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Job DescriptionThe Opportunity At Maze Therapeutics, we believe that precision medicine has the power to transform the lives of patients with both common and rare diseases. As a Clinical Trial Manager (CTM) at Maze Therapeutics, you'll play a hands-on role in co-leading and driving the execution of our Chronic Kidney Disease (CKD) clinical trials. You'll have the opportunity to contribute to mid to late-stage clinical studies, work cross-functionally with internal teams and external partners, and ensure trials run efficiently and with the highest quality standards. If you enjoy rolling up your sleeves, collaborating across teams, and bringing innovative medicines to patients, this role could be the perfect fit for you. The Impact You'll Have • Steer the execution of one or more of our Phase 2 CKD clinical trials; from protocol development to achievement of corporate and study milestones such as first patient in, interim analysis, database lock, and study report completion., • Manage external vendors including CROs, additional key vendors, and global investigative sites., • Ensure adherence to study protocols, SOPs, ICH GCP guidelines by overseeing monitoring activities at investigative sites., • Coordinate the development of study materials such as CRFs, ICFs, patient diaries., • Act as the voice of Clinical Operations on cross-functional teams, including the Study Execution Team (SET)., • Partner with Clinical Operations and Clinical Science Team to engage with therapeutic area KOLs and Investigators. What We're Looking For, • A degree in a scientific discipline or health related field., • Minimum of 4 years clinical research experience, including 2 years as a Clinical Trial Manager at a biopharmaceutical company or CRO., • Experience with planning and executing Phase I-II trials is preferred., • Demonstrated proficiency in implementing, monitoring, and management of clinical trials, from start-up to close-out., • General knowledge of FDA regulatory requirements and ICH GCP guidelines., • Strong organizational skills, ability to prioritize and multi-task., • Excellent verbal and written communication skills., • Demonstrated problem-solving and negotiation abilities., • Ability to work as part of a team and build strong working relationships with internal and external partners., • Capacity to roll-up sleeves to perform a broad range of clinical trial related tasks as needed., • Willingness to travel as necessary, consistent with project needs., • Excellent computer proficiency (Microsoft Office Suite, Project, Word, Excel, PowerPoint, Outlook). Impact Obsessed – We embrace the bold, take calculated risks, and learn from our mistakes to improve the lives of others. Stand True – Our integrity is foundational; it guides us no matter the obstacle. The expected annual salary range for employees located in the San Francisco Bay Area is $143,000 - $175,000. Additionally, this position is eligible for an annual performance bonus. Maze performs position-based compensation benchmarking to industry market data to ensure we pay competitive wages. Determination of starting salary will depend upon a variety of job-related factors, which may include professional experience, skills, and job location. The expected salary range for this role may be modified in the future. Maze offers a robust benefits package to our eligible employees including competitive medical, dental, and vision insurance, mental health offerings, equity incentive plan, 401(k) program with employer match and a generous holiday and PTO policy. #LI-Hybrid

Job DescriptionJob Description: We are seeking an experienced Product Manager / Strategic Initiatives Lead with a strong background in biotechnology, digital transformation, and data-driven healthcare solutions. The ideal candidate will have experience driving strategic initiatives in Medical Affairs, Clinical Trials, and Patient Safety, while leveraging machine learning, predictive analytics, and digital tools to improve operational efficiency and patient outcomes. Key Responsibilities:· Lead strategic initiatives in Medical Affairs to support a shift toward a patient-centric healthcare model.· Utilize machine learning and predictive analytics to enhance productivity, efficiency, and patient experience in Clinical Trial and Patient Safety programs.· Serve as a Product Manager within Digital Enablement and Therapeutic Area teams, supporting the Commercial Portfolio group in achieving business objectives.· Collaborate with cross-functional teams including clinical, commercial, data science, and IT to deliver scalable digital solutions.· Analyze internal and external healthcare ecosystems to identify opportunities for innovation and improved patient engagement.· Support development and implementation of digital platforms and business tools to streamline processes and improve operational performance.· Drive data-driven decision-making to optimize business outcomes and improve healthcare delivery. Required Skills:· Strong experience in biotechnology, healthcare, or life sciences industry.· Experience with digital transformation, product management, and strategic initiatives.· Knowledge of machine learning, predictive analytics, and healthcare data systems.· Understanding of Clinical Trials, Patient Safety, and Medical Affairs operations.· Strong stakeholder management and cross-functional collaboration skills. Qualifications:· Bachelor’s degree in Biology, Life Sciences, or related field (e.g., Integrative Biology).· Master’s degree in Healthcare, Business, or related discipline preferred.· 10+ years of experience in healthcare, biotech, or pharmaceutical industry.

Job DescriptionCompany Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok. Job Description The Medical Affairs organization provides patients, healthcare providers, and payers everywhere with the practical and clinically relevant information and solutions they need to use AbbVie products safely and effectively, throughout the product lifecycle and the patient’s journey. The Scientific / Medical Director, Medical Affairs provides specialist medical and scientific input into core strategic and operational medical affairs activities for AbbVie’s Oncology portfolio such as: health-care professional and provider interactions; generation of clinical and scientific data (enhancing therapeutic benefit and value); educational initiatives, scientific communications, value propositioning, and safeguarding patient safety (risk minimization activities and safety surveillance activities). The Scientific / Medical Director works closely with commercial and research and development teams to provide critical medical input into evolving core medical, brand (product), and value and access strategies to support our evolving on-market and therapeutic area needs. Responsibilities • In collaboration with Global Medical teams, Clinical Development, Commercial, Market Access, Regulatory, HEOR and other functional areas, provides leadership and support for assigned indications/projects., • Works closely with Brand Teams and relevant cross-functional, area/affiliate medical teams, to provide strategic input into core asset strategy, and is responsible for executing medical support/launch activities for gynecologic oncology initiatives., • Conducts promotional review and assists in the development of scientifically accurate marketing materials, medical education programs, advisories, and symposia., • Serves as Medical expert for internal and external stakeholders regarding asset clinical profile, value, and appropriates; and provides Medical review for cross-functional deliverables, ensuring compliance and scientific accuracy., • Develops innovative research concepts, generates evidence, and drives execution of scientific communication plans, including high-quality publications, presentations, and educational programs., • Engages and cultivates relationships with key opinion leaders, scientific advisors, and advocacy groups within the gynecologic oncology community., • Monitors the evolving relevant therapeutic landscape to inform business decisions and anticipate future needs., • Leads the development and execution of advisory boards., • May lead delivery of medical functional plan, brand plan, and/or integrated evidence plan.Qualifications Position will be commensurate with education and experience. For Scientific Director: • Advanced Degree PhD or PharmD. Additional post doctorate experience highly preferred., • 7-10 years of experience in Medical Affairs with Global Medical Affairs experience highly preferred., • Substantial understanding of relevant therapeutic area required., • Medical Doctorate (M.D.) degree or equivalent (D.O. or non-US equivalent of M.D). Relevant therapeutic specialty in an academic or hospital environment preferred. Completion of residency and/or fellowship is preferred., • Knowledge of clinical trial methodology, data analysis and interpretation, regulatory requirements governing clinical trials and experience in development strategy and the design of protocols., • Ability to run a clinical study independently with little supervision., • Proven strategic leadership, influencing, and collaboration skills in cross-functional environments. Ability to interact externally and internally to support global business strategy., • Expertise in evidence generation, scientific communication, and health economics/outcomes research., • Must possess excellent presentation, organizational, and written/oral communication skills. Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: * The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this postingbased on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more orless than the posted range. This range may be modified in the future. * We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. * This job is eligible to participate in our short-term incentive programs. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission,incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paidand may be modified at the Company’s sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

