Global Blood Therapeutics

Global Blood Therapeutics San Francisco, CA, USA
Nov 18, 2019
Full time
PAYROLL ANALYST Position Summary: The Payroll Analyst is an integral part of a growing accounting team and needs have strong operational experience with full-cycle payroll processing. 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, pre-commercial environment. Essential Duties and Responsibilities: Responsible for the preparation and processing of semi-monthly payroll for the entire company Establish strong partnerships with human resources and stock administration to create efficient and scalable processes Understand payroll strategies and deliver recommendations for improving the payroll process Provide prompt, friendly, and efficient customer service to employees who have questions regarding their pay, deductions, or the payroll process Ensure SOX compliance by adhering to internal control requirements and maintaining updated documentation for payroll related processes Perform account reconciliations, month-end and quarter-end activities as it relates to payroll and compensation Ensure proper taxation of stock options (NQSO, RSU etc) as well as timely recording and remittance of tax liabilities to the IRS and state taxing agencies Process ESPP enrollment, deductions, contributions, withdrawal and reconciliation Process Fidelity 401K enrollment, deductions, contributions, withdrawal and reconciliation Records and reconciles 401K contribution and company match Maintain various accounting/payroll systems for active and inactive employees, including but not limited to ADP, Fidelity, Kronos, and NetSuite systems Perform special projects or other duties as requested Qualifications: Bachelor's Degree in Business, Accounting or Finance 5+ years of full-cycle payroll Experience working in a publicly-traded, high-growth biotech company preferred Expert knowledge of payroll and payroll tax rules and regulations in US Experience with ADP Workforce Now, Fidelity and Kronos, time allocations systems are preferred Experience with financial accounting software such as NetSuite Ability to maintain confidentiality and exercise extreme discretion A committed team player, detail oriented and an effective communicator Intermediate to advanced knowledge of Excel Excellent verbal, written, and interpersonal communication skills are required Fit with GBT culture: Ability to build strong relationships with co-workers of various backgrounds and expertise Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor Values-based leadership consistent with GBT's Core Values Excitement about the vision and mission of GBT Flexibility Integrity NOTE: This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization. Global Blood Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
Global Blood Therapeutics San Francisco, CA, USA
Nov 17, 2019
Full time
IT HELP DESK SPECIALIST Position Summary: We are seeking a Help Desk Specialist who is highly motivated to join our IT team. The Help Desk Specialist will deliver excellent support with issues related to (but are not limited to) operating system problems, network troubleshooting, new-hire equipment and application troubleshooting. Essential Duties and Responsibilities: Installing, configuring and supporting Windows computers, printers and peripherals Creation and termination of Active Directory accounts and Exchange mailboxes Troubleshooting TCP/IP and network issues Providing first tier technical support to end users, both on-site and remote End user support of corporate applications, including Microsoft Office 365, Exchange and SharePoint Providing end user training Providing audio/visual support for meetings and seminars Documenting IT assets and maintaining IT inventory Maintenance of user accounts on the phone system Supporting smartphone connectivity to Office 365 applications Ensuring that end user machines are patched appropriately Documenting new procedures as appropriate and consistently following existing procedures Qualifications: 3+ years of related IT experience Demonstrated knowledge and proficiency in troubleshooting Exceptional working knowledge of Windows desktop operating systems and Microsoft Office applications. Microsoft certification is a plus Experience with desktop imaging systems Strong written and verbal communication skills and the ability to work with multiple groups Must be a team player and have strong attention to detail Experience with spyware and malware removal Basic working knowledge of security policies and practices Must enjoy interacting with end users at all levels of the company Experience in a laboratory or biopharma environment is highly desired Fit with GBT culture: Ability to build strong relationships with co-workers of various backgrounds and expertise Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor Values-based leadership consistent with GBT's Core Values Excitement about the vision and mission of GBT Flexibility Integrity NOTE: This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization. Global Blood Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
Global Blood Therapeutics San Francisco, CA, USA
Nov 17, 2019
Full time
