1070 jobs in Initial Therapeutics, Inc.

ADMA Biologics is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection. It is our devotion to this underserved population that fuels us and our hands‑on approach to production and development that sets us apart. If you are looking for a dynamic, innovative, growing company in the biopharmaceutical industry that is committed to excellence and integrity, then consider ADMA Biologics. We currently have an exciting opportunity available for a Senior Medical Science Liaison supporting the US Southwest Region!

Job Title: Senior Medical Science Liaison

The Senior Medical Science Liaison identifies, develops, maintains, and leverages collaborative relationships with current and future Key Opinion Leaders (KOL’s) in therapeutic areas of interest to ADMA Biologics, Inc. as well as key members of Pharmacy and Therapeutics (P&T) Committees and Healthcare Organizations (HCOs) in the private and public sectors. The Senior Medical Science Liaison is the expert in presenting, training, and educating stakeholders in the use of our products and contributes medical perspective to the process of product development and brand planning and supports the clinical research group in the management of clinical trials and the writing of scientific articles.

• Leads efforts in recognizing, identifying, cultivating, and integrating KOL relationships in specific therapeutic areas of interest to ADMA. Identifies opportunities for scientific growth and medical evidence in support and/or expansion of current utilization of therapies and execution of mutual interest initiatives such as research and continuing medical education (CME) in support of company objectives and enhancing ADMA’s reputation as a scientifically innovative industry partner.
• Maintains a level of medical‑scientific knowledge in an assigned therapeutic area(s) and/or disease state(s) involving clinical issues related to ADMA’s products.
• Remains current to be able to interpret and convey pertinent scientific data and evaluate new information.
• Provides current clinical and research‑related information on diseases for which company products may be utilized (including competitive pipeline information) and information on the management of diseases (including clinical and post‑marketing experience information on the efficacy, safety, pharmacokinetic and pharmaco‑economic profiles of marketed and pipeline products) Works to secure acceptance and favorable product positioning on drug lists and formularies.
• Assists in identifying potential investigators and sites for clinical trials. Manages, monitors, and communicates IIR study activity to meet established budgets and timelines. Contributes expertise in the internal review of study data, facilitates publication opportunities, and executes tactical plans.
• Provides scientific, medical, and/or clinical expertise to departments and other areas as needed including periodic updates to standard response letters sent in response to a Medical Information Requests.
• Supports sales and marketing in conducting competitive surveillance of disease states and products in our areas of commercialization and pipeline development.
• Actively involved in creating and managing ADMA Advisory Boards and Key Opinion Leader Programs.

• Doctoral level in sciences or degree in the life sciences (PharmD, MD, DO, PhD, Nursing or equivalent) a minimum.
• At least 3 years relevant work experience as MSL in immunology, pulmonology/respiratory or Infectious Disease field. Excellent written and verbal communication skills required.

• Doctoral level in the sciences required (MD, DO, PharmD).
• Training and/or clinical experience in Immunology, Pulmonology/Respiratory or Infectious Disease a Plus.
• 5 years (Senior MSL) related MSL work experience.
• Minimum 5 years’ experience in Immunology, Respiratory, and/or Infectious Disease preferred.
• Previous experience with product launches and life cycle management in relevant disease area.

The minimum compliance expectation for this role entails strict adherence to FDA regulations and company policies governing sales and marketing activities. This includes completion of required compliance training, accurate documentation of sales interactions, and adherence to data privacy regulations. Additionally, the role requires proactive participation in compliance reviews, prompt reporting of any potential issues, and ongoing education to stay updated on relevant FDA regulations.

• 401K plan with employer match and immediate vesting
• Medical, Vision, Life and Dental Insurance
• Pet Insurance, Company paid STD and LTD
• Company Paid Holidays
• 3 Weeks’ Paid Time Off (within the first year)
• Tuition Assistance (after the first year)
• Easily accessible to Tri-Rail
• Free shuttle to the Boca Tri-Rail station

ADMA Biologics uses E-Verify to confirm the employment eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit

ADMA Biologics is an Equal Opportunity Employer.

