Associate Medical Director, Clinical Development
hace 11 días
Anaheim
Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead’s RNAi-based therapeutics leverage this natural pathway of gene silencing. Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates. Arrowhead’s corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need. The Position The Associate Medical Director will report to Arrowhead’s Medical Director and play a key role in advancing innovative RNA interference-based therapies to patients. This individual will work collaboratively with Arrowhead’s scientific and clinical teams, guiding drug candidates from discovery through early-stage clinical development. The initial focus will be on siRNA programs targeting metabolic, renal, neuro, and complement-mediated diseases. While experience in these areas is preferred, it is not required. In this role, the Associate Medical Director will take hands-on responsibility for designing and managing translational studies and early-phase clinical trials, assessing the efficacy, safety, clinical pharmacology, and pharmacokinetics of product candidates across various disease areas. This is a unique opportunity to contribute to the development of cutting-edge therapeutics and make a meaningful impact on patient care. This is a fulltime, onsite position based from Arrowhead’s Corporate Headquarters in Pasadena, CA. Responsibilities • Support the design, development, execution and communication of translational and clinical studies across a wide variety of therapeutic areas;, • Act as a medical lead in a cross functional team that includes medical scientific, clinical, safety, program and regulatory staff, • Effectively communicate protocols and other relevant information with clinical site investigators and staff, • Interpret clinical trial data and communicate results clearly and accurately, • Act as medical monitor for clinical studies and provide clinical input to safety assessments, • Contribute to documents, including IRB submissions, protocols, CSRs, publications and regulatory submissions, • Identify key opinion leaders and participate in clinical advisory board meetings, • Make scientific presentations at advisory boards, key scientific meetings and external committee meetings, • Identify and evaluate medical need and clinical path for new applications of RNA interference for the treatment of disease, • Collaborate with scientific staff to drive new drug candidates through preclinical development, • Monitor and understand new developments in RNA interference in industry and academia, • M.D., Ph.D. or M.D. combined with research experience, • Hands-on translational research experience within a pharmaceutical or biotechnology company or in an academic setting, • Demonstrated understanding of the drug development process and a strong desire to contribute to the development of meaningful therapeutics, • Knowledge of Good Clinical Practices, FDA regulations and guidelines and applicable regulatory requirements, • Ability to effectively evaluate outside expert advice, • Ability to clearly elucidate complex scientific and medical concepts via written and oral communication, • Working independently and effectively in a fast-paced, team-based environment, • Strong clinical/scientific/technical skills, • Strong interpersonal skills and the ability to communicate effectively with people in diverse and different settings, • Possesses sense of urgency; identifies challenges and problems and takes the initiative to identify solutions, • Support the design, development, execution and communication of translational and clinical studies across a wide variety of therapeutic areas;, • Act as a medical lead in a cross functional team that includes medical scientific, clinical, safety, program and regulatory staff, • Effectively communicate protocols and other relevant information with clinical site investigators and staff, • Interpret clinical trial data and communicate results clearly and accurately, • Act as medical monitor for clinical studies and provide clinical input to safety assessments, • Contribute to documents, including IRB submissions, protocols, CSRs, publications and regulatory submissions, • Identify key opinion leaders and participate in clinical advisory board meetings, • Make scientific presentations at advisory boards, key scientific meetings and external committee meetings, • Identify and evaluate medical need and clinical path for new applications of RNA interference for the treatment of disease, • Collaborate with scientific staff to drive new drug candidates through preclinical development, • Monitor and understand new developments in RNA interference in industry and academia, • M.D., Ph.D. or M.D. combined with research experience, • Hands-on translational research experience within a pharmaceutical or biotechnology company or in an academic setting, • Demonstrated understanding of the drug development process and a strong desire to contribute to the development of meaningful therapeutics, • Knowledge of Good Clinical Practices, FDA regulations and guidelines and applicable regulatory requirements, • Ability to effectively evaluate outside expert advice, • Ability to clearly elucidate complex scientific and medical concepts via written and oral communication, • Working independently and effectively in a fast-paced, team-based environment, • Strong clinical/scientific/technical skills, • Strong interpersonal skills and the ability to communicate effectively with people in diverse and different settings, • Possesses sense of urgency; identifies challenges and problems and takes the initiative to identify solutions
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