Vertex Pharmaceuticals

Vertex Pharmaceuticals Boston, MA, USA
Jan 17, 2020
Full time
Vertex currently operates at the forefront of rare disease scientific innovation and has successfully developed and commercialized multiple breakthrough medicines for Cystic Fibrosis (CF). In addition to clinical development programs in CF, Vertex has more than a dozen ongoing research programs focused on the underlying mechanisms of other serious diseases including programs in pain, hemoglobinopathies, focal segmental glomerulosclerosis (FSGS) and Alpha-1 Antitrypsin Deficiency (AAT), among others. In consideration of our expanding pipeline and an increasingly complex and challenging Global market access environment, Vertex is expanding its Global Pricing & Market Access (GPMA) team. Our focus is to extend our expertise in this functional area in order to deliver impactful market access strategies and contextualize the rapidly evolving healthcare landscape for the pricing and reimbursement of Vertex therapies. We are driven by a desire to deliver groundbreaking pricing & reimbursement solutions to allow our medicines to reach patients faster than ever before. The Senior Director, GPMA role will join the Non-CF Pipeline team within GPMA and serve as Market Access Lead for our Hemoglobinopathy gene therapy programs. These programs are part of our collaboration with CRISPR Therapeutics for the treatment of hemoglobinopathies, including β-thalassemia and sickle cell disease. In this capacity, the individual will be responsible for leading the development of Global Market Access strategies, as well as co-lead for the Global Commercial Team. This role will also support initiatives within the Non-CF Pipeline team as needed including business development initiatives. This position reports to the Senior Director, Non-CF Pipeline, within GPMA, and is a member of the Global Market Access & Value (GMAV) organization. Key Responsibilities: * Responsible for Global payer strategic planning to support value and access optimization for gene therapies in development for Hemoglobinopathies * Lead development of Market Access strategies and core Global P&R deliverables operating within the cross-functional, cross-regional commercialization process * Ensure the payer position is consistently represented to internal stakeholders and ensure robust strategic input into commercialization and development decisions * Support strategies with deep functional knowledge, in-depth market research, environmental data & analogs * Inform financial forecasts * Partner with HEOR and Global Marketing to ensure robust value proposition and integrated evidence plans are optimized to support global market access and reimbursement * Co-lead Global Commercial Team (with Global Marketing) for Hemoglobinopathy programs, and work cross-functionally to develop optimal commercial and market access strategies * Develop market access strategy including robust payer landscape, initial pricing assumptions * Partner with HEOR and Global Marketing to ensure the development of a robust value proposition and supporting value story * Lead capability building and thought leadership projects that advance knowledge of and readiness for the rapidly evolving Global payer environment. * The individual in this role is expected to be the internal thought leader on payer-related aspects of the funding, pricing, and access for gene therapies * Support payer pricing & access assumptions for business development and emerging pipeline opportunities * Collaborate closely with HEOR, International P&R, Corporate Affairs, US Managed Markets, Countries, Marketing and Clinical Development counterparts to ensure value and access optimization Qualifications: * 7+ years of direct biotechnology / pharmaceutical industry experience and/or payer experience * Experience developing Global payer strategies for one-time/curative treatments preferred (e.g., gene therapies) at a biotechnology/pharmaceutical company * Experience in comparable Global role considered a plus; deep working knowledge of both US and ex-US healthcare systems required * Demonstrated ability to think strategically and make sound pricing and market access recommendations * Strong practical, quantitative and analytical skills combined with a sound understanding of how to successfully apply pricing & reimbursement / HEOR principles to support Vertex * General experience in commercialization and drug development * Exhibits outstanding written and oral communication skills, including the ability to effectively write and deliver presentations to professionals at all levels within Vertex * Demonstrated relationship building at all levels of the organization and across geographies * Recognized as a team player with excellent interpersonal skills who is flexible and reliable * Displays sound ethics and a fit for Vertex's core values Education: * BA in field of study requiring quantitative analysis; advanced degree preferred
Vertex Pharmaceuticals Boston, MA, USA
Jan 17, 2020
Full time
Senior Manager, Project Management The Senior Manager, Project Management is a global Portfolio Operations & Effectiveness (PO&E) role within the Program and Portfolio Management (PPM) organization. PPM PO&E is responsible for delivering projects that mature or improve cross-functional drug development processes at Vertex. PO&E's scope includes cross-functional project and portfolio management, technology and automation, and team effectiveness capabilities across the drug development lifecycle (Research through Commercialization). The Senior Manager will be integral to the identification, definition and implementation of PO&E projects and programs. KEY RESPONSIBILITIES This role is a key position within PPM and is responsible for: * Successfully partnering with diverse functional areas to understand cross-functional inputs and interdependencies for drug development including, but not limited to, Research, Preclinical, CMC, Global Clinical Development, Regulatory/Safety, Medical Affairs, Real World Evidence, Commercial, Pharm Ops, Finance, Corporate Development and Global Information Systems, as well as throughout Research, Clinical Development, and Commercial. * Facilitation of cross-functional teams to map current state processes, identify opportunities and define solutions. * Effective change management for buy-in and integration of processes, deliverables, technologies and roles/responsibilities into existing teams and infrastructure. * Strong presentation skills in communication and delivering messaging within the organization. * Understanding reporting and portfolio management best practices. * Project management excellence that includes