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.

Job Summary:

As a key member of the cross-functional Development Team responsible for providing regulatory writing expertise and leadership to formulate the writing strategy for key regulatory documents for submission. The Sr. Director, Head of Regulatory & Medical Writing will be responsible for providing guidance to the medical and or regulatory writing group (contractors and internal writers) assigned to deliverables and ensuring appropriate work allocation and document preparation.; will also provide review and substantive editing of documents to ensure delivery of high-quality documents. This individual will work effectively with many other functional groups, including with Clinical Scientist(s), Medical Monitors, Regulatory and other functions as applicable, and collaborate with clinical medical writing as applicable to ensure scientific excellence in the execution of clinical trials. The Head of Regulatory Writing will build a medical writing group internally when appropriate.

Reporting to the SVP, Head of Regulatory Affairs, this role will be responsible for the regulatory writing & medical writing deliverables of assigned project(s), in accordance with the agreed timelines and quality standards.

Responsibilities:

• Ensure appropriate allocation of internal and external resources needed for all regulatory writing deliverables.
• Hire and manage medical writers internally and manage external medical writing contractors.
• Forecasting and maintaining budget for the regulatory writing team.
• Assess efficiencies, help identify areas of improvement and initiate improvement processes.
• Coordinate, author and edit documents used to support clinical trial conduct and reporting including but not limited to:
• Clinical study protocols and clinical protocol amendments (in partnership with Clinical Science/Clinical Development)
• Clinical study reports
• Investigator’s brochures and annual updates
• IND submissions and annual reports
• Lay-person summary
• Integrated summary reports
• Clinical, Nonclinical and Multidisciplinary Information Amendments
• NDA, BLA, MAA, (e)CTD submissions
• Risk Management Plans
• Health Authority responses
• Briefing Documents, ODDs, BTDs/PRIME, FTD etc
• Participate in relevant subteam(s) and ensure effective planning and management of timelines for all components of assigned documents across all projects.
• Participate in document strategy sessions, including messaging, document flow, logic, and consistency for assigned projects.
• Support and develop deliverables required for global transparency and disclosure requirements (e.g., plain language lay summary, applicable redactions to regulatory documents subject to EU posting regulations and results for EU CTR).Partner with Biometrics in developing standard TFLs and in text tables for deliverables as applicable
• Maintain and support developing and reviewing standard processes and templates.
• Review and edit documents as required.
• Work effectively and lead in cross-functional working groups.

Qualifications:

• Candidates must have a BS with 15+ years, or MS or other advanced science degree (e.g.: RN, NP, MSN, PharmD, PhD, MD) with 10+ years of experience in oncology clinical research experience as a clinical or regulatory medical writer within the pharmaceutical/biotech industry.
• Prior experience leading a regulatory writing group
• Experience writing/leading the writing of critical clinical documents in major regulatory filings (NDA, BLA, MAA).
• Proficiency in the use and understanding of computer software e.g. word processing, graphics, reference manager, document management systems.
• Familiarity with all phases of drug development processes (discovery to market), clinical study protocol design, CTA/IND submissions, investigator’s brochures and clinical study data collection and results reporting.
• Advanced knowledge of routine document content preparation, including the use of style guides, medical dictionaries, and regulatory guidance documents and templates.
• Experience writing, at a minimum, protocols (Phase 1-3, in oncology), investigator’s brochures, clinical study reports, Health Authority briefing packages, and Health Authority responses. Experience with Pediatric Investigational Plans (PIPs) is preferred.
• Advanced understanding/knowledge of regulatory requirements and drug development processes, Good Clinical Practice (GCP), regulatory requirements and guidelines associated with regulatory documents (e.g., protocols, investigator brochures, and clinical study reports).
• Ability to interpret and summarize complex tabular and graphical data presentations.
• Strong organization, documentation and communication skills with an ability to multitask.
• Adaptable / flexible, willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism.
• Detailed knowledge of GCP, ICH Guidelines and current US FDA regulations.

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 (https://www.nurixtx.com/privacy-policy/).

Position Title:  

Associate 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.

Job Summary:

Nurix Therapeutics, Inc. is seeking a Manager/Sr. Manager/Associate 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.

Responsibilities:

• Provides regulatory strategic direction and support for assigned global development programs/development program 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, tracks major submission deliverables, and ensures 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

Experience and Skills:

• Bachelor's degree in life-sciences or related scientific discipline; advanced degree preferred Manager:
• Must have minimum of 8 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
• Ability to comply with changing regulatory
• 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 (https://www.nurixtx.com/privacy-policy/).

About this Role

Our pharmaceutical team is looking for a highly motivated and creative Director of Chemistry, Manufacturing and Control (CMC) to lead expansion and growth of partner pharma activities toward clinical production. This role will be responsible for all CMC activities across the external drug development pipeline of Varda’s partners. Reporting to the VP, Pharma Program Management), this position requires collaboration across multiple departments and external partners to design, develop, and implement novel approaches to manufacture drug products in low Earth orbit. This is an opportunity in an exciting area of growth for Varda, the role will shape Varda’s product culture and will play a significant role in establishing the low Earth orbit economy. The ideal candidate must create and lead the CMC development team for drug products from early stage through clinical manufacturing.

Responsibilities

• Develop and lead all GMP CMC-related activities (biologics and small molecule) including process chemistry, drug product, analytical, and formulation from lead optimization phase through to clinical development and commercialization  
• Build and lead internal GMP CMC team with functions around process development, quality control, and quality assurance. 
• Manage external drug product manufacturing service providers and API supply chains to support clinical trial development  
• Collaborate with Varda pharma R&D teams to understand future CMC needs and handle internal tech transfers 
• Author all CMC sections of regulatory filings including FDA, EMA and other national authorities to support the conduct of clinical trials 
• Act as subject matter expert for non-clinical CMC to both preclinical and clinical development teams, interact with all internal and external stakeholders to support CMC needs 
• Ensure high-quality standards, develop SOPs, implement GMP compliance and QC/QA 
• Monitor progress and regularly report to the C-suite team 
• Manage and monitor the CMC timelines and budget 

Basic Qualifications

• 8+ years of CMC leadership experience advancing drug product development programs to successful clinical trials 
• B.S. or M.S. in life sciences such as Chemistry, Biochemistry, or related fields 
• Firm understanding of cGMP and FDA regulatory guidelines as they pertain to CMC 

Preferred Skills and Experience

• 12+ years of CMC leadership experience advancing drug product development programs to successful clinical trials 
• PhD in life sciences such as Chemistry, Biochemistry, or related fields 
• Documented evidence of prior successful CMC project leadership from early phase, late phase leading to clinical trials. 
• Experience in leading and direct management of research, analytical laboratories, process development, and manufacturing 
• Advanced understanding of cGMP and FDA regulations and guidelines relating to CMC-related areas 
• Command of global CMC-related regulatory requirements and guidelines 
• Excellent leadership, managerial and communications skills in a cross functional environment 
• Hands-on experience in managing multiple internal and external stakeholders (e.g. working with CMOs on managing drug product development) 
• Experience with writing CMC sections for regulatory filings and knowledge of current regulations in US and EU 
• Fluent communication in English, written and verbal 

Pay Range

• Salary range: $200,000 - $230,000/per year
• This role is on-site in El Segundo, CA
• Leveling and base salary is determined by job-related skills, education level, experience level, and job performance
• You will be eligible for incentives in the form of stock options and/or long-term cash awards

Seeking talent near: Princeton, NJ

Position Summary

The Associate Director, Drug Product Development is responsible for the formulation, primary package, and manufacturing process development for Acadia’s growing portfolio of drug candidates at all stages of development, and will provide technical oversight, expertise and guidance of externalized drug product development related activities. The scope includes development of formulations, package, and process for all modes of administration including oral solid, liquid, and injectable dosage forms for candidates ranging from clinical development to process validation and life cycle management. The incumbent will be responsible for management of activities relating to the above at the Contract Service Providers (CSPs) and will contribute both internally and externally in resolution of complex technological issues and implementation of new manufacturing process technology for products intended for clinical and commercial distribution. The role will be critical in ensuring that we optimize development, reduce risk and accelerate the development of new assets for commercialization.

Primary Responsibilities

• Designs and develops pharmaceutical formulations and manufacturing processes to support clinical trials, registration and product launch.
• Evaluate and validate new drug product CSPs (Contract Service Providers) to support development, scale up, and commercialization of the new drug candidates in the Acadia pipeline.  Initiate and manage supplier contract agreements as necessary.
• Coordinate and supervise the development, scale-up to manufacturing of clinical formulations and finished dosage forms at CSPs.  Serves as person-in-the plant at the CSP sites.
• Plans project-related scientific and technical activities, e.g. interpretation of results, evaluation of data, formulates relevant and scientifically based conclusions, writes and presents technical reports.
• Review the clinical supply requirements with the clinical supply managers and plan requisite manufacturing schedule with the CSPs to ensure uninterrupted supply of clinical trial materials.
• Perform risk assessments of manufacturing process and product at key development milestones and address the findings with the relevant CSPs.
• Authors and reviews technical reports and documents suitable for regulatory submissions. Reviews MBRs, BPRs, development reports and relevant documents prepared by CSPs.
• Liaises with analytical, manufacturing, quality assurance and regulatory counterparts to develop plans and protocols for drug product development and for life cycle management of the established products.
• Adheres to cGMP work practices and works closely with the Quality Assurance to ensure strict compliance with applicable GXP procedures and compliance requirements. Assist the CSPs in preparation for health authority inspections and for pre-approval inspections.
• Other responsibilities as assigned.

Education and Experience

• Advanced degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Materials Science, or related field. An equivalent combination of relevant education and applicable industry experience may be considered.
• A minimum of 10 years’ experience in progressively responsible roles in formulation and manufacturing process development with some experience in leadership role desired.
• Demonstrated success in the field of formulations and dosage form development.  
• Experience authoring technical reports and CMC sections for regulatory filings. 

Must possess:

• Comprehensive understanding of the dosage form formulation and package development, manufacturing process development, scale-up, optimization and validation processes.
• Extensive knowledge of cGMPs.
• Skilled at managing CSPs.
• Demonstrated verbal and written communication skills.
• Adept at effectively aligning resources across multiple functional areas to achieve functional area goals.
• Flexibility to travel domestically and internationally.

