Full-Time

Associate Director Clinical Study Quality Lead

Vertex Pharmaceuticals

Vertex Pharmaceuticals

5,001-10,000 employees

Develops therapies for serious genetic diseases

Compensation Overview

$160.6k - $240.8k/yr

+ Annual bonus + Annual equity awards

Company Does Not Provide H1B Sponsorship

Boston, MA, USA

Hybrid

Hybrid work allows remote work up to two days per week or five days per week on-site. Travel up to 10% is required.

Bachelor's

Category
Biology & Biotech (1)
Required Skills
FDA Regulations
Medical Terminology
Visio
Word/Pages/Docs
Quality Assurance (QA)
Risk Management
Google Cloud Platform
Excel/Numbers/Sheets

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Requirements
  • A bachelor's degree in a scientific or allied health field, or an equivalent degree, and 8+ years of relevant work experience or a relevant comparable background.
  • In-depth knowledge of ICH-GCP guidelines and applicable global regulations and guidance for clinical development, including FDA, EMA, and MHRA requirements.
  • Experience across phases of clinical trial development involving drugs and biologics.
  • In-depth understanding of Event Management processes and requirements, including investigation, root cause analysis, CAPA plan development, and effectiveness checks.
  • Ability to translate business partner needs into innovative, creative, and risk-based approaches to quality management.
  • Professional, clear, and concise verbal and written communication with internal and external customers.
  • Organizational, problem-solving, and conflict-resolution skills.
  • Ability to organize and prioritize work effectively to meet timelines with quality deliverables.
  • Scientific education and knowledge sufficient to manage quality oversight for clinical trials, understand medical terminology, standards of care, and disease states, and assure the ethical treatment of participants.
  • Ability to work independently and in a collaborative team setting.
  • Proficiency with Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Smartsheet, and Visio.
  • Strong experience with key performance indicators, metrics analysis, and monitoring and trending quality and compliance metrics.
Responsibilities
  • Serve as a key technical resource and Good Clinical Practice subject matter expert to clinical study execution functions.
  • Provide strategic, risk-based Good Clinical Practice quality compliance oversight of studies within assigned disease areas to support regulatory compliance and protect participant safety, rights, and well-being and study data integrity.
  • Provide consultation, interpretation, and information on regulations, standards, and quality systems to clinical study execution functions.
  • Partner with clinical and study functional teams on proactive quality management approaches supporting risk mitigation and quality outcomes.
  • Identify study and program quality risks and ensure they are communicated and mitigated in a timely manner.
  • Participate in risk management forums, assess Good Clinical Practice compliance risk areas, and develop and implement quality risk management plans and measures.
  • Partner with operational teams to develop risk-based quality and audit plans for assigned programs and ensure audits are conducted according to plan.
  • Review audit reports and evaluate responses and corrective and preventive action plans as needed.
  • Develop and execute inspection preparedness strategies for assigned studies and programs in collaboration with functional area and quality partners.
  • Participate in inspection activities from preparation through response execution.
  • Conduct directed or for-cause audits and site inspection preparation visits as needed.
  • Oversee investigations and approve quality event investigations and corrective and preventive actions.
  • Provide study and program status updates to the R&D Quality Leadership Team and senior stakeholders in Good Clinical Practice Quality as needed.
  • Provide direction and expertise at management review meetings on Good Clinical Practice-related activities, risks, and issues as needed.
  • Represent Quality in study management, quality and compliance forums, teams, and governance, and in interdepartmental process-improvement and business initiatives involving Good Clinical Practice systems, processes, procedures, regulations, and tools.
  • Provide subject matter expertise and participate in developing and reviewing procedural documents related to the Quality Management System, including corrective and preventive action, quality issue management, regulatory inspections, and quality risk management.
  • Maintain an in-depth understanding of business principles, industry trends, standards, methodologies, and the regulatory environment related to clinical development, quality management, and Good Clinical Practice.
  • Participate in evaluating and selecting Good Clinical Practice service providers.
  • Monitor key quality indicators and departmental metrics and identify opportunities to optimize standard operating procedures and work instructions.
  • Act on behalf of the Clinical Quality Program Lead as needed.
  • Mentor and train junior Clinical Study Quality Leads as needed.
Desired Qualifications
  • Prior experience with medical device manufacture and transition to clinical studies or Cell and Gene Therapy.
  • Professional clinical trial certification, such as CCRP or RQAP-GCP.
Vertex Pharmaceuticals

Vertex Pharmaceuticals

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Vertex Pharmaceuticals develops medicines for serious diseases, with a focus on cystic fibrosis. It conducts extensive research and partners with other biotech firms to discover and develop new therapies, including ex vivo engineered cell treatments. Its products, such as ivacaftor, treat cystic fibrosis and other therapies undergo clinical testing to expand the pipeline. Revenue comes from selling approved drugs and from licensing and collaboration agreements. The company distinguishes itself through deep R&D investment, strategic partnerships, and a global reach aimed at addressing unmet medical needs. The overall goal is to bring effective new drugs to patients worldwide and improve outcomes and quality of life.