Job DescriptionCompany Description Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) is an innovative, research-based, commercial-stage biopharmaceutical company based in China and the United States focused on bringing transformative medicines for oncology, autoimmune disorders, infectious diseases, and neurological disorders to patients in China and around the world. Our goal is to leverage our competencies and resources to positively impact human health worldwide. Founded in 2014, our experienced team has secured partnerships with leading global biopharmaceutical companies, generating a broad and late-stage pipeline of innovative drug candidates. Based on our proven track record of success, Zai Lab has earned the reputation as a trusted partner of choice for global biopharmaceutical companies seeking to not only access the Chinese market but also find a long-term strategic partner for global clinical development. Our unique business model builds on our in-licensed assets and innovative partnerships to expand our internal discovery and development capabilities and has created a portfolio of potential best-in-class and/or first-in-class therapies. Zai currently has four products on the market in China Zai Lab was successfully listed on the Nasdaq Stock Market in September 2017 and completed secondary listing on Hong Kong Stock Exchange in September 2020. In 2022, Zai Lab became dual-primary listed on both the Nasdaq and the Hong Kong Stock Exchanges. Since its inception, Zai Lab has expanded significantly with several offices across China. In 2021, Zai Lab established its U.S. Headquarters in Cambridge, Massachusetts. As of January 2022, the Company has a global team of approximately 2000 employees. Job Description The Senior Clinical Trial Manager will lead, manage and co-ordinate the operational strategy, risk management, and overall execution of clinical trials from study start-up to close out at a global level in accordance with ICH-GCP and applicable local regulations. Collaborate with cross functional stakeholders to ensure deliverables are met in terms of quality, compliance, budget, and timing. This role may work collaboratively on one trial or across several trials to support clinical operations activities. This position is based in our South San Francisco, CA office. • Lead and coordinate a cross-functional study team to ensure the clinical trial progresses as planned., • Accountable for the overall operational strategy and delivery (e.g., country and site selection/start-up, site contracts, patient recruitment and retention, etc.) of assigned clinical trials; ensuring that study-level deliverables are met according to timeline, budget, and quality requirements., • Participates in developing and finalizing cross-functional activities to ensure delivery of critical clinical trial documents such as informed consent forms (ICFs), protocols, site and country budget templates, EDC, IxRS, central/specialty lab, ECG, imaging, PRO specifications, drug supply, biomarker/sample management plans, TMF, and CSRs., • Drafts and implements study plans including; vendor oversight, risk, quality, safety, communication, trial monitoring, and TMF., • Ensures TMF creation and QC completion., • Supports EDC, IxRS, and CTMS systems and data maintenance., • Tracks budget, timelines, milestones, and critical study activities, identifies issues and proposes potential resolutions., • Accountable for the study budget and manages assigned vendor budget(s); communicates variances in actual versus forecasted spend in vendor budgets and presents an action plan for resolution., • Drives the selection of vendors (participates in the Request for Proposal (RFP) process) on a global scale., • Oversees delegated outsourced activities to ensure CRO and vendor delivery against the contracted scope of work., • Leads the Investigator Meeting preparation and execution with the support from cross-functional team members, • Stays current on relevant therapeutic area knowledge and clinical research best practices., • Ensures study adherence to ICH/GCP and company SOPs.Qualifications REQUIRED: • Undergraduate degree in a scientific or health-related discipline., • Minimum of 8 years relevant experience of which 5 years are clinical experience in the pharmaceutical industry, including 3 years in study management or equivalent combination of education, training, and experience., • Prior people management experience., • Demonstrated ability in clinical study management processes and clinical/drug development., • Highly effective verbal and written communication skills; effectively deliver key messages; aptitude to independently communicate with teams and stakeholders., • Ability to effectively lead projects and persuade and influence peers; ability to build trusting and collaborative relationships globally., • Experience with effective vendor management., • Strong customer focus with investigators, functional peers, vendors, etc., • Excellent planning and organizational skills., • Working knowledge of international regulatory and ICH Good Clinical Practice guidelines., • Maintains the highest standards of integrity and ethics. Additional Information The pay range for this position at commencement of employment is expected to be between $177K and $229K/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. At Zai, we are proud of the gender diversity of our company and our promotion of women in biotech. We have achieved gender base pay equity at all levels, 58% of our employees are women and 54% of our management positions are held by women. We are committed to the health of patients and our planet. That’s why our environmental protection, social responsibility, and corporate governance strategy, called “Trust for Life” is integrated within our business. Disclaimer: This description is not intended to be construed as an exhaustive list of duties, responsibilities, or requirement for the position. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or based on disability. Zai Lab is committed to protecting the privacy and security of the information we collect and to being transparent about the purposes for which we use your information. We have a Privacy Notice which sets forth our policies and practices for handling the information we collect and use in the employment context. Privacy Notice available upon request.

Job DescriptionThe Opportunity At Maze Therapeutics, we're on a mission to make a difference in the lives of people affected by common and rare diseases. If you're looking for a role where you can be hands-on in the execution of global clinical trials and directly contribute to advancing treatments for patients, this could be the perfect opportunity for you. As a Clinical Trial Specialist, you'll play a key role in supporting our Clinical Operations team as we deliver an exciting and diverse pipeline of precision medicines. You'll collaborate closely with internal teams, CROs, and vendors to ensure the smooth execution of our clinical studies. This role is ideal for someone who enjoys problem-solving, thrives in a fast-paced environment, and is eager to take ownership of critical trial activities such as vendor and site management. This role will be supporting the MZE782 program for Chronic Kidney Disease. This position reports to the Senior Clinical Trial Manager. The Impact You'll Have You'll be a critical part of our clinical team, ensuring our trials are executed with precision, efficiency, and the highest standards of quality. Your contributions will include: • Driving Study Execution: Support the Clinical Operations Study Leads to oversee and monitor the conduct of our clinical studies, monitoring progress, identifying trends or issues, and collaborating with Study Leads to implement corrective actions when necessary., • Site & Vendor Oversight: Support site management oversight to ensure CRO activities align with the Monitoring Plan and facilitating protocol deviation discussions for quick resolution., • Ensuring compliance & Best Practices: Ensure that all clinical trial activities adhere to ICH/GCP Guidelines, study protocols, and Maze SOPs., • Supporting Key Study Materials: Assist in the design and development of study documents, including protocols, informed consent forms (ICFs), amendments, and content creation for study materials., • Collaboration & Leadership: Attend and contribute to vendor meetings, lead resolution of study-related issues, and foster a culture of continuous process improvement with CROs and other external partners, • Tracking & Documentation: Develop study trackers and tools to best support study conduct and track study metrics and deliverables. Oversee Trial Master File (TMF) activities, ensuring proper documentation, metric tracking and reconciliation efforts as needed. Manage process for submitting and executing clinical contracts, as appropriate., • Sample & Data Management: Work with study team to coordinate sample shipments, sample analysis, and data reconciliation efforts., • A strong clinical trial and/or industry background: Bachelor's degree with 2+ years of experience in clinical trials – either at an academic institution or within a biotech/pharmaceutical environment., • A systematic and problem-solving mindset: You enjoy solving complex challenges and thinking critically to improve processes., • Exceptional organizational skills: You can manage multiple priorities, stay detail-oriented, and keep trials on track., • A proactive and collaborative approach: You're a strong team player who takes initiative and builds meaningful relationships with internal and external partners., • Hands-on experience with trial systems: Familiarity with clinical trial databases such as Medidata Rave, Veeva, or similar platforms., • Flexibility and adaptability: You're comfortable working in a fast-paced, evolving environment and willing to roll up your sleeves to perform a broad range of clinical trial related tasks as needed., • Learning agility: Ability to rapidly acquire, apply, and adapt knowledge, skills, and insights in dynamic and unfamiliar situations., • Willingness to travel: Up to 10-15% travel, with the possibility of more based on project needs.as necessary, consistent with project needs. About Maze Therapeutics Maze Therapeutics is a clinical-stage biopharmaceutical company harnessing the power of human genetics to develop novel, small molecule precision medicines for patients living with renal, cardiovascular and related metabolic diseases, including obesity. The company is advancing a pipeline using its Compass platform, which allows it to identify and characterize genetic variants in disease and then link those variants to the biological pathways that drive disease in specific patient groups through a process it refers to as variant functionalization. The company's pipeline is led by two wholly owned lead programs, MZE829 and MZE782, each of which represents a novel precision medicine-based approach for chronic kidney disease. Maze is based in South San Francisco. Our People Maze is comprised of a team of passionate and creative professionals committed to discovering and delivering transformative medicines to patients suffering from both rare and common genetic diseases. We are fostering a culture that encourages vision, initiative and the development of talent. Our supportive work environment inspires creative thinking and freedom of expression, resulting in a stimulating atmosphere where people enjoy coming to work. While we have a passion for advanced science and pride ourselves on excellence in execution, ultimately, everything we do is about patients. Our Core Values Further Together – Our path is paved with challenges, but with resilience and a team-first mentality, we'll achieve our mission. Impact Obsessed – We embrace the bold, take calculated risks, and learn from our mistakes to improve the lives of others. Stand True – Our integrity is foundational; it guides us no matter the obstacle. The expected annual salary range for employees located in the San Francisco Bay Area is $114,000 - $140,000. Additionally, this position is eligible for an annual performance bonus. Maze performs position-based compensation benchmarking to industry market data to ensure we pay competitive wages. Determination of starting salary will depend upon a variety of job-related factors, which may include professional experience, skills, and job location. The expected salary range for this role may be modified in the future. Maze offers a robust benefits package to our eligible employees including competitive medical, dental, and vision insurance, mental health offerings, equity incentive plan, 401(k) program with employer match and a generous holiday and PTO policy. #LI-Hybrid

