• Job Description

  Req#: 202304-109525

  The Position

  Senior Director, Modeling & Simulation (M&S)-Preclinical and Translational PKPD (PTPK)

  The Position

  The Preclinical and Translational PKPD (PTPK) Department at Genentech, Inc. is seeking a highly motivated, dynamic leader to lead the preclinical and translational PK/PD Modeling and Simulation (M&S) group. In this role, the head of PTPK M&S is accountable for strategic and scientific oversight of all M&S activities in PTPK to support preclinical predictive and translational efforts in support of our project portfolio, using state of the art computational approaches such as mechanistic PK/PD & PBPK modeling, QSP, and advanced analytics/AI/ML. Our project portfolio includes modalities such as antibodies, bispecifics, fusion proteins, antibody fragments, antibody-drug conjugates, peptides, vaccines, imaging agents, and cell & gene therapies across multiple therapeutic areas including oncology, immunology, neurology, ophthalmology and infectious diseases with a focus on early stage research through IND. The successful candidate will have a strong and compelling vision and strategy for advancing predictive sciences and M&S in the preclinical and translation research space to develop transformative therapeutics for patients.

  Key Accountabilities

  • Lead a strong preclinical M&S group with direct oversight of ~8 core members plus matrix scientific oversight over additional scientists across PTPK for M&S deliverables.
  • Key member of the PTPK department core leadership
  • Chair PTPK scientific M&S review meetings
  • Provide strong scientific and strategic oversight over all M&S efforts in PTPK which encompasses a wide range of predictive tools from molecule specific models to platform models in support of our portfolio
  • Drive implementation of innovative M&S methodology and oversee the development and application of novel and state-of-the-art M&S strategies, methodologies and tools with the ultimate goal of i) optimal molecule design and selection to maximize therapeutic window, ii) determination of dose/route/regimen for non-clinical efficacy & toxicity studies, and first-in-human (FIH) clinical trials, iii) prediction of human PK and clinically efficacious dose/regimen.
  • Act as expert advisor and key PTPK M&S reviewer on multifunctional governance committees to represent PTPK M&S in strategic decisions affecting our portfolio
  • Partner directly with project/program teams from Research (discovery) to Early Development (to IND filing & FIH) as well as other M&S/computational groups in other functions such as Clinical Pharmacology, DMPK and Computational Sciences, to provide M&S support for key decision-making. Understand the needs of and strongly influence partners and stakeholders in Research, Development Sciences, Translational Medicine, Computational Sciences, Pharma Technical development and Clinical Development to drive success of programs.
  • Responsible for M&S related budget and planning processes, staffing, and regulatory compliance. Ensure support allocated to assigned projects is optimal in terms of quality, timing and cost. Monitor deliverables including timelines, objectives and budgets to ensure their alignment with discovery and development team goals.
  • Ensure successful preparation of all internal and external documentation including regulatory documents related to M&S aspects of the project (e.g. Investigator's Brochure, IND, BLA, etc.)
  • Leadership in driving department’s mission to advance PKPD sciences by maintaining scientific expertise in advanced computational tools and methodologies in areas of PK/PD modeling through publications, external scientific activities such as scientific societies, industry consortia.
  • Lead recruitment, hiring, training, developing, and mentoring for M&S staff and actively foster an inclusive and diverse departmental culture.

  Qualifications

  We are looking for an individual who is inspired by our mission and would fit in well with the collaborative, rigorous and entrepreneurial spirit of the company culture.

  • Ph.D. in Pharmacokinetics, Pharmacometrics, Pharmaceutical Sciences, Biomedical Engineering, Chemical Engineering, or a related discipline with a computational focus.
  • Experienced leader with 15+ years of relevant industry experience in preclinical & translational PK/PD M&S and 10+ years of experience in leading PK/PD M&S groups with demonstrated impact on drug discovery and translational drug development
  • Experience in applying PK/PD M&S and QSP for discovery & development of biotherapeutics such as antibodies, bispecifics, antibody-drug conjugates, etc.
  • Working knowledge of PK/PD modeling software (e.g. Matlab, Simbiology WinNonlin, NONMEM, ADAPT II, Berkeley Madonna, Monolix, , R, etc.)
  • Strong knowledge and experience in either oncology, immunology, and/or immuno-oncology are highly desired
  • Excellent communication skills and ability to work effectively on cross-functional teams and influence key stakeholders across the organization
  • A proven track record of both scientific achievement and leadership is required.

  The expected salary range for this position based on the primary location of California is $203,600- $378,200. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.

  Benefits

  Relocation Assistance is provided for this posting.

  Who we are

  A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.

  Diversity and Inclusion (D&I) are critical to the success of our company and our impact on society. We believe that by championing diversity of background, thought and experience, we can foster a sense of belonging and provide an environment where every employee feels valued, included, and able to contribute their best for the patients we serve. We’re focused on attracting, retaining, developing and advancing our people to their full potential by rewarding bold ways of thinking and integrating inclusive behaviors into every aspect of our work.

  Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status. For more information about equal employment opportunity, visit our Genentech Careers Homepage.

• About the company

  606018 F. Hoffmann-La Roche AG is a Swiss multinational healthcare company that operates worldwide under two divisions: Pharmaceuticals and Diagnostics.

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