Company Size

5,001-10,000

Company Stage

IPO

Headquarters

Boston, Massachusetts

Founded

1989

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Simplify Jobs

Simplify's Take

What believers are saying

  • Q2 2026 revenue hit $3.33 billion, and full-year guidance rose to $13.2 billion.
  • JOURNAVX prescriptions reached 535,000 in Q2 2026, with 260 million covered lives.
  • Povetacicept's FDA decision lands November 30, 2026, opening IgA nephropathy before competitors.

What critics are saying

  • August 24, 2026, Judge Bibas rejected Vertex's ivacaftor infringement claims against Lupin.
  • Sionna's Phase 2a CF data threatens Vertex's monopoly if it lifts sweat chloride.
  • A failed CF patent defense or rival modulator erodes Vertex's cash engine.

What makes Vertex Pharmaceuticals unique

  • ALYFTREK and TRIKAFTA still treat about 95% of core-market cystic fibrosis patients.
  • September 1, 2026 Crinetics adds PALSONIFY and atumelnant, widening Vertex into endocrinology.
  • Vertex pairs validated biomarkers like sweat chloride and PLA2R with specialty-disease commercialization.

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Benefits

Hybrid Work Options

Growth & Insights and Company News

Headcount

6 month growth

8%

1 year growth

8%

2 year growth

8%
Yahoo Finance
Sep 12th, 2026
Vertex eyes $5B from Crinetics acquisition, expanding beyond cystic fibrosis

Vertex Pharmaceuticals is expanding beyond cystic fibrosis following its recent Crinetics acquisition, which adds PALSONIFY for acromegaly and late-stage congenital adrenal hyperplasia drug atumelnant. The company estimates these assets could generate combined peak sales of $5 billion. Key upcoming milestones include a 30 November FDA decision for povetacicept in IgA nephropathy and Phase II data for inaxaplin expected before year-end. Phase III studies of suzetrigine for diabetic peripheral neuropathy are expected to complete enrollment by year-end. JOURNAVX is emerging as a major commercial growth driver, with Vertex targeting a tripling of prescriptions in 2026 versus 2025 as insurance coverage and its sales force expand. The company evaluates opportunities through a framework focused on causal human biology, validated biomarkers and specialty markets.

Lifescience Intellipedia Pvt. Ltd.
Sep 2nd, 2026
Vertex completes $10 billion acquisition of Crinetics Pharmaceuticals.