SENIOR ADMINISTRATIVE ASSISTANT, FIELD SALES TEAM Position Summary: Reports to VP, Sales; Provides administrative and operational support to the Field Sales team (and other field organizations) as outlined and/or needed. The ideal candidate will thrive in a service and support role and is highly detail-oriented. Essential Duties and Responsibilities: Provides encompassing administrative support to the VP Sales (and their direct reports) Proactively manages and maintains VP Sales calendar; arranges travel, travel expenses, organize meetings at their request, etc. Provides administrative and operational support to Field Sales organization Be the first point of contact for the Field Sales organization (field sales leaders and field sales professionals) Must be able to prioritize and manage multiple projects simultaneously including: Be the Field Sales organization's first point of contact for training/trouble-shooting any in-house support needs Coordinate on-boarding/off-boarding of field sales employees (work cross-functionally with HR, IT, Sales Ops, Training, etc.) to ensure employees receive (or return) their equipment and access Manages Field Team/Rep Rosters (that feed into internal systems); coordinates with internal partners to maintain Audits, processes and triage exhibit, sponsorship/display applications; communications payments back to the field organization Supports meetings/events lead and training lead as needed in the planning of field sales off-cycle meetings, regional based and training meetings Provides meetings operational/admin support to training lead as it relates to executing HQ-based training events Will eventually become point of contact for, and maintaining/processing credentialing requests Handles confidential material with discretion and professionalism Handles special projects as requested Qualifications: A minimum of 8 years of administrative experience (biotech preferred) in increasing positions of responsibility Strong knowledge of MS Office; Excel, Word, PowerPoint, Outlook Excellent verbal and written skills and attention to detail Ability to juggle multiple priorities and manage complicated calendars across multiple executives and external personnel Ability to work independently and be flexible, adjusting priorities and tasks in real time to support the objectives of the departments Successful experience in fast-paced, high growth environment Proven ability to handle confidential material with discretion and professionalism Must have excellent customer-service orientation, high degree of professionalism, and be a strong team player Fit with GBT culture: Ability to build strong relationships with co-workers of various backgrounds and expertise Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor Values-based leadership consistent with GBT's Core Values Excitement about the vision and mission of GBT Flexibility Integrity NOTE: This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization. Global Blood Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
Global Blood Therapeutics San Francisco, CA, USA
Nov 14, 2019
Full time
VICE PRESIDENT, PHARMACOVIGILANCE Position Summary: Global Blood Therapeutics is seeking a seasoned leader to oversee the overall development of the Pharmacovigilance department - Operations, Risk Management, and Compliance. The Vice President, Pharmacovigilance and Drug Safety will report directly to the Senior Vice President, Clinical Development. The successful candidate is responsible for hands-on leadership for all Pharmacovigilance activities in support of clinical development programs as well as future marketed products. Essential Duties and Responsibilities: Direct and supervise global Pharmacovigilance activities (operations, compliance, systems, and signal and risk management) for products in clinical development Provide global strategic Pharmacovigilance expertise to align with corporate clinical development and commercial goals Lead and oversee Pharmacovigilance signal detection and risk management activities for all products in clinical development and implement appropriate risk mitigation strategies to ensure patient safety Actively participate and provide strategic planning and Pharmacovigilance input to support product regulatory submissions (IND, NDA, MAA, product labeling) Participate in oversight of patient safety in clinical development clinical trials Participate and provide strategic planning, assessment and implementation of pharmacovigilance activities to support products in clinical development Lead and serve as Pharmacovigilance expert in responding to and resolving safety questions received from or requested by regulatory authorities Provide medical safety expertise in reviewing critical documents for clinical development products Lead Pharmacovigilance Committee meetings and manage communication of product risk-benefit profile to internal and external stakeholders Actively participate and serve as Pharmacovigilance representative in senior leadership committees Lead internal safety team and oversee safety vendors to ensure timely delivery of Pharmacovigilance and safety deliverables Must actively participate in daily Pharmacovigilance activities with a "can-do, hands-on, positive attitude" Qualifications: MD degree with 10+ years of global pharmacovigilance and drug safety and management experience Expert knowledge of global safety regulations - FDA, EU GVP, ICH guidelines, and other applicable global safety regulations and guidance Expert in clinical safety assessments, signal detection and risk management Experience in Pharmacovigilance inspections