appropriate scoping, reporting, risk management and issue escalation. * Performance management, metrics design and measurement, success criteria and outcomes realization. MINIMUM QUALIFICATIONS * Doctorate degree & 3 years of Project Management experience OR * Master's degree & 5 years of Project Management experience OR * Bachelor's degree & 7 years of Project Management experience AND significant experience with project management tools and technology in the healthcare industry. PREFERRED QUALIFICATIONS * MBA or equivalent * 8+ years of experience in Life Sciences or healthcare industry * 5+ years experience in management consulting, business transformation and/or change management * 5+ years of matrix project management experience within a project management office (PMO) or equivalent * 5+ years of portfolio management experience or comparable experience as a contributor to portfolio management (i.e. finance, sales forecasting, etc.) * Knowledge of cross-functional drug development processes * Strong cross-functional collaboration skills * Strong knowledge of project management principles, practices tools, technology and methodologies. * Excellent written, presentation and communication skills
Vertex Pharmaceuticals Boston, MA, USA
Jan 17, 2020
Full time
The Administrative Assistant provides high-level administrative support in an efficient, professional manner. Responsibilities include establishing work flow priority based on an assessment of tasks and consideration of interdepartmental needs. The work is generally non-routine in nature and is performed using individual discretion under minimal supervision. The Administrative Assistant interacts with both internal and external contacts to coordinate the accomplishments of departmental business needs. Key Responsibilities: * Departmental expert for Vertex's internal technologies such as iProcurement, SharePoint, Concur, and Vlearn * Contact for department projects: PON, LaunchPad and manages project pipeline * Training Coordinator for Biometrics (maintains and builds department CURs) * Manages meetings, internal and off-site, including meeting set up and reschedules, catering orders, the day-of support * Ensures timely processing of group purchase orders, invoices, and contracts * Plans, schedules, and coordinates departmental off-site meetings and events * Provides support to the team with various projects, including compilation and formatting of documents and meeting materials, which will require ability to balance multiple projects at a time * Takes initiative to continuously improve processes and approaches for ongoing effectiveness of the department and company as a whole (self-starter) * Performs other administrative duties related to the group management, including conference registrations, managing technical and facilities for related issues, ordering office supplies, and other tasks, as needed * Assists with travel arrangements and expense reports for VP's of Biometrics and Biostatistics * Identify and coordinate space planning needs for Biometrics Department * Running and documentation of Department Meetings Minimum Qualifications: * Bachelors degree * 3 years of administrative experience; * MS Office Suite experience
Vertex Pharmaceuticals Boston, MA, USA
Jan 17, 2020
Full time
Key Responsibilities: * Provide logistical planning and administrative support including: calendar management, travel, expense reporting, catering, and document production * Setup conference calls and web casts for meetings with domestic and international participants * Work with internal resources to prepare meeting rooms for key meetings, including video conference with international teams * Schedule/manage key team meetings such as bi-weekly GPMA team meetings, monthly Global/International alignment meetings, bi-weekly direct report meetings; coordinate and prepare agendas as required * Handle all expenses for designated leadership in a timely fashion and per company policy/guidelines * Work with cross-functional internal and external Administrative Assistants to facilitate executive meetings and travel * Submit purchase orders, amendments and changes on behalf of the GPMA team, working with Contracts and iProcurement; support quarterly budget tracking for GPMA team * Provide project support for GPMA team * Partner with Market Access Leads to develop and maintain brand-level trackers for Global Market Access Working Teams (GMATs) * Coordinate and develop agendas and develop/circulate minutes for TC, SYM and OKB/KLD GMATs * Provide ad hoc support and alignment with Global marketing project management as required * Perform various supporting tasks: mailing, filing, typing, creating/amending atting documents/presentations in Word, Excel or PowerPoint, printing, etc. * Serve as the face for designated leadership while liaising with key internal and external customers * Liaise with other offices in other Vertex sites * Work with Human Resources, Commercial departments, Meetings/Events Planning, and other Administrative Assistants to facilitate interview schedules, large team meetings, and outside vendor meetings * Interview other administrative staff to help select and onboard new administrative hire Minimum Qualifications * Bachelor's degree and 6+ years of experience in a similar role * Proven ability to prioritize effectively and successfully implement multiple projects on competing timelines * Proficient in Microsoft Office suite, Outlook Calendar Management, and Concur Expense reporting systems * Proven experience working in a fast-paced environment where multi-tasking is a part of doing business * Excellent verbal and written communication skills * Exceptional interpersonal skills, especially with senior executives, and experience across organizational functions * Able to be trusted with highly confidential and sensitive information * Team player with a track record of developing rapport and credibility with colleagues * Detail oriented with the ability to proactively identify and communicate conflicts in scheduling/priorities * Able to work independently on most aspects of projects * Ability to clearly present project status and outline processes in oral and written formats * Able to solve non-routine, complex issues in a proactive manner * Consistently displays sound ethics, good judgment and demonstrates Vertex's core values
Vertex Pharmaceuticals Boston, MA, USA
Jan 17, 2020
Full time