#LI-HYBRID #NC1

Role Overview

We are seeking a Sr. Technical Product Manager to lead the strategy and execution of data product, AI/ML system, AI-powered tooling, and automation initiatives across Patient Experience and Commercial Operations functions. This role is focused on improving how patients navigate testing and billing while enabling operational teams to efficiently progress cases from order to completion. You will play a crucial part in supporting initiatives to reduce friction, improve patient trust, and increase operational efficiency, ultimately driving better conversion, collections, and experience.

This role focuses on building, scaling, and leveraging platforms and products that power decision intelligence and activity orchestration across these domains. You will work in close collaboration with domain leaders while building through centralized Data & AI organization platforms, standards, and governance. You will own the full product lifecycle from discovery through production, ensuring solutions are adopted, trusted, and deliver measurable business impact. In doing so, you will work hands-on as an empowered builder of AI and software solutions to improve workflow efficiency, productivity, and quality for the teams you support.

This is a technical product role requiring fluency in data systems, modern data platforms, ML, and AI implementation patterns (and the ability and drive to build with them directly), combined with strong experience and stakeholder intuition across the associated functions. The role has direct ownership of high-impact initiatives that deeply influence organizational success.

What You’ll Do

Strategy & Roadmap

• Define and own the Data & AI product strategy and roadmap for the Patient Experience + Commercial Operations pod by deeply partnering with business leaders to proactively identify high-impact opportunities, shape problem definitions, and drive aligned priorities
• Translate ambiguous business problems (e.g., stuck cases, fragmented patient communication, support inefficiencies, billing friction) into clear product direction and measurable outcomes
• Own the line between 'what the business needs' and 'what gets built' end-to-end

Discovery, Experimentation, & Requirements

• Develop deep context on the domain so you can proactively propose solutions rather than field requests
• Be hands-on with data: query datasets, review schemas, and validate assumptions through analysis
• Lead end-to-end product discovery with interviews, workflow mapping, data assessments, ROI modeling, etc.
• Define clear product requirements (PRDs, user stories, acceptance criteria) and success metrics
• Design and run experiments to validate product performance and measure causal impact
• Establish leading indicators and KPIs for proactive product and process health assessments

Delivery, Data, & ML Lifecycle

• Partner with data and AI/ML engineering resources to deliver scalable products and capabilities
• Guide development of robust data pipelines and unified data models (360° views across key entities)
• Own the end-to-end ML lifecycle: feature definition, evaluation, deployment, monitoring, drift detection, and retraining
• Ensure training–serving consistency, model versioning, and clear deployment decision gates
• Establish strong observability across data pipelines and models (data quality, latency, reliability, cost)

AI Productization & Hands-On Building

• Define and implement AI product patterns, including agentic workflows and tool/function-calling integrations
• Build process automations and internal tools that improve workflow efficiency, productivity, and output quality for the teams you support
• Establish evaluation frameworks for LLM-powered features (faithfulness, relevance, safety, cost, latency)
• Implement prompt strategies, guardrails, and continuous evaluation pipelines

Governance, Compliance, & Data Quality

• Ensure products meet regulatory and compliance requirements
• Champion data quality, lineage, and reliability through data contracts and observability standards
• Maintain strong documentation practices (e.g., model cards, dataset documentation, audit trails)
• Partner with governance teams (Security, Legal, Compliance, AI Governance) to operationalize AI responsibly

Adoption, Change Management, & Impact

• Launch products with supporting enablement activities to ensure solutions are embedded in workflows with confidence
• Partner with stakeholders to integrate products into proactive, day-to-day decision-making
• Monitor product usage, performance, and business outcomes to iterate based on data and feedback
• Quantify and communicate impact (e.g., revenue lift, cost reduction, cycle time improvements, case completion turnaround)
• Influence Patient Experience and Commercial Operations stakeholders through delivery, not authority

Qualifications

Required

• 7+ years of relevant experience (e.g., product management, applied AI/ML engineering, technical founder, forward-deployed engineering), including 3+ years building data products, AI/ML systems, or related platforms
• Demonstrated domain fluency in Patient Experience and/or Commercial Operations
• Strong understanding of patient journeys, support channels (e.g., chat, voice, call centers), and operational workflows that drive conversion and test completion
• Familiarity with key domain-relevant tooling (e.g., patient portals, support platforms) and associated data
• Strong technical capability (e.g., comfortable scripting, performing EDA, with AI-aided application development)
• Hands-on experience shipping LLM-powered features or automations (e.g., prompting, RAG, tool/function calling, agentic orchestration, evals)
• ML/MLOps literacy (evaluation metrics, experimentation, feature stores, CI/CD, monitoring, drift)
• Familiarity with modern data stacks (e.g., Snowflake, dbt, AWS/SageMaker, Airflow/Dagster)
• Strong stakeholder leadership and communication skills, with the ability to work across technical and business teams
• Experience working in regulated environments (e.g., healthcare, life sciences, fintech)

Preferred

• Experience in healthcare, diagnostics, life sciences, and/or digital health
• Familiarity with healthcare data domains and systems, including patient, provider, payer, claims, billing, and clinical trial data
• Experience with vendor evaluation, platform selection, or external AI tooling ecosystems
• Advanced degree in a technical and/or business discipline

What Success Looks Like

• Production-grade data and AI products are deployed and embedded in day-to-day decision-making workflows
• Process automations and internal tools you build are reducing manual effort and improving output quality across the teams you support
• Measurable improvements seen in key business metrics (e.g., case completion turnaround time, patient satisfaction, cost-to-serve)
• Reliable, high-quality data foundations connect patient, provider, clinical, operational, and billing/financial insights end-to-end
• AI systems are continuously monitored, evaluated, and improved with measurable business impact
• Stakeholders trust and adopt implemented solutions across both corporate and business-unit teams
• Internal teams have transparent access to the function's roadmap, trust in delivery against it, and visibility into the evaluation logic that prioritizes initiatives based on their impact to organizational goals

Caribou Biosciences is a leading clinical-stage CRISPR genome-editing biopharmaceutical company dedicated to developing transformative therapies for patients with devastating diseases. Our next-generation genome-editing technology enables superior precision to develop cell therapies that are armored to potentially improve activity against diseases. We believe the future of cell therapy is off-the-shelf, and we are advancing our pipeline of off-the-shelf, or allogeneic, cell therapies from our CAR-T cell therapy platform as readily available treatments for patients with hematologic malignancies and autoimmune diseases.

Members of the Caribou herd open their minds to new ideas and welcome diverse perspectives. We proudly assert that teams do their best work when their members are personally engaged, their ideas are taken seriously, and contributions are recognized. Members of the herd work from our headquarters in Berkeley, California, or remotely.

About the Role

The Director of Clinical Operations will serve as the cross-functional study team lead for a high-priority hematology program, with overall accountability for the strategic planning and execution of all operational activities. This role will provide leadership and oversight of CROs and vendors, including governance, to ensure delivery against timelines, quality, and budget expectations.

The individual will work collaboratively with internal functional leads (Clinical Development, Regulatory, Translational, Data Management, and Biostatistics) to drive integrated study execution, while providing strategic direction and ensuring alignment across stakeholders. They will demonstrate strong matrix leadership, proactive risk identification and mitigation, and effective problem-solving to achieve key program milestones.

This role requires the ability to balance budget, timelines, and evolving trial needs, maintaining transparency and a solution-oriented approach to decision-making. A strong focus on data quality, inspection readiness, and overall trial execution excellence is essential.

This candidate can be remotely based, and ideally attends relevant congresses, conducts on-site visits and joins the greater team at Caribou headquarters (Berkeley, CA) as able.

Responsibilities:

• Provide strategic operational leadership and oversight for a key clinical program, ensuring alignment with clinical development objectives and corporate goals
• Oversee CROs and vendors, leading governance and partnering closely to ensure accountability for delivery of operational activities, timelines, quality, and budget, and driving proactive risk management and mitigation across the study
• Lead study-specific and cross-functional meetings, driving clear decisions, accountability, and timely issue resolution
• Collaborate cross-functionally (Clinical, Regulatory, Translational, Data Management, Biostatistics) to ensure integrated and efficient study execution
• Oversee study progress and performance using key metrics (e.g., enrollment, eligibility, data quality, primary endpoints), ensuring transparent communication and a solution-oriented approach
• Proactively identify, assess, and manage study and program-level risks, including mitigation planning and escalation of critical issues
• Ensure data quality, integrity, and completeness to support analyses, regulatory submissions, and program decision-making
• Establish and oversee vendor governance, including performance management, SOW/budget review, and financial tracking (forecasts, accruals)
• Ensure inspection readiness, including TMF quality, audit preparedness, and compliance with GCP and internal SOPs
• Build and maintain strong relationships with investigators, study staff, and external partners, and represent Clinical Operations in internal governance and external interactions

Requirements:

• Bachelor’s Degree is required, in a science or a health-related field
• A minimum of 10 years of global clinical trial management experience within the pharmaceutical or biotechnology industry
• Early phase oncology focus is key, preferably within the hematology space
• In-depth understanding and experience across clinical operations with a track record of success in CRO and vendor delivery oversight
• Being a key contributor to study planning, execution, data cleaning, database locking, study report generation and regulatory inspection
• Experience with developing protocols, SOPs, Clinical Study Reports, INDs, NDAs, as well as other clinical, regulatory, and safety documents preferred
• Ability to lead cross functional study teams in a dynamic, evolving organization
• Excellent communication and interpersonal skills, with the ability to lead and motivate teams and collaborate effectively across functions (internally and externally)
• Ability to travel up to 20% based on business needs

Nice-to-Haves:

• Prior experience in the CAR-T space, with a specific focus in hematology
• An emphasis on inspection readiness for Clinical Operations
• Ease and confidence in being Investigator and site-facing

Caribou compensation and benefits include:

• Comprehensive compensation package, which includes competitive salary, bonus, and equity for all employees
• Salary Range: $240,000-$255,000; this represents the present low and high end of the Company’s pay range for this position; actual pay will vary based on various factors, including but not limited to location, skill, experience, and performance
• Generous paid vacation time, in addition to company-observed holidays
• Excellent medical, dental, and vision insurance
• 401(k) retirement savings plan, which includes matching employer contributions
• Employee stock purchase plan (ESPP)
• Tuition reimbursement program

The benefits and stock purchase described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility.

Caribou is an equal opportunity employer and does not discriminate based on race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical conditions, veteran status, sexual orientation, gender (including gender identity and gender expression), sex (which includes pregnancy, childbirth, and breastfeeding), genetic information, taking or requesting statutorily protected leave, or any other basis protected by law. In addition, Caribou prohibits the harassment of any individual on any of the bases listed above or any other characteristics protected under federal, state, or local laws.