Initial Therapeutics, Inc. is seeking a Medical Science Liaison (MSL) to build relationships with key opinion leaders in Florida. The MSL will provide scientific information, support clinical trials, and ensure compliance with regulations.

The ideal candidate will have at least 4 years of experience in hematology/oncology and hold an advanced medical degree. This role involves significant travel within the territory and offers a comprehensive benefits package.

Position Summary

The primary responsibility of the Medical Science Liaison (MSL) is to identify, develop, and maintain collaborative working relationships with national and regional medical and scientific key opinion leaders (KOLs) to align interests, discuss medical/scientific information and research for ADMA products and associated disease states. The MSL is the scientific and clinical expert for providing comprehensive, accurate, fair balanced, scientifically rigorous information and appropriate products and disease state education to KOLs, other health care professionals, formulary decision makers, and internal partners based on business needs in compliance with all policies and procedures. The MSL contributes medical perspective to product development and brand planning as well as supporting the clinical research group in the management of clinical trials and writing of scientific articles.

• Provides current clinical and research-related information on the ADMA product portfolio (including clinical and post‑marketing experience information on the efficacy, safety, pharmacokinetic and pharmacoeconomic profiles of marketed and pipeline products) and management of disease states (hepatitis B, primary or secondary immunodeficiency, transplantation (HSCT and SOT), and infections in the immunocompromised host) for which ADMA products may be utilized.
• Provides relevant clinical and research-related information including competitive pipeline information to the medical/research community.
• Builds relationships and maintains periodic structured contact with KOLs in the company’s niche market in a specific geographic region and conducts onsite visits, as necessary.
• Responds to unsolicited requests for medical information from healthcare providers.
• Assists in identifying potential investigators and sites for company-sponsored clinical trials and aids in navigating investigator-initiated research proposals through the review process.
• Provides clinical expertise to departments and other areas as needed.
• Delivers formal presentations on scientific information to KOLs and others as necessary in the private and public sectors.
• Provides scientific and medical information that supports product consideration on Drug Lists/Formularies with population health decision makers.

• Works collaboratively with medical and regulatory to ensure compliance with the FDA and other regulatory agency requirements.
• Partners with cross-functional colleagues (sales, marketing, market access, etc.) to ensure medical strategies and business plans are both patient and business focused.
• Supports sales and marketing in conducting competitive surveillance of disease states and products in our areas of commercialization and pipeline development.
• Attends scientific conferences to gather, analyze, and synthesize new scientific information relevant to the ADMA products and disease states of interest; and gains medical voice of the customer.
• Actively involved in the development and management of our Advisory Boards and Key Opinion Leader Programs.

• Education Requirements: An advanced medical degree required: PharmD, NP, PA, MD, or PhD

• Experience Requirements:
  • A minimum of 4 years scientific or clinical experience in hematology/oncology or solid organ (lung) transplant.
  • A minimum of 2 years previous MSL experience necessary in hematology/oncology, solid organ transplant, immunology, pulmonology/respiratory, rare disease, infectious disease.

• Ability to support specific territory with up to 70% travel with overnight stays.

• Preferred Education Requirements: An advanced degree including DO or RPh is preferred.
• Residency/fellowship training
• Relevant board certification

The minimum compliance expectation for this role entails strict adherence to FDA regulations and company policies governing sales and marketing activities. This includes completion of required compliance training, accurate documentation of sales interactions, and adherence to data privacy regulations. Additionally, the role requires proactive participation in compliance reviews, prompt reporting of any potential issues, and ongoing education to stay updated on relevant FDA regulations.

• 401K plan with employer match and immediate vesting
• Medical, Vision, Life and Dental Insurance
• Pet Insurance
• Company paid STD and LTD
• Company Paid Holidays
• 3 Weeks’ Paid Time Off (within the first year)
• Tuition Assistance (after the first year)
• Easily accessible to Tri‑Rail
• Free shuttle to the Boca Tri‑Rail station

ADMA Biologics uses E-Verify to confirm the employment eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit

ADMA Biologics is an Equal Opportunity Employer.

At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission to serve patients living with serious illnesses drives all that we do.

Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas: Oncology, Inflammation, General Medicine, and Rare Disease, we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller, happier lives.

Our award-winning culture is collaborative, innovative, and science-based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

In this vital role, you will support the Rare Disease Therapeutic Area (RDTA) MSL teams and report into the Field Medical Excellence (FME) team. The FME Strategy Lead will partner with the RDTA leadership, serving as a member of their SLT to advance organizational strategies and goals. Responsibilities can include:

• Serve as the TA POC for designated cross-functional medical and commercial teams for prioritized meetings, updates, and ongoing strategy (examples include QMR, planning and execution of Therapeutic Area Meetings, operational activities related to TA-specific national meetings and calls) as designated by the TA MSL Lead.
• Provide TA leadership and collaborate with FME Field Systems and Capabilities, Data & Analytics, and other stakeholders regarding specific TA needs for ALIGN documentation and MAX reporting needs for MSL and senior leadership.
• Conduct briefings on key strategic MSL priorities, including Execution, Leading, and Lagging measures, outcomes, and qualitative insights for senior management.
• Influence the analysis, design, and construction of the SEP and tactical implementation plans for the MSL team. Provide insights and recommendations into long-range goals, training, and resource needs for the MSL team, in conjunction with K&L, Medical, and SciComm.
• Participate in and handle administrative departmental activities such as budgets, resources, and staffing needs for specified products.
• Under the direction of MSL TA Lead, set strategic role for MSLs and serve as POC for Congresses/Medical Meetings/scientific exhibits pertinent to identified products and pipeline molecules.
• Represent the department or Amgen as a primary internal and external contact, as directed by the MSL TA Head or FME leadership.
• Provide oversight and consistent updates to the MSL SharePoint site and Teams to ensure ready access to MSL resources that optimize efficiency.
• Lead and conduct projects with vendors and cross-functional departments as assigned by the TA Lead or FME leadership (examples include the MSL TA Feedback Survey, Veeva Link, and AI projects).
• Partner closely with cross-TA FME Strategy Leads and FME leadership to ensure consistent practices across TAs with respect to compliance, documentation and reporting practices, and use of internal and external data sources for profiling and consulting.
• Travel up to 10% as required.
• Position is remote anywhere in the continental US.

We are all different, yet we all use our unique contributions to serve patients. The FME Strategy Lead (Sr Manager) for the Rare Disease Field Medical Teams will actively collaborate with the teams, deploying their outstanding qualifications to serve patients.

Basic Qualifications:

• Doctorate degree and 2 years of Medical Affairs experience.

OR

• Masters degree and 4 years of Medical Affairs experience.

OR

• Bachelors degree and 6 years of Medical Affairs experience.

Preferred Qualifications:

• Ph.D., M.D., Pharm. D., or D.O. in a medical field.
• 3 or more years of directly related clinical and/or scientific experience.
• 2 or more years as a medical science liaison.
• Rare Disease therapeutic area expertise.

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan.
• Stock-based long-term incentives.
• Award-winning time-off plans.
• Flexible work models, including remote and hybrid work arrangements, where possible.

for a career that defies imagination.

Objects in your future are closer than they appear. Join us.

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is 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, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Senior Director, Regulatory Affairs (Strategy, Hematology Oncology)

Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation medicines, the next frontier in innovative drug design aimed at improving treatment options for patients with cancer and inflammatory diseases. Powered by a fully AI-integrated discovery engine capable of tackling any protein class, and coupled with unparalleled ligase expertise, Nurix’s dedicated team has built a formidable advantage in translating the science of targeted protein degradation into clinical advancements. Nurix aims to establish degrader-based treatments at the forefront of patient care, writing medicine’s next chapter with a new script to outmatch disease.

Nurix Therapeutics, Inc. is seeking a Senior Director Regulatory Affairs (Strategy, Hematology Oncology) to join the Regulatory team. The successful candidate will be a core member of the Regulatory team and will be responsible for helping build and execute on global regulatory strategy, objectives, policies and programs pertaining to development and future marketing of products for guiding and executing upon regulatory strategy of compliant, high quality, nonclinical and clinical submissions and interactions in support of early development, registration and life cycle management activities. This includes supporting regulatory activities to enable clinical development plans and studies, working cross‑functionally across the organization.