Experience and knowledge in NDA, MAA submissions Excellent communication skills (verbal and written) Strategic assessment and evaluation skills with strong decision-making abilities Ability to navigate fast-paced and dynamic work environment with ability to collaborate with various functions Leader with teamwork and collaborative perspective GBT values driven leader: Science dedicated to patients; Embrace open communication and debate; Trust, respect, and accountability; One team, one purpose; and always do the right thing Fit with GBT culture: Ability to build strong relationships with co-workers of various backgrounds and expertise Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor Values-based leadership consistent with GBT's Core Values Excitement about the vision and mission of GBT Flexibility Integrity NOTE: This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization. Global Blood Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
Global Blood Therapeutics San Francisco, CA, USA
Nov 08, 2019
Full time
SENIOR DIRECTOR, MEDICAL WRITING Position Summary: Reporting to the VP, Clinical Development, the Senior Director, Medical Writing will direct and provide technical and operational writing support across GBT programs and manage external and/or internal medical writing staff. The Medical Writer will be responsible for working cross-functionally with internal customers and stakeholders to develop, implement and maintain a standardized document development process for clinical and regulatory documents. This includes, but is not limited to: directing, authoring, editing and providing input to clinical documents, documents required for regulatory submissions to US and other global health authorities, presentations, posters, publications and regulatory fulfillment. He/she may also author/edit and/or direct the development of pre-clinical documents. The Medical Writer will be responsible for managing external resources in support of the Medical Writing requirements. Preference would be for someone to be on-site with flexibility to work remotely. Essential Duties and Responsibilities: Works with the clinical and regulatory teams to prepare clinical documents (including Clinical Study Reports (CSRs), protocols, protocol amendments, Briefing Documents, Investigator Brochures (IBs), safety updates, Clinical Summaries of Safety and Efficacy, Clinical Overview) and pre-clinical study protocols and reports under strict timelines Provides leadership in planning and completing key regulatory submissions to US and global health authorities (including but not limited to: New Drug Applications (NDAs), Marketing Authorization Applications (MAAs), Investigational New Drug (IND) submissions, and annual reports) Ensures key messages are clear and consistent within and across documents. Contributes strategically and scientifically at the project and/or study team level. Provides editorial or review support (or coordinates external resources) for other types of documents, such as abstracts, manuscripts, posters, and presentations for scientific meetings and journals Collaborates with cross-functional team members (e.g., PK, Toxicology, Research, Clinical Development, Regulatory Affairs, Biometrics, Quality, CMC etc.) to ensure accurate and timely completion/delivery of high-quality, scientifically-justified documents Demonstrated ability to communicate and write clearly, concisely, and effectively. Aptitude for compilation, analysis, and presentation of data Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members Ensures a consistent style of document presentation to maintain quality and ease of review, and adherence to company standards Procures and manages external medical writing resources (e.g., Contract Research Organizations (CRO), document quality reviewers, freelance medical writers, etc.) Contributes to the development and standardization of templates and related processes, including updating, revising and developing relevant SOPs and internal best practices and processes for critical document development Qualifications: Advanced degree (e.g. PhD, PharmD, MD) with 8+ years in medical writing experience in pharmaceutical industry At least 8 years of experience in a medical writing role, including participation in submissions to the US FDA (NDA, BLA) and EMA (MAA) Demonstrated experience in the preparation of protocols, study reports, investigator brochures, safety updates, and Regulatory documents, including IND and NDA submissions Demonstrated ability to incorporate pre-clinical data into clinical and regulatory documents Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects Excellent attention to detail, including fact checking, logical flow, parallelism, formatting, and document structure Well-organized: ability to prioritize tasks, to work simultaneously on multiple projects, and to complete high quality documents according to tight timelines. Demonstrated internal and external stakeholder management and project management experience Demonstrated ability to represent and advocate for Medical Writing and influence without direct authority Manages, coaches and mentors' direct reports. Assists in the day-to-day operational activities and other assignments as needed and specified by management Broad knowledge of EMA/ICH guidelines and FDA guidance beyond those pertaining to specific regulatory documents Proficiency