Legal authorization to work in the United States is required. In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.

We do not accept unsolicited resumes or candidate submissions from staffing agencies. All agencies must have a valid written agreement with Caribou Biosciences, Inc. for service in place. Any resume or candidate submitted by a staffing agency without such an agreement in place will be considered unsolicited, and Caribou Biosciences, Inc. will not be obligated to pay any referral or placement fee.

The Opportunity:

Revolution Medicines is seeking a motivated Summer Intern to support a strategic Clinical Operations initiative focused on optimizing study-level execution and alignment with internal Clinical Operation tools such as the Clinical Operations Handbook. This individual contributor role will partner with the Clinical Operations Execution (CORE) Team to assess consistency, tool utilization, and workflow execution from protocol finalization through site activation. The intern will gain hands-on exposure to cross-functional clinical trial operations while delivering actionable process improvement insights.

Responsibilities:

• Review one to two active clinical studies for detailed operational assessment.

• Evaluate utilization of key study management tools including logs used for study tracking, e.g., risks, actions, issues, decisions.

• Study Dashboards, Vendor Oversight Plans, and Study Startup Timelines.

• Document end-to-end workflows from protocol finalization through site activation.

• Identify gaps, redundancies, and inconsistencies in process execution across studies.

• Conduct structured interviews with Clinical Operations Leads (COLs) and Clinical Trial Assistants (CTAs).

• Shadow Clinical Study Execution Team (CSET) meetings to observe dashboard and RAID log utilization.

• Review Smartsheet tools and Egnyte folder structures to assess organization and consistency.

• Compare real-world study execution against documented Clinical Operations Handbook processes.

Required Skills, Experience and Education:

• Currently pursuing a Bachelor’s or Master’s degree in Life Sciences, Public Health, Clinical Research, Business, or related field.

• Strong analytical and organizational skills.

• Effective written and verbal communication skills.

• Proficiency in Microsoft Office (Word, Excel, PowerPoint).

• Interest in clinical trial operations and process optimization.

Preferred Skills:

• Familiarity with Smartsheet or similar project management tools.

• Prior exposure to clinical research or regulated environments. 

  #LI-Hybrid  #LI-AP1

The Opportunity:

We are seeking an experienced drug developer and effective leader to serve as Executive Director of Clinical Development in support of Revolution Medicines’ clinical-stage molecule(s) and/or pre-clinical molecule(s). In this critical role, you will be responsible for developing the strategic plans and ensuring efficient operational execution of the molecule(s)’ clinical development program in one or more disease indications, from early-stage studies to regulatory submissions and potential commercialization. You will play a pivotal role in shaping the future of our pipeline and driving the development of transformative therapies for patients.

• Provide critical insights/contributions and implement comprehensive/execute upon the clinical development plans for Revolution Medicines’ molecules, ensuring alignment with scientific, regulatory, and commercial objectives.

• Lead, mentor, and manage a high-performing cross-functional team of clinical development professionals, fostering a culture of collaboration, innovation, and excellence.

• Oversee all aspects of clinical trial design and execution, including site selection, patient recruitment, data management, and regulatory compliance.

• Establish and maintain strong relationships with clinical investigators, regulatory agencies, and key stakeholders.

• Gather, analyze and interpret clinical data, providing strategic insights to inform critical decisions and guide program development.

• Manage clinical development timelines effectively, ensuring efficient resource allocation and achievement of milestones.

• Stay abreast of the latest scientific advancements and regulatory trends in the field of clinical development.

• Partner with cross-functional teams, including research, regulatory affairs, commercial, and finance, to ensure seamless program execution and achieve shared goals.

• Manage multiple direct reports; potentially be a manager of managers.

Required Skills, Experience and Education:

• MD, PhD or similar advanced biomedical graduate degree with 13+ or more years experience in pharmaceutical/biotech industry or academic background at the level of Associate Professor or higher.

• Extensive experience working with the principles and techniques of data analysis, interpretation, and clinical relevance as related to the pharmaceutical/biotech industry.

• Proven track record of successfully designing and conducting multiple clinical trials as part of a wider clinical development programs from early-stage to late-stage, direct experience with Phase 1 drug development.

• Experience authoring and clinical development strategy(ies) and bringing forward for governance.

• Extensive understanding of medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMA, and other relevant guidelines and regulations.

• Proven experience to steer an IMP during its clinical development plan through major and varied Health Authority interactions (e.g. FDA, EMA, others). Has led Health Authority interaction(s).

• Strong orientation to teamwork. Excellent leadership, communication, and interpersonal skills, with the ability to inspire, motivate and mentor a diverse team.

• Expertise in building and maintaining strong relationships with internal and external stakeholders.

• Superb strategic thinking and analytical skills, with the ability to make data-driven decisions in a fast-paced environment. Able to recognize trade-off decisions and can determine priorities and goals.

• Outstanding written and business presentation skills. Experience publishing results of a clinical trial in a peer-reviewed journal is required.

• Proven ability to manage budgets and timelines effectively.

• Passion for innovation and a commitment to developing therapies that make a meaningful difference in patients' lives.

Preferred skills:

• Experience in ongoing enhancements/development of core and sub-team processes, structures, systems, tools and other resources in the pharmaceutical/biotech industry.

• Experience creating clinical development strategy(ies) that led to label-enabling outcomes and commercialization.

• Experience submitting an NDA/BLA/MAA to global health authorities is a significant plus.

• Has led regulatory and other internal partners/stakeholders in the completion and submission of regulatory documentation. Successfully provided clinical science information and input for regulatory development of label(s) and packaging language, etc.

• Has led or overseen data generation to address unmet medical needs and identify new or extended Clinical Development studies for the assigned program or other programs.

• Direct experience with Phase IV drug development.

• Has proven abilities to present [a] compelling business case and facilitates effective and expeditious decision-making. Has demonstrated the ability to serve as a company spokesperson both internally and externally.

• Has demonstrated collaborate behaviors on enterprise-level strategic initiatives with a variety of internal and external partners and stakeholders - including clinical investigators/clinicians, scientists and key opinion leaders (KOLs), as well as internal groups, including other groups in development, research, business development, commercial, legal, etc. - resulting in demonstrable outcomes (e.g. new study proposals or new disease indications).

• Has demonstrated courage and conviction in past positions and responsibilities. Skilled in conflict resolution.  

  #LI-Hybrid  #LI-GL1

Team Description:

The Convoy team, a specialized group within the Robot Mechanical Engineering team, is working on developing a first-of-its-kind brain-controlled assistive robotic arm (ARA). Our focus is on developing high-dimensional neural control of hardware, specifically robotic arms and hands. We design and integrate robotics systems, work directly with our clinical trial participants, and collaborate cross-functionally with hardware, software, electrical, and BCI engineers. We believe this work may be one of the best and most advanced paths to giving physical independence back to users with unmet medical needs.

Job Description and Responsibilities:

As a Mechanical & Robotics Engineer at Neuralink, you will design and produce hardware solutions for our assistive robotic arm. Your responsibilities may also include working on our brain-computer interface devices, surgical robotics, automation, microfabrication, and more. You will have the opportunity to own projects from concept to production, leveraging your mechanical engineering background in the challenging field of brain interfaces and human-robot interaction. Your responsibilities will include:

• Designing and integrating robot mechanical and electrical components and assemblies with a heavy emphasis on usability and safety
• Collaborating with clinical trial participants, neuroscientists, biologists, and engineers to establish design criteria
• Rapidly and effectively building systems to meet project goals
• Applying analytical methods, including calculations and simulations, for the design and optimization of structures and mechanical components
• Actively driving every phase of device launch, from hands-on early feasibility prototyping through manufacturing release

Required Qualifications:

• Bachelor’s degree in one of the following disciplines or equivalent experience: Mechanical Engineering, Robotics, Mechatronics
• Strong understanding of engineering first principles
• Minimum of 3 years of mechanical engineering industry experience, including internships and project teams where you owned products from concept to production
• Proficient in 3D CAD

Preferred Qualifications: 

• Experience with robotic systems such as robot arms, grippers, actuators, human-robot interaction
• Multidisciplinary experience in robotics software and control (e.g., Python, ROS, MATLAB, control theory)
• Electrical engineering proficiency (e.g., PCB design, wire harnessing, circuit design)
• Proficiency with conventional machining and rapid prototyping technologies

Team Description:

The Brain Computer Interface (BCI) Applications Team is responsible for delivering a product that gives people with paralysis the ability to control computers, phones, gaming consoles, and robotic arms with their minds at the same speed and functionality level as able-bodied people can. In addition,the team is also working on restoring speech to mute individuals, this will also open the option for direct and natural silent communication with AI agents.  The team works closely with the PRIME clinical study patients which allows them fast and direct feedback about new features from users. The work in the team is multidisciplinary and team members have diverse backgrounds in software engineers, design engineering, ML engineering and neuro-engineering.

Job Description and Responsibilities:

As a Software Engineer Intern  in the BCI team, you will collaborate with our users, specifically clinical trial participants, to comprehend their requirements and engineer brain-computer interface software systems that deliver exceptional user experiences. You will take the lead in creating innovative applications, implementing new features, and resolving existing issues to enhance the overall functionality of the software. Additionally, you will be expected to:

• Develop, test, and validate software systems
• Work with cross-functional teams to design new BCI functionalities and novel computer user interfaces
• Work with study participants to iterate on and further refine the software
• Design and implement algorithms to decode brain activity
• Design user experiences centered around brain control

Required Qualifications:

• Strong experience with full-stack development 
• Fluent in programming languages such as Swift, Objective-C, Kotlin or Java
• Experience in architecting elegant, maintainable, performant and reliable user facing software applications 
• Evidence in delivering high-impact projects to users or businesses with clear metrics and fast iteration cycle
• Evidence of exceptional ability in engineering
• Strong understanding of engineering first principles
• You are resourceful, flexible, and adaptable; no task is too big or too small
• Excellent communication and collaboration skills
• Currently pursuing a Bachelor’s degree in Computer Science or a related field 

Preferred Qualifications:

• Experience with native (desktop/ Android/ iOS) preferred 
• Strong experience in operating system knowledge in low latency concurrency programming, memory management and networking

Team Description:

The Neuralink Clinical team is at the heart of an ecosystem that merges neuroscience, engineering, and medicine. We work to shape the future of brain-computer interface (BCI) technology through the planning, launch, and execution of groundbreaking human clinical trials. Our team is built on a foundation of excellence, aiming to uphold the highest standards of Good Clinical Practice (GCP) while redefining what’s possible and revolutionizing the way people interact with technology. Through strict compliance with ethical and regulatory protocols, we focus on ensuring the well-being of our trial participants while advancing the frontiers of neuroscience! Every day will bring fresh challenges and unprecedented opportunities to pioneer new approaches in the pursuit of our mission. From navigating regulatory pathways, designing trial protocols and documentation, and executing clinical trials, our team is instrumental in translating Neuralink’s BCI technology for use in people!