Vertex completes $10 billion acquisition of Crinetics Pharmaceuticals. Deal expands Vertex into rare endocrine diseases. Vertex Pharmaceuticals has completed its acquisition of Crinetics Pharmaceuticals, strengthening its presence in endocrine diseases and adding new commercial and clinical-stage medicines to its portfolio. The acquisition was completed on September 1, 2026, after receiving the required regulatory clearances and approval from Crinetics shareholders. Vertex had announced the definitive agreement on July 6, 2026. Under the deal, Vertex agreed to acquire Crinetics for a total equity value of approximately $10.0 billion. After accounting for estimated cash acquired, the transaction has a net value of approximately $8.8 billion. The acquisition gives Vertex access to PALSONIFY (paltusotine), an approved oral treatment for acromegaly, as well as atumelnant, an investigational treatment being developed for congenital adrenal hyperplasia and Cushing's syndrome. Vertex expects the acquisition to support revenue growth, expand its innovation pipeline, and strengthen its long-term earnings profile. PALSONIFY becomes part of Vertex's commercial portfolio. One of the biggest additions from the Crinetics acquisition is PALSONIFY. PALSONIFY is a once-daily oral therapy for acromegaly and is currently the only treatment of its kind approved for this use. The medicine has already been launched in the United States and approved in the European Union. It is also under regulatory review in other markets around the world. Acromegaly is a rare endocrine disorder that occurs when the body produces too much growth hormone. The excess hormone can cause abnormal growth of bones and tissues and may lead to serious health complications if left untreated. With PALSONIFY now part of Vertex's portfolio, the company plans to continue expanding the medicine globally. Atumelnant adds a new late-stage pipeline program. The acquisition also brings Atumelnant into Vertex's development pipeline. Atumelnant is a once-daily oral adrenocorticotropic hormone, or ACTH, receptor antagonist. The medicine is currently being studied in Phase 3 clinical development for congenital adrenal hyperplasia, also known as CAH. It is also being evaluated in Phase 2 development for Cushing's syndrome. Congenital adrenal hyperplasia is a group of inherited disorders that affect the adrenal glands and can interfere with the body's production of certain hormones. Cushing's syndrome occurs when the body is exposed to excessive levels of cortisol over an extended period. Atumelnant could give Vertex another opportunity to develop oral treatments for rare endocrine diseases. Combined revenue potential of more than $5 billion. Vertex expects PALSONIFY and Atumelnant to have significant commercial potential. At peak sales, the two medicines are expected to generate more than $5 billion in combined annual revenue. The company also expects the acquisition to become accretive to non-GAAP operating income in 2029. The financial impact of the acquisition will be reported in more detail as Vertex provides its third-quarter financial results. The transaction is being accounted for as a business combination. Vertex plans to provide additional information about the accounting treatment and financial impact during its third-quarter earnings call scheduled for November 2, 2026. Rare endocrine diseases become a new growth area. The Crinetics acquisition adds rare endocrine diseases as a new major area of focus for Vertex. The company already has four established areas of focus: cystic fibrosis, hematology, acute pain, and renal diseases. Rare endocrine diseases will now become another pillar of Vertex's growth strategy. This expands the company's business beyond its traditional areas while giving it access to an established endocrine medicine and additional late-stage research programs. Vertex expands its executive leadership team. Along with completing the Crinetics acquisition, Vertex announced several changes to its executive leadership team. Charles Wagner, Vertex's executive vice president and chief operating and financial officer, will immediately take on additional responsibility for leading the integration of Crinetics. Wagner will continue serving as Vertex's chief operating officer while overseeing the integration of the newly acquired company. His expanded role is expected to help Vertex bring Crinetics' operations, employees, products, and development programs into the broader Vertex organization. Jonathan Poole to become chief financial officer. Vertex also announced that Jonathan Poole will become executive vice president and chief financial officer effective January 1, 2027. Poole currently serves as Vertex's senior vice president of finance. He has led Vertex's global finance organization since March 2020 and has been involved during a period of major expansion for the company. During his time at Vertex, Poole has supported the expansion of the company's research and development pipeline, global commercial operations, business diversification, and several acquisitions. In his new role, Poole will report directly to Reshma Kewalramani, M.D., Vertex's chief executive officer and president. He will also join the company's Executive Committee. Poole Brings Extensive Biopharma Finance Experience Before joining Vertex, Poole held several senior finance positions in the biopharmaceutical industry. He previously served as chief financial officer of Evelo Biosciences and Genocea Biosciences. He also served as senior vice president of finance at Shire Plc. His experience includes financial leadership during periods of business growth, portfolio development, and corporate transactions. At Vertex, he will take over the CFO role while Wagner continues in his expanded position as chief operating officer. Jasper van Grunsven to Lead Pain and New Product Planning Vertex is also adding Jasper van Grunsven to its executive leadership team. Van Grunsven will join Vertex on September 8, 2026, as executive vice president, chief of pain, and new product planning officer. He will be responsible for Vertex's pain franchise, including JOURNAVX (suzetrigine), which is approved for moderate-to-severe acute pain. He will also oversee global new product planning. Van Grunsven will report to Dr. Kewalramani and become a member of the Vertex Executive Committee. Van Grunsven Brings Global Commercial Experience Van Grunsven has experience across sales, marketing, and business operations in different countries, disease areas, and treatment technologies. Most recently, he served as senior vice president of Amgen's Rare Disease portfolio and its Global Customer Capabilities Data & Analytics function. Before Amgen, he held a number of roles with increasing responsibility at AbbVie, Abbott Laboratories, and Nycomed. Vertex said his experience will support the company's growing pain business and its plans for future product launches. Vertex Looks to Its Next Phase of Growth Vertex CEO and President Reshma Kewalramani said the company is entering a new phase of growth and diversification as its research pipeline and commercial portfolio continue to expand. She welcomed the Crinetics team to Vertex and said the company will work to continue the global launch of PALSONIFY while accelerating the development of atumelnant. The company also highlighted the expanded responsibilities of Wagner and Poole and the addition of van Grunsven to the leadership team. Vertex's Broader Pipeline Continues to Expand The Crinetics acquisition is part of a broader strategy by Vertex to develop medicines across serious diseases where the company believes it has strong knowledge of human biology. Vertex currently has approved therapies for conditions including cystic fibrosis, sickle cell disease, transfusion-dependent beta thalassemia, acute pain, and acromegaly. The company also has a clinical pipeline covering several other diseases. These programs include treatments being investigated for IgA nephropathy, neuropathic pain, APOL1-mediated kidney disease, primary membranous nephropathy, congenital adrenal hyperplasia, ACTH-dependent Cushing's syndrome, autosomal dominant polycystic kidney disease, type 1 diabetes, generalized myasthenia gravis, and myotonic dystrophy type 1. The company's research programs also cover several different treatment approaches and technology platforms. Vertex Adds Another Commercial Medicine With the completion of the Crinetics acquisition, Vertex now has PALSONIFY as an additional commercial product. The medicine expands Vertex's presence in rare endocrine diseases and provides the company with an already launched product that can be developed further in international markets. At the same time, atumelnant gives Vertex a late-stage development program that could potentially add another important endocrine medicine to its portfolio. The combination of an established commercial product, a Phase 3 program, and earlier pipeline assets gives Vertex a broader position in endocrine diseases. About Vertex Pharmaceuticals Vertex Pharmaceuticals is a global biotechnology company focused on developing medicines for serious diseases and conditions. The company was founded in 1989 and is headquartered in Boston, with its international headquarters in London. Vertex has research and development locations and commercial offices across North America, Europe, Australia, Latin America, and the Middle East. The company has built its business around scientific research and the development of medicines designed to address serious diseases. With the completion of the Crinetics acquisition, Vertex is adding rare endocrine diseases to its existing focus areas while expanding its commercial portfolio, clinical pipeline, and global operations.