• Provides regulatory strategic direction and support for assigned global development programs and activities.
• Assists Sr. Regulatory Affairs staff with their development program activities and deliverables.
• Designs and implements regulatory strategies with Regulatory Affairs staff to obtain and maintain product investigative and marketing applications for assigned programs, as well as their life cycle management.
• Acts as regulatory representative on early and/or late phase clinical studies, ensuring compliant execution of trials.
• Strong competency in understanding regulatory requirements and emerging regulatory landscapes associated with US and global regulatory authorities.
• Experienced in responding to inquiries from global regulatory authorities as well as the preparation and conduct of meetings with global regulatory authorities.
• Assist in the preparation and maintenance of Annual Reports, Development Safety Update Reports (DSURs), Investigator’s Brochures and other documents required for INDs, CTAs, NDAs and other related regulatory development and marketing applications.
• Assist in the cataloging and maintenance of regulatory application submissions.
• Conduct research and stay up‑to‑date on regulatory requirements and changes.
• Collaborate with cross‑functional teams to ensure product compliance throughout the development lifecycle.
• Monitor and assess regulatory risks and develop mitigation strategies.
• Oversee quality assurance processes to ensure compliance with regulatory standards.
• Review SOPs pertaining to Regulatory.
• Works strategically with all regulatory functions to develop detailed, actionable submission plans, track major submission deliverables, and ensure consistent management submission documents, health authority communications, and all other regulatory information supporting Nurix’s investigational and marketing applications.
• Plays an essential part in defining requirements for, implementing, and supporting future systems and tools to be employed by Nurix in the areas of document management, submission content planning, and regulatory information management.
• Tracks the status of major deliverables for regulatory submissions (e.g., study reports, summary documents, labeling) along with their dependencies.
• Develops and maintains submission plan templates to ensure Nurix regulatory submissions are consistently planned and executed across programs.
• Participates in cross‑functional process initiatives impacting regulatory submission processes and systems.
• Manages consultants and contractors as needed.

• Bachelor’s degree in life sciences or related scientific discipline; advanced degree preferred.
• Must have a minimum of 12 years in regulatory affairs strategy.
• Strong demonstration of knowledge of drug development, FDA, EMA and ICH guidelines and regulations.
• Experience providing hands‑on support for planning clinical trial and marketing applications to health authorities including but not limited to FDA, EMA.
• Ability to read, analyze and interpret scientific and technical information, as well as regulatory.
• Ability to understand and explain detailed regulatory affairs and compliance programs and/or to effectively present information to senior regulatory management, other departments or external stakeholders.
• Ability to comply with changing regulatory requirements.
• Proven track record of supporting regulatory affairs in the planning and execution of major filings and ongoing maintenance of clinical trial and marketing applications.
• Strong project management and critical thinking skills.
• Experience applying project management techniques and tools (e.g., MS Project, Smartsheet, Excel trackers) to the planning and execution of regulatory submissions.
• Excellent organizational and communication skills, both written and verbal.
• Ability to work independently as well as part of a team environment.
• Positive attitude, energetic and proactive.
• Proven ability to manage multiple projects, identify and resolve regulatory issues.
• Strong interpersonal skills and the ability to effectively work with others.

Nurix Therapeutics, Inc. is committed to protecting and respecting your privacy and personal information, including information collected by Nurix when you apply for a job with Nurix or in the course of your employment with Nurix. By applying for a position at Nurix, you agree to our collection and use of personal information as described in our Privacy Policy.

Initial Therapeutics, Inc. is seeking a Senior Manager / Associate Director of Computer Systems Assurance in Brisbane, CA. This role will involve overseeing the CSA program and ensuring compliance with regulatory expectations while validating SaaS GxP systems.

The ideal candidate will have over 7 years of experience in computer systems validation and be proficient in managing assurance strategies in a biopharmaceutical environment. Competitive salary ranges from $170,538 to $216,360 depending on experience.

Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation medicines, the next frontier in innovative drug design aimed at improving treatment options for patients with cancer and inflammatory diseases. Powered by a fully AI-integrated discovery engine capable of tackling any protein class, and coupled with unparalleled ligase expertise, Nurix’s dedicated team has built a formidable advantage in translating the science of targeted protein degradation into clinical advancements. Nurix aims to establish degrader-based treatments at the forefront of patient care, writing medicine’s next chapter with a new script to outmatch disease.

Senior Manager / Associate Director, Computer Systems Assurance (CSA) is an important technical and operational leader within the Nurix Quality Systems organization, responsible for owning and advancing Nurix's computer systems assurance program. As a virtual drug developer, Nurix operates through a lean internal infrastructure and relies on a curated ecosystem of Software-as-a-Service (SaaS) and cloud-hosted platforms to support GxP-regulated activities across clinical development, quality operations, manufacturing oversight, and regulatory submissions. This role will serve as the primary subject matter expert and program owner for all CSA and computerized system validation (CSV) activities at Nurix.

Reporting to the Vice President / Senior Director, Quality Systems, this individual will establish and maintain Nurix's risk-based CSA framework aligned with current regulatory expectations, including the FDA's 2022 guidance on computer software assurance, GAMP 5 (2nd edition), and applicable 21 CFR Part 11 and Annex 11 requirements. The role requires an individual who combines deep technical knowledge of GxP computerized systems with practical experience in SaaS and cloud-based platform qualification, and who can translate regulatory requirements into pragmatic, fit-for-purpose validation approaches that support a modern, agile biotech environment. This is a high-impact, program-ownership role requiring both strategic vision and hands‑on execution. The successful candidate will work closely with Quality, IT, Regulatory Affairs, CMC, Clinical Operations, and external vendors to ensure that all GxP‑critical systems are appropriately assessed, validated, and maintained in a compliant state. The individual will champion a risk-based, science-driven approach to CSA across the organization.

• Own and maintain Nurix's Computer Systems Assurance policy framework, SOPs, and risk‑based validation strategy, aligned with FDA CSA guidance (2022), GAMP 5 (2nd edition), 21 CFR Part 11, EU Annex 11, and applicable ICH guidelines.
• Define and implement a fit‑for‑purpose, risk‑tiered approach to system qualification for SaaS and cloud‑hosted GxP applications, recognizing the vendor‑managed nature of modern software platforms.
• Maintain the GxP system inventory; conduct and document periodic system risk assessments to classify systems and determine appropriate validation scope and rigor.
• Establish and maintain processes for vendor assessment, including review of vendor SOC 2 reports, quality agreements, and audit strategies appropriate for SaaS providers.
• Drive continuous improvement of the CSA program through benchmarking, regulatory intelligence, and adoption of industry best practices.

• Lead and execute validation activities for GxP SaaS platforms including, but not limited to, eQMS (e.g., Veeva Vault), electronic document management, clinical data management, regulatory information management, and laboratory information systems.
• Author and review validation documentation including Validation Master Plans (VMPs), User Requirements Specifications (URS), Risk Assessments, Vendor Assessments, Validation Protocols (IQ/OQ/PQ), Traceability Matrices, and Validation Summary Reports.
• Manage validation activities associated with system implementations, major configuration changes, upgrades, and periodic re‑validation reviews, applying critical thinking to scope validation effort proportionate to system risk and change impact.
• Coordinate validation testing activities with cross‑functional stakeholders; ensure test scripts are appropriately designed to demonstrate fitness for intended use.
• Review and approve validation deliverables prepared by internal teams, vendors, or external validation consultants.

• Serve as the internal subject matter expert for 21 CFR Part 11 and EU Annex 11 requirements; assess systems for compliance and provide guidance to cross‑functional partners.
• Partner with IT and system owners to ensure electronic records and electronic signature controls are properly implemented and documented in all GxP systems.
• Support data integrity assessments and remediation initiatives; apply ALCOA+ principles to guide compliant system design and use.

• Manage the computerized systems change control process; evaluate proposed changes for validation impact and establish appropriate assessment, testing, and documentation requirements prior to implementation.
• Own and execute the periodic review program for validated GxP systems; assess continued fitness for intended use and compliance with current regulatory expectations.
• Maintain validation status documentation and ensure validation files are audit‑ready at all times.