Job DescriptionCompany Description About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube. Job Description Leads the Gastroenterology team in developing and executing the Medical Affairs strategy for Upadacitinib. Responsible for practical and clinically meaningful data strategy and delivery to inform clinical use and transform standard of care. Aligning all internal parties on Medical Benefit-Risk Evidence based positions. Deeply understanding the patient journey and apply insights into determining the medical need. Expected to work closely with Clinical Development and Asset Teams to ensure that global customer insights and health care practices, current and future are incorporated in the clinical development and regulatory plans. Provide strategic medical input into core brand strategies, and to support medical marketing activities and market access. Responsibilities: -Actively participates in advancing and communicating corporate and GMA philosophy and agenda. Participates as a member of TA Management. Coordinates induction, mentoring, training, and development of team. Identifies training needs. May supervise 2-10 employees, including other MDs or PhDs. Responsible for all aspects of talent management for own team and provides feedback as part of TA management. May assist in developing/mentoring junior medical affairs staff. -Participates in design and execution of clinical trial safety, product safety and risk management plans. May also carry responsibility for routine and adhoc safety monitoring reports to regulatory agencies. May review, assess and report applicable Adverse Events (AE’s) and Serious Adverse Events (SAE’s) if assigned to AbbVie conduct on clinical studies. -Oversees the conduct of clinical trials and is medically and scientifically accountable for resolution of safety (AE’s SAE’s) issues, interpretation of statistical analyses for clinical significance, PI selection, scientific documents reporting safety monitoring and other scientific reports submitted to the regulatory authorities. -All clinical research / development activities for products under development, and for post approval commitments such as regulatory agency mandated trials, or those intended to support product registration or to generate data for label inclusion remain the primary responsibility of TA development teams. Assists with the scientific review, development, approval, execution and communication of affiliate/area/global medical affairs sponsored or supported clinical research activities. -Drives medical affairs activities and generation and dissemination of data supporting overall product scientific and business strategy. May interact with and coordinates appropriate scientific and medical activities with internal stakeholders (i.e. commercial, clinical operations, discovery, statistics, regulatory, etc…) as they relate to on-going medical affairs projects. -Oversees scientific/medical education of investigators, clinical monitors, and Global Project Team members related to therapeutic area or disease specific information. Keeps abreast of professional information and technology through conferences and/or medical literature and acts as a therapeutic area resource. May develop scientifically accurate marketing materials, medical education programs, advisories, and symposia. Maintains an up-to-date analysis of competitor product information. -May act as consultant/liaison with other corporations when working under licensing agreements and/or in the evaluation of new business development opportunities. Represents AbbVie at external meetings including investigator meetings, scientific association meetings, etc. May act as medical/scientific leader for several programs within an area. May represent the medical function on cross-functional integrated teams for medical affairs activities. -Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. Serves as the scientific team interface for key regulatory discussions. -Drives Medical Affairs strategies and is a key internal contact/subject matter expert. May lead cross functional teams in development and execution of strategic initiatives requiring integration of multiple subprojects within the therapeutic area or Medical Affairs function. Ensures budgets, timelines, compliance requirements are factored into programs' scientific activities. -Accountable for the medical review of complex advertising and promotional materials for assigned therapeutic area(s) within Medical Affairs. Provides strategic guidance to cross-functional team members related to the medical content. Maintains oversight of TA specific medical content included in commercial communications. . Qualifications • Advanced degree (MD, PhD, DO) with relevant therapeutic specialty in an academic or hospital environment highly preferred. Relevant therapeutic area clinical experience and/or Medical Affairs in an academic, hospital or pharma environment required., • Typically 8 years of clinical trial or medical affairs experience in the pharmaceutical industry or academia or equivalent., • Proven leadership skills in a cross-functional global team environment. Ability to interact externally and internally to support global business strategy. Ability to run a complex medical affairs team(s) independently., • Extensive knowledge of clinical trial methodology, regulatory requirements governing clinical trials and experience in development strategy and the design of protocols. Expert knowledge in a relevant therapeutic specialty. Must have basic understanding of Pharmacovigilance practices for Clinical Development programs., • Demonstrated sense of urgency and strong goal orientation, an ability to make decisions and a history of meeting deadlines and objectives., • Works independently and leads team., • Can address complex problems within discipline or across several projects., • Exercises judgment within broadly defined practices and policies in selecting methods and techniques for obtaining solutions., • Works on complex problems in which analysis of situation or data requires an in-depth evaluation of various complex factors Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: • The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future., • We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

Job DescriptionThe Opportunity Join us at Maze Therapeutics as our Director of Data Management, where you will play a key role in shaping the data strategy that supports our clinical development programs. You'll partner closely with Biostatistics, Statistical Programming, Clinical Operations, and Regulatory Affairs, and oversee external vendors to deliver high-quality, reliable clinical data across our studies. Reporting to the Vice President of Biometrics, you'll provide strategic direction and hands-on leadership for clinical data management activities spanning multiple clinical trials. Your work will ensure timely, compliant, and analysis-ready data that supports regulatory submissions and key program decisions. The Impact You'll Have • Lead data management activities across multiple clinical studies and development phases., • Shape and implement data management strategies, standards, and best practices., • Mentor and support data management team members, fostering growth and knowledge sharing., • Serve as a subject matter expert for data management processes, systems, and regulatory expectations., • Oversee critical study deliverables including DMPs, CRFs/eCRFs, edit checks, and database locks., • Guide accurate, consistent, and timely clinical data collection, cleaning, and reconciliation., • Review and approve key study documentation and ensure readiness for analysis and reporting., • Drive database lock planning and partner closely with Biostatistics and Medical Writing to support analyses and study reports., • Manage CROs and external vendors, ensuring clarity around timelines, quality expectations, and contractual commitments., • Support the evaluation, implementation, and optimization of EDC and data management technologies., • Collaborate closely with Clinical Operations, Biostatistics, and other partners across the organization., • Communication and Influence, • Builds communication channels across Maze for sharing information., • Influences Senior Management decisions through persuasive arguments., • Respectfully addresses differing opinions leading to support of decisions., • Teamwork and Collaboration, • Champions partnerships and connections across Maze., • Proactively addresses issues that could result in breakdown of team relationships., • Spotlights team and individual contributions in public forums., • Execution and Results, • Addresses gaps and leverages strengths to get best results., • Maintains a steadying presence and clarifies priorities during change., • Anticipates and removes barriers that put functional/corporate goals at risk., • Develop Others and Self, • Remove barriers to staff development and empowers them to make their own decisions., • Stays current on industry trends and keeps direct-reports prepared and responsive.What We're Looking For, • Bachelor's or advanced degree in Life Sciences, Computer Science, or related field, • 8+ years of clinical data management experience in biotech, pharmaceutical, or CRO environments, • 3+ years of people and/or project leadership experience, • Hands-on experience with EDC systems (e.g., Medidata Rave, Oracle InForm), • Strong understanding of clinical trial operations, data flows, and regulatory expectations Our Core Values Further Together – Our path is paved with challenges, but with resilience and a team-first mentality, we'll achieve our mission. Impact Obsessed – We embrace the bold, take calculated risks, and learn from our mistakes to improve the lives of others. Stand True – Our integrity is foundational; it guides us no matter the obstacle. The expected annual salary range for employees located in the San Francisco Bay Area is $232,000 - $284,000. Additionally, this position is eligible for an annual performance bonus. Maze performs position-based compensation benchmarking to industry market data to ensure we pay competitive wages. Determination of starting salary will depend upon a variety of job-related factors, which may include professional experience, skills, and job location. The expected salary range for this role may be modified in the future. Maze offers a robust benefits package to our eligible employees including competitive medical, dental, and vision insurance, mental health offerings, equity incentive plan, 401(k) program with employer match and a generous holiday and PTO policy. #LI-Hybrid

