Global Blood Therapeutics

DIRECTOR, HEAD OF ANALYTICAL Position Summary: The Head of Analytical will be responsible for the in-house analytical method development and stability studies, and analytical activities related to the manufacturing of drug substance and drug product for clinical use at the CMOs. Such CMO analytical activities include setting specifications, reference standard qualification, analytical change controls, release testing and stability studies. GBT places a high value on cooperative team dynamics and a positive, "can-do" work ethic. The ideal candidate thrives in a fast-paced environment where a strong sense of urgency is the norm and exceptional communication and interpersonal skills are needed. Essential Duties and Responsibilities: Provide analytical leadership to CMOs and manage their analytical activities and timelines Manage a group of GBT analytical scientists and managers and their deliverables Manage the in-house analytical development activities and technical reports Perform critical review of analytical study protocols and reports Responsible for authoring, review, and adjudication of analytical related CMC sections for US and ex-US regulatory filings Participate in the CMC strategic planning Responsible for analytical budget and expenses Qualifications: Doctoral degree in chemistry, pharmaceutical sciences, or related discipline, and minimum 10 years of experience, or MS/BS degrees with minimum 10 years of experience in the small molecule pharmaceutical industry Sensitive to timelines and solution oriented Thorough understanding of cGMPs, USP and ICH guidelines and industry best practices Good understanding of the work flow for drug substance and drug product manufacturing Familiar with the current analytical techniques for pharmaceutical development Excellent written and verbal communication skills 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.

SICKLE CELL THERAPEUTIC SPECIALIST (SCTS) - ST. LOUIS, MISSOURI AND CENTRAL ILLINOIS Position Summary: Global Blood Therapeutics is seeking an experienced sales specialist for the continued launch of Oxbryta (Voxelotor). 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 competitive base pay, incentive compensation and a comprehensive employee benefits program. Therapeutic Specialist Competencies & Behaviors Competitive Mindset: Business Acumen & Results Orientation: Evaluates and proposes business opportunities while leveraging all available resources and balances priorities to drive results. Resilience & Confidence: Is self-reliant and helps others build their resilience and self-confidence. Customer Focus: Build Trusting Relationships: Leverages current relationships and identifies underlying concerns. They are a trusted advisor that both anticipates and addresses customer needs. Clinical Acumen & Learning Agility: Continually builds and applies their own clinical and technical knowledge and is someone sought out for their product and disease state expertise. Account Success: Influence with Impact: Effectively persuades others by leveraging complex influence strategies while developing their own resilience and self-confidence. Teamwork and Coordination: Puts the success of the business ahead of personal/professional interests. Works collaboratively with leadership and teammates to support the business. Essential Duties and Responsibilities: Achieve launch excellence as defined by the Launch Scorecard Achieve annual sales goals Understand role, responsibilities, objectives and metrics for success Serve as a role model for compliant behavior that is consistent with the mission, vision and values of GBT Model high touch engagement with all external stakeholders Adhere to assigned territory operational budget Participate in implementation of national and regional sales strategies and tactics Establish and maintain effective communications internally and externally Attend and participate in all Regional and National Sales Meetings Qualifications: 5+ years' experience in the pharmaceutical industry BS/BA Required, MBA Preferred but not required Specialty experienced preferred Hematology experience or knowledge of the hematology market highly preferred Previous experience in launching new products or indications, preferably through a specialty pharmacy Proven successful track record of consistent high performance Strong leadership, planning and organization, analytics, business acumen, decision making and problem- solving skills Ability to prioritize and execute on plan Proven leadership skills with a history of holding oneself to a high level of accountability Ability to influence without authority, internally as well as externally Excellent written and oral communication skills Adherence to GBT's high ethical standards Significant travel may be required Driving is an essential duty of the job; candidates must have a valid driver's license to be considered Must live within the assigned territory and within 30 miles of the territory work center 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.