Vertex Pharmaceuticals Incorporated is looking to hire a Senior Executive Assistant to support the Chief Regulatory Affairs Officer (CRO) in Boston, MA. This position is responsible for performing a variety of complex administrative duties for the CRO. This individual will work on projects involving concentration, initiative, tact, and must exercise utmost discretion and confidentiality in all assignments. The Senior Executive Assistant must be a leader with proven experience in building collaborative relationships among his/her superiors, peers and subordinates. The successful candidate is a self- starter and able to understand the business priorities and work with little supervision. The candidate must have strong achievement drive, with an impeccable work ethic, able to provide full support for the CRO and enable her to maximize his productivity and time. The candidate must have experience in operating within the "C-Suite" executives. Key Responsibilities: * Meets negotiated deadlines, demonstrating initiative and independence in completing tasks. Frequently meets and anticipates needs; consistently recognizes ways to offer additional support, completing tasks to satisfaction * Encourages team cooperation and fosters the development of trust. Actively facilitates and supports team decisions. Goes beyond responsibilities to help teams accomplish tasks and goals * Manages administrative document preparation, file maintenance and storage with accuracy and in a timely manner. Utilizes expert administrative skills to create quality documentation and office systems; acts independently, with minimal supervision. Consistently produces high quality work * Demonstrates proficiency in preparing meeting materials such as Power Point presentations, meeting binders, agendas, minutes, making reservations, planning dietary needs, scheduling travel arrangements, communicating essential information to participants, etc. * Operates computer and other office equipment in preparation, editing and distribution of various administrative documents and correspondence. Exhibits high degree of computer knowledge and word processing skills to creatively, accurately and efficiently produce various documents especially Power Point * Uses good judgment in setting work priorities, planning and organizing workload in the midst of many interruptions. Demonstrates ability to work with deadlines and handles emergent situations calmly * Acts as confidential assistant, preserving the confidentiality of information related to the organization and staff. Assists with confidential and/or sensitive matters; provides explanation and support where needed * Manages and maintains calendar management, requiring interaction with both internal and external executives and assistants, as well as consultants, to coordinate a variety of complex meetings and travel. Able to manage calendars across various Vertex offices and time zones. * Prepares responses to correspondence containing routine inquiries * Positively represents the team and Company to internal and external contacts, including company executives, Board members, potential business partners, vendors and dignitaries * Communicates with internal and external customers to take instructions, obtain information and prepare reports * Demonstrates poise and flexibility in a fast paced and dynamic environment. Able to prioritize and manage multiple projects simultaneously, and follows through on issues in a timely manner * Knowledge and competence with personal computer to include multiple data bases, Excel, Power Point, and Microsoft Office Minimum Qualifications: * Bachelor's Degree required * 10+ years of work experience in an administrative role * Minimum five years of experience as a Senior-level administrative assistant in a corporate setting * Preferred Qualifications: * Ability to navigate and be successful in a fast-paced, highly-matrixed, dynamic work environment * Strong work ethic with high standards, exuding high energy and self confidence * Demonstrates good judgment and discretion on a consistent basis * A team player who is helpful and constructive, always interested in helping others succeed * Has a flawless attention for details * A desire to be part of a highly innovative company aimed at transforming the lives of people with serious diseases, their families and society * Excellent communication skills, both verbal and written * Embody the Vertex Core Values of Uncompromising Commitment to Patients, Fearless Pursuit of Excellence, Innovation is Our Lifeblood, and "We" Wins
Vertex Pharmaceuticals Boston, MA, USA
Jan 17, 2020
Full time
Vertex is seeking Senior Administrative Assistant to provide administrative support to the Vice President, New Product Planning, Global Marketing. This individual, through individual work and in concert with other stakeholders, plays an important role ensuring the effective and efficient maintenance of departmental processes, procedures, and programs inclusive of travel arrangements, calendar management, scheduling, vendor meetings, and expenses. Key Responsibilities: * Provide extensive calendar support for Vice President that will require effective prioritizing and communications with Administrative Assistants and others across the company * Manage internal and external meetings, including set up (dial-in, WebEx, etc.), catering orders, and day-of support with internal IT, if needed * Assist with travel arrangements and expense reports * Plans, schedules, and coordinates departmental off-site meetings and events * Provide broader support to the team with various projects, including compiling and formatting documents and meeting materials, which will require ability to balance multiple projects at a time * Take initiative to continuously improve processes and approaches for ongoing effectiveness of the department * Serve as the departmental expert for Vertex internal technologies such as iProcurement, SharePoint, Concur, etc. * May lead department projects * Handles details of a confidential and critical nature * Perform other administrative duties related to the group management, including conference registrations, managing technical and facilities related issues, ordering office supplies, and other tasks, as needed * Participate in monthly commercial administrative team update meetings * Work with commercial contracts team to help execute vendor contracts and process purchase orders * Communication and Interpersonal skills: * Exercises independent judgment to optimize internal processes and procedures * Demonstrates excellent communication, both verbal and written * Displays ability to independently interpret policies and solve non-routine complex issues * Possesses thorough understanding of departmental and company policies Minimum Qualifications * BA or equivalent and 3-6 years of relevant experience Preferred Qualifications: * Bachelor's degree * Extensive experience with Microsoft Office (Outlook and PowerPoint in particular) as well as other technologies such as SharePoint, WebEx, MarkView and Concur * Ability/experience working with employees at all levels in the organization and across varying functions * Experience coordinating and managing logistics meetings both small and large * Flexible, adaptable, and the able to work in a dynamic, fast-paced, environment managing multiple tasks * Eager to take initiative and be innovative