Job Description and Responsibilities:

As a Field Clinical  Engineer, you will be on the front lines of Neuralink’s clinical programs, working directly with participants, clinicians, and internal teams to translate cutting-edge neurotechnology into meaningful functional outcomes. This role is ideal for individuals with a background in PM&R, occupational therapy, or physical therapy who also have experience in medical devices and thrive in dynamic clinical environments.

You will play a critical role in bridging clinical care, engineering, and research by supporting device use, optimizing participant performance, and ensuring high-quality data collection in both clinical and home settings.

This role requires someone who is hands-on, clinically grounded, technically curious, and able to adapt quickly. You should be comfortable working with participants with significant neurological impairments and motivated by improving independence and quality of life.

In this role, you will:

• Work directly with study participants to support device use, training, and optimization during clinical sessions and at home
• Apply principles of rehabilitation (PM&R, OT, PT) to maximize participant outcomes and functional performance with the system
• Collaborate closely with surgeons, investigators, and site staff to ensure seamless clinical execution across all phases of the study
• Serve as the primary interface between participants and the technology, troubleshooting issues in real time and escalating when needed
• Support surgical and post-operative workflows, including intraoperative and early post-implant sessions where applicable
• Ensure high-quality, protocol-compliant data collection by aligning participant activities with study endpoints and data capture requirements
• Partner with clinical, engineering, and data teams to translate real-world use into actionable insights for product and algorithm development
• Identify trends in participant performance, usability challenges, and safety signals, and communicate clearly to cross-functional teams
• Contribute to development and refinement of training protocols, user workflows, and clinical best practices
• Support site onboarding, training, and ongoing engagement to ensure consistency and scalability across clinical sites
• Assist in preparation for regulatory inspections and ensure activities are conducted in compliance with GCP, protocol requirements, and internal procedures
• Travel to clinical sites as needed to support study execution and participant care

The ideal candidate:

• Has a clinical background in PM&R, occupational therapy, or physical therapy, with hands-on experience working with neurological populations (e.g., SCI, ALS, stroke)
• Has experience working with medical devices in a clinical or field-based role
• Is highly adaptable, proactive, and comfortable operating in a fast-paced, evolving environment
• Is technically curious and able to engage with engineers to troubleshoot and improve system performance
• Communicates clearly and builds trust with participants, clinicians, and cross-functional teams
• Is detail-oriented and understands the importance of protocol adherence and data integrity in clinical research

Required Qualifications: 

• Clinical training and hands-on experience in PM&R, occupational therapy, or physical therapy, with a focus on neurological populations (e.g., SCI, ALS, stroke)
• 3+ years of experience in a clinical, field-based, or medical device–adjacent role (rehab, neuromodulation, assistive technology, or similar)
• Demonstrated experience working directly with patients and clinicians in dynamic care environments
• Strong problem-solving skills with the ability to troubleshoot clinical and technical issues in real time
• Ability to interpret participant performance, functional outcomes, and device behavior to inform next steps
• Comfort working with technology, including basic data review and interaction with software-driven systems (no need to be a coder, but not afraid of one either)
• Working knowledge of clinical research principles, including protocol adherence, endpoint-driven activities, and data quality expectations
• Familiarity with Good Clinical Practice (GCP) and general clinical study conduct
• Ability to collaborate effectively across clinical, engineering, and operations teams
• Strong communication skills, with the ability to engage both participants and highly technical teams
• High attention to detail, with the ability to manage multiple participants, sites, and priorities simultaneously
• Willingness to travel frequently to support clinical sites and participants

Preferred Qualifications:

• Degree or formal training in bioengineering, biomedical engineering, or a related field, with exposure to neurotechnology or implantable systems
• Experience working with neuromodulation, brain-computer interfaces, or other neurorehabilitation technologies
• Prior experience in a clinical field engineer, clinical specialist, or applications role within a medical device company
• Experience supporting surgical procedures, intraoperative environments, or early post-implant programming and troubleshooting
• Familiarity with signal-based systems (e.g., neural data, EMG, EEG) and comfort interpreting system performance in real time
• Exposure to rehabilitation technology integration, including assistive devices, digital interfaces, or adaptive control systems
• Experience supporting multi-site clinical studies or working directly with investigators and study coordinators
• Comfort working with data systems (e.g., EDC platforms, basic data visualization tools) to review participant performance and study metrics
• Understanding of usability, human factors, and patient-centered design principles
• Prior involvement in training clinicians or participants on device use and workflows
• Experience working in early-stage or rapidly evolving clinical programs where processes are still being defined

Team Description:

The Brain Computer Interface (BCI) Applications Team is responsible for delivering a product that gives people with paralysis the ability to control computers, phones, and robotic arms with their minds at the same speed and functionality level as able-bodied people can. The team works closely with the PRIME clinical study patients which allows them fast and direct feedback about new features from users. The work in the team is multidisciplinary and team members have diverse backgrounds in software engineers, design engineering, ML engineering and neuro-engineering.

Job Description and Responsibilities:

As a Software Engineer in the BCI team, you will collaborate with our users, specifically clinical trial participants, to comprehend their requirements and engineer brain-computer interface software systems that deliver exceptional user experiences. You will take the lead in creating innovative applications, implementing new features, and resolving existing issues to enhance the overall functionality of the software.

• Develop, test, and validate software systems
• Work with cross-functional teams to design new BCI functionalities and novel computer user interfaces
• Work with study participants to iterate on and further refine the software
• Mentor others in achieving engineering excellence and be a catalyst on the team through code review, design review, and technical presentations
• Write algorithms to decode brain activity
• Design user experiences centered around brain control

Note: The team is hiring software engineers at all levels, both junior and senior. What matters most is evidence of exceptional abilities and a drive to succeed.

Required Qualifications: 

• Strong experience with full-stack development; experience with native (desktop/ Android/ iOS) preferred 
• Strong experience in operating system knowledge in low latency concurrency programming, memory management and networking
• Fluent in programming languages such as Swift, Objective-C, Kotlin or Java
• Experience in architecting elegant, maintainable, performant and reliable user facing software applications 
• Evidence in delivering high-impact projects to users or businesses with clear metrics and fast iteration cycle
• Evidence of exceptional ability in engineering
• Strong understanding of engineering first principles
• You are resourceful, flexible, and adaptable; no task is too big or too small
• Excellent communication and collaboration skills
• Bachelor’s degree in Computer Science or a related field or equivalent experience

Fast forward to 37:43 to learn more about software and UI:

The Opportunity:

We are seeking an experienced clinical science drug developer to serve as Medical Director of Clinical Development in support of Revolution Medicines’ molecule(s) in clinical or late pre-clinical development. In this critical role, you will support various clinical science deliverables and enable effective and efficient execution of the clinical development plan for a molecule(s) within its particular indication(s). The scope of activities spans early-stage clinical research and may extend to studies supporting regulatory submissions including Breakthrough-Therapy-Designation (BTD) or Accelerated Approvals (AA). You will play a vital role in leading the clinical science aspects of the Clinical Development Plan (CDP) strategy, driving the development of transformative therapies for patients.

• Lead clinical science and medical aspects of the clinical development strategy and clinical documentation. Represent the clinical development plan on appropriate teams, sub-teams and forums; oversee training of study site personnel, act as primary point-of-contact for questions/enquires regarding the CDP at a program level, oversee the conduct of medical/safety data reviews and study reporting.

• Potential assignment to complex and high-priority strategic studies for Revolution Medicines’ molecules, with expectation to perform responsibilities with independence and clear self-directed leadership.

• Cross-functionally align efforts seamlessly with scientific, regulatory, and commercial objects while executing upon the clinical development plan.

• Lead, mentor, and contribute to a high-performing cross-functional team of clinical development professionals, fostering a culture of collaboration, innovation, and excellence.

• Oversee all aspects of clinical trial design and execution, including site selection, patient recruitment, data management, and regulatory compliance.

• Establish and maintain strong relationships with clinical investigators, regulatory agencies, and key stakeholders.

• Gather, analyze and interpret clinical data, providing strategic insights to inform critical decisions and guide program development.

• Manage clinical development timelines effectively, ensuring efficient resource allocation and achievement of milestones.

• Stay abreast of the latest scientific advancements and regulatory trends in the field of clinical development.

• Potential to manage multiple direct reports.

Required Skills, Experience and Education:

• MD (oncology training preferred) with 5+ years of experience in clinical development in the pharmaceutical/biotech industry and/or academic/other clinical trial setting; some experience in and understanding of early phase drug development preferred.

• Extensive experience working with the principles and techniques of data analysis, interpretation, and clinical relevance as related to the pharmaceutical/biotech industry.

• Experience in independent generation of trial design, protocol writing/ICF (writing or amendment), constructing appropriate CRF and coordinating cross-functionally.

• In-depth therapeutic area experience/expertise, and relevant clinical trial experience (or clear ability to adapt with transferable skills).

• Strong knowledge of medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMA and other relevant guidelines and regulations is required.

• Proven ability to work effectively and efficiently within cross-functional teams involved in the drug development process; proven ability to efficiently integrate multiple perspectives into the CDP.

• Experience authoring regulatory briefing packs, write responses to Health Authority questions, and proven ability to contribute to strategic approach and cross-functional coordination in support of regulatory activities/interactions.

• Demonstrated success in driving various aspects of cross-functional study level strategy, e.g. study design, supporting feasibility and timelines/budget projections, protocol amendment requirements. Ability to drive relevant discussion at key internal decision-making bodies/governance.

• Proven ability to build and maintain strong relationships and contribute to interactions with external key opinion leaders to optimize clinical programs (e.g. advisory boards, individual engagements, steering committees, etc.).

• Experience in (or clear ability) investigator engagement to optimize clinical trial conduct. Includes presenting at investigator meetings.

• Strong orientation to teamwork. Excellent leadership, communication, and interpersonal skills with the ability to inspire, motivate and mentor across a diverse team.

