-alcoholic steatohepatitis (NASH) and is wholly-owned by NGM.  Another drug candidate, NGM621, is in a Phase 2 study in geographic atrophy (GA) secondary to age-related macular degeneration (AMD).  NGM’s strategic collaboration with Merck, with a current term running to March 2022, provides us with the resources and flexibility to pursue our ambitious R&D goals and further extend our pipeline of novel drug candidates. 
 
We are seeking qualified and motivated senior Clinical Scientist/Clinical Scientist to join our Clinical Development Immuno-Oncology (I-O) team.  Qualified candidates will be essential contributors to the scientific, clinical, and operational scope of clinical development program with emphasis on protocol-specific activities.  The Clinical Scientist will participate and significantly contribute to whole Clinical Development Plan (CDP) from First-in-Human (FIH) through Proof-of-Concept (POC) studies and beyond.  This role will help drive the design, planning and implementation of study protocols for the assigned I-O program(s), starting from playing a key role in supporting related regulatory activities at IND to operational execution at study conduct, including monitoring of clinical trials, assisting with data interpretation and communication to both internal and external stakeholders. To achieve these goals, candidates will work cross-functionally with the product development team (PDT) and the Clinical Study Team to support the assigned Clinical Development Physician(s)/Medical Monitor(s) with various deliverables necessary for effective and efficient CDP execution for the assigned molecule(s)/indication(s).

Specific Responsibilities for Role:

    • Responsibilities may include, but are not limited to:
    • Partner with cross-functional program- and study-level teams with minimal oversight from senior team members to oversee the design and conduct of clinical studies, including operational feasibility, data management deliverables, preparation of meeting materials, communication plans, safety and medical monitoring, preparation of status update reports, and study close-out activities.
    • Support senior team members with medical monitoring reports, safety reviews, site interactions, and reviewing Tables, Figures & Listings (TFLs).  At Senior Clinical Scientist level, may perform medical and related safety/efficacy data reviews with minimal oversight from senior team members.
    • May be responsible for analytical support of clinical trial data (safety and efficacy), including gathering, analyzing, reviewing, interpreting, and providing preliminary assessments and recommendations.
    • Analyze information to assess issues relating to protocol conduct and/or individual subject safety.
    • Prepare and communicate or assist communicating a clear overview of trial results.
    • Provide organizational support for Safety Monitoring Committee (SMC) at the Dose Level Review Meeting (DLRM) and other applicable data review committees including operationalizing the charter, preparing updates and data reviews, execution of meetings and adjudications, and communication of synthesized data reports.
    • Author protocols and contribute to authoring of clinical study reports, Investigator Brochures (IBs), Informed Consent Forms (ICFs), training documents, and other clinical and regulatory documents.
    • Interact with internal and external stakeholders (study sites, vendors, committees, etc.) in support of clinical trial objectives; responds to or triages questions for appropriate escalations.
    • Act as recognized clinical expert for assigned studies both within and external to NGM.
    • Write and/or review collaborative abstracts, posters, and content for scientific meetings, conferences and publications.
    • Support publication strategy execution including collaboration with investigators, Key Opinion Leaders (KOLs), medical affairs and other internal/external stakeholders.
    • Present at investigator meetings and scientific conferences.
    • Conduct literature reviews as needed.

Education, Experience, and Skills Required:

    • Master/PhD degree in health science field, PharmD, MD or non-US equivalent, or other relevant advanced degree in a health science field.
    • At least 5 years of experience at a pharmaceutical, CRO or biotechnology company as a clinical scientist or related role.
    • Experience in oncology or oncology immunotherapy clinical trials preferred. Early drug development experience in FIH trials highly desirable.
    • Experience with data analysis and interpretation as an understanding of safety and pharmacovigilance principles required.
NGM offers a creative, collaborative, highly challenging scientific environment, along with a strong compensation package that includes salary, stock options, 401(k) and a comprehensive benefits package.
 
Interested applicants should apply through the NGM Biopharmaceuticals website: https://www.ngmbio.com/open-positions/
 
We have become aware of false offers of employment being made by individuals impersonating NGM representatives in order to collect personal information and/or payment. Please exercise caution when receiving unsolicited recruiting offers. NGM always lists all open positions on the NGM careers page and all employment applications must be submitted through our online portal. NGM will never solicit payment or payment information from candidates. Please be advised that NGM is not currently hiring in any countries other than the US. We never request that candidate information be sent to a non-ngmbio.com email address.  
 
Note to Recruitment Agencies: Please do not forward any agency résumés. NGM Bio is not responsible for any fees related to résumés that are unsolicited.   

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This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.