ASSOCIATE DIRECTOR, BIOLOGICS VALIDATION Position Summary: The Associate Director co-owns and oversee global Chemistry, Manufacturing and Controls (CMC) development for GBT biologic compounds for the treatment of Sickle Cell Disease (SCD). Responsibilities will mainly focus on the development and execution of a BLA enabling GMP process characterization and process validation of a monoclonal antibody. The candidate will develop strategies and manage study execution and data generation for applicable global regulatory submissions. Deliverable expectations to include: Partner with internal resources and external CMOs to drive process characterization and validation for a monoclonal antibody program Plan, Design and execute major BLA enabling projects through sound DOE, early risk assessments and thorough itemization of applicable deliverables. Have full awareness of the potential consequences (defects and failure modes) of design parameters to established robust and reproducible processes Lead technical process characterization and validation of a monoclonal antibody including risk assessments, process characterizations, variability assessments and statistical evaluation of multiple complex parameters Company steward for obtaining the highest product quality including leading technical discussions and influencing stakeholder acceptance of critical process and quality-based decisions Responsible and accountable for monitoring process performance/process history/ technical assessments and ownership of change controls and process deviations both internally and at CMO sites Essential Duties and Responsibilities: Demonstrates in-depth knowledge of current Good Manufacturing Practices (GMPs) Proficient in Stage 1, Stage 2, Stage 3 biologics validation including; PHA, CQA, CPP, KPI, DOE OFAT, PC, PV, PPQ Excellence in breadth and depth across engineering disciplines and is recognized as a subject matter expert for bio process development, characterization, and validation Strong biologics process characterization and validation, preferably with Monoclonal antibodies; Process Specific SME Significant experience and contribution to generation of relevant regulatory sections of BLA and MAA filings, data capture and management, process monitoring and trending, including control charting and statistical process control, and supporting regulatory and site inspections Extensive experience with Upstream and Downstream operations from thaw through DS. DP experience a plus. In-depth understanding of cell culture scale-up, engineering principles, and associated equipment - i.e. cell growth rates, nutrient consumption, gas transfers and velocities, titers and production rates General knowledge of the workstreams in the development of monoclonal antibodies; upstream and downstream processing preferred. Formulation, drug substance and drug product development, molecule characterization, analytical development, and stability testing Strong individual contributor. Must be able to work in a fast paced, multi-project and changing environment with ability to manage multiple competing responsibilities with a high degree of independence and self-motivation Outstanding written and verbal communication skills Strong organization and time management skills Team Player. Ability to thrive in flat organizational structure with strong cross functional communications and contributions. The team output is greater than the sum of the parts. This Lean team depends on everyone working together for the common goals Partner with Cross functional teammates from Tech Ops, Analytical, Quality Assurance, Regulatory, and Clinical Operations Qualifications: B.S./M.S./PhD. in Pharmaceutical Sciences, Chemical Engineering, Bioengineering, or related field with extensive experience in biotech or pharmaceuticals industry 10+ years of relevant experience in the pharmaceutical industry and a BS or BA 8+ years of relevant experience and a MS 7+ years of relevant experience and a PhD in a relevant scientific discipline Relevant industry experience in development of monoclonal antibodies or biologics platform modalities (5-8 years). Position level will be commensurate with education level and previous industrial experience Biologics Process Engineering, MSAT, Technical Services SME Demonstrates excellent verbal, technical writing, and interpersonal communication skills Has proven analytical and conceptual skills Demonstrates ability to effectively manage multiple projects/priorities 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.