Vertex Pharmaceuticals Boston, MA, USA
Jan 17, 2020
Full time
Title: Vice President, Enterprise Architecture Position Summary: Vertex is seeking a unique talent that can play a role at the intersection of science, data and technology to enable life changing impacts to people's lives. We seek a leader who can work with our business and scientific strategists and drive an enterprise technology architecture that matches high ambitions. Vertex is a fast-moving organization which depends upon multiple technologies to compel our mission forward. Vertex is in a transformational period where we are accelerating our capabilities, technology and data to augment our scientific mission, enable Vertex to grow in scale and be a be on the forefront of science and medicine. This position provides leadership and direction to the Information Technology organization related to architecture and innovation. This includes assessing existing, new and emerging technologies, working closely with business areas in understanding business needs and ensure products and platforms are architected in a forward-thinking, scalable, rapid and innovative manner. This position requires a strong sense of urgency and be ability to plan and deliver high quality architectures and solutions in a fast-paced environment. They will define an architecture current state and a future state that aligns with business strategy, and manages gaps, risk, and technical debt. The role will stay on the leading edge of thought/technology in bringing relevant emerging technologies, vendors, best practice engineering practices and innovation to Vertex. This role will help drive the development of short, medium, and long-term plans to achieve strategic objectives. Regularly interacts across functional areas with senior executives to ensure objectives are met. The ability to influence thinking or gain acceptance of others in sensitive situations is important. The VP will require top-tier leadership skills and the ability to recruit and maintain a high-performing organization that achieves significant business impact through technology driven products. Key Responsibilities: * Drive technology strategy and influence business stakeholders on strategic product direction * Develop and maintain a current/future state architecture that achieves business goals * Ability to lead a diverse, multidisciplinary team of systems, cloud, solution and application architects * Develop a technology governance model and implement by leading architecture reviews of technology initiatives * Lead team through application rationalization * Demonstrate and ensure customer focus and align technical solutions with business strategy and objectives * Develop in-depth knowledge of strategic, tactical and operational business requirements and develop effective architectures and designs * Ability to conceptualize and develop alternative solution approaches, articulating the benefits and tradeoffs of each solution * Investigate and understand industry trends and emerging technologies, and plan for adoption where appropriate * Proven track record in consistent and timely delivery of high-quality products and services within budget * Demonstrated leadership and influence skills across organizational levels and functions * Proven track record leading highly effective teams in strategic planning, enterprise and systems architectures and design/development of * strategic business solutions * Positive thinking, can-do attitude, initiative, and ability to see the whole picture and integrate multiple points of view for the optimal overall * Present company evolution based on industry trends Qualifications: * Strong knowledge of current digital trends, disruptive forces, and modern technology concepts and expertise in cloud architectures and concepts * Minimum of 5 years senior leadership experience, preferably as a VP or comparable level responsibility in a large, global organization architecting and designing technology solutions in an innovative and realistic manner that focuses on delivery * Ability to balance high-level identification of innovation opportunities with oversight of technical development processes * Demonstrated technical and business aptitude that allows you to understand, translate, and guide discussions and decisions at a strategic enterprise level as well as at a detailed execution level * Demonstrated ability for development of global strategic plans including analysis, strategic priorities, capabilities and multi-year plans with supporting operating plans. * Ability to translate complex business strategies and needs into strategic priorities that leverage industry trends and emerging technologies while integrating existing architectures, platforms and data. * Ability to consolidate complex existing environmental descriptions into an existing Architecture for a current state architecture and the development of an ongoing future state Architecture. Proven track record re-platforming highly-complex and large scale legacy systems for global customers. * Experience in leading development of Micro services and containerized application (Docker images or Kubernetes) with expertise in distributed cache and load balancing. Experience with SOA, design patterns, web services technologies, APIs, Applications, Application Ecosystem, and Micro API's. * Experience in architecting solutions with information security built-in and that account for and incorporate relevant security governance in the ongoing lifecycle of design and engineering * Must have relevant cloud experience and assist in the transition to a "cloud-first" and cloud-platform direction for the company products * Ability to build and maintain trusted relationships with customers and stakeholders. * Must possess a unique blend of business and technical savvy; a big-picture vision, and the drive to make that vision a reality. * A hands-on leader; broadly shares responsibility and accountability of both routine and important tasks and decisions. * Holds others accountable by monitoring progress and results and giving effective feedback; able to make tough decisions when appropriate. * Professional with a high degree of integrity and honesty. Thrives in a high pressure, fast-paced environment.
