Global Blood Therapeutics

Global Blood Therapeutics San Francisco, CA, USA
Jul 09, 2020
Full time
CONTRACT - RESEARCH ASSOCIATE, PHARMACOLOGY Position Summary: Research Associate - Pharmacology to support in vivo studies for target validation and preclinical research activities. Essential Duties and Responsibilities: Perform in vivo pharmacology studies with hematological disease models and conduct in vivo drug efficacy studies to support early drug discovery projects Develop and troubleshoot novel in vivo disease models for mechanism of action studies Plan, execute, analyze, and document experiments Work in a team environment Qualifications: BS degree with 0-2 years relevant hands-on laboratory experience in industry; or equivalent Background in hematology, pharmacology or related disciplines is a plus Hands-on experience performing in vivo studies, preferably with small molecule drug candidates, using multiple dose routes, tissue sample collection Organized, self-motivated, able to multitask and deliver results with high degree of attention to...
Global Blood Therapeutics San Francisco, CA, USA
Jul 09, 2020
Full time
SENIOR RESEARCH ASSOCIATE - PHARMACOLOGY Position Summary: Senior Research Associate - Pharmacology to support in vivo studies for preclinical research activities. Essential Duties and Responsibilities: Perform in vivo pharmacology and PK studies in a team environment to support early drug discovery projects Evaluate the mechanism of action in drug efficacy studies Set up new disease models to validate novel and existing targets Plan, execute, analyze, and document experiments and present results at internal meetings Qualifications: BS degree in biology, or related discipline, with at least 8 years of experience, preferably in industry Hands-on experience performing in vivo studies, dose administration, and sample collection required Experience in surgical models is required Statistical understanding and knowledge of common statistical software Experience in hematological models is a plus Organized, self-motivated, able to multitask and deliver...
Global Blood Therapeutics San Francisco, CA, USA
Jul 09, 2020
Full time
CLINICAL RESEARCH ASSOCIATE Position Summary: The Clinical Research Associate (CRA) is a critical position within Global Blood Therapeutics' clinical team. In close collaboration with the Clinical Trial Manager, the CRA will work to manage and monitor clinical trial sites. The CRA will assist in managing and or leading the day-to-day operations of assigned studies to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements. Essential Duties and Responsibilities: Participate in and may facilitate cross-functional study teams, liaise with other functional areas (preclinical development, pharmaceutical sciences, safety, regulatory affairs) to accurately coordinate clinical study activities Provide monitoring oversight by reviewing monitoring schedules, metrics and reports. May oversee or manage clinical documentation and reports Accurately update and maintain clinical systems...
Global Blood Therapeutics San Francisco, CA, USA
Jul 08, 2020
Full time
ASSOCIATE DIRECTOR, HEALTH ECONOMICS AND OUTCOMES RESEARCH (HEOR) Position Summary: Global Blood Therapeutics (GBT) is seeking a talented individual to join its Health Economics and Outcomes Research group in South San Francisco, CA. The primary responsibility of the Associate Director is to execute strategic plans to optimize the supporting evidence and value demonstration of GBT's leading product, Voxelotor, in sickle cell disease products. This position reports to the Senior Director of HEOR at GBT. Essential Duties and Responsibilities: Assist in the design, development, and execution of health economic and outcomes research tactics to support lifecycle management of Voxelotor and demonstrate value to key stakeholders Help to manage the integration of economic and patient-centric outcomes into development programs Execute prospective and retrospective studies including database analyses, comparative effectiveness, meta-analyses/systematic reviews, and...
Global Blood Therapeutics San Francisco, CA, USA
Jul 07, 2020
Full time
SENIOR DIRECTOR, REGULATORY AFFAIRS CMC Position Summary: The Senior Director Regulatory Affairs CMC will report to the Vice President Regulatory Affairs and will lead the Regulatory Affairs CMC group within the Regulatory Affairs function. This includes strategic and operational oversight of all US and ROW Regulatory Affairs CMC activities, as well as management of the personnel and contractors in the Regulatory Affairs CMC group. The candidate will serve as an internal subject matter expert with respect to the interpretation of relevant drug development regulations and guidance and provide strategic input for the Company's global regulatory strategies for the life cycle management of OxbrytaTM and the development of pipeline products. This person will contribute to all FDA and other health authority interactions for the Company's marketed and pipeline products while ensuring the highest integrity in regulatory and quality compliance. Essential Duties and Responsibilities:...