REGIONAL BUSINESS DIRECTOR - WEST COAST Position Overview The Regional Business Director will provide leadership and strategic direction to Sickle Cell Therapeutics Specialists to achieve performance objectives. This is accomplished through effective coaching, mentoring of the team, utilization of resources and strong collaboration internally and externally. Other responsibilities include building comprehensive strategic business plans, including specific, measurable, action-oriented objectives in accordance with national and regional goals. Manage funds and resources and ensure their ethical, targeted allocation towards maximizing sales and return on investment. Create a motivating environment for the team by further ensuring clarity of purpose and aligning to GBT's vision. Execute at a high level and drive operational excellence to ensure the sales team is making impact, and in a compliant way. Lead and navigate through challenging sales environments and help the team continue to adapt to the new reality of virtual and in-person engagement. The Regional Business Director position will report directly to the Zone Director Mid Atlantic. This exciting role provides the opportunity to build, manage and mentor a best in class sales team. Preferred locations: San Francisco Bay Area, Los Angeles, San Diego, Seattle, Las Vegas, Phoenix Leadership Competencies: Lives the Values: Embraces the GBT core values and exhibits behaviors that consistently reflect our core values. Execution and Results: Leverages resources and balances priorities to drive results and achieve business outcomes. Influence: Effectively persuades others and seeks out alternative points of view. Develops Talent: Develops individuals and teams, within and outside of one's direct area of responsibility, to support individual and organizational growth. Communication: Communicates in a clear and concise manner to both internal and external stakeholders. Accountability: Holds self and others accountable for outcomes, including successes and mistakes, and the behaviors used to achieve those outcomes. Teamwork and Engagement: Works with others towards a common goal and encourages others to perform their best. Strategic Perspective: Balances both short-term and long-term outcomes by integrating data and anticipating future directions. Essential Duties and Responsibilities: Achieve annual sales goals Recruit, hire, train, and develop Sickle Cell Therapeutic Specialists (SCTS) Coach SCTSs in all aspects of job performance and ensure training and development of SCTSs in their region Establish clear roles, responsibilities, objectives and metrics for team members consistent with Region and Nation Serve as a role model for compliant behavior that is consistent with the mission, vision and values of the organization Model high touch engagement with all external stakeholders Develop and adhere to assigned region operational budget Develop, present and execute quarterly Divisional Regional business plan Provide ongoing assessment and feedback of Sickle Cell Therapeutic Specialists Participate in development and implementation of national and regional sales strategy and tactics Establish and maintain effective regional communications Responsible compensation planning including salary adjustments, merit increases, promotions, etc. Plan and execute Regional Sales Meetings Qualifications: Minimum of 7+ years' experience in the pharmaceutical industry BS/BA degree requires. MBA preferred Specialty experienced preferred Minimum of 3 years' pharmaceutical or biotech sales management experience Hematology experience or knowledge of the hematology market highly preferred Previous experience in launching new products or indications Proven successful track record of consistent high performance Strong leadership, planning and organization, analytics, business acumen, decision making and problem- solving skills Ability to prioritize and execute on plan Proven leadership skills/high level of accountability Ability to influence without authority in a matrixed environment Excellent written and oral communication skills Adherence to GBT's high ethical standards Additional commercial experience preferred Significant travel required Driving is an essential duty of the job; candidates must have a valid driver's license to be considered 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.

DIRECTOR, HEAD OF COMMERCIAL MANUFACTURING Position Summary: The Head of Commercial Manufacturing will be responsible for the commercial production of small molecule pharmaceutical materials, including drug substances and drug products. This role will lead the group to manage the CMOs' manufacturing and QC testing plans and activities. GBT places a high value on cooperative team dynamics and a positive, "can-do" work ethic. The ideal candidate thrives in a fast-paced environment where a strong sense of urgency is the norm and exceptional communication and interpersonal skills are needed. Essential Duties and Responsibilities: Provide GBT leadership to the commercial drug substance and drug product manufacturing at the contract manufacturing Organizations (CMOs) Work closely with Supply Chain and Quality on setting production schedules and resource allocations Lead the contract negotiation with CMOs. Work with Legal and Finance to optimize contract terms and to develop the budget planning Maintain healthy working relationship with CMOs to ensure consistent delivery of commercial supplies Monitor KPIs across the CMOs Maintain the GBT records to demonstrate adequate CMO oversight Partner with DS and DP process development groups to implement process improvement for commercial manufacturing Partner with Regulatory and QA to update the regulatory filings as required Qualifications: BS/BA degree in business, engineering or a related discipline with 10+ years of industry experience with progressive leadership responsibility Excellent cost analysis and planning skills Experience with commercial MSAs and contract negotiations is required Experienced with global commercial marketing, distribution requirement A team player who can fit into different team dynamics internally and externally Strong verbally and written communication skills Working knowledge of Good Manufacturing Practices (GMP) and regulatory requirements on the commercial pharmaceuticals 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.