Job Description Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients. Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients. We are seeking an experienced Regional Director of Medical Science Liaisons (MSLs) with expertise in medical dermatology. The successful candidate will be responsible for leading and overseeing MSLs, ensuring the effective dissemination of scientific and clinical information, building relationships with key opinion leaders (KOLs), and supporting the strategic goals of the Medical Affairs organization. This role will require a deep understanding of medical science, excellent leadership capabilities, and a strong ability to drive the success of cross-functional teams. We will be seeking one individual for the Western US and one for the Eastern US. Responsibilities: Field-based Leadership of Regional DPEGs and IDNs Serve as primary point of contact with the clinical leaders, educational leaders, and C-suite executives of Dermatology Private Equity-backed Groups, DPEGs, to build trusting professional relationships Develop deep understanding of DPEG structures, performance metrics, and educational needs Develop cross-functional engagement strategy to build the groundwork for launch Co-create data-driven value proposition to improve patient outcomes Leadership & Team Management: Lead, mentor, and manage a team of MSLs, fostering a collaborative, high-performing, and scientifically rigorous culture. Provide guidance on the development and execution of territory plans, objectives, and key performance indicators (KPIs) for each MSL. Conduct regular performance evaluations, identify skill gaps, and support MSL development through coaching, training, and career growth opportunities. Collaborate with the Medical Affairs leadership team to align MSL activities with organizational priorities and strategic initiatives. Strategic Planning & Execution: Contribute to the development of MSL tactics in line with corporate and therapeutic area goals. Drive the execution of MSL tactics within assigned region. Ensure MSLs are equipped with the latest scientific data and clinical information, and support their integration into both regional and national-level initiatives. Scientific Exchange & KOL Relationship Management: Cultivate strong, long-lasting relationships with KOLs, healthcare providers, academic researchers, and key stakeholders through active field engagement in the region. Serve as a scientific resource and point of contact for KOLs to address inquiries regarding the company's pipeline, products, and scientific advancements. Represent the company at scientific congresses, advisory boards, and other relevant forums to enhance scientific and therapeutic understanding. Cross-Functional Collaboration: Provide strategic input into the development of clinical trials, publication plans, and other medical activities by leveraging field insights and customer feedback. Collaborate with the Medical Affairs leadership to ensure appropriate deployment of MSL resources to support clinical, regulatory, and commercial objectives. Compliance & Reporting: Ensure all MSL activities are conducted in compliance with regulatory, ethical, and company standards, including GxP (Good Clinical Practice) and HIPAA regulations. Provide regular updates to MA management on team progress, KOL engagement, and other key initiatives, including metrics on impact and outcomes. Stay abreast of the competitive landscape and emerging trends in dermatology, rheumatology, and neurology, ensuring MSL activities reflect the latest scientific advancements. Qualifications: Education: o PhD, PharmD, MD, or other advanced degree in a relevant scientific discipline (e.g., Biology, Pharmacology, Medicine). Experience: o Minimum of 10 years of experience in Medical Affairs or related scientific roles, with leadership experience in managing a team of MSLs or scientific professionals. o In-depth knowledge of medical dermatology, including clinical practice, research, and evolving treatment paradigms. o Proven track record of successful relationship-building with KOLs, HCPs, and key stakeholders within the medical community. o Experience working in cross-functional teams, with a demonstrated ability to collaborate effectively with commercial, clinical, regulatory, and other business functions. Skills & Competencies: o Excellent leadership and team management skills, with the ability to inspire and develop a high-performing team. o Strong communication, presentation, and interpersonal skills, with the ability to engage effectively with internal and external stakeholders. o Deep understanding of the pharmaceutical industry, including regulatory and compliance requirements, scientific data dissemination, and product lifecycle management. o Ability to translate complex scientific information into actionable insights for diverse audiences, including KOLs, healthcare professionals, and internal teams. o Strong problem-solving, strategic thinking, and decision-making skills. Travel: o Willingness to travel extensively (50-75%) as required for KOL engagement, scientific meetings, and team management activities. Preferred Qualifications: · Experience in therapeutic areas of medical dermatology. · Previous experience working in a leadership role within a biopharmaceutical company or a global pharmaceutical organization. · Familiarity with clinical trial processes, publication planning, and scientific communication in a corporate environment. The salary range for this position is $220,00 to 250,000 USD annually. This salary range is an estimate, and the actual salary may very based on the Company's compensation practices degree and background. This position is primarily remote with travel. Alumis Inc. is an equal opportunity employer. Alumis compensation packages include generous stock option grants for all employees as well as an annual bonus program. Other benefits include: • Health insurance premiums paid at 90% for employee, 80% for dependents, • Free access to Genentech Bus & Ferry Share program, • $100 monthly cell phone stipend, • Unlimited PTO for Exempt employees