Vertex Pharmaceuticals Boston, MA, USA
Jan 16, 2020
Full time
Key Responsibilities: Provide logistical planning and administrative support including: calendar management, travel, expense reporting, catering, and document production Setup conference calls and web casts for meetings with domestic and international participants Work with internal resources to prepare meeting rooms for key meetings, including video conference with international teams Schedule/manage key team meetings such as bi-weekly GPMA team meetings, monthly Global/International alignment meetings, bi-weekly direct report meetings; coordinate and prepare agendas as required Handle all expenses for designated leadership in a timely fashion and per company policy/guidelines Work with cross-functional internal and external Administrative Assistants to facilitate executive meetings and travel Submit purchase orders, amendments and changes on behalf of the GPMA team, working with Contracts and iProcurement; support quarterly budget tracking for GPMA team Provide project support for GPMA team Partner with Market Access Leads to develop and maintain brand-level trackers for Global Market Access Working Teams (GMATs) Coordinate and develop agendas and develop/circulate minutes for TC, SYM and OKB/KLD GMATs Provide ad hoc support and alignment with Global marketing project management as required Perform various supporting tasks: mailing, filing, typing, creating/amending atting documents/presentations in Word, Excel or PowerPoint, printing, etc. Serve as the face for designated leadership while liaising with key internal and external customers Liaise with other offices in other Vertex sites Work with Human Resources, Commercial departments, Meetings/Events Planning, and other Administrative Assistants to facilitate interview schedules, large team meetings, and outside vendor meetings Interview other administrative staff to help select and onboard new administrative hire Minimum Qualifications Bachelor's degree and 6+ years of experience in a similar role Proven ability to prioritize effectively and successfully implement multiple projects on competing timelines Proficient in Microsoft Office suite, Outlook Calendar Management, and Concur Expense reporting systems Proven experience working in a fast-paced environment where multi-tasking is a part of doing business Excellent verbal and written communication skills Exceptional interpersonal skills, especially with senior executives, and experience across organizational functions Able to be trusted with highly confidential and sensitive information Team player with a track record of developing rapport and credibility with colleagues Detail oriented with the ability to proactively identify and communicate conflicts in scheduling/priorities Able to work independently on most aspects of projects Ability to clearly present project status and outline processes in oral and written formats Able to solve non-routine, complex issues in a proactive manner Consistently displays sound ethics, good judgment and demonstrates Vertex's core values
Vertex Pharmaceuticals Boston, MA, USA
Jan 16, 2020
Full time
Key Responsibilities: Provide logistical planning and administrative support including: calendar management, travel, expense reporting, catering, and document production Setup conference calls and web casts for meetings with domestic and international participants Work with internal resources to prepare meeting rooms for key meetings, including video conference with international teams Schedule/manage key team meetings such as bi-weekly GPMA team meetings, monthly Global/International alignment meetings, bi-weekly direct report meetings; coordinate and prepare agendas as required Handle all expenses for designated leadership in a timely fashion and per company policy/guidelines Work with cross-functional internal and external Administrative Assistants to facilitate executive meetings and travel Submit purchase orders, amendments and changes on behalf of the GPMA team, working with Contracts and iProcurement; support quarterly budget tracking for GPMA team Provide project support for GPMA team Partner with Market Access Leads to develop and maintain brand-level trackers for Global Market Access Working Teams (GMATs) Coordinate and develop agendas and develop/circulate minutes for TC, SYM and OKB/KLD GMATs Provide ad hoc support and alignment with Global marketing project management as required Perform various supporting tasks: mailing, filing, typing, creating/amending atting documents/presentations in Word, Excel or PowerPoint, printing, etc. Serve as the face for designated leadership while liaising with key internal and external customers Liaise with other offices in other Vertex sites Work with Human Resources, Commercial departments, Meetings/Events Planning, and other Administrative Assistants to facilitate interview schedules, large team meetings, and outside vendor meetings Interview other administrative staff to help select and onboard new administrative hire Minimum Qualifications Bachelor's degree and 6+ years of experience in a similar role Proven ability to prioritize effectively and successfully implement multiple projects on competing timelines Proficient in Microsoft Office suite, Outlook Calendar Management, and Concur Expense reporting systems Proven experience working in a fast-paced environment where multi-tasking is a part of doing business Excellent verbal and written communication skills Exceptional interpersonal skills, especially with senior executives, and experience across organizational functions Able to be trusted with highly confidential and sensitive information Team player with a track record of developing rapport and credibility with colleagues Detail oriented with the ability to proactively identify and communicate conflicts in scheduling/priorities Able to work independently on most aspects of projects Ability to clearly present project status and outline processes in oral and written formats Able to solve non-routine, complex issues in a proactive manner Consistently displays sound ethics, good judgment and demonstrates Vertex's core values
Vertex Pharmaceuticals San Diego, CA, USA
Jan 16, 2020
Full time
Vertex Pharmaceuticals Incorporated is seeking an exceptional scientific leader to drive the development and incorporation of human disease models and assays into drug discovery programs. The individual will lead a department of approximately 15 staff who are responsible for the design, development and execution of in vitro and in vivo assays to support progression and optimization of human therapeutics. This includes design and execution of pharmacology assays to determine drug potency, efficacy and mechanism of action. The ideal candidate must be able to think strategically and possess leadership abilities to inspire, direct and manage scientists, and coordinate activities across multiple drug discovery programs and departments. The Sr. Director of Biology will serve as a member of the research leadership team in our San Diego site and will be expected to influence the sites direction and lead cross-site or cross-departmental projects and initiatives. In addition, the candidate must work well in a matrix organization, make clear decisions in a fast-paced drug discovery environment and be highly proficient in both verbal and written communication to audiences with diverse scientific, professional and drug discovery backgrounds. Minimum Qualifications: Ph.D. in Molecular Biology, Cell Biology, Systems Biology, Pharmacology or related field with, relevant -post-doctoral employment experience 12+ years of drug discovery experience with demonstrated excellence in early stage drug discovery and development Strong strategic scientific and technical leadership in the design, execution, analysis and interpretation of a broad range of ion channel pharmacology/electrophysiology assays to drive compound progression and elucidate mechanism of action Understanding of classical pharmacological principles and drug discovery process, in order to support assessment of potency, efficacy and contribute to predictions of human efficacy Ability to critically analyze and interpret data, and effectively document and communicate results and recommend next steps to diverse audiences Ability to propose and/or support external collaborations leading to innovative solutions Successful track record in managing functional or cross-functional research groups, including Ph.D. Scientists and Research Associates Preferred Qualifications: Experience leading groups in a pharmaceutical or biotechnology setting Assay development expertise, including biochemical and cell-based assays Evidence of development of innovative translational in vitro and/or in vivo models that predict human efficacy Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Vertex Pharmaceuticals Boston, MA, USA