REGIONAL BUSINESS DIRECTOR - MID ATLANTIC Position Overview The Regional Business Director will provide leadership and strategic direction to Sickle Cell Therapeutics Specialists to achieve performance objectives. This is accomplished through effective coaching, mentoring of the team, utilization of resources and strong collaboration internally and externally. Other responsibilities include building comprehensive strategic business plans, including specific, measurable, action-oriented objectives in accordance with national and regional goals. Manage funds and resources and ensure their ethical, targeted allocation towards maximizing sales and return on investment. Create a motivating environment for the team by further ensuring clarity of purpose and aligning to GBT's vision. Execute at a high level and drive operational excellence to ensure the sales team is making impact, and in a compliant way. Lead and navigate through challenging sales environments and help the team continue to adapt to the new reality of virtual and in-person engagement. The Regional Business Director position will report directly to the Zone Director Mid Atlantic. This exciting role provides the opportunity to build, manage and mentor a best in class sales team. Preferred locations: Raleigh/Durham/Charlotte, NC, Richmond, VA, Leadership Competencies: Lives the Values: Embraces the GBT core values and exhibits behaviors that consistently reflect our core values. Execution and Results: Leverages resources and balances priorities to drive results and achieve business outcomes. Influence: Effectively persuades others and seeks out alternative points of view. Develops Talent: Develops individuals and teams, within and outside of one's direct area of responsibility, to support individual and organizational growth. Communication: Communicates in a clear and concise manner to both internal and external stakeholders. Accountability: Holds self and others accountable for outcomes, including successes and mistakes, and the behaviors used to achieve those outcomes. Teamwork and Engagement: Works with others towards a common goal and encourages others to perform their best. Strategic Perspective: Balances both short-term and long-term outcomes by integrating data and anticipating future directions. Essential Duties and Responsibilities: Achieve annual sales goals Recruit, hire, train, and develop Sickle Cell Therapeutic Specialists (SCTS) Coach SCTSs in all aspects of job performance and ensure training and development of SCTSs in their region Establish clear roles, responsibilities, objectives and metrics for team members consistent with Region and Nation Serve as a role model for compliant behavior that is consistent with the mission, vision and values of the organization Model high touch engagement with all external stakeholders Develop and adhere to assigned region operational budget Develop, present and execute quarterly Divisional Regional business plan Provide ongoing assessment and feedback of Sickle Cell Therapeutic Specialists Participate in development and implementation of national and regional sales strategy and tactics Establish and maintain effective regional communications Responsible compensation planning including salary adjustments, merit increases, promotions, etc. Plan and execute Regional Sales Meetings Qualifications: Minimum of 7+ years' experience in the pharmaceutical industry BS/BA degree requires. MBA preferred Specialty experienced preferred Minimum of 3 years' pharmaceutical or biotech sales management experience Hematology experience or knowledge of the hematology market highly preferred Previous experience in launching new products or indications Proven successful track record of consistent high performance Strong leadership, planning and organization, analytics, business acumen, decision making and problem- solving skills Ability to prioritize and execute on plan Proven leadership skills/high level of accountability Ability to influence without authority in a matrixed environment Excellent written and oral communication skills Adherence to GBT's high ethical standards Additional commercial experience preferred Significant travel required Driving is an essential duty of the job; candidates must have a valid driver's license to be considered 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.