Job DescriptionThe Opportunity At Maze Therapeutics, we believe that precision medicine has the power to transform the lives of patients with both common and rare diseases. As a Senior Clinical Trial Manager (Sr. CTM) at Maze Therapeutics, you'll play a hands-on role in driving the execution of our Chronic Kidney Disease (CKD) clinical trials. You'll have the opportunity to contribute to mid to late-stage clinical studies, work cross-functionally with internal teams and external partners, and ensure trials run efficiently and with the highest quality standards. If you enjoy rolling up your sleeves, collaborating across teams, and bringing innovative medicines to patients, this role could be the perfect fit for you. The Impact You'll Have • Clinical Trial Execution & Leadership, • Co-lead a mid-stage Phase II clinical trial in Chronic Kidney Disease, ensuring high-quality execution from study design to completion. Contribute to the Study Execution Team (SET), from study design and protocol development to completion of key study milestones (FPI, enrollment completion, interim analysis, database lock, and final CSR)., • Drive study feasibility efforts to inform site selection strategy to ensure timely study enrollment and completion; develop study enrollment forecasts., • Partner with Clinical Science to engage with therapeutic area KOLs., • Vendor, CRO & Site Management, • Lead and facilitate request for proposals from CROs and clinical trial vendors through final vendor selection as well as budget and contract negotiations, • Oversee CRO and vendor onboarding, and day-to-day oversight, ensuring adherence to budgets, protocols, and ICH-GCP guidelines., • Budget & Financial Oversight, • Support Clinical Operations Leadership with study-specific budget tracking and vendor spend management., • Data Quality, Compliance & Regulatory Readiness, • Ensure clinical trial data integrity and adherence to protocols, SOPs, and ICH-GCP guidelines through oversight of CROs, vendors, and site monitoring activities., • Partner with Quality Assurance on inspection readiness efforts., • Process Optimization & Technology Implementation, • Contribute to evaluating and implementing clinical trial systems (e.g., eTMF, CTMS, RBM) to enhance efficiency., • Assist in developing SOPs and scalable processes for clinical operations., • Cross-functional Collaboration, • Partner with internal teams, such as CMC and Clinical Supply Chain, to manage study drug supply and distribution. Work closely with other functions to ensure smooth study execution.What We're Looking For, • A Bachelor's degree in a scientific discipline or health related field with 5–8 years of clinical operations experience, including at least 4 years as a CTM, with, • hands-on experience managing Phases II–III clinical trials. Global trial experience is a plus., • Experience in common disease drug development preferred., • Familiarity with regulatory guidelines (FDA, EMA, ICH-GCP), • Experience conducting a broad range of clinical trial related activities including study start-up to study close-out, clinical trial databases (e.g., Medidata RAVE, Veeva), knowledge of clinical trial budgeting, and managing CROs and vendors., • Strong executional leadership, problem-solving skills, and ability to manage cross-functional teams at the study level., • A startup mindset, willingness to roll up sleeves, and ability to work in a fast-paced, evolving, and collaborative team environment., • Excellent communication skills and the ability to manage cross-functional relationships effectively. Impact Obsessed – We embrace the bold, take calculated risks, and learn from our mistakes to improve the lives of others. Stand True – Our integrity is foundational; it guides us no matter the obstacle. The expected annual salary range for employees located in the San Francisco Bay Area is $176,000 - $215,000. Additionally, this position is eligible for an annual performance bonus. Maze performs position-based compensation benchmarking to industry market data to ensure we pay competitive wages. Determination of starting salary will depend upon a variety of job-related factors, which may include professional experience, skills, and job location. The expected salary range for this role may be modified in the future. Maze offers a robust benefits package to our eligible employees including competitive medical, dental, and vision insurance, mental health offerings, equity incentive plan, 401(k) program with employer match and a generous holiday and PTO policy. #LI-Hybrid

Job DescriptionRole and Responsibilities • Manages overall operation of one or more clinical trials, including project planning, budget, resource management and contract research organization management, • Manages clinical operational plan, and incorporates the study and scientific plan, • May develop study related documents and overall direction for the clinical sites to establish protocol development, • Ensures compliance with international Good Clinical Practices, IRBs/Ethics Committees and National Health Authority regulations, • Recommend and implement innovative process ideas to impact clinical trials management, • Oversee CRO clinical operations services and may act as the central coordinator of other functional group CRO services oversight, • May oversee clinical trial budgets and contracts for CROs, other operational vendors and clinical sites, • Oversee Corvus internal operational platforms including Clinical Trial Management System, Trial Master File and select components of a Quality Management System, • Acts as a cross functional liaison to ensure study plans align with clinical development strategies, • Collaborate with other relevant functional groups on study planning, protocol development and maintenance, and scientific abstracts and publications, • Exercises independent judgment in selecting methods, techniques and evaluation criteria for obtaining results, • Acts independently to determine methods and procedures on new or special assignments, • May supervise the operational responsibilities and professional development of other Clinical Operations staffPosition Plan and Location, • This is an in-house position working from the Corvus office in South San Francisco 100% of time (Monday - Friday)Qualifications and Education Requirements, • Thorough knowledge of ICH Good Clinical Practices, • Bachelor’s degree or equivalent experience required, • Minimum 4 years of related experience required Preferred Skills, • Excellent teamwork and collaboration skills m4RmKijplu

Job Description About Nudge At Nudge, our mission is to develop the best technology for interfacing with the brain to improve people's lives. We're starting with an approach that we believe can help the most people the fastest, and also allow us to learn as much about the brain as possible: developing a non-invasive, ultrasound-based device that can stimulate and image the brain at high resolution and depth. This is a vertically integrated effort building cutting-edge hardware, software, and research capabilities to create products that can benefit millions — and eventually billions — of people. To succeed, we need to assemble world-class teams across everything we do. We hire people who are exceptional at their craft, believe hard things are worth doing, and execute relentlessly — people who expect the highest levels of both rigor and integrity from each other. About the role As a Quality Systems Engineer at Nudge, you will: * Ensure that new and existing product designs and processes meet all internal and regulatory requirements with respect to safety and performance * Partner in new product development by leading quality critical discussions, influencing key decisions, and driving necessary process changes across design controls, investigational studies, and clinical trials. * Effectively manage multiple tasks and drive execution of change orders * Initiate and/or support corrective action and preventive action (CAPAs) and non-conformances, leading investigations and implementing mitigations * Represent and cultivate a culture of quality by working with interdisciplinary teams to set expectations, identify gaps, and meet a high internal bar for rigor About you We are looking for Quality Systems Engineers with at least 2 years of industry experience. Regardless of career level, you should have: * Experience with design controls, product/process validation, and risk management * A degree in an engineering or scientific discipline (e.g., biomedical engineering, electrical engineering, neuroscience) or equivalent hands-on experience * Familiarity with Good Clinical Practice (GCP) and human factors * Familiarity with the FDA QMSR, ISO 13485, and ISO 14971 * Experience conducting risk management activities using tools such as failure mode and effects analysis (FMEA) * Strong technical writing skills * High integrity

Job DescriptionCompany Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok. Job Description Data Science and Analytics is an ambitious team of Data Scientists and Data Engineers with a unique blend of Business, Scientific, and Machine Learning expertise that seeks to unleash the full potential of AbbVie’s data assets by bringing technology and/or data and insights to the forefront of decision making via fit-for-purpose solutions. The Director, Data Science and Analytics is a leadership role and is responsible for driving vision, strategy, talent management and operations delivery of key planning, feasibility and real-world data products and insights across AbbVie’s portfolio. Identifies new capabilities and opportunities to drive analytics innovation and value creation. Fosters a culture of experimentation to enable data-driven insights for complex business problems. Influences cross-functional leaders to unleash the full potential of data and advanced analytics techniques like Machine Learning and Artificial Intelligence. Co-creates strategies with cross-functional stakeholders for next-generation analytics solutions in anticipation for future Clinical Development and R&D needs. Roles and Responsibilities: • Manages line-level people managers and guru data scientists to execute on the Data Science and Analytics strategy, • Lead next generation technology and process to enable enterprise data analytics on pace with emerging integrated data sources (operational data, real world data, clinical trial data, and other public data sources); Monitors emerging trends across the external technology and analytics environment. Assess impacts to current and future strategies, • Responsible for coaching, mentoring and performance management of direct reports; Develops future leaders in alignment with R&D business needs, • Identifies new capabilities and opportunities to drive analytics innovation and value creation for the responsible business areas (Clinical Trial Feasibility and Start-up). Forms cross-functional teams to implement new capabilities; Responsible for crafting functional area strategies while ensuring alignment with the cross-functional stakeholder groups, • Influences the cross-functional stakeholders and Sr. Executives to identify opportunities to unleash the full-potential of data and analytics, including advanced ML techniques and Artificial Intelligence, • Influences AbbVie’s enterprise data governance as a steward of clinical trials data and other sources that are utilized and analyzed by the team. Influence data owners from across R&D as well as areas that collaborate with R&D, • Translate R&D strategy into functional area plans. Works with cross-functional leaders to gain alignment on project prioritization and timelines, • Fosters innovation and entrepreneurial culture within the team that attracts and retains top talent; creates an environment of continuous learning, • Ensures adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and to functional quality standards. Stays abreast of new and/or evolving local regulations, guidelines and policies related to clinical developmentQualifications, • Bachelor’s degree statistics, analytics, bioinformatics, data science or equivalent field. Master’s degree preferred, • Must have 8-10+ years of experience with enabling novel analytics capabilities across business areas with 5-6 years of experience leading a team or cross functional initiatives, • Advanced domain knowledge in clinical trial planning, feasibility, start-up, and relevant data sources, • Expertise in current and emerging technologies (e.g., Data Visualizations, Big Data, AI, Machine Learning, NLP/NLG, Cognitive Analytics etc.) preferred, • Intermediate proficiency with visualization tools like Spotfire, Tableau or equivalent, • Track record with building high-performing Analytics and Data Science teams; Ability to attract, challenge, develop and retain specialized talent with expertise in clinical development., • Experience with Machine Learning and other advanced analytics techniques preferred, • Demonstrated effective communication skills. Demonstrated ability to communicate analytical and technical concepts in layman’s terms, • Demonstrated problem-solving and analytical skills. Track record with scaling multiple data science and analytics capabilities across the function/enterprise, • Demonstrated history of leading in a fast-paced environment and delivering meaningful impact on business outcomes, • Demonstrated ability to influence Sr. Executives and cross-functional leaders, • Good understanding of clinical development functional areas and related processes is preferred, • Proven track-record with leading complex cross-functional initiatives and change management efforts Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: * The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. * We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. * This job is eligible to participate in our short-term incentive programs. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