Jan 16, 2020
Full time
The Associate Director/Director will be a strategic leader within Regulatory Affairs, responsible for developing and executing regulatory plans for assigned programs. As an expert within Regulatory, the Director will be relied on to articulate clear and compelling regulatory strategy, highlighting risks and opportunities when appropriate. Specifically, the Director will take accountability and ownership of all regulatory opportunities, plans, and deliverables for his or her assigned project(s). The Director may also oversee a therapeutic area with multiple projects. Key Responsibilities: Serve as overall global regulatory lead accountable for all regulatory aspects of his or her assigned project(s), including development and implementation of the global regulatory development plan for the projectRepresent Global Regulatory Affairs (GRA) on cross-functional teams, including Project Development Teams Effectively communicate the regulatory strategy, risks, mitigations and overall plans to the GRA Management Team, Project Development Team and senior management, as relevant Ensure the global regulatory strategy for assigned project(s) is consistent with the business objectives and have been negotiated with relevant health authorities as appropriate Ensure alignment of regulatory strategy and plan on a continuous basis with the GRA Management Team and key cross-functional stakeholders Provide overall regulatory functional leadership to the GRA sub-team, including participating in the skill development, coaching, and performance feedback for members of the regulatory sub-team, regardless of formal reporting relationshipMay act as Regional Regulatory Program Lead in his or her base region, including leading all regional Health Authority interactions Monitor changes in the regulatory environment with potential strategic impact, working closely with the Head of Regulatory PolicyMay be responsible for line management and development of direct reports Identify areas in need of improvement and lead the development and implementation of process improvements Manage resources for assigned project(s), including ensuring adequate regulatory resources, skills, and budgets are available to deliver the project deliverables Capable of leading significant general projects for the function, including due diligence activities Minimum Qualifications Minimum of Bachelor's degree in relevant scientific discipline, higher degree desirable A minimum 10 years Pharma experience, of which at least 10 years is in Regulatory Affairs Experience with developing and implementing competitive regulatory strategies Experience with line and matrix management Demonstrated track record in securing product approvals and maintaining a complex portfolio Experience dealing with broad range of stakeholders at all levels internal and external to the company Demonstrated competence in employee management and development Knowledge of and broad experience with regulatory procedures and legislation for drug development, product registration, line extension and license maintenance preferably from at least both US and EU Direct experience of leading regulatory authority meetings in different phases of drug development Regulatory knowledge in a number of therapeutic areas
Vertex Pharmaceuticals Boston, MA, USA
Jan 16, 2020
Full time
Lead the GRA CMC large molecule and gene therapy team, reporting to the head of Regulatory CMC Design, develop, and implement regulatory CMC strategy across all large molecule and gene therapy projects Deliver regulatory strategy objectives for GRA CMC, including operational risk management Work collaboratively across functions and teams to develop and implement regulatory CMC strategies Develop and maintain relationships with health authorities and lead the preparation of health authority interactions Develop regulatory strategies integrated with cross-functional project teams to facilitate timely submissions and approvals Provide regulatory expertise and serve as internal consultant on relevant global regulations and guidelines, current regulatory environment and regulatory precedent Assess project plans and timelines and assign and manage team effectively to ensure projects are appropriately prioritized and goals are met Evaluate current processes and communication links and assess opportunities for improvement Manage team performance and play a key role in developing career growth opportunities Recognized internally and externally as an expert in large molecule and gene therapy regulations, guidelines and precedents related to pharmaceutical development Minimum Qualifications Advanced degree in a scientific discipline 12+ years of pharmaceutical industry experience 8+ years of experience working in regulatory affairs CMC Proficiency in regulatory (FDA, EMA, Health Canada and ICH) guidelines Experience in leading CMC submission preparation and Health Authority interactions Strategic thinking and strong problem solving skills Strong interpersonal skills and the ability to communicate effectively cross-functionally Strong oral and written communication skills Sound understanding of CMC and GMP related issues. Strong sense of planning and prioritization, and the ability to work with all levels of management Proven ability to work with interdisciplinary teams and dealing with unfamiliar situations
Vertex Pharmaceuticals Boston, MA, USA
Jan 16, 2020
Full time
This role provides testing support for Release and Stability Laboratory (RSL) department supporting validation, testing and reporting of in-process, release and stability samples. Specific assigned persons are responsible to ensure activities occur in an efficient and cGMP compliant manner while fostering the Vertex vision and values. KEY RESPONSIBILITIES: Perform in-process, release, and stability testing independently following established methodology, procedures and SOPs Participate in executing method validations and/or method transfers Troubleshoot analytical methods with the assistance of supervisor when necessary Maintain accurate testing records and adhere to cGMP/GDP expectation May be required to author and review data, SOPs, analytical methods, protocols and reports Participates in compliance related teams working towards the goal of continuous improvement. EDUCATION AND EXPERIENCE: A minimum of a Bachelor Degree in science or related discipline is required. 6+ years of experience in GMP pharmaceutical/biopharmaceutical industry with at least 2 years of method validation/transfer experience. Knowledge of US and EU cGMP regulations/guidance and some experience with regulatory agency inspections. Strong knowledge of analytical methodologies such as chromatography, dissolution, and Karl Fisher and applying/interpretation of GMP requirements. Expertise with HPLC and/or GC is required. The ability to work in a fast-paced environment, manage priorities and maintain timelines for multiple projects is essential. Strong attention to detail Effective communication skills, both verbal and written.