• Experience in mentoring other clinical scientists. Experience or clear potential as an effective line manager.

• Expertise in building and maintaining strong relationships with internal and external stakeholders.

• Superb strategic thinking and analytical skills, with the ability to make data-driven decisions in a fast-paced environment. Able to recognize trade-off decisions and can determine priorities and goals.

• Strong written and business presentation skills is required.

• Passion for innovation and a commitment to developing therapies that make a meaningful difference in patients' lives.

• Demonstrated strong leadership presence.

• Has demonstrated adaptability and flexibility.

• Anticipates needs, assesses and manages business and organizational risks.

Preferred skills:

• Has made significant contributions to clinical development plan conception, conduct and delivery, including successful alignment with scientific governance.

• Experience in ongoing enhancements/development of core and sub-team processes, structures, systems, tools and other resources in the pharmaceutical/biotech industry.

• Has led or supported clinical development contributions to major regulatory submissions (e.g. IND for First-in-Human studies, EOP2 briefing books (Type C/D); PIP/PSP, label negotiation, Breakthrough Therapy Designation, Accelerated Review is a major plus.

• Proven ability to present the clinical development aspects of a program(s) to key major reference health authorities (FDA, EMA, others.) by teleconference or in-person. Has led Health Authority interaction(s).

• Proven ability to set out the clinical development strategy for CTA/EC submissions and responses to health authority questions.

• Has demonstrated collaborative behaviors on enterprise-level strategic initiatives with a variety of internal and external partners and stakeholders - including clinical investigators/clinicians, scientists and key opinion leaders (KOLs), as well as internal groups, including other groups in development, research, business development, commercial, legal, etc. - resulting in demonstrable outcomes that have further enhanced strategic goals.

• Influential and inspiring leader, with proven ability to bring teams and individuals along with them.

• Has demonstrated courage and conviction in past positions and responsibilities. Demonstrated skills in conflict resolution.

#LI-Hybrid  #LI-SH1

Position: Vendor & Budget Manager, Clinical Operations

Location: South San Francisco, CA

Opportunity:

Epicrispr Biotechnologies is seeking a Vendor and Budget Manager to join our growing Clinical Operations team. This role will play a critical part in overseeing vendor relationships, contracts, and budgets to support the successful execution of our clinical programs. This is a highly cross-functional role partnering closely with Clinical Operations, Finance, Legal, and external vendors to ensure studies are executed efficiently and in alignment with timelines, scope, and budget.

Roles and Responsibilities:

• Primary administrative point of contact for vendor coordination and communications, ensuring alignment with study priorities defined by Clinical Operations.
• Handle logistical setup of new vendors including coordinating contract reviews with internal stakeholders and legal and budget negotiation, in alignment with study scope and requirements defined by Clinical Operations.
• Manage all existing clinical vendors, requiring contract oversight and coordination with legal and internal teams, budget and PO oversight alongside internal finance and accounting, while partnering with the CTM and other Clinical Operations team members to ensure vendor deliverables align with study needs.
• Oversee site master budgets and ensure alignment with protocol updates, in coordination with CTM and Clin Ops priorities.
• Approve vendor invoices and budgets, including pass throughs from CRO, ensuring consistency with agreed scopes of work and escalation of discrepancies as needed.
• Support CMO, CTM, and Clinical Operations Lead with review of budget reporting from CRO alongside finance and accounting team.
• Track vendor performance, deliverables, contractual obligations, and escalate risks or delays to the Clinical Operations Lead.

Requirements:

• Bachelor’s degree in life sciences, business, or related field required
• Typically 5+ years of experience in clinical operations, vendor management, or clinical trial management within biotech, pharma, or CRO environments
• Strong understanding of clinical trial processes, vendor oversight, and GCP/ICH guidelines
• Experience managing contracts, budgets, and vendor relationships across multiple studies or programs
• Familiarity with CRO models, pass-through costs, and financial tracking processes
• Excellent organizational and project management skills with strong attention to detail
• Strong communication and stakeholder management skills, with the ability to work cross-functionally
• Ability to manage multiple priorities in a fast-paced, evolving environment
• Proficiency with clinical systems (e.g., CTMS, eTMF) and financial tracking tools preferred

Compensation: The salary range for this position is $135,000 to $145,000 USD annually. This salary range is an estimate, and the actual salary may vary based on various factors, including, without limitation, individual education, experience, tenure, skills, and abilities, as well as internal equity and alignment with market data, including potential adjustments for geographic location. 

Position: Senior Clinical Research Associate

Location: South San Francisco, CA

Opportunity:
Epicrispr Bio is seeking a detail-oriented and proactive Senior Clinical Research Associate (CRA) to support the execution and oversight of clinical trials. This role will play a key part in ensuring studies are conducted in compliance with regulatory requirements, GCP guidelines, and company protocols, while maintaining the highest standards of quality and data integrity.

The ideal candidate will bring a strong foundation in clinical operations, experience working cross-functionally with CROs and clinical teams, and the ability to independently manage site activities while contributing to process improvements in a fast-paced, growing environment. This is an opportunity to have meaningful impact on clinical development programs while helping to build and scale operational excellence within the organization.

Roles and Responsibilities:

• Assist the Clinical Operations team with on-site sample operations, including sample receipt, registration, and shipments in a GCP environment.
• Support clinical trial manager with site management, including: site startup activities, co-monitoring visits alongside CRO, reviewing monitoring visit reports, coordinating vendor trainings, reviewing study newsletters, and other duties as needed, in alignment with study priorities and CTM guidance.
• Assist clinical trial manager with data verification and ICF reviews as needed, alongside CRO, to support data quality and protocol compliance.
• Partner with CTM and clinical team to help identify areas to improve our processes, with priorities defined by the CTM, and support implementation of agreed-upon improvements.
• Identify and communicate site-level issues, protocol deviations, and operational risks to the CTM to support timely resolution.
• Maintain study trackers, logs, and documentation across regulatory, site, data, and sample operations to support study oversight and execution.

Qualifications:

• Bachelor’s degree in life sciences or related field preferred
• 2 - 5+ years of CRA or clinical research experience (biotech, pharma, or CRO environment)
• Strong understanding of GCP, ICH guidelines, and clinical trial processes
• Experience working with CROs and managing clinical sites
• Excellent organizational, communication, and problem-solving skills
• Ability to manage multiple priorities in a fast-paced environment

Compensation: The salary range for this position is $115,000 to $121,000 USD annually. This salary range is an estimate, and the actual salary may vary based on various factors, including, without limitation, individual education, experience, tenure, skills, and abilities, as well as internal equity and alignment with market data, including potential adjustments for geographic location. 

About the role: We are hiring frontline sales professionals to be part of a diverse and elite biopharma sales team dedicated to helping patients in need. With a laser focus on the eye care customer, the Territory Leader will be responsible for territory disease state education along with the launch and ongoing growth of XDEMVY. They will deliver high standards for the ongoing launch and beyond and will champion a culture of outstanding performance, compliance and full ownership of all activity and results. The Territory Leader will be experts in account management, business ownership, sales execution, resource utilization, and they will build and foster relationships with key eye care customers. The Territory Leader will relentlessly pursue excellence to maximize sales in their territory while learning to adapt to changes and needs of the business. In doing so, they will have the unique opportunity to meaningfully contribute to the growth and performance of Tarsus. This critical sales role will be ideal for someone who thinks strategically, operates with tactical precision and strives for excellence.

Geography: Fremont, Oakland, Berkeley, Walnut Creek, PLeasanton, Antioch, Brentwood, Concord, San Ramon, Livermore, Danville, Stockton and Turlock.

Let’s talk about some of the key responsibilities of the role:

Account Management & Eye Care Experts

• Experts in eye care clinical information: anatomy, disease state, products, XDEMVY and office treatment patterns
• Experts in selling skills and account development including building relationships with all key stakeholders
• Experts in pull through tactics with a full understanding of managed care hurdles
• Understand all functions within an ophthalmology/optometry practice and how their roles impact product prescribing and pull through
• Maximize managed care opportunities within the territory and have an understanding of how it impacts the District, Region and Nation and share important feedback
• Understand key opinion leaders within respective geographies and foster engagement with Tarsus leadership
• As eye care experts, champion compliant promotion in alignment with our corporate values

Business Acumen & Sales Execution

• Drive top tier execution by exceeding sales performance goals and key productivity metrics across the territory
• Use expert analytical skills to guide highly productive activity – prioritize key customer engagements, drive reach and frequency to extend depth and breadth of product trial and utilization
• Drive a successful launch and ongoing performance by monitoring all key performance metrics weekly, monthly, quarterly, and annually – ability to adjust approach as needed based on data
• Ensure actionable business plans are set - align all selling activities to drive impact
• Share ongoing insights with leadership and internal stakeholders to ensure feedback is captured
• Personal accountability for driving the highest standards of ethics and compliance

Business Owners & Culture Champions

• Drive our culture of commitment, empowerment and teamwork which includes extreme ownership, high accountability, continuous improvement and relentless pursuit of excellence
• Achieve success and be prepared to adapt in a complex selling environment partnering with many stakeholders: district leaders, marketing, market access, medical affairs, sales ops, inside sales, training, and other important stakeholders
• Provide frontline feedback and intel to sales leadership and the broader organization
• Ensure PDMA compliance and adhere to all company & industry compliance guidelines
• Share ongoing best practices among peers and leadership to elevate national performance
• Maximize all key resources that lead to territory success

Factors for Success:

• Bachelor’s degree in business, science, or related field or commensurate experience
• 2+ years pharmaceutical sales / relevant healthcare sales experience or a proven track record of business to business sales - required
  • Proven track record of pharmaceutical launch experience - strongly preferred
  • Eye Care experience- preferred
• Established track record with evidence of excellent problem solving and collaboration
• Highly adaptable to change, able to quickly pivot and respond given new market information in a fast-paced environment
• Strong communication and change management skills
• Proven ability to escalate difficult issues and make tough decisions
• Established track record in the following job competencies:
  • Selling skills
  • High performance
  • Impact & influence
  • Customer focus & account management
  • Maximizing resources
  • Analytical skills
  • Relationship building
  • Decision making & judgment
  • Teamwork & collaboration
  • Adaptability & GRIT

A Few Other Details Worth Mentioning:

• This is a field-based position reporting to the District Sales Leader
• Geography: Candidates must live in Livermore/ Danville/ Stockton/ or Turlock.
• Travel will be required within the selling geography and beyond to sales meetings, possibly across various customer conventions and occasional travel to HQ in Irvine CA
• 40% - 50% travel required in some larger geographies
• Territory Leader Salary Range;
• • Associate Territory Leader – 2+ years proven B2B selling - $110,000
  • Territory Leader – 1-2 years pharma selling - $123,000
  • Territory Leader – 2-5 years pharma selling - $139,000
  • Sr. Territory Leader – 5-8 years pharma selling - $145,000
  • Sr. Territory Leader – 8+ years pharma selling - $161,000

At Tarsus, we understand the importance of attracting and retaining top talent. In addition to a competitive base pay, we offer an incentive bonus, stock equity, and comprehensive benefits. The base pay range reflects the target range for this position, but individual pay will be determined by additional factors such as job-related skills, experience and relevant education or training. Our benefits include health, dental and vision insurance benefits to ensure your well-being. We believe in work-life balance and offer generous paid time off, including vacation, holidays, and personal days. For more details regarding Tarsus benefits, please visit: https://eb.alliant.com/26tarsusbenefitssnapshot.