CONTRACT - BIOLOGICS CMC QUALITY CONSULTANT Position Summary: The CMC/Quality specialist will support the GBT biologics Drug Substance and Drug Product GMP production to supply clinical trials. The candidate will be responsible for timely initiating, maintaining and driving to closure all CMC related GMP documentations as required by GBT SOPs and regulatory guidance. The candidate will also be responsible to review and verify process and CMC analytical data from CMOs for critical GMP/regulatory documents. The candidate will also provide support to organize and archive the completed internal and external CMC documents. The candidate may perform other duties to support GBT biologics CMC development and manufacturing as appropriate. Essential Duties and Responsibilities: Initiates Drug Substance and Drug Production GMP production related Deviation Records per GBT SOPs and drive the assessment process with GBT internal state holders to ensure the appropriate on-time closure Initiates Drug Substance and Drug Production GMP production related Change Control per GBT SOP and drive the assessment process with GBT internal state holders to ensure the appropriate on-time closure Reviews the Master/Executed Batch Record for Drug Substance and Drug Production GMP production at various Contract Manufacturing Organizations and provides review summary to CMC management Reviews and verifies process data from Contract Manufacturing Organizations for critical documents such as regulatory IND/BLA filings Coordinates, maintains and archives all GMP CMC documents at a designated central location Performs other job duties as assigned Qualifications: A degree in Biochemistry, Biotechnology, Chemical Engineering or related discipline to biotech industry. Minimum working experience requirement: PhD with 2 years, MS with 5 years, BS with 7 years Experience with biologics drug substance and drug production unit operations including bioreactor, chromatography purification, formulation, fill & finish, etc. Must has a working knowledge in biologics drug substance or drug product GMP manufacturing with constant interactions with Quality Control/Quality Assurance Solid knowledge in regulatory requirements for GMP compliance in biologics manufacturing Experience with Veeva Electronic Document Management System is a plus Skillful in Microsoft office applications, including Word, Excel, and PowerPoint Strong technical writing and verbal communication skills Highly goal-driven and strong ability to focus on time-sensitive objectives and meet deadlines Must be able to work independently with minimal supervision

CONTRACT - GLOBAL LOGISTICS, TRADE AND SUPPLY MANAGEMENT SME Position Summary: This position will manage the process leading to the development of the vision and strategic plan for building a global logistics operations and trade compliance function at GBT. Essential Duties and Responsibilities: Develop the Global Logistics function for GBT including detailing team member competencies, logistics processes and tools leveraging industry best practices Support implementation of Trade Compliance program for GBT, including development of required processes and procedures to ensure a continued state of compliance and mitigation of risks Support in developing business continuity plans for logistics and distribution management Partner with GBT's commercial team in executing global distribution strategies, including cold chain management, shipping lane definition, transport qualification and other related areas impacting logistics and distribution activities Assess and implement required logistics processes and procedures for an effective end to end supply chain Develop relevant Key Performance Indicators for logistics and distribution processes Provide guidance on distribution strategies and requirements by partnering with internal resources and external contract manufacturers, third party logistic providers (3PL's) Review logistics partners contracts and criteria for vendor selection and continued oversight. Identify continuous improvement opportunities Collaborate with Supply Chain leadership to manage logistics and distribution costs and budget. Identify best practices and opportunities to ensure cost effectiveness Recommend processes and methodologies to ensure end to end supply chain continuity Support on-going projects addressing inventory management, jurisdictional control, planning and forecasting Qualifications: BS/BA or MBA degree Typically requires 15+ years of experience in clinical or commercial supply chain management, including logistics management Vendor management experience, specifically with Logistics and Distribution vendors Working knowledge of cGXP's, familiar with US, EU regulations applicable to investigational drugs and drug development process, commercial pharmaceutical and biologics distribution Good organizational and communication skills, effective project and time management skills, and able to meet tight timelines. Excellent interpersonal skills Clinical and/or commercial supply chain, planning or materials management, inventory management, and business process facilitation Demonstrated capabilities to identify and implement supply chain strategies related to logistics, distribution, product security ensuring compliance with applicable regulations