with Microsoft Office and use of electronic document templates Experience analyzing references for scientific appropriateness and regulatory ramifications of reference selection; familiarity with PubMed and/or other reference-gathering search tools Proficiency with Adobe Acrobat, and Electronic Common Technical Document (eCTD) templates Familiarity with GCP, applicable regulatory requirements and guidance documents (e.g., 21 CFR Parts 312 and 314, EMA Clinical Trials Directives, ICH guidelines) company SOPs and internal style guides, researches, authors, and edits Travel - 20% Fit with GBT culture: Ability to build strong relationships with co-workers of various backgrounds and expertise Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor Values-based leadership consistent with GBT's Core Values Excitement about the vision and mission of GBT Flexibility Integrity NOTE: This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization. Global Blood Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
Global Blood Therapeutics San Francisco, CA, USA
Oct 31, 2019
Full time
SENIOR MEDICAL DIRECTOR, CLINICAL DEVELOPMENT Position Summary: Global Blood Therapeutics is looking for an experienced physician, leader and innovative drug developer with passion and creativity and who places the patient at the center of everything they do. The individual will be a self-starter with excellent leadership, communication (within and outside of the organization) and multi-tasking skills. They should have a strong experience with clinical study conduct, data analysis and health authority document preparation and interactions. This position will also afford the individual the opportunity for increasingly more responsibility and leadership roles encompassing strategic planning, broad portfolio product development and personnel management within the Clinical Development team. Essential Duties and Responsibilities: Clinical Lead for Sickle Cell Disease (SCD) Program clinical studies including adult and pediatric programs Clinical point of contact for all study related matters including data gathering, analysis and interpretation, safety assessments, regulatory documentation and publications Clinical lead for development and execution of Clinical Development (CD) plans for the SCD program and including contributing to scientific, clinical and publication planning. Clinical lead in communications to senior management and governance committees on study progress and strategic updates Perform responsibilities independently and exhibit proficiency at the Medical Director role Support Health Authority document writing, review and interactions Support Business Development efforts Clinical leadership of other pipeline molecules as needed Cross-Functional Team and People Management Participate in Study Execution Team (SET) Meetings and represent Clinical Science in program sub-teams Provide clinical leadership to support the training and monitoring of study sites Review and provide guidance on appropriate personnel assignments and budgets Where applicable, hiring, retaining and managing direct reports and clinical consultants Clinical Development Planning Take a leadership role in proposal development to identify effective clinical and regulatory implementation strategies Stay abreast of internal and external clinical and SCD landscape developments and update Clinical Development functions Participate in Health authority document preparation and interactions Provide clinical input into the relevant therapeutic/disease area scientific state Provide clinical input for transitioning new drugs/indications into clinical development Clinical Development Plan Implementation Provide clinical oversight of relevant studies and progress, including participation in Study Execution Team meetings, reviews of medical/safety data, CSR writing Provide clinical leadership for study site interactions, fielding medical questions and conducting Investigator Meetings Represents GBT through collaborations with internal and external partners such as investigators, clinicians, scientists and key opinion leaders Collaborate with Statistics to ensures appropriate medical/scientific data interpretation for study reporting and health authority interactions Lead, or otherwise develops and provides, clinical science input into annual and strategic lifecycle plans Qualifications: Demonstrated proficiency in the Medical Director role MD degree or MD, PhD degrees. 5+ years of drug development experience for the Medical Director and 6-7+ for a Sr. Medical Director Must be board certified in medicine; optimally in hematology and/or pediatrics Experience in writing and submission of Health Authority documents including IND and desirably NDA and pediatric investigational plans Have strong cross-functional team leadership skills Ability to work independently and in a fast paced, hands-on, growth-oriented work environment Fit with GBT culture: Ability to build strong relationships with co-workers of various backgrounds and expertise Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor Values-based leadership consistent with GBT's Core Values Excitement about the vision and mission of GBT Flexibility Integrity NOTE: This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization. Global Blood Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or any other characteristic protected by law.