Job DescriptionPosition:Medical Assistant (MA/CMA)Location:San Francisco, CA (and other No Cal locations)Schedule:Full-Time and Part-Time positionsSalary:Competitive Salary & Bonus ProgramBenefits:Health, Dental, Vision, EAP, 401(k), FSA, Costco, AAA, etc. ABOUT US With a growing network of locations, California Foot & Ankle Centers (CALFAC) and Basso Podiatry Group (BPG) provides comprehensive podiatric care and surgery, including advanced wound care and amputation-prevention therapies, lower extremity peripheral nerve surgery, vascular medicine, and reconstructive surgery. We have been serving patients in Northern California for over 60 years, building a loyal patient base keeping our clinic locations busy with little to no marketing during that time. Our highly-competent doctors and medical staff all believe in giving a caring approach to each patient, as well as our utilizing the most modern technology available. Further, we conduct clinical trials and podiatric research at all of our locations. As a part of our team, you will be welcome in working with us for years to come as we do good work in our communities. We value team building, and our staff oftimes engages in after work activities in order to build relationships and play an essential role in our community. JOB BRIEF A Medical Assistant is essentially a technical assistant to the doctor or other clinicians. Duties include setting up the exam or procedure room in advance of a patient visit, with the proper supplies, instruments, and equipment. The Scribe will also take notes during the patient's visit, and assist with the charting and coding. Documentation will be using our EHR system, EPIC. As a Medical Assistant, you will partner with the doctors and other clinicians to provide a high level of efficient patient care, while always presenting a caring and professional experience for the patients. ESSENTIAL FUNCTIONS • Prepare and assemble medical record documentation/charts for doctors and other clinicians, • Set up the exam or procedure room in advance of a patient visit, with the proper supplies, instruments, and equipment, • With the doctor or other clinician during the patient visit, capture and transcribe medical record documentation utilizing electronic medical record applications, • Update patient history, physical exam, and other pertinent health information in the patient, • Prepare and send all documentation to doctor for review and approval via authentication of detailed data entry and facility-specific procedures, • Monitor the duration of basic lab results and screening procedures, • Accompany the clinician into patient examination rooms in order to transcribe the patient's history, physical exam findings, consultations, labs, X-rays, and other evaluations, as stated by the provider, directly into the medical record, • Prepare plans for follow-up care, as directed by the provider, • Assist with check-in, check-out, and follow-up procedures and documentation, • Provide advanced support to providers, including documenting phone calls, alerting the physician with labs/radiology reports are complete, getting and inserting emails and faxes, etc., • Comply with all hospital, medical facility, and office policies, including those relating to HIPAA, • Perform other clerical duties and tasks to improve provider productivity and clinic workflow as assigned, • All other duties and special projects, as assigned Position Requirements: • Professional demeanor, • Knowledge of medical terminology and human anatomy a plus, • Skilled in operating various medical record software and hardware, word-processing, and database software programs, • Ability to efficiently type using computer laptops or tablets., • Must have a passion for medicine and a desire to grow, • Must be adaptable and be willing to take constructive criticism, • Ability to multitask, prioritize, and work in fast-paced environment, • Ability to move about and follow a healthcare provider for extended periods of time, • Ability to read, write, comprehend through listening, and speak fluent English, • Spanish is a big plus (conversationally fluent), • Must have a high school diploma or equivalent, • Ability to operate a computer and/or laptop through proficient typing, clicking, and viewing a monitor for extended periods, • Must have a computer or access to a computer for virtual/online training SKILLS aND ABILITIES REQUIRED: • Detail-oriented, • Time management and task completion skills, • Team player, • Reporting skills, • Strong organizational skills, • Record-keeping skills, • Microsoft Office, and other office software, • Strong typing skills and administrative writing skills, • Ability to maintain strict confidentiality, • Excellent written and verbal communication skills Job Posted by ApplicantPro

Job Description Septerna is a biotechnology company based in South San Francisco, CA on a mission to develop life-changing medicines for patients with the vision to become the industry-leading G protein-coupled receptor (GPCR)-focused drug discovery company. The company's Native Complex Platform™ recapitulates GPCRs with their native structure, function, and dynamics outside of the cellular context. This approach enables novel access to modern structural and screening technologies used in industrial-scale drug discovery for the entire class of GPCRs. Septerna has an emerging pipeline of GPCR-targeted small molecule programs with potential for growth to target many GPCRs that have been undruggable and unexploited to date. We are excited to expand our multidisciplinary team of individuals focused on creating revolutionary medicines to address the unmet needs of patients. At Septerna we strive to embrace diversity of thought, expertise, and background through collaboration. To join our ambitious team, be prepared to bring your real self to work every day; grow and learn from a talented team of drug hunters, scientists, and business professionals; and contribute your passion, creativity, and energy to accomplish our mission. We share a fearless pursuit of ground-breaking innovations and cultivate an environment where our employees succeed by learning from each other and working as a team. We are committed to the development of meaningful therapeutics for patients with indications of high unmet need. This is a tremendous opportunity to work with talented individuals on the frontlines of therapeutic discovery and development. You will directly help move therapies through preclinical research, positioning them for success in the clinic. The successful candidate will add their passion, unique talents, and expertise to a dynamic team motivated to discover new disease-modifying therapeutics for patients in a fast-paced environment. For more information see: . About The Role Septerna has an exciting new opportunity to join the team as a Vice President, Clinical Development, reporting to the Chief Medical Officer. The VP, Clinical Development will join the Senior Leadership Team and provide key strategic leadership for clinical development strategy, planning, and tactical implementation for all clinical development functions. This position will also serve as the Product Development Team Leader (PDTL) for one or more of Septerna's clinical stage programs. The PDTL is responsible for product strategy and the design and successful cross-functional implementation of the development plan. S/he will also participate in regulatory interactions and contribute to building relationships with KOLs. Ability to bridge clinical, scientific, and business needs with the aptitude to translate and align business and scientific goals and objectives. Must be a dynamic leader with outstanding strategic, communication, and collaboration skills. Responsibilities • Enterprise leader of program strategy, collaborating in a matrixed working environment with clinical operations, regulatory, clinical pharmacology, research, CMC, and other functions to ensure the success of drug development programs., • Work with key internal and external stakeholders to lead the design and implementation of robust CDPs and integrated development plans to achieve the desired target product profile., • Guide the development team(s) with aggressive, creative, but realistic approaches to drug development., • Direct and design fit-for-purpose clinical trials across all phases in drug development; design and draft protocol synopses, clinical trial protocols, amendments, and supporting documents., • Contribute to IBs, regulatory documents, CSRs, and publications associated with clinical trials., • Provide medical oversight of multiple clinical studies and provide medical input and guidance on scientific, clinical and safety monitoring issues., • Be accountable via collaboration across functions and clinical operations for all relevant timelines and deliverables., • Collaborate with regulatory affairs to develop high-quality strategic regulatory strategies and engagement., • Communicate to management and relevant functions any potentially significant issues to the CDP or emerging safety risks in a timely manner., • Provide strategic consultation and guidance to Research on decision that have significant clinical components and implications., • Ensure compliance with SOPs, ICH, GCP, and other national and international regulatory requirements., • In conjunction with the Chief Medical Officer, ensure organizational growth plans for clinical Development scales with Septerna's current and future needs., • Mentor and develop more junior physicians and other clinical development staff to successfully advance to higher levels of responsibility., • MD or MD/PhD required and 10+ years of experience in Clinical Development or related pharmaceutical capacity., • Endocrinology/Board Certified Endocrinologist preferred., • Proven track record of drug development in multiple therapeutic areas., • Rare disease experience is preferred., • Excellent communicator with team building and collaboration skills., • In depth knowledge of drug development process and oversight of clinical trials; well versed in first-in-human trials as well as late phase development and product filing/ registration., • Has seen and managed significant accelerations and challenges in clinical programs., • Outstanding management skills a must, both with respect to managing the development team but also evidence of successful enterprise/matrix leadership., • Demonstrated ability to lead cross-functional teams to make significant recommendations and persuasively present synthesis of team diligence to gain alignment with senior management., • Expertise in innovative clinical trial design, scientific writing, and the successful implementation of clinical protocols and clinical study reports., • Experience in all phases of regulatory submissions and interactions; international experience also required, along with negotiation experience with the FDA., • Comprehensive knowledge of Good Clinical Practices (GCP), ICH, ICJME Guidelines, FDA and other international regulatory body requirements., • Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency., • Superb presentation skills., • Thrives in a highly entrepreneurial biotech environment. The anticipated salary range for candidates who will work in South San Francisco, CA is $380,000 - $420,000. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, work location and relevant education or training. Septerna's compensation package also includes benefits, stock options, and annual target bonus for full-time positions. We are an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. Note to Employment Agencies: Please do not forward any agency resumes. The company will not be responsible for any fees related to resumes that are unsolicited. Note to Employment Agencies: Please do not forward any agency resumes. The company will not be responsible for any fees related to resumes that are unsolicited. We are an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. Septerna participates in the E-Verify program. California Consumer Privacy Act Privacy Notice For Job Applicants. If you are a California resident, click here for our CCPA Notice.