STOCK PLAN ADMINISTRATOR Position Summary: The Stock Plan Administrator will be an integral part of a growing accounting team and needs, as we continue to grow our organization. The successful candidate will be responsible for hands-on, end-to-end administration of GBT's equity plans (including but not limited to options, RSUs and ESPP). The successful candidate will maintain equity plan records, including new grants, equity transactions, grant cancellations/expirations, and our ESPP, process equity transactions and communicate transaction details to the U.S. and international accounting and payroll teams. The ideal candidate will have at least five years of public company experience and be exceptionally organized, responsible, detail-oriented and resourceful. Essential Duties and Responsibilities: Administer GBT's equity plans for all employees in the U.S. and globally Partner closely with GBT's stock transfer agent, stock administration service providers, internal accounting, legal, payroll, HR and other teams, as necessary Provide a superior level of customer service to employees, management and others Process and manage all stock transactions for the global workforce and tax payments associated with each transaction Manage and track new issuances, shares outstanding, and shares available under GBT's stock plans Review equity grants to ensure they are granted in accordance with Equity Plan documents Support employee understanding of equity awards and company programs and policies and provide live and recorded presentations to new and existing employees Maintain GBT's equity data using E*TRADE's Equity Edge Online (EEO) platform Prepare reports and reconciliations to assist in the review of equity and transaction data, and to support compensation reviews and grant planning Support international locations to identify and resolve issues regarding tax, legal, payroll withholding, and other items related to equity and equity reporting Process leave of absence vesting suspensions Ensure compliance with Sarbanes-Oxley Section 404 key controls Maintain supporting documents for internal and external SoX auditors and respond accurately, thoroughly and timely to requests for data Assist with Form 3, 4 and 5 for Board of Directors and Section 16 officer Assist with preparation of stock-related sections of Form 10-Qs, 10-Ks and proxy statements Assist with review of newly proposed 10b5-1 trading plans Perform other duties and ad hoc requests as assigned Qualifications: Bachelor's degree required, CEP Level III preferred 6+ years of relevant experience in administration of global equity plans Strong working knowledge of equity plans and various equity award types Demonstrated experience working directly with E*TRADE Demonstrated analytical abilities and Excel skills Strong attention to detail and a customer-focused approach Ability to function in a fast-paced, highly confidential environment Strong verbal, written and interpersonal communication skills with an ability to communicate effectively Payroll experience is a plus 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.

SENIOR MANAGER, REGULATORY AFFAIRS CMC Position Summary: The Senior Manager, Regulatory Affairs CMC will provide regulatory guidance on global Chemistry, Manufacturing and Controls (CMC) regulatory activities for Global Blood Therapeutics (GBT) compounds (small molecule) for the treatment of sickle cell disease (SCD) and other disorders. Responsibility will focus mainly on CMC regulatory filings, and providing strategic as well as operational management of the project teams in this area. In addition, responsibilities may include support to on-going clinical activities. The candidate will develop regulatory strategies and manage US and ex-US clinical applications and marketing applications, FDA and other regulatory interactions (responses to requests for information), for the product candidates. This will be an individual contributor and will report to Sr. Director, RA CMC. Essential Duties and Responsibilities: Manage internal review / approval process for CMC related submissions and regulatory questions; manage internal stakeholder meetings, adjudications meetings, and maintain internal trackers and databases, as appropriate Provide interpretation of regulatory authorities' feedback, policies and guidelines to GBT personnel. Support GBT during regulatory authority inspections on designated programs Develop regulatory strategic plans in conjunction with project teams and assist in the preparation of CMC submissions required for regulatory approval Work with project teams to resolve complex project issues. Utilize regulatory expertise and knowledge of regulatory requirements and regulations to strategically interpret, plan, and communicate requirements to ensure regulatory agency approvals are obtained Responsible for supporting the filing of IND/CTA/NDA/MAA submissions. Support strategy developed for submissions of product registration documents to health authorities worldwide. Interact with other functions and external vendors, as necessary, in the preparation, review, and completion of documents for regulatory submissions Support the planning and preparation of formal meetings with regulatory agencies. Assure compliance with project team timelines and milestones Contribute to the preparation of regulatory impact assessments for change control management and deviation reports Accrue regulatory intelligence on the regions of interest for GBT products and educate the department of RA at large on the evolution of the regulatory landscape Qualifications: Bachelor degree in a Chemistry, Life Sciences or equivalent, advanced degree preferred. 6-9+years of relevant experience (at least 3 years of Regulator Affairs CMC experience) and has earned a BS or equivalent degree Experience providing guidance to team members Experience in eCTD format and structure Balance strategic thinking and strong analytical skills with ability to execute. Detail oriented with strong written, verbal communication and presentation skills Strong project management skills. Experience with international and particularly EU regulatory submissions and an understanding of worldwide small molecule guidelines and regulations a plus Demonstrated excellence in regulatory liaison/strategy Strategic thinking, leadership skills, assertiveness, strong technical background, and excellent negotiation and project management skills as evidenced by past performance on drug development project teams Can prioritize deadlines, projects, and adapt to quickly changing environment Can maintain excellent relationships with peers, despite workoad pressure and tight timelines 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 Excitement about the vision and mission of GBT Integrity Values-based leadership Flexibility 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 race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.