Vertex Pharmaceuticals San Diego, CA, USA
Jan 16, 2020
Full time
We are seeking a highly motivated computational chemist to join the San Diego, California site of Vertex Pharmaceuticals. This individual will be at the interface of chemistry, protein sciences and biology and be responsible for impacting drug discovery programs using computational methods. In addition to molecular modeling and SAR data analysis, this individual will be a member of our global Computational Chemistry group with exposure to chem and tox informatics, image analysis and PBPK modeling.
Vertex Pharmaceuticals Watertown, MA, USA
Jan 16, 2020
Full time
KEY RESPONSIBILITIES Perform studies to progress our portfolio of CRISPR-based gene editing therapies. Assume project responsibilities and effectively present updates to the senior leadership team. Oversee study design and execution, data analysis and report writing. Effectively collaborate with a fully integrated team to facilitate the success of projects. REQUIREMENTS PhD or equivalent in a relevant biological discipline and 3+ years of pharmaceutical industry experience. Deep understanding of drug discovery, gene therapy, molecular pharmacology and drug development. Working experience with AAV vectors and/or CRISPR/Cas9 system. Familiarity with the preclinical regulatory requirements for gene therapy/editing programs. Excellent communication skills with the proven ability to work effectively as a member of a multidisciplinary team.
Vertex Pharmaceuticals Boston, MA, USA
Jan 16, 2020
Full time
Leveraging advanced communication and translation skills, strategic planning, and consensus building across Regulatory, Biostatistics, Global Medical Affairs, Global Clinical Development, Early Clinical Development, Translational Medicine, Health Economics and Outcomes Research, International Medical Affairs, Market Access, Patient Advocacy and Digital Sciences. The Executive Director oversees the strategic planning and execution of real world evidence conducted by RWE directors and their direct reports, across the portfolio, to ensure the timely delivery of scientifically valid epidemiology and observation research in rare diseases. Key Responsibilities First line manager for RWE disease area directors across the portfolio Assess research gaps and objectives across key partners and disease areas to determine epidemiology/observational research strategy, research objectives and tactical plans for cross disease area projects, as well as appropriate differentiation strategies Possess superb communication skills, advanced multi-stakeholder experience, comprehensive understanding of Vertex business and development goals, and a highly-evolved capability to translate RWE methodology to diverse audiences Effectively manage internal and external stakeholder expectations regarding strategic objectives and execution of research Responsible for robust study concept development and execution of incidence/prevalence, burden of Illness and natural history of disease assessment for key disease areas/initiatives Cross-functional collaboration with Global Clinical Development to provide strategic and tactical leadership for developing RWD historical control and methods Establishing innovative methods and integrating into RWE, global safety and medical affairs observational research Identify opportunities for efficient development of innovative research initiatives and application across disease areas Ability to make compliant decisions and execute on those decisions in their research agenda within RWE standard operating processes and working documents Oversee RWE study leads compliance with study conduct and tracking according to standard operating processes and working documents Proactively identify opportunities and initiate process improvements for optimal quality, cost, speed, innovation, efficiency and effectiveness Support VP & Head of RWE COE in developing and implementing operational processes for internal department as it relates to daily RWE activities Participate in multiple projects to ensure RWE capabilities are utilized, both cross-functionally and internally Serve as delegate for VP & Head of RWE COE on key teams including NiPPRC Oversee performance metrics and dashboards for RWE projects across the portfolio Assess real world data assets and establish real world data plan, including data licenses and data platforms, in collaboration with RWD Governance Committee Key Internal Stakeholders: Regulatory, Biostatistics, Global Medical Affairs, Global Clinical Development, Early Clinical Development, Translational Medicine, Health Economics and Outcomes Research, International Medical Affairs, Market Access, Patient Advocacy and Digital Sciences. Minimum Qualifications: PhD in biostatistics, epidemiology, health economics and outcomes research, health policy, or similar required Formal training in Epidemiology/Health Services Research required At least 12+ years-experience in observational research study management AND data analytics, either within industry or with an observational research consulting firm Demonstrated leadership in global role leading strategy across multiple disease areas Demonstrated development of talented observational researchers within a matrix environment Preferred Qualifications: Solid understanding of global conduct of observational research, including privacy standards Advanced knowledge in observational research design Excellent interpersonal communication and study management skills Ability to take detailed observational study results and communicate them in a clear, non-technical manner to internal cross-functional teams, using language that resonates with the teams, while maintaining the integrity of key findings Ability to work effectively in a constantly changing, diverse, and matrix environment Strong working knowledge of the Microsoft Office Suite (Word, PowerPoint, Excel)
Vertex Pharmaceuticals Boston, MA, USA
Jan 16, 2020
Full time
DESCRIPTION Vertex Pharmaceuticals is working to discover and develop innovative genetic therapies with the potential to provide transformative benefit to patients. Vertex is currently advancing multiple CRISPR-based genetic therapies that have the potential to cure or stop the progression of disease, including for degenerative neurological and muscular diseases. Vertex is seeking a creative, self-motivated individual with a passion for science to join our team. This is a fantastic opportunity to work on cutting edge science, apply state-of-the-art gene editing technologies, and take part in discovering and developing next-generation therapies for Duchenne Muscular Dystrophy, Myotonic Dystrophy Type 1 and other genetic disorders. We are looking for a researcher who brings enthusiasm, intellectual curiosity, scientific rigor and a desire to innovate new medicines for patients. KEY RESPONSIBILITIES Develop analytical methods for release and characterization of AAV gene therapy vectors. Establish molecular and cell-based assay platforms to support rapid advancement of multiple programs. Provide subject matter expertise on method transfers/qualification sat CMO. Establish sample and data management platforms and strategy. Establish product specifications and contribute to regulatory filings. Effectively collaborate with a fully integrated team to facilitate the success of projects. Additional duties and responsibilities as required. REQUIREMENTS PhD in Biochemistry, Cell & Molecular Biology, Genetics or related discipline and 1 to 3 years experience required. Masters degree and 10+ years experience or Bachelors degree and 12+ years experience considered. Direct industry experience developing molecular and/or cell-based release and characterization assays is required. Experience working with contract research or manufacturing organizations is preferred. Experience working with viral vectors for gene therapy is a plus. Excellent communication skills with the proven ability to build open and collaborative relationships and work effectively as a member of a multidisciplinary team.