• Support preparation for regulatory agency inspections; serve as the CSA subject matter expert during FDA, EMA, and other Health Authority inspections and ensure validation documentation is complete, current, and accessible.
• Contribute to relevant sections of regulatory submissions and respond to agency questions related to computerized systems and data integrity.
• Monitor evolving regulatory guidance and industry standards related to CSA, CSV, data integrity, and cloud‑based systems; proactively adapt Nurix's program to reflect current expectations.

• Serve as the primary point of contact and internal consultant for all GxP system owners across Quality, IT, Regulatory Affairs, CMC, and Clinical Operations.
• Develop and deliver CSA training for system owners, end users, and other stakeholders to build organizational capability and awareness.
• Partner with IT and vendor project teams to embed validation requirements early in system selection and implementation processes.

• Bachelor's degree in computer science, information systems, life sciences, pharmaceutical sciences, or a related field.
• 7–10+ years of progressive experience in computer systems validation and/or computer systems assurance in a GxP‑regulated pharmaceutical, biopharmaceutical, or biotechnology environment.
• Demonstrated expertise in current regulatory requirements for computerized systems, including FDA 21 CFR Part 11, EU Annex 11, FDA CSA guidance (2022), and GAMP 5 (2nd edition).
• Hands‑on experience validating SaaS and cloud‑hosted GxP platforms; understanding of vendor‑managed environments and shared responsibility models.
• Proficiency authoring and reviewing CSA/CSV deliverables: VMPs, URSs, Risk Assessments, IQ/OQ/PQ protocols, traceability matrices, and validation summary reports.
• Strong working knowledge of data integrity principles (ALCOA+) and their application to electronic records management and GxP system design.
• Experience managing system change control and periodic review programs for validated GxP systems.
• Ability to operate as both program owner and individual contributor in a lean, virtual organizational model; comfortable managing validation activities without a large internal support team.
• Excellent written and verbal communication skills; able to translate complex technical and regulatory requirements into practical guidance for diverse stakeholders.
• Strong organizational skills and attention to detail; demonstrated ability to manage multiple concurrent programs and priorities in a fast‑paced environment.

• Experience with eQMS validation (e.g., Veeva Vault) and familiarity with Veeva's Qualified System approach and available supplier documentation.
• Familiarity with clinical development platforms such as electronic data capture (EDC), regulatory information management (RIM), or clinical trial management systems (CTMS) in a validated context.
• Experience supporting FDA, EMA, or equivalent Health Authority inspections as a CSA subject matter expert.
• Exposure to laboratory informatics systems (LIMS, ELN) and their GxP qualification requirements.
• Experience in a virtual or lean biotech environment managing validation activities through external vendors and consultants.
• Working knowledge of cybersecurity frameworks and their intersection with GxP system compliance (e.g., NIST, SOC 2).
• Advanced degree in a relevant scientific, engineering, or regulatory discipline.

• You know the regulations deeply and apply them with judgment, designing validation approaches that are rigorous where it matters and efficient everywhere else. You bring expertise with pragmatism —
• You are comfortable as the go-to expert, driving the CSA program forward proactively rather than waiting for direction, and you take accountability for outcomes. You own the program —
• You build trusted relationships across Quality, IT, and the business, and you understand that a well-designed, compliant systems environment is an enabler of Nurix's mission to develop important medicines for patients. You partner with purpose —

Location: Brisbane, CA - Onsite

Salary Ranges: Senior Manager, CSA(Quality) - $170,538 – $193,493
Associate Director, CSA(Quality) - $190,269 – $216,360

Initial Therapeutics, Inc. is seeking a Vice President, Medical Affairs, Hematology-Oncology to lead a top-tier Medical Affairs organization. The successful candidate will provide strategic and operational leadership across the Medical Affairs function, ensuring alignment with development plans and corporate objectives.

This role demands a strong background in oncology and hematology, with substantial experience in launching and post-approval medical strategies. Responsibilities include shaping the scientific narrative and engaging with key external experts within the hematology domain.