#LI-Remote

About Natera

Natera is a global leader in cell-free DNA (cfDNA) testing, dedicated to helping families and healthcare providers make more informed decisions. Through cutting-edge technology and a commitment to innovation, Natera offers genetic testing solutions that span reproductive health, oncology, and organ health. We are passionate about delivering accurate, actionable insights that improve patient outcomes and transform the way diseases are detected and managed.

POSITION SUMMARY:

The Lead Paralegal, Healthcare Transactions is an individual contributor who performs general legal review and analysis, and provides advice on a variety of matters in a busy, high-performing legal department within a cutting-edge molecular diagnostics company. This position will have a focus on supporting research activities performed under Attorney oversight. Experience in drafting commercial and research agreements is a must. This is a mid-senior level transactional Paralegal position, however Natera often encourages employees to take on additional assignments and projects that interest them and they are capable of. This position requires being a nimble Paralegal who can focus on key risks and provide clear, focused, actionable advice and timely review. 

PRIMARY RESPONSIBILITIES:

• Independently draft, review, and negotiate a wide range of contracts needed for the effective functioning of the Company, focusing mainly on research collaboration agreements, investigator initiated trial agreements, clinical study agreements, material transfer agreements and data use agreements with Attorney oversight.

• Perform legal review and approval of other company documents, such as clinical study consent forms and study protocols.

• Appropriately manage a heavy workflow, setting priorities with internal clients and meeting deliverable timelines.

• Liaise with internal clients and respond to inquiries regarding contracts and other matters, as assigned.

• Learn and contribute to the ongoing development of the Legal Department “playbook” for contract negotiations.

• Collaborate closely with attorneys to design, implement, and refine efficient workflows that streamline the contracting lifecycle, including template management, intake triage, document tracking, and coordination across business stakeholders to improve turnaround times and operational consistency.

• Employees must complete training relating to HIPAA/PHI privacy, General Policies and Procedure Compliance training and security training as soon as possible but not later than the first 30 days of hire.

• Must maintain a current status on Natera training requirements.

QUALIFICATIONS:

• 5+ years of experience as a Paralegal in commercial research contracts and general corporate practice, including 3+ years of experience in a major law firm; in-house experience a big plus.

• Experience in advising clients in biotech, life science and/or health care industries.

• Experience in reviewing, drafting, negotiating and finalizing commercial contracts, including complex arrangements independently, with Attorney oversight

KNOWLEDGE, SKILLS, AND ABILITIES:

•  Strong analytical, communication and written skills.

• Strong interpersonal skills and business acumen.

• Ability to multitask and strong attention to detail

• Nimbleness; ability to thrive in a fast-paced, dynamic environment.

• High levels of initiative, confidence and ability to appropriately influence others.

• Demonstrated high ethical behavior.

• Strong technology skills and proficiency with Microsoft Office, including Word, PowerPoint and Excel.

The Opportunity:

Position requires 14+ years of Statistical Programming experience with exploratory-stage oncology clinical trials, providing programming support and oversight of one or more clinical programs (early or late phase) within Statistical Programming function. In addition to hands-on Programming, this position requires providing oversight and programming support and guidance for internal deliverables and regulatory submissions while ensuring conformance to CDISC standards and submission guidelines. Based on company needs, this position will be required to lead one or more early Phase or late phase studies/programs. Specific responsibilities include:

• Effective collaborating with cross functional teams to provide programming timelines for various deliverables.

• Provide SAS Programming technical support and guidance to programming team.

• Oversight/participation in any internal/mock or regulatory authority audits.

• Timeline and vendor management for deliverables, including submission-related activities,  complying with regulatory standards (e.g., FDA 21 CFR Part 11, GxP).

• Oversee the programming support for relevant deliverables, such as Investigator Brochures, publications, US and ex-US regulatory submissions, including CDISC compliant datasets (SDTM, ADaM) and data documentation, Reviewer’s Guide, TLFs, Statistical Analysis Plans (study specific, ISS, ISE, Exposure-Response), blank and annotated CRFs, and actual patient CRFs.

• Hands-on programming and management of in-house deliverables including but not limited to Dose Committee meetings, Board of Director meetings, Exploratory Analysis, etc.

• Oversight and Verification Review of documents, spreadsheets, slides for in-house presentations and external publications.

Titles may vary based on candidate experience.

Required Skills, Experience and Education:

• 14+ years of Statistical Programming experience with early or late phase oncology trial studies.

• BS/BA degree or other suitable qualification with relevance to the field.

• Experience leading one or more statistical programming contractors, and programming vendors.

• Proficiency in providing hands-on SAS Programming support for production or validation of analysis datasets, tables, listings and figures.

• Demonstrated ability to multi-task, prioritize options, anticipate challenges, and execute goals as a member of an interdisciplinary team is extremely important.

Preferred Skills:

• A demonstrable record of strong leadership and teamwork.

• Thrives in a collaborative team setting and is driven by a desire to deploy innovative approaches and technologies in a high energy environment.

• Experience working in a small to mid sized biotech/pharma environment.

• Experience collaborating on development of processes, SOPs and guidance documents for the Statistical Programming function. 

  #LI-Hybrid  #LI-DN1

The Opportunity:

This is a unique opportunity for a Clinical Operations Professional. As a Clinical Program Manager (CPM), you will be responsible for acting as a central contact for the Clinical Study Team(s) and assist with the execution and management of Revolution Medicines (RevMed) clinical trials.

• Adhere to Clinical Standard Operating Procedures (SOP), Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) Guidelines.

• Be a team leader, providing guidance and oversight for the successful management of all aspects of clinical trials within timelines and designated program budgets.

• Partner with cross-functional teams to manage, adjust, and revise project timelines and budgets as needed.

• Analyze data health metrics to be shared with stakeholders.

• Actively partner with cross-functional teams and vendors to drive the query resolution and data listings review process to meet objectives in a timely and efficient process.

• Conduct risk management, contingency, and scenario planning.

• Supervise, communicate project status/issues, and problem solve to ensure project team goals are met.

• Participate in the development of all study-related documentation, including study protocols.

• Actively contributes in the selection and management of contract research organizations (CROs) and/or vendors, including development of requests for proposals (RFPs).

• Use all available tools to track, oversee, and communicate on program status to all key stakeholders.

• Participate in other Clinical Operations activities as appropriate.

• Leads a larger, more complex trial with some oversight from senior members of Clinical Operations.

• With minimal support, lead cross-functional Clinical Study Execution Team (CSETs).

• Participate in and contribute to SOP development, implementation, and training.

• Support junior team members through mentorship.

Required Skills, Experience and Education:

• RN or Bachelor’s or Masters degree in biological sciences or health-related field required.

• 8+ years direct Clinical Operations experience in the pharmaceutical or biotech industry, preferably in Clinical Operations or Clinical Research-related experience. Relevant indirect experiences may also meet the requirement.

• Minimum of 4 years of cross-functional study management or related leadership experience in life sciences, including multiple years’ experience managing project teams.

• Strong working knowledge of FDA Regulations, ICH Guidelines, and GCP.

• Proven ability to successfully start-up, manage, and close-out clinical trials, including authoring clinical study and regulatory documentation and SOPs.

• Experience in selection of CROs/vendors and management of external resources.

• Thrives in a collaborative team setting that demonstrates flexibility required to maintain a fast pace and is driven by a desire to deploy innovative approaches and technologies in a high-energy environment.

• Be solution-oriented by anticipating obstacles and difficulties, and proactively providing risk assessment and mitigation strategies to achieve project goals.

• Excellent written/verbal communication and interpersonal skills.

• High sense of priority and commitment to excellence in the successful execution of deliverables.

• Ability to analyze operational data, contribute with a mind on quality, timeliness and fiscal responsibility, make and drive decisions, multi-task, prioritize tasks, anticipate challenges, and execute on goals as a member of an interdisciplinary team.

• Demonstrate proficiency in Microsoft Office Suite (Outlook, MS Word, Excel, PowerPoint); MS Project and/or Smartsheet a plus.

• Travel may be required (~25%).

Preferred Skills:

• Familiarity working with vendor systems/portals (e.g., eTMF, EDC, IRT, CTMS).

• Oncology experience, early and/or late stage, strongly preferred.

• Knowledge and/or familiarity with Ex-US region(s) clinical trial operations.

• Some experience mentoring jr staff. 

  #LI-Hybrid  #LI-DN1

The Opportunity:

Revolution Medicines is seeking an Associate Director, Clinical Quality Assurance, who will play a key role within Quality Assurance and is responsible for providing leadership and compliance support for RevMed sponsored clinical trials with respect to RevMed’s Standard Operating Procedures, applicable regulatory requirements (FDA, EU, ICH & country-specific), and current industry standards and practices.

• Support the development and maintenance of applicable Quality Systems and procedures that comply with applicable GCP standards and guidelines.

• Collaborate with clinical functions (e.g., Clinical Operations, Clinical Development) to provide GCP compliance support.

• Participate in clinical study execution teams (CSETs) to enable risk-based quality management and a culture of quality and open dialogue.

• Perform quality review of clinical trial documents with a focus on compliance / regulatory requirements and risk management.

• Collaborate with internal stakeholders, external auditors, and auditees to support the planning, preparation, conduct, reporting, and closure of GCP audits.

• Provide risk-based quality oversight for clinical trial activities and perform routine clinical vendor assessments.

• Provide support for Inspection Readiness activities (e.g., TMF activities, study documentation).