Vertex Pharmaceuticals Watertown, MA, USA
Jan 16, 2020
Full time
Vertex Pharmaceuticals is working to discover and develop innovative genetic therapies with the potential to provide transformative benefit to patients. Vertex is currently advancing multiple CRISPR-based genetic therapies that have the potential to cure or stop the progression of disease, including for degenerative neurological and muscular diseases. Vertex is seeking a creative, self-motivated individual with a passion for science to join our team. This is a fantastic opportunity to work on cutting edge science, apply state-of-the-art gene editing technologies, and take part in discovering and developing next-generation therapies for Duchenne Muscular Dystrophy, Myotonic Dystrophy Type 1 and other genetic disorders. KEY RESPONSIBILITIES Perform molecular and biochemical assays to support sample analysis from preclinical studies. Assays to be performed include (but are not limited to): Protein extraction, western blot, ELISA, and immunostaining. Coordinate sample storage and analysis. Support assay development using new technologies as required. Execute assays using good documentation practices. Effectively collaborate with a fully integrated team to facilitate the success of projects. REQUIREMENTS A Bachelor's (B.S) or Master's (M.S.) degree in biochemistry, cell biology, or related discipline with 2+ years working experience in biotech or pharmaceutical industry. Demonstrated experience in standard in vitro techniques, assay development, and data analysis. Excellent communication skills with ability to build open and collaborative relationships and work effectively as a member of a multidisciplinary team. Excellent organizational skills and documentation practices.
Vertex Pharmaceuticals Watertown, MA, USA
Jan 16, 2020
Full time
KEY RESPONSIBILITIES Perform molecular and biochemical assays to support sample analysis from preclinical studies. Assays to be performed include (but are not limited to): Protein, DNA and RNA isolation, qPCR, RT-PCR, Western blots and ELISAs. Support CRO management and oversight of bioanalytical assay development, validation and sample analysis Contribute to assay development using new technologies as required Execute assays using good documentation practices Effectively collaborate with a fully integrated team to facilitate the success of projects. REQUIREMENTS Bachelor's or Master's degree in biochemistry, molecular biology, biology, or related discipline with 3+ years directly related experience Demonstrated experience in standard in vitro techniques, assay development, validation and data analysis Familiarity with CRO management Excellent organizational skills and documentation practices Excellent communication skills with ability to build open and collaborative relationships and work effectively as a member of a multidisciplinary team
Vertex Pharmaceuticals San Diego, CA, USA
Jan 16, 2020
Full time
Vertex is seeking a proven scientific leader in Chemical Biology for our San Diego research facility. You will report to the head of chemistry and will be a member of the chemistry leadership team. This will include leading a multi-disciplinary team of scientists to design and synthesize compounds that can probe novel drug binding sites and elucidate the chemical features required for activity without the constraints of developing a drug candidate. If you have a proven track record in Chemical Biology as demonstrated by peer reviewed publications and influence in the field, we would welcome the opportunity to consider you for this newly created leadership role with us. Key Responsibilities: Integrate team activities with drug research projects and clearly articulate and communicate key questions that chemistry can help answer. Develop knowledge of and make recommendations about future applications of chemistry to tackle new types of targets, such as DNA or RNA. Stay fluent with recent developments in the Chemical Biology field including advances in tagging proteins (preferably in live cells), biochemical and/or biophysical assay development and the rapidly evolving field of protein degradation. Minimum Qualifications: PhD in Chemistry or Biology and 10+ years of experience; 3-5 years experience leading a small or mid-sized group preferably in an industrial setting Demonstrated contributions in target and drug binding site identification and validation Expertise in cell and molecular biology, biochemistry, and pharmacology and broad understanding of drug discovery Expertise in biochemical and/or biophysical tools to evaluate small molecule drug binding to target protein Experience in the application of genetic and/or computational methods to study pathways and identify targets Expertise in chemistry, especially as it relates to probe design and/ or tissue targeting Proven experience developing and mentoring group members Effective communication skills, both verbal and written Preferred Qualifications: Experience in target and drug binding site validation and/or identification Experience in planning, project leadership, laboratory and budget management Shown ability to champion and advance creative concepts Ability to manage complexity and ambiguity in a highly matrixed work environment Ability to identify and lead collaborations in chemical biology field A desire to be part of a highly innovative and dynamic company aimed at transforming the lives of people with serious diseases, their families and society