Job DescriptionCompany Description Zai Lab is a patient-focused, innovative, commercial-stage, global biopharmaceutical company based in China and the United States. We are dedicated to discovering, developing, and commercializing best-in-class and first-in-class therapies that address medical conditions with significant unmet needs in oncology, immunology, neuroscience, and infectious disease. Guided by innovation and driven by purpose, our mission is to leverage our expertise and resources to make a lasting, positive impact on human health worldwide. Zai Lab’s global team of 2,100 talented professionals includes industry leaders and professionals dedicated to advancing novel therapies to patients. With headquarters in Cambridge, Massachusetts, and Shanghai, and teams in the U.S., China and Europe, we collaborate across time zones to deliver meaningful impact where it’s needed most. Founded in 2014 by Dr. Samantha Du, Zai Lab was purpose-built to become a leading global biopharma, combining scientific innovation, operational scale, and strong execution. Our global pipeline features ZL-1310, a DLL3 antibody-drug conjugate (ADC) with best-in-class and first-in-class potential in small cell lung cancer, now in clinical trials. At the same time, our R&D team is progressing several other global programs into the clinic, including ZL-1503, a bispecific IL-13/IL-31 antibody for atopic dermatitis, and ZL-6201, an LRRC15 ADC for solid tumors. In China, we’ve earned a reputation as a partner of choice for leading global biopharmaceutical companies, leveraging our proven commercial infrastructure and clinical trial capabilities to accelerate market access to our innovative products. Due to its large population, China is the second largest pharmaceutical market in the world. Our unique business model combines in-licensed assets with strategic partnerships, leveraging our in-house research capabilities to build a regional portfolio of late-stage, potential best-in-class and first-in-class therapies. Today, with eight products on the market in China, we are delivering meaningful impact for patients and building opportunities for talented professionals to shape the future of medicine. Zai Lab is publicly traded with dual-primary listings on both the Nasdaq Stock Market and the Hong Kong Stock Exchange, underscoring our commitment to transparency, global reach, and long-term growth. Job Description The Senior Medical Director will lead late-stage clinical development programs in Oncology, including pivotal Phase III trials and registration studies. Responsibilities include independently contributing to and executing on the clinical strategy, serving as Medical Monitor, supporting regulatory submissions and commercialization efforts, and collaborating and leading cross-functional teams. The role plays a key part in scientific oversight to ensure successful execution and advancement of oncology assets and representing Zai Lab externally. This role is based in our Cambridge, MA office. • Clinical Trial Leadership: Provide medical leadership for the design and execution of late-stage clinical trials, including pivotal and confirmatory studies. Collaborate closely with clinical operations to ensure trials are conducted in alignment with scientific objectives, patient safety standards, and regulatory requirements., • Medical Monitoring: Serve as Medical Monitor for Phase III and registration trials, ensuring patient safety, protocol compliance, and timely medical oversight. Review safety data, support data monitoring activities, and act as the primary medical contact for study teams and investigators., • Strategic Input: Contribute expert medical and scientific leadership to clinical development strategies, regulatory submissions, and lifecycle planning., • Cross-functional Collaboration: Work closely with regulatory affairs, clinical operations, pharmacovigilance, biostatistics. medical affairs, and commercial teams to align clinical and business objectives., • External Representation: Represent Zai Lab in interactions with investigators, key opinion leaders, regulatory authorities, and external collaborators., • Data Analysis & Interpretation: Analyze clinical trial data and real-world evidence to identify trends, assess efficacy and safety signals, and support data-driven decision-making. Collaborate with cross-functional teams to translate findings into actionable insights that inform clinical strategy, regulatory submissions, and program advancement., • Lifecycle Management: Develop strategies for label expansion, post-marketing commitments, and long-term product differentiation., • Regulatory Support: Lead the preparation of regulatory documents, participate in health authority interactions globally, and contribute to risk management planning and mitigation strategies throughout the development lifecycle., • Business Development: Provide clinical expertise to support licensing opportunities, partnerships, and due diligence activities., • Stakeholder Engagement: Build strong relationships, challenge ideas constructively, and drive impactful decision-making based on scientific evidence., • Scientific Leadership: Maintain up-to-date knowledge of oncology trends, the competitive landscape, and regulatory changes to inform clinical strategy., • Ability to work across several time zones and travel up to 30%. Qualifications REQUIRED • Proven track record as a Medical Monitor for pivotal trials and successful regulatory submissions., • Deep understanding of oncology drug development, clinical endpoints, and regulatory pathways., • Proven ability to lead cross-functional teams and manage complex clinical programs., • Clinical practice experience or experience as an investigator is a plus., • Excellent leadership, strategic thinking, and communication skills., • Strong collaboration skills to effectively interact with internal and external stakeholders., • Demonstrated commitment to high personal values and ethical standards. Additional Information The pay range for this position at commencement of employment is expected to be between $299K and $349K/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. At Zai Lab, we are proud of the gender diversity of our company and our promotion of women in biotech. We have achieved gender base pay equity at all levels, 59% of our employees are women and 53% of our management positions are held by women. We are committed to the health of patients and our planet. That’s why our environmental protection, social responsibility, and corporate governance strategy, called “Trust for Life,” is integrated within our business. Disclaimer: This description is not intended to be construed as an exhaustive list of duties, responsibilities, or requirement for the position. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or based on disability. Zai Lab is committed to protecting the privacy and security of the information we collect and to being transparent about the purposes for which we use your information. We have a Privacy Notice which sets forth our policies and practices for handling the information we collect and use in the employment context. Privacy Notice available upon request.