• Assess and coordinate activities relevant to potential quality issues associated with GCP and clinical trial conduct including but not limited to investigations, and root cause analysis, CAPA planning and management.

• Escalate identified issues to QA Management and other relevant leadership as needed in a timely manner.

• Enable other assigned GCP or GXP related tasks, as appropriate.

• Support GCP audits and inspections of RevMed, Vendors, and clinical investigator sites by regulatory authorities or business partners.

• Build positive professional relationships and trust to support learning, respect, open communication, collaboration, and teamwork.

Required Skills, Experience and Education:

• Bachelor’s degree in scientific or technical discipline.

• A minimum of 10+ years of experience in GCP Quality in the pharmaceutical or biotechnology industry.

• 8 years in any of the following areas: audit or audit management experience, inspection readiness, Deviation/CAPA management, or related quality management system responsibilities.

• Extensive knowledge of ICH GCP, other relevant ICH guidelines and regulatory requirements (minimally US FDA) regarding applicable drug development regulations.

• Effective communication (verbal and written).

• Ability to build and sustain positive relationships with GxP colleagues, internal stakeholders, and external partners.

• Ability to create innovative solutions to problems, while integrating stakeholder input and feedback.

• Ability to critically evaluate and troubleshoot complex problems with diligence.

• Ability to manage multiple priorities and aggressive timelines.

• Highly responsible, self-motivated professional with enthusiasm and passion for the work.

• Highly proficient with various Microsoft and other computerized systems (e.g., Word, Outlook, Excel, PowerPoint, Visio, etc.).

Preferred Skills:

• Good knowledge of Computer System Validation. 

  #LI-Hybrid #LI-JC1

The Opportunity:

The Executive Director of GCP QA is a senior leadership role responsible for setting and executing the global GCP quality strategy across clinical development programs. This position ensures compliance with regulatory requirements, industry standards, and company policies governing clinical trials. The role provides strategic oversight of GCP QA activities, including leadership of a high-performing QA team, governance of contract research organizations, and advancement of continuous improvement initiatives to uphold the highest standards of quality and patient safety.

Serving as the GCP QA lead for late-stage clinical programs, this individual is accountable for GCP, GLP, and Pharmacovigilance/Safety oversight across multiple RevMed studies and represents QA in cross-functional and executive forums. The Executive Director will serve as a key advisor to senior leadership on clinical quality risk and regulatory readiness, helping to shape development strategy and enable successful regulatory outcomes. This position reports to the Vice President, Global Quality.

Key Responsibilities:

• Develop and execute the global GCP QA strategy aligned with corporate objectives, regulatory requirements, and RevMed SOPs.

• Serve as the Clinical QA Lead for global Phase 2/3 oncology studies, representing QA in governance forums and providing decision-making oversight on GCP related matters.

• Establish and maintain GCP QA frameworks, including policies, procedures, systems, and risk-based quality management (RBQM) to ensure compliance with global regulations (FDA, EMA, ICH).

• Provide end-to-end QA oversight of clinical studies, including:

• Review and approval of key study documents (protocols, monitoring plans, vendor oversight plans, quality agreements)

• Trial Master File (TMF) quality and inspection readiness

• GxP computerized systems and data integrity controls

• Lead and oversee GCP audit and inspection activities, including investigator sites, vendors, internal processes, and regulatory inspections (e.g., BIMO, PV), ensuring timely resolution of findings and CAPAs.

• Serve as the primary QA interface with global regulatory authorities, leading inspection strategy and representing the organization during health authority interactions.

• Drive global inspection readiness through structured planning, mock inspections, and cross-functional preparedness activities to support successful regulatory submissions and approvals.

• Oversee vendor and CRO quality management, including selection, qualification, governance models, performance monitoring (KPIs), and compliance with quality agreements.

• Proactively identify and mitigate systemic quality risks across the clinical portfolio, influencing development strategies and ensuring effective escalation to senior leadership.

• Monitor, trend, and report quality metrics (e.g., KPIs, QTLs, TMF health, CAPAs), leveraging insights to drive continuous improvement and operational excellence.

• Provide QA oversight of pharmacovigilance activities, ensuring compliance with safety reporting requirements and vendor performance expectations.

• Partner cross-functionally with Clinical Development, Clinical Operations, Regulatory Affairs, and Pharmacovigilance to drive quality, compliance, and continuous improvement.

• Drive innovation in QA through adoption of digital tools, advanced analytics, and modern risk-based quality approaches.

• Build, scale, and lead a high-performing global GCP QA organization, fostering a culture of quality, accountability, and operational excellence.

• Serve as a subject matter expert on GCP/GLP/PV regulations, advising senior leadership and influencing quality strategy across the organization.

Required Skills, Experience and Education:

• Advanced degree in life sciences, pharmacy, chemistry, or a related field (PhD, MS, or equivalent preferred).

• Minimum of 15 years of experience in the pharmaceutical or biotechnology industry, including at least 10 years in GCP QA or clinical quality leadership roles, with demonstrated experience leading and hosting regulatory inspections (e.g., FDA BIMO, EMA, MHRA, PMDA).

• Demonstrated experience interacting directly with global health authorities and leading inspection strategy and execution.

• Experience supporting late-stage clinical development and regulatory submissions (e.g., NDA, MAA), preferably in oncology.

• Proven track record and relevant industry experience in leading GCP QA functions within a global organization, preferably in oncology.

• Strong knowledge of global GCP regulations, ICH guidelines, and clinical trial processes.

• Excellent leadership, communication, team building and people skills, with the ability to influence stakeholders at all levels.

• Analytical thinker with a focus on continuous improvement and innovation.

• Experience working within outsourced clinical trial models and managing global CRO/vendor networks is highly desirable.

• This role may require occasional travel (up to 15%) for audits, inspections, and meetings.

• Flexibility to work in a fast-paced, dynamic environment with evolving priorities.

Preferred Skills:

• Experience implementing advanced RBQM frameworks and leveraging analytics-driven approaches (e.g., centralized monitoring, signal detection) to enhance clinical quality oversight.

• Prior experience in a small-to-mid-size biotech environment, with demonstrated ability to build and scale QA functions within highly outsourced, global clinical development models. 

  #LI-Hybrid  #LI-GL1

The Opportunity:

RevMed is seeking an experienced privacy executive to support RevMed’s business.  The Executive Director, Global Privacy will lead the strategy, development, and execution of the company’s Privacy Program, ensuring all activities are conducted ethically and in accordance with applicable laws, regulations, and industry codes. This attorney will be instrumental in shaping and sustaining a culture of integrity as the company advances and commercializes its oncology pipeline.

The Executive Director, Global Privacy is a senior leader responsible for driving the organization’s global privacy strategy, governance, and compliance framework. This role ensures that all business activities involving personal data are conducted ethically and in compliance with applicable international laws, regulations, and industry standards.

Reporting to the Vice President, Compliance, this role serves as a key advisor to the General Counsel (GC) and other senior executives on global privacy, data protection, and responsible data use, while fostering a culture of privacy-by-design across all business functions worldwide.

The position can be based in the US or Switzerland.

Key responsibilities include:

Strategic Leadership & Governance

• Lead the development and execution of a comprehensive global privacy strategy aligned with business objectives and the broader compliance program.

• Serve as a senior advisor to the General Counsel (GC) and other senior executives on global privacy risks, regulatory developments, and data governance.

• Establish and maintain enterprise-wide global privacy governance frameworks, policies, and standards.

• Design the Global Privacy team structure and operating model leveraging both regional and global resources, support design and implementation of technology-enabled systems and processes for regional adaptation where appropriate and recruit a high-performing team.

• Provide regular updates to the General Counsel and other senior executives on global privacy program performance, risks, and mitigation strategies.

Global Privacy Program Management

• Design, implement, and continuously enhance a global privacy program aligned with international laws and best practices.

• Ensure alignment of the privacy program with the company’s overall compliance framework and enterprise risk management approach.

• Ensure compliance with global privacy and data protection regulations, including GDPR, UK GDPR, HIPAA, CCPA/CPRA, and other applicable international and local laws.

• Oversee Data Privacy Impact Assessments (DPIAs), cross-border data transfer mechanisms, and global risk assessments.

• Monitor and report on privacy metrics, trends, and program effectiveness across regions.

Clinical and Commercialization Data-Driven Activities

• Serve as the primary privacy lead for all clinical trial-related activities, including data collected from clinical sites, investigators, and patients.

• Partner with R&D and clinical teams to ensure compliant handling of sensitive clinical and health data.

• Collaborate with Commercialization teams to advise on processes, controls, and risks related to data-driven activities, including analytics, digital initiatives, and commercialization strategies.

Operational Integration

• Embed privacy-by-design and privacy-by-default principles into systems, products, and business processes globally.

• Partner cross-functionally with Compliance, Legal, IT Security, R&D, HR, and Commercial teams across regions.

• Support global initiatives involving sensitive data, including clinical, digital, and analytics-driven programs.

• Work closely with HR and Information Security (IS) to address employee and internal data privacy matters, including monitoring, investigations, and governance of workforce data.

Risk Management, Investigations & Incident Response

• Lead or oversee global privacy incident response, including breach assessment, notification, and remediation across jurisdictions.

• Lead and/or oversee privacy-related investigations, including internal reviews and regulatory-driven inquiries.

• Collaborate with Compliance and Information Security to ensure consistent global controls and preparedness.

• Identify, assess, and mitigate global privacy risks in alignment with enterprise risk management priorities.

Regulatory & External Engagement, Third-party & Contractual Oversight

• Serve as a key point of contact for global data protection authorities and regulators, in coordination with Compliance and Legal.

• Support global regulatory inquiries, audits, and inspections related to privacy.

• Oversee global privacy due diligence and risk management for third-party vendors and partners.

• Own and maintain privacy-related standards across the organization, including templates and playbooks.

• Review, negotiate, or oversee negotiation of privacy and data protection terms in contracts, including data processing agreements (DPAs), standard contractual clauses (SCCs), and related provisions.

• Ensure consistent and appropriate privacy language across all contractual forms and third-party engagements.

Training, Culture & Awareness

• Develop and deliver global privacy training and awareness programs aligned with compliance initiatives.

• Promote a culture of privacy, ethics, and accountability across all geographies.

• Partner with Compliance to integrate privacy into Code of Conduct, global policies, and enterprise training programs.

Required Skills, Experience and Education:

• Juris Doctor (JD); active bar membership a plus.