Yahoo Finance
Aug 31st, 2026
Vertex Pharmaceuticals shows promise while GE HealthCare and Wells Fargo face challenges

Vertex Pharmaceuticals has emerged as a standout S&P 500 stock, according to StockStory's analysis. The company, which focuses on developing transformative medicines for serious diseases including cystic fibrosis and sickle cell disease, boasts a market capitalisation of $137.3 billion. Meanwhile, StockStory recommends avoiding two large-cap stocks. GE HealthCare, spun off from General Electric in 2023, faces concerns over stagnant organic revenue growth and declining operating margins. The medical equipment provider has a market cap of $32.4 billion. Wells Fargo also made the avoid list. The diversified financial services company, with a $262.2 billion market cap, has seen its net interest margin shrink by 33.6 basis points over two years, suggesting increased competition or declining loan profitability.

Yahoo Finance
Aug 26th, 2026
Vertex Pharmaceuticals up 15% in a month on strong Q2 results and raised guidance

Vertex Pharmaceuticals' stock has climbed 15.4% in a month, buoyed by strong second-quarter results and an improved outlook. The company reported revenues of $3.33 billion, up 12% year over year, and raised its full-year guidance to $13.1–$13.2 billion. Vertex's cystic fibrosis (CF) products generated $6.1 billion in the first half of 2026, growing 8.4% year over year. Its newest CF medicine, Alyftrek, performed particularly well, with second-quarter sales of $573.6 million, up 35% sequentially. The drug surpassed $1 billion in cumulative global revenues in the first half of the year. Vertex holds a leadership position in CF, treating nearly 95% of patients in core markets, with no near-term competitive threats. Label expansions and launches in new geographies are expected to drive continued growth.

Ticker Report
Aug 19th, 2026
Wealthfront Advisers LLC Makes New $20.67 Million Investment in Vertex Pharmaceuticals Incorporated $VRTX

Wealthfront Advisers LLC acquired a new stake in Vertex Pharmaceuticals Incorporated (NASDAQ:VRTX – Free Report) during the 2nd quarter, according to the company in its most recent 13F filing with the Securities & Exchange Commission. The institutional investor acquired 41,608 shares of the pharmaceutical company’s stock, valued at approximately $20,668,000. Other hedge funds also recently […]