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VP / Director of Clinical Development - Neurodegenerative Diseases

Company: Neurocentria, Inc.
Location: Walnut Creek
Posted on: October 22, 2019

Job Description:

VP / Director of Clinical Development - Neurodegenerative DiseasesLocation:--Walnut Creek, CA--USA----Hours:--Full-TimeBenefits: YesApply at:--Please submit your CV to info@ with the the position in the subject line to be considered.Company Summary:Neurocentria is a clinical stage San Francisco area-based pharmaceutical company striving to develop treatments for neurodegenerative diseases such as Mild Cognitive Impairment and Alzheimer's Disease. Currently, we have positive Phase II data demonstrating strong efficacy and safety for treating Alzheimer's Disease with our primary candidate compound, and we are set to launch Phase III clinical trials.Position Overview and Job SummaryWe are seeking an enthusiastic and innovative pharmaceutical professional with 5-10 years of industry experience to join and help build our growing team.The Director of Clinical Development will play a key role at all stages of the clinical development program.--The ideal candidate will have oversight for ongoing and planned clinical trials, establish, direct and manage the clinical efforts and interact closely with senior management, scientists and functional group leaders.--S/he is responsible for all clinical trial management and successful execution of clinical trials according to applicable regulations, legislation, and guidelines.--S/he must facilitate effective internal and external relationships and is responsible for achievement of project goals and objectives on time and on budget.Primary Duties and Job Functions:Build and manage the Clinical Development departmentAssist CMO/CSO to design and implement phase II-IV clinical protocolsDevelop SOPs for trial subject safety monitoring and efficacy data collection systemsManage CROs/ CT Vendors:negotiate study contracts and budgetsevaluate and develop action plans as appropriate to address issues with investigational sites, CRAs, and CROsOversee the execution of clinical trials, data collection activities, and study reporting to ensure timely delivery of clinical deliverablesMonitor adherence to protocols including assessment of eligibility, drug safety, toxicitymanagement, reporting adverse events and determining study completionCoordinate the collection and analysis of clinical data for internal analysis and reviewEnsure adherence to regulatory requirements of study conduct and industry standards of Good Clinical PracticeProvide ongoing medical monitoring for clinical trials, including assessment of eligibility criteria, toxicity management, and drug safety surveillance (applicable to MD or equivalent candidates)Manage the preparation/review of regulatory documents including clinical study reports, briefing documents, responses to questions from regulatory authorities and IRBs, IND annual reports, IND safety reports, investigator brochures, NDA filings, and development plansKnowledge, Experience and Skills:PhD, PharmD, MD (Medical Doctor or equivalent)5 + years of clinical trial experience or Clinical Development experience in a pharmaceutical or biotechnology industry setting, ideally in neurodegenerative disease drug developmentDemonstrated knowledge of GCP, ICH and CFR guidelines, and regulatory compliance related to phase II-IV clinical trialsDirect experience in the strategic and tactical implementation of drug developmentProven track record of project, personnel, and vendor management in clinical development leading to on-time completion of clinical trial preparation, execution, and regulatory filings (Required)Excellent scientific written and oral communication skillsAbility to think analytically and strategically to formulate, develop, and execute clinical plansBe able to identify challenges and provide solutions in a proactive mannerAbility to work effectively in a multidisciplinary team to cultivate an inclusive environment of respectful, open, and honest dialogue and to foster a robust sharing of ideas and creative problem solvingWell-developed sense of integrity, strong work ethic, scrupulous attention to detail, clear ability to establish and maintain timelines, and persistent commitment to ensuring a high level of qualityAbility to travel domestically and internationally to company, scientific, regulatory, investigator, and other meetings as necessaryOnly candidates that can commute M-F to the Walnut Creek Office will be considered.What we offer: A competitive compensation and relocation package (commensurate on experience and qualifications)Comprehensive health/insurance plans including medical, dental and vision, lifeCompetitive 401(k) investment options with corporate matching after 1 yr.Paid annual vacation, holidays and Sick time off

Keywords: Neurocentria, Inc., Sunnyvale , VP / Director of Clinical Development - Neurodegenerative Diseases, Executive , Walnut Creek, California

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