Job DescriptionThe Position As the Director, Biostatistics, you will play an important role in shaping and supporting the clinical development of Maze's therapeutic programs. You will partner closely with Clinical Science, Regulatory Affairs, Clinical Pharmacology, Development Science, and Translational Science to ensure our clinical studies are robust, data-driven, and impactful. In this role, you'll oversee biostatistical strategy and execution, from study design through regulatory submissions, balancing hands-on expertise with strategic leadership. You will also represent Biostatistics on clinical study teams, guide interpretation of complex data, and oversee CRO partners to ensure high-quality statistical deliverables. The position will report to the Vice President, Biometrics. The Impact You'll Have • Serve as the biostatistics lead for clinical studies, providing expert input on study design, endpoints, and statistical strategy, • Oversee and contribute to completion of all technical and operational statistical activities for a group of clinical trials. Ensure development and review of statistical analysis plans (SAPs), including complex and innovative methodologies, • Collaborate with cross-functional partners in protocol development, study design discussions, and data interpretation, • Partner with Statistical Programming to generate and validate analyses for internal use, publications, and regulatory submissions, • Oversee CRO execution of statistical tasks: managing timelines, quality, and analytical approaches, • Represent biostatistics in regulatory interactions (FDA, EMA, PMDA, etc.), contributing to briefing documents, meeting preparation, and responses to agency questions, • Contribute to clinical study reports (CSRs), integrated summaries (ISS/ISE), and regulatory submissions (NDA/BLA/MAA), • Apply advanced statistical techniques to explore, analyze, and interpret clinical, safety, biomarker, and exploratory data, • Advise internal and external partners on statistical approaches, data reliability, model selection, and interpretation of results, • Lead the gathering, organization and analysis of different data sources to enable delivery of special projects and / or the statistical analysis plan and clinical study endpoints for assigned products, • Review and analyze safety reporting, biomarker analyses and other aspects of clinical trial monitoring, • Develop enhancements to statistical software, as appropriate, by programming new techniques; maintain knowledge of current and emerging trends in statistical analysis methodologies and tools, • Provide biostatistical input into clinical development documentation, scientific publications and presentations, and regulatory documentation, • Adhere to regulatory requirements of study conduct, statistical analysis principles, industry standards, and Maze SOPs, • Communication and Influence, • Builds communication channels across Maze for sharing information., • Influences Senior Management decisions through persuasive arguments., • Respectfully addresses differing opinions leading to support of decisions., • Teamwork and Collaboration, • Champions partnerships and connections across Maze., • Proactively addresses issues that could result in breakdown of team relationships., • Spotlights team and individual contributions in public forums., • Execution and Results, • Addresses gaps and leverages strengths to get best results., • Maintains a steadying presence and clarifies priorities during change., • Anticipates and removes barriers that put functional/corporate goals at risk., • Develop Others and Self, • Remove barriers to staff development and empowers them to make their own decisions., • Stays current on industry trends and keeps direct-reports prepared and responsive.What We're Looking For, • An advanced degree in Biostatistics, Statistics, or a related field., • Master's degree with 10+ years of experience, or Ph.D. with 8+ years of experience, • Comfortable being hands-on with analysis, simulations, and document review, • Direct experience designing early-stage trials (Phase I/II) and late-stage trials in resource-constrained settings, • Confident decision-maker who can influence at the executive level About Maze Therapeutics Maze Therapeutics is a clinical-stage biopharmaceutical company harnessing the power of human genetics to develop novel, small molecule precision medicines for patients living with renal, cardiovascular and related metabolic diseases, including obesity. The company is advancing a pipeline using its Compass platform, which allows it to identify and characterize genetic variants in disease and then link those variants to the biological pathways that drive disease in specific patient groups through a process it refers to as variant functionalization. The company's pipeline is led by two wholly owned lead programs, MZE829 and MZE782, each of which represents a novel precision medicine-based approach for chronic kidney disease. Maze is based in South San Francisco. Our People Maze is comprised of a team of passionate and creative professionals committed to discovering and delivering transformative medicines to patients suffering from both rare and common genetic diseases. We are fostering a culture that encourages vision, initiative and the development of talent. Our supportive work environment inspires creative thinking and freedom of expression, resulting in a stimulating atmosphere where people enjoy coming to work. While we have a passion for advanced science and pride ourselves on excellence in execution, ultimately, everything we do is about patients. Our Core Values Further Together – Our path is paved with challenges, but with resilience and a team-first mentality, we'll achieve our mission. Impact Obsessed – We embrace the bold, take calculated risks, and learn from our mistakes to improve the lives of others. Stand True – Our integrity is foundational; it guides us no matter the obstacle. The expected annual salary range for employees located in the San Francisco Bay Area is $228,000 – $280,000. Additionally, this position is eligible for an annual performance bonus. Maze performs position-based compensation benchmarking to industry market data to ensure we pay competitive wages. Determination of starting salary will depend upon a variety of job-related factors, which may include professional experience, skills, and job location. The expected salary range for this role may be modified in the future. Maze offers a robust benefits package to our eligible employees including competitive medical, dental, and vision insurance, mental health offerings, equity incentive plan, 401(k) program with employer match and a generous holiday and PTO policy. #LI-Hybrid

Job DescriptionCompany Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok. Job Description The Biologics Drug Product Development group within AbbVie is a global organization responsible for developing and characterizing drug product formulations and manufacturing processes for biologic therapeutics (antibodies, antibody-drug conjugates (ADCs), neurotoxins, and novel biologic formats) from preclinical development through clinical proof of concept. We have an exciting opportunity available for an Scientist I or Associate Scientist II to join our team at our Bay Area site in South San Francisco, CA. This is a lab-based position and requires fulltime on-site presence. Successful candidates will thrive in a collaborative lab environment. Key responsibilities include: • Own & support stability / in-use / process studies: work within the process operations team to fill development drug product batches for GLP toxicology studies, reference standard fills, and representative drug product batches. Develop skills to plan and execute screening, in-use, and formulation stability studies to support formulation and process development for clinical trials., • Perform analytical assays & support troubleshooting: conduct analytical assays to evaluate protein and excipients stability (i.e. HPLC/UPLC, SEC, CEX, CE‑SDS, icIEF, UV-Vis, CD, Karl Fischer titration, HIAC, MFI). Generate high-quality data to support selection of formulation composition, development of dose administration guidance, and drug product manufacturing instructions. Develop the skills to independently troubleshoot assays and instruments to ensure consistent quality data output., • Analyze & communicate results: analyze study results, organize and document the results in an electronic lab notebook (ELN), and effectively communicate updates, troubleshooting, and results to the team. Interpret results and draw conclusions from multistage experiments with support from study owners and project leads. Communicate aberrant data and lab issues to management to gain input and alignment on solution., • Write technical reports and communicate technical updates: Author technical reports to support regulatory filings and present the study results and findings to the team, • Collaboration: Collaborate closely with highly matrixed team members to support pipeline programs and participate in project teams as a study ownerQualifications, • Associate Scientist II Qualifications: Degree in chemistry, chemical engineering, biochemistry, pharmaceutical sciences or equivalent, • Bachelor’s Degree with 3 or more years’ experience or Master’s Degree (no additional experience), • Scientist I Qualifications: Degree in chemistry, chemical engineering, biochemistry, pharmaceutical sciences or equivalent, • Bachelor’s Degree with 5 or more years’ experience or Master’s Degree with 2+ years of experience, • Strong technical background encompassing protein chemistry and protein handling., • Hands-on experience with running and troubleshooting analytical techniques used for protein characterization and stability testing such as SEC, CEX, iCIEF, CE-SDS, HIAC, and MFI., • Ability to work in cross-matrixed team supporting multiple projects and participate in project-focused teams., • Technical ability to execute and troubleshoot experiments through rational and critical thinking. Must be highly organized and detail oriented., • Eagerness to learn and apply new scientific techniques., • Excellent verbal and written communication skills., • Strong collaborative skills for working effectively within the team., • Prior experience in protein formulation development, process development, drug delivery, or analytical functions is highly preferred., • Prior experience utilizing automated liquid handlers and/or executing high-throughput screening workflows is highly preferred. Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: * The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. * We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. * This job is eligible to participate in our short-term incentive programs. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

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