• Privacy certifications (e.g., CIPP/E, CIPP/US, CIPM, CIPT).

• 15+ years of experience in privacy, data protection, legal, compliance, or risk management

• Significant experience managing or leading global privacy programs in multi-jurisdictional environments.

• Experience in regulated industries (e.g., biotech, pharmaceutical, healthcare, or technology) preferred.

• Deep knowledge of global privacy regulations and frameworks (e.g., GDPR, UK GDPR, HIPAA, CCPA/CPRA, and other international laws).

• Experience with cross-border data transfers, data localization requirements, and global data governance.

• Strong understanding of privacy risk assessments, data lifecycle management, and compliance program integration.

• Familiarity with emerging areas such as AI/ML governance, digital health, and global data strategy.

• Ability to influence senior leadership and drive global, cross-functional initiatives.

• Strong strategic thinking with practical, business-oriented judgment.

• Excellent communication and stakeholder management skills across diverse geographies.

• Proven ability to lead teams and operate effectively in a matrixed, global organization.

• Strong organizational and project management capabilities.

#LI-Hybrid  #LI-YG1

POSITION SUMMARY:

Natera is seeking a highly motivated and experienced Clinical Scientist to support the development and execution of our innovative Oncology programs.

The Director, Clinical Science will ensure the successful execution of clinical development programs and deliverables in partnership across the organization, with external vendors, and with external academicians and collaboration partners. The Director, Clinical Science will be accountable to jointly develop clinical program strategy and work collaboratively together with other functional representatives to assure that activities are executed within expected scope, compliance, budget, and timelines. Specifically, the candidate will work closely with colleagues cross functionally in clinical development, clinical operations, data management safety/pharmacovigilance, regulatory, biostatistics, translational medicine, and program leadership.

PRIMARY RESPONSIBILITIES:

• Develop study concepts, including study design, schedule of assessments, objectives/endpoints, and eligibility criteria  
• Collaborate cross-functionally to develop Protocol and ICF documents / amendments and present these to governance committee and early clinical development team meetings as required
• Provide protocol training and contribute to CRF design
• Ensure study manuals align with protocol and engage investigators in study design
• Seek input from key investigators on study design and methodology to ensure alignment with research objectives, and actively participate in pre-site selection discussions, site initiation visits, and investigator meetings to support successful study execution
• Contribute to and oversee real-time clinical data reviews (including oversight of CROs when applicable)
• Serve as a clinical science representative on internal and external meetings 
• Develop clinical project execution timelines and provide status updates to senior management to ensure the timely delivery of program milestones
• in collaboration with Data Management will develop Data Review Plan, and monitor clinical data for specific trends, ensure CRF design adequately supports data collection in alignment with the protocol in collaboration with Data Management/Programming
• Support meetings (advisory boards, etc) and deliver presentations
• Drive clinical research plans, including company and investigator-initiated studies
• Effectively interact with senior members in other functional areas for strategic planning to ensure optimized clinical development in accordance with corporate objectives 
• Build relationships with KOLs, consortiums, and sites
• Provide scientific input into design & implementation of clinical trial(s), their delivery, clinical data review and data cleaning, interpretation of results, reporting successfully on time, and activities required for registration of the product 
• As appropriate, participates in ongoing enhancements/development of team processes, structures, systems, tools, and other resources; As appropriate, coaches and guides less experienced Clinical Scientists
• Manage one or more direct reports including being responsible for hiring, training, developing, and retaining talent on staff, as needed
• As appropriate, participates in competitive intelligence and/or other market/industry assessment activities and projects
• Maintains scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment
• Ensure HIPAA/PHI compliance and maintain training requirements
• Perform other duties as assigned

QUALIFICATIONS:

• Advanced degree in Life Sciences (MD, PhD, Pharm D, MS, RN or similar scientific field) preferred
• 10+ years of pharma/biotech industry experience in clinical development in oncology clinical trials
• Deep understanding and preferably experience in oncology molecular diagnostics, oncology companion diagnostics or early cancer detection 
• Experience in data review, data cleaning, managing and interpreting clinical trials results as well in writing clinical trial protocols
• Possesses sound foundational knowledge of FDA and other major country regulations and detailed knowledge of Good Clinical Practice other regulations governing clinical research
• Experience with managing direct reports, ensuring that roles are performed in accordance with job descriptions and that training is conducted and maintained appropriately

KNOWLEDGE, SKILLS, AND ABILITIES:

• Problem-solving skills and a fast learner
• Strong communication (oral and written) and attention to detail
• Ability to work independently and collaboratively
• Analytical and creative thinking
• Familiarity with Google and Microsoft suites
• Desire to work in a dynamic environment
• "Hands-on" leadership and a strong work ethic
• Ability to apply business knowledge, exercise judgment, and escalate issues appropriately
• Strong project management, organizational, and interpersonal skills
• Adaptability, initiative, and team-building skills
• Demonstrated success in working in a cross-functional environment
• Successful and superior influencing skills across all levels of the organization and external collaborators
• Conflict resolution and follow-through skills
• Results and goal-oriented
• Strategic and flexible thinking

PHYSICAL DEMANDS & WORK ENVIRONMENT:

• Office or home office setting with internet access
• Ability to use a computer, phone, and read materials 
• Flexibility to work with colleagues in a global setting
• Able to engage in work-related travel up to 25%

POSITION SUMMARY:

Natera is seeking a highly motivated and experienced Clinical Scientist to support the development and execution of our innovative Oncology programs.

The Associate Director, Clinical Science will ensure the successful execution of clinical development programs and deliverables in partnership across the organization, with external vendors, and with external academicians and collaboration partners. The Associate Director, Clinical Science will be accountable to jointly develop clinical program strategy and work collaboratively together with other functional representatives to assure that activities are executed within expected scope, compliance, budget, and timelines. Specifically, the candidate will work closely with colleagues cross functionally in clinical development, clinical operations, data management safety/pharmacovigilance, regulatory, biostatistics, translational medicine, and program leadership.

PRIMARY RESPONSIBILITIES:

• Develop study concepts, including study design, schedule of assessments, objectives/endpoints, and eligibility criteria  
• Collaborate cross-functionally to develop Protocol and ICF documents / amendments and present these to governance committee and early clinical development team meetings as required
• Provide protocol training and contribute to CRF design
• Ensure study manuals align with protocol and engage investigators in study design
• Seek input from key investigators on study design and methodology to ensure alignment with research objectives, and actively participate in pre-site selection discussions, site initiation visits, and investigator meetings to support successful study execution
• Contribute to and oversee real-time clinical data reviews (including oversight of CROs when applicable)
• Serve as a clinical science representative on internal and external meetings 
• Develop clinical project execution timelines and provide status updates to senior management to ensure the timely delivery of program milestones
• in collaboration with Data Management will develop Data Review Plan, and monitor clinical data for specific trends, ensure CRF design adequately supports data collection in alignment with the protocol in collaboration with Data Management/Programming
• Support meetings (advisory boards, etc) and deliver presentations
• Drive clinical research plans, including company and investigator-initiated studies
• Effectively interact with senior members in other functional areas for strategic planning to ensure optimized clinical development in accordance with corporate objectives 
• Build relationships with KOLs, consortiums, and sites
• Provide scientific input into design & implementation of clinical trial(s), their delivery, clinical data review and data cleaning, interpretation of results, reporting successfully on time, and activities required for registration of the product 
• As appropriate, participates in ongoing enhancements/development of team processes, structures, systems, tools, and other resources; As appropriate, coaches and guides less experienced Clinical Scientists
• Manage one or more direct reports including being responsible for hiring, training, developing, and retaining talent on staff, as needed
• As appropriate, participates in competitive intelligence and/or other market/industry assessment activities and projects
• Maintains scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment
• Ensure HIPAA/PHI compliance and maintain training requirements
• Perform other duties as assigned

QUALIFICATIONS:

• Advanced degree in Life Sciences (MD, PhD, Pharm D, MS, RN or similar scientific field) preferred
• 8+ years pharma/biotech industry experience in clinical development in oncology clinical trials
• Deep understanding and preferably experience in oncology molecular diagnostics, oncology companion diagnostics or early cancer detection 
• Experience in data review, data cleaning, managing and interpreting clinical trials results as well in writing clinical trial protocols
• Possesses sound foundational knowledge of FDA and other major country regulations and detailed knowledge of Good Clinical Practice other regulations governing clinical research
• Experience with managing direct reports, ensuring that roles are performed in accordance with job descriptions and that training is conducted and maintained appropriately

KNOWLEDGE, SKILLS, AND ABILITIES:

• Problem-solving skills and a fast learner
• Strong communication (oral and written) and attention to detail
• Ability to work independently and collaboratively
• Analytical and creative thinking
• Familiarity with Google and Microsoft suites
• Desire to work in a dynamic environment
• "Hands-on" leadership and a strong work ethic
• Ability to apply business knowledge, exercise judgment, and escalate issues appropriately
• Strong project management, organizational, and interpersonal skills
• Adaptability, initiative, and team-building skills
• Demonstrated success in working in a cross-functional environment
• Successful and superior influencing skills across all levels of the organization and external collaborators
• Conflict resolution and follow-through skills
• Results and goal-oriented
• Strategic and flexible thinking

PHYSICAL DEMANDS & WORK ENVIRONMENT:

• Office or home office setting with internet access
• Ability to use a computer, phone, and read materials 
• Flexibility to work with colleagues in a global setting
• Able to engage in work-related travel up to 25%

Position Title:   Director, Regulatory Affairs (Strategy, Immunology and Inflammation)

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 Director, Regulatory Affairs (Strategy, I&I) to join the Regulatory team.  The successful candidate will be a core member of the Regulatory team and will serve as the global regulatory lead (GRL) for the immunology and inflation therapeutic area. This role will be responsible for developing the global regulatory strategy in collaboration with key internal stakeholders, as well as tactical implementation of that strategy guiding and executing compliant, high quality, nonclinical and clinical submissions and interactions in support of early development, registration and life cycle management activities.  This position works cross-functionally with regulatory affairs and clinical development organizations to facilitate the completion of regulatory filing documentation according to company timelines. It also ensures adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as required. This position is on site in the Brisbane, CA office.

Responsibilities:

• Develop and implement competitive and effective global clinical & nonclinical regulatory strategies for various immunology and inflammation indications and identify potential risks and mitigation strategies associated with proposed strategies
• Work in close collaboration with the SVP, Head of Regulatory Affairs and the