Global Blood Therapeutics Richmond, VA, USA
Jul 07, 2020
Full time
SICKLE CELL THERAPEUTIC SPECIALIST (SCTS) - RICHMOND, VA Position Summary: The SCTS responsibilities include developing a comprehensive strategic business plan that includes specific, measurable and action-oriented objectives to ensure they achieve/exceed their sales goals. They must demonstrate the ability to target and strategically manage their territory. The SCTS will manage funds and resources efficiently and ethically to maximize sales to ensure ROI. The Sickle Cell Therapeutic Specialist will report directly to the Regional Business Director. This role provides the opportunity to be part of a first in class sales team with responsibility for launching an exciting product that will positively impact and change the course of Sickle Cell treatment. This is a great opportunity to come in on the ground floor and be part of the launch team in a growing entrepreneurial-minded team-oriented environment, where sales performance and territory ownership are paramount. GBT offers...
Global Blood Therapeutics San Francisco, CA, USA
Jul 07, 2020
Full time
SENIOR RESEARCH ASSOCIATE - DRUG METABOLISM AND PHARMACOKINETICS Position Summary The Drug Metabolism and Pharmacokinetics Department at Global Blood Therapeutics is searching for a Senior Research Associate. Global Blood Therapeutics. A successful candidate for Senior Research Associate will have extensive experience in in vitro ADME assays and in vivo bioanalysis supporting PK, PK/PD and Toxicology studies. The Senior Research Associate will be responsible for the characterization of absorption, distribution, metabolism, excretion and pharmacokinetic properties of small molecule drug candidates from early discovery through clinical stage development. Essential Duties and Responsibilities Perform DMPK assays including bioanalysis, in vitro ADME, and PK analysis Support discovery formulation identification and preparation Generate and upload assay data, communicate results/reports to multi-disciplinary project teams influencing compound progression in discovery and...
Global Blood Therapeutics San Francisco, CA, USA
Jul 07, 2020
Full time
DIRECTOR OF CLINICAL OPERATIONS Position Summary: The Director of Clinical Operations is a leadership position within Global Blood Therapeutics' Clinical team. In close collaboration with the Development Operations leadership team and others, the Director of Clinical Operations will influence the clinical operations strategy and execution for one of GBT's small molecule clinical programs. Essential Duties and Responsibilities: The Director is responsible for the operational management, including documentation and reporting requirements of a clinical development program The Director will work closely with the Head of Clinical Operations, the VP of Development Operations, CMO, and other key functions both internally and externally to ensure successful completion of all clinical activities/project deliverables within the required time frame and budget Accountable for the work product for the program and contributes to the planning and implementation of clinical...
Global Blood Therapeutics San Francisco, CA, USA
Jul 07, 2020
Full time
ASSOCIATE DIRECTOR, REGULATORY AFFAIRS Position Summary: Reporting to Senior Director, Regulatory Affairs, the Associate Director will support day-to-day regulatory activities of assigned projects. These include providing strategic input on global regulatory strategies for pipeline products and/or life cycle management of marketed products, leading preparation and compilation of regulatory submissions, managing regulatory submission processes and timelines, and collaborating with Regulatory Operations to ensure timely submissions. The candidate may serve as the primary contact with the FDA and other health authorities, and may manage the activities of other Regulatory Affairs staff, consultants and/or contractors in the performance of the duties outlined below. Essential Duties and Responsibilities: Provide strategic guidance to multidisciplinary teams on the regulatory requirements to support all stages of clinical development of small molecules and/or biologics,...
Global Blood Therapeutics San Francisco, CA, USA
Jul 06, 2020
Full time
MANAGER, SALES OPERATIONS Position Summary: This Individual is responsible for leading the operations of GBT's foundational commercial data eco system and related sales operations processes. This individual will report directly to the Sales Strategy and Operations Lead. Essential Duties and Responsibilities: Sales Operations: Lead quarterly operations cycles as it relates to targeting, alignments, customer universe updates. Manage ongoing Reporting Operations for field teams - sales, payer etc. Work with IT team to execute on Veeva Updates with a robust understanding of impact to downstream systems and processes. Responsibility also includes ensuring day-to-day field operations support from HQ Lead setup of communication protocols with the field teams. Incentive Compensation Operations: End to end incentive compensation operations including administration of the approved plan, reporting, communication, awards/contests, data integrity/accuracy and IC...
