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Director, Ophthalmology/Neuroscience Clinical Pharmacology and Modeling and Simulation (M&S)

Company: Genentech
Location: San Francisco
Posted on: April 10, 2021

Job Description:

Director, Ophthalmology/Neuroscience Clinical Pharmacology and Modeling and Simulation (M&S) We are seeking a highly motivated, dynamic, and experienced leader for the Clinical Pharmacology Department at Genentech. The Director will develop, oversee and lead the strategy and execution of efforts for Clinical Pharmacology (Clin Pharm) as well as Modeling and Simulation (M&S) aspects in Ophthalmology and Neuroscience, which consists of molecules with different modalities - small molecules, biologics, and novel molecule types from Phase I to post-market stage. The successful candidate should be a forward thinking organizational leader with strong and compelling vision, who will lead with empathy, supporting direct reports in issue resolution, enabling their development, and unleashing their potential. Capability to lead across diverse regions, cultures, and time zones, creating an environment of belonging, inclusion and diversity is essential. Scientists and scientific researchers at various level in this organization are responsible to impact portfolio using their technical and drug development expertise in project team settings, as well as drive for continuous innovation in Clin Pharm and M&S areas. With an increase in the complexity and diversity of molecules and therapeutic areas in our portfolio, as well as the growing interest and needs of applying advanced analytics integrating data of higher complexity from all sources in our R&D strategy, we expect the leader to provide extensive experiences and influential visions in all aspects of Clin Pharm and M&S, working in close partnership with other leaders of the Oncology and OMNI Clin Pharm and M&S organizations, as well as key cross-functional stakeholders and external academic/industrial/regulatory leaders in the scientific discipline. Scope of the Position: Reporting to the Executive Director, Global Head of M&S and Ophthalmology/Neuroscience Clinical Pharmacology (OMNION), the Director will be responsible for the oversight of the development of global Clin Pharm and M&S strategies for all molecules in Ophthalmology/Neuroscience (OMNI-ON) portfolio including small molecules, biologics, and novel molecule types from Phase I to post-market stage. M&S strategies include both project M&S support for individual molecules and platform M&S support for disease and modality platforms, leveraging novel data types, diverse data sources, and broad range of analytics approaches. Currently, there are 8 unique molecules in Ophthalmology/Neuroscience portfolio, in disease areas including (but not limited to) wet Age-related Macular Degeneration (wAMD), Diabetic Macular Edema (DME), Geographic Atrophy (GA), pain, and alzheimer's disease. RESPONSIBILITIES: Be a key member of the organization's core leadership in drug development. As a member of key senior management level decision-making committees (such as DRCs in gRED and Advisory Meetings in Late-stage), represent Clin Pharm as well as M&S for strategic decisions in Ophthalmology/Neuroscience. Understand the needs of and strongly influence senior management partners and stakeholders in Discovery, Early- and Late-stage development functions for the success Accountable for Clin Pharm and M&S strategy, design, execution, result interpretation, troubleshooting, reporting, and regulatory interactions for all molecules in Ophthalmology/Neuroscience. Partner directly with cross-functional stakeholders and project/program teams in Research, Early Development (pre-IND to EOPII) and Late Development (Phase III through filing to post-market and new indications) for Clin Pharm and M&S application in drug development, including decision-making, regulatory acceptability, and issue resolution. Oversee the development and execution of novel and state-of-the-art Clin Pharm and M&S strategies to impact dose/route/regiment decision, trial design, interpretation, development and regulatory strategy, with the ultimate goal to bring personalizing treatment options to patients faster. M&S oversight include both project M&S strategy/deliverables for individual molecules and platform M&S strategy/deliverables for disease and modality platforms, leveraging novel data types (omnics, imaging, wearable etc), diverse data sources (MPS, RWD, Transcelerate, etc), and broad range of analytics approaches (statistical modeling, population modeling, PBPK, QSP, MBMA, disease modeling, AI/ML, etc.). Ensure the successful preparation and presentation of all internal and external documentation related to Clin Pharm and M&S (e.g. Investigator's Brochure, IND, M&S Reports, Summary of Clinical Pharmacology sections of BLAs/NDAs, IMPD, Health Authority briefing books). Clearly identify and communicate potential project hurdles, suggest solutions, and establish priorities and contingency plans in collaboration with line management, key partners in Early and Late Clinical and project team participants, and DRC chairs. Assure deliverables for all assigned projects is optimal in terms of quality, timing, and cost; negotiate effectively as necessary. Monitor deliverables including timelines, objectives, and budgets, and ensure their alignment with development team goals. Manage communications and relationship-building with internal and external stakeholders like Clinical Sciences, Biometrics, DMPK/PTPK, Biomarkers, Bioanalytical Science, Informatics, RWD science, Regulatory functions in Clinical and CMC, Technical Development, Clinical Operations, Clinical Safety, Safety Assessment, pRED, Chugai, as well as external stakeholders like global Health Authorities. Drive and/or contribute to the Department's core missions and business Member of Clin Pharm Leadership Team (CPLT) and M&S Leadership Team (MSLT) Effective people management with attention to continuous growth and development Play a major role in training, developing, and mentoring staff in specialized areas across department Continue to advance scientific and regulatory expertise as well as cutting edge technologies in the fields of drug development, clinical pharmacology, and modeling and simulation Contribute to and provide leadership for the Department's mission to advance the science of Clinical Pharmacology through publications, active involvement and leadership in external scientific societies and industry consortia, scientific interactions with Health Authorities, and collaborations with external partners. REQUIREMENTS: The ideal candidate will satisfy many of the following requirements: Candidate should have a Ph.D., M.D., or an equivalent degree in a pharmaceutical or life sciences or engineering with a minimum of 10 years of experience in Clinical Pharmacology and M&S, in either the small and/or large molecule environment. A proven track-record of scientific and drug development achievement, strong organizational leadership, and effective people management is required. The candidate should have extensive experience in overseeing and managing the Clin Pharm as well as M&S aspects of regulatory filings, including BLA and/or NDA/MAA submissions. An in-depth understanding of R&D process and global regulatory experience, as well as rich and diverse hands-on M&S experience is a must. Therapeutic knowledge and drug development experience in Ophthalmology/Neuroscience is desired, but not required. Very strong verbal communication skills accompanied by outstanding writing skills are required. The ability to effectively interact with and influence senior leaders in the discovery and clinical development environment is critical for success. Candidate should thrive and work well in a fast-paced, multi-tasked, and hands-on environment. #DevSci #ClinPharm #ASCPT2021 #LI-HB2 Who We Are Genentech, a member of the Roche group and founder of the biotechnology industry, is dedicated to pursuing groundbreaking science to discover and develop medicines for people with serious and life-threatening diseases. To solve the world's most complex health challenges, we ask bigger questions that challenge our industry and the boundaries of science to transform society. Our transformational discoveries include the first targeted antibody for cancer and the first medicine for primary progressive multiple sclerosis. 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. The next step is yours. To apply today, click on the "Apply for this job" button. Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page .

Keywords: Genentech, San Francisco , Director, Ophthalmology/Neuroscience Clinical Pharmacology and Modeling and Simulation (M&S), Executive , San Francisco, California

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