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Head of Clinical Operations (Sr. Director ~ VP)

Genesis Therapeutics

Genesis Therapeutics

Operations
San Diego, CA, USA
Posted on Saturday, September 2, 2023
We started Genesis Therapeutics in 2019 with origins in field-leading AI + biophysics research. Since then, we’ve dramatically accelerated innovation in Machine Learning and molecular simulation technologies for drug discovery, with the goal of providing new treatments for patients with severe diseases.
We are a mission-driven group of researchers, engineers, and drug developers. We believe close-knit, interdisciplinary collaboration is crucial for inventing important new technology and rapidly advancing optimal therapies.
Genesis Therapeutics is seeking a Head of Clinical Operations to play a key role in delivering high-quality clinical results across multiple programs. The individual in this position will have the unique opportunity to grow and shape the Genesis Therapeutics clinical operation team at a rapidly growing biotechnology company. In addition, this individual will develop a new project team within the clinical organization to ensure Genesis Therapeutics is on the cutting edge of clinical innovation. This position will contribute to Genesis Therapeutics success by leading the clinical operations activities while working closely with other functional area leads at Genesis Therapeutics and third-party CROs and vendors.

Responsibilities

  • This is a high-profile management position
  • Oversee the overall execution of the assigned clinical program(s) with a focus on quality, budget and timelines, including making decisions or recommending operational strategies in support of achieving Phase III clinical program objectives
  • Leads the strategy and tactics to successfully work with vendors, investigators, and cross-functional departments to develop, implement and deliver clinical studies/programs supporting our Phase 1-III programs
  • Champions, promotes, and supports the development of high-quality, hard-working study teams to deliver outstanding clinical trials
  • Has broad experience selecting, managing, troubleshooting, and negotiating with CROs and supporting vendors
  • Leads strategies for patient recruitment and retention in clinical trials
  • Establishes performance, quality, business efficiency, and innovation metrics for the clinical teams and vendors in collaboration with Quality and Risk Management; seeks to improve quality across study programs and ensures quality processes are followed
  • Maintains awareness of industry trends and developments to help define the future strategic direction for the clinical programs
  • Prepares and delivers training, both internally and externally, on new objectives or mandates from authorities, and on training associated with the clinical trials (Investigator Meetings, Re-training)
  • Oversees and is accountable for program budgets, staffing, and timelines

Qualifications

  • Experience leading and handling complex global clinical development programs is required
  • Demonstrated track record of interpreting executive-level research/scientific business requirements into operational strategies globally
  • Thorough understanding of local and international regulations applicable to clinical development; demonstrative knowledge of regulatory requirements globally and prior success in providing timely and quality support of regulatory submissions
  • Strong written and verbal communication skills; willingness to engage with investigators, key opinion leaders, external advisors, and regulatory authorities; and ability to effectively give presentations at conferences, advisory meetings, and other public forums
  • A hands-on, entrepreneurial style with a sense of urgency, a bias toward action, comfort with calculated risk, and the ability to analyze situations rapidly and make
  • Engaged, hands-on, independent, and goal-oriented mentality; willingness to work in a highly dynamic work environment and embrace uncertainty
  • Known to work with cross-functional collaboration and lead multiple assignments with timely and accurate output
  • Adept at crafting and presenting a clear vision among direct reports, efficiently aligning resources, and motivating teams to achieve goals
  • Demonstrated analytical abilities and proficient planning and negotiation skills
  • Sound strategic, clinical, technical, operational, and ethical judgment with uncompromising integrity
  • Hybrid work-from-home options (dependent upon position and level), with travel up to 10%- domestic and international travel
  • At least Bachelor’s degree in the life sciences or related field (required)
  • Awareness of local country requirements is also required

What We Offer

  • We offer a competitive salary and equity
  • Excellent medical, dental and vision coverage (Genesis pays 100% of premiums for employees)
  • Free lunches (and dinner if needed) in the office, along with fully stacked kitchen with snacks
  • Work closely with a team on the cutting edge of AI research
  • Open, flexible PTO
  • 401K Plan
Genesis Therapeutics is unifying AI and biotech to discover novel and breakthrough treatments for patients with severe and devastating conditions. Genesis was founded on groundbreaking molecular ML research and since has established itself as the industry leader in AI for small molecule drug discovery. Our team of accomplished biotech leaders and expert drug hunters joins forces with deep learning researchers and software engineers who are pioneering predictive and generative AI technologies for molecules.
Our team has created the industry's most advanced molecular AI platform called GEMS (Genesis Exploration of Molecular Space), to accelerate and optimize small molecule drug discovery and to enable the discovery of novel first-in-class and best-in-class small molecule drugs for challenging and/or undruggable targets.
The company has leveraged GEMS to build an internal pipeline with multiple programs against high-value targets, including data-poor and canonically undruggable targets where GEMS is uniquely advantaged. In addition, Genesis has two AI platform collaborations across a range of therapeutic areas: Eli Lilly (signed in 2022, with a $20M upfront payment and a $670M total deal size), and Genentech (signed in 2020).
We raised a $200M series B in August 2023, and have 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.
Genesis is headquartered in Burlingame, CA, with a fully integrated laboratory in San Diego. We are proud to be an inclusive workplace and an Equal Opportunity Employer.
Finding the best talent is our top priority at Genesis Therapeutics. If you are interested in potential partnership on recruitment, please reach out to recruiting@genesistherapeutics.ai.