Global Blood Therapeutics San Francisco, CA, USA
Jul 06, 2020
Full time
ASSOCIATE DIRECTOR, ACCOUNTING OPERATIONS The Associate Director, Accounting Operations will manage a set of accounting activities to ensure compliance with generally accepted accounting principles, corporate policies and external financial and Sarbanes Oxley audits. This person will manage the accounts payable function, payroll function, monthly closing of accounts and preparation of reports in support of the financial statements. The Associate Director, Accounting Operations will report to and work closely with the Corporate Controller and others in the organization in analysis and reconciliation of accounts and in development and implementation of accounting policies, procedures and controls. The ideal candidate possesses leadership capabilities, solid operational and technical accounting background and works proactively to drive results. This person is a self-starter, flexible, has a high level of integrity, and is action and goal-oriented in a fast-paced, team-oriented,...
Global Blood Therapeutics San Francisco, CA, USA
Jul 06, 2020
Full time
SENIOR SCIENTIST - DRUG METABOLISM AND PHARMACOKINETICS Position Summary: As a senior scientist, a successful candidate will serve as DMPK project representative on cross-functional discovery and development project teams to drive target product profile milestone transitions from lead identification to regulatory submissions. The position will be responsible to characterize the absorption, distribution, metabolism, excretion and PK-PD-efficacy (exposure-effect) relationship of drug candidates spanning from early discovery to clinical stage development. Essential Duties and Responsibilities: Serve as a DMPK project representative, design and execute DMPK strategies to support product advancement Draft study protocols and coordinate execution of DMPK studies with multiple functional areas and CROs, work closely with project teams, line management and CROs to ensure high quality and timely delivery of results and reports Perform DMPK data analysis and generate study...
Global Blood Therapeutics San Francisco, CA, USA
Jul 06, 2020
Full time
EXECUTIVE DIRECTOR, MEDICAL EVIDENCE Position Summary: The Executive Director (ED), Medical Evidence will lead development and implementation of research strategies to provide supplementary evidence and long-term follow-up for GBT products and therapeutic areas of interest. The ED will assess evidence gaps and develop a roadmap to support the Medical Affairs and Value Evidence strategy, with a focus on the design and execution of Phase 3b/4 studies, Externally Sponsored Research Collaborations, Expanded Access Programs, and Product Registries. As a member of the Medical Leadership team and in partnership with Clinical Development and the Brand Team, the ED will develop and implement strategic evidence generation plans to support the medical objectives and meet the needs of key internal and external stakeholders. The ED, Medical Evidence will report directly to the Head of Medical Affairs. Essential Duties and Responsibilities: Work closely with cross-functional...
Global Blood Therapeutics San Francisco, CA, USA
Jul 05, 2020
Full time
VICE PRESIDENT, CLINICAL DEVELOPMENT Position Summary: This position will be responsible for leading the clinical development and clinical pharmacology groups and will be accountable for the clinical elements of development strategies and plans for development stage and marketed products from First in Human through lifecycle management. The position requires building, developing and mentoring a team that will provide hands-on clinical leadership of cross-functional clinical and/or project teams. The leader will partner with Research on early pipeline strategies and will work closely with Business Development to assess potential in-licensing product candidates. Individual in this role will manage a team of physicians and scientists at various levels responsible for clinical and clinical pharmacology studies and may include management of additional staff and functions closely allied to clinical science. This position will provide strategic guidance to the teams during the...
Global Blood Therapeutics San Francisco, CA, USA
Jul 05, 2020
Full time
ACCOUNTING MANAGER Position Summary: The Accounting Manager is an integral part of a growing accounting team and needs have strong operational experience with full-cycle accounts payable and month-end close process. The position requires the individual to have the ability to effectively multi-task, prioritize work, demonstrate accountability, and meet established deadlines. The ideal candidate will have strong operational experience who enjoys a fast-paced, commercial environment, while managing a staff of 2. A successful candidate is someone who is articulate, professional, and understands the ins and outs of wearing multiple hats at a growing organization. Essential Duties and Responsibilities: Review AP vouchers and payments for accuracy and completeness Prepares monthly, quarterly and year-end reconciliation and reporting in AP area Analyzes and reviews general ledger accounts in preparation for month end close Prepare and record journal entries in accordance...
