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(Sr.) Director of Clinical Science

Genesis Therapeutics

Genesis Therapeutics

Burlingame, CA, USA · San Diego, CA, USA
Posted on Tuesday, July 25, 2023
Location
If you can join us in our lab in San Diego or in our Burlingame office, that'd be wonderful. However we are open to all qualified candidates who may work remotely.
About Genesis Therapeutics:
Genesis Therapeutics is a pioneering AI Biotech company focusing on the discovery of novel drugs using unique approaches to both undrugged and underdeveloped targets with the goal of providing new treatments for patients with severe diseases.
Genesis has raised over $280M in funding from top technology and biotech investors, including Andreessen Horowitz, Rock Springs Capital, T. Rowe Price, Fidelity, Radical Ventures, NVentures (NVIDIA's VC arm), BlackRock, and Menlo Ventures. In addition, Genesis has announced two AI platform collaborations across a range of therapeutic areas with Genentech and h Eli Lilly, the latter of which entailed a $20M upfront payment with a $670M total deal size. We’ve also been featured in Forbes 30u30 and in Forbes AI 50.
Genesis originated in graph machine learning research in Vijay Pande’s lab at Stanford, when it was joined by legendary drug hunters and biotech entrepreneurs (including Dr. Leonard Bell, founder and CEO of Alexion Pharmaceuticals, acquired by Astra Zeneca for $39Bn; and Peppi Prasit, storied chemist from Merck known for Vioxx, Arcoxia, Singulair, who then went on to found Amira Pharmaceuticals, acquired by BMS, and Inception Sciences). The company is making strong progress in expanding the domain of our AI technology with the advance of our pipeline of best-in-class and first-in-class programs, both internal targets and those in partnership with Genentech and Lilly.

Responsibilities: This individual will

  • Be an essential contributor to the scientific, clinical, and operational scope of clinical development programs with an emphasis on program-specific activities
  • Drive the design, planning, and implementation of study protocols for assigned investigational products and will play a key role in supporting related operational and regulatory activities
  • Work on cross-functional program development and study management teams for the design, execution, and monitoring of clinical trials, and assist with data interpretation and communication to both internal and external stakeholders
  • Help establish and support internal process improvement initiatives within the clinical department
  • Partner with cross-functional program- and study-level teams to oversee the 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
  • Perform medical and related safety/efficacy data reviews
  • Be responsible for analytical support of clinical trial data, 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 a clear overview of trial results
  • Provide organizational support for Data Monitoring Committees 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, IBs, ICFs, training documents, and other clinical and regulatory documents
  • Interact with internal and external stakeholders (study sites, vendors, committees, etc.) in support of program-level development strategy as well as clinical trial objectives; responds to or triages questions for appropriate escalations
  • Act as recognized clinical expert for assigned programs
  • Write and/or review collaborative abstracts, posters, and content for scientific meetings, conferences and publications
  • Support publication strategy execution including collaboration with investigators, KOLs, medical affairs and other internal/external stakeholders
  • Present at investigator and other meetings as needed
  • Conduct literature reviews as needed
  • Be responsible for Line management and training of junior clinical scientists as needed

Qualifications

  • PhD degree, PharmD, or other relevant advanced degree in a health science field
  • At least 8+ years of experience for Director, and 12+ years of experience for Senior Director at a pharmaceutical, biotechnology company or CRO as a clinical scientist/scientific director or related role
  • Significant Early-stage drug development experience with Phase 1 and 2 Oncology studies (>6 years) required
  • Experience with authoring and amending Oncology Protocols, Investigator Brochures and ICFs
  • Experience with working with Clinical Sites and Investigators
  • Experience with Oncology data analysis and interpretation of safety and pharmacovigilance principles required
  • Demonstrated ability to evaluate, interpret and present complex scientific data (preclinical, clinical and translational) to inform scientific hypotheses and development strategy
  • Working knowledge of GCP, biostatistics and regulatory requirements for clinical studies
  • Must be able to work effectively in a fast-paced, team-based environment as well as the ability to function independently as appropriate
  • Flexible to accommodate changes in team and project needs
  • Ability to handle multiple projects at a time and have a strong attention to detail while understanding and helping to formulate higher-level strategy
  • Excellent interpersonal, verbal, and written communication skills
  • Ability to make and communicate independent, timely and appropriate recommendations and decisions