Global Blood Therapeutics San Francisco, CA, USA
Jul 03, 2020
Full time
CONTRACT - MEDICAL AFFAIRS, STRATEGY AND OPERATIONS Job Summary: This role is a key member of the Medical Affairs teams reporting to the Sr. Director of Strategy and Operations, Medical Affairs. The individual will be accountable for providing operational support to the Medical team to ensure project milestones and deliverables are met, and that program activities are well executed and managed. Essential Duties and Responsibilities: Project Planning Creates and maintains project plans utilizing planning tools Proactively identifies potential issues and risks to meeting project goals, and works with the team to develop mitigation strategies and ensures proper escalation as needed Tracks and reports department deliverables (KPIs, metrics, goals) Research key elements of department deliverables and evaluate if the projected timelines are impacted Plan and coordinate system evaluation, implementation and/or upgrade deliverables. Meeting Management: Partners...
Global Blood Therapeutics San Francisco, CA, USA
Jul 03, 2020
Full time
CONTRACT - SENIOR RESEARCH ASSOCIATE - IN VITRO (BIOLOGY) Company Overview: Global Blood Therapeutics, Inc. (GBT) is a biopharmaceutical company dedicated to discovering, developing and commercializing novel therapeutics to treat grievous blood-based disorders with significant unmet need. GBT is developed its lead product Oxybryta for the treatment of sickle cell disease. Position Summary: The Biology Department at Global Blood Therapeutics is looking for a qualified research associate with extensive experience performing HPLC, especially protein HPLC. Experience with clinical chromatography instruments (such as Bio-Rad variant II) is a plus. The candidate should be highly experienced with HPLC, or LC-MS operation, troubleshooting, and method development. Essential Duties and Responsibilities: Perform chromatography of human and murine proteins and blood samples Develop/optimize chromatography conditions to allow for reliable quantitation of Hemoglobin variants...
Global Blood Therapeutics San Francisco, CA, USA
Jul 03, 2020
Full time
CONTRACT - SENIOR CLINICAL TRIAL MANAGER Job Summary: The Contract - Senior Clinical Trial Manager (CTM) is a critical position within Global Blood Therapeutics' clinical team. In close collaboration with the Clinical Operations & Regulatory Affairs leadership, the Senior CTM will be responsible for the operational management of GBT's clinical trials. The Senior CTM will partner with GBT's Medical Monitor and other internal and external constituents to ensure clinical trial activities and deliverables are completed on-time and within budget. Essential Duties and Responsibilities: Manage and lead the day-to-day operations of assigned studies to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements Manage and lead cross-functional study teams, including vendors; liaise with other functional areas (preclinical development, pharmaceutical sciences, safety, regulatory...
Global Blood Therapeutics San Francisco, CA, USA
Jul 03, 2020
Full time
CONTRACT - CLINICAL TRIAL ASSISTANT Job Summary: The Contrat - Clinical Trial Assistant (CTA) is responsible for providing support to the lead Clinical Trial Manager and the study management team, clinical tracking and document maintenance as applicable to study vendors and clinical trial sites. The CTA will work closely with a cross-functional team to ensure that clinical trials are conducted in a timely fashion and in compliance with GBT SOPs, ICH/GCP/regulatory guidelines, company goals, and budgets. The CTA must work well under pressure and can meet multiple and sometimes competing deadlines. The CTA must demonstrate cooperative and professional behavior with colleagues and vendors. The CTA should be able to show flexibility with changing project-specific priorities. Essential Duties and Responsibilities: Performs general administrative functions such as clinical trial tracking, providing logistical support to one or more study management teams (SMTs), scheduling...
Global Blood Therapeutics San Francisco, CA, USA
Jul 02, 2020
Full time
VICE PRESIDENT, FINANCE Position Summary: The Vice President, Finance has broad responsibility for the strategic and operational leadership of the finance function and accounting activities. The position reports to the Chief Financial Officer of the company and oversees all global accounting-related activities, including accounts payable, payroll, revenue recognition, financial planning and analysis, treasury, Sarbanes Oxley, taxes and stock administration, as well as procurement and purchasing for company operations. Essential Duties and Responsibilities: Ensuring internal and external financial reporting, SEC filings and Sarbanes-Oxley compliance as well as interfacing with the company's outside accounting firm Regularly interacting with the Audit Committee Working closely with staff and senior management to ensure appropriate processes to report and forecast key operating and financial data critical to the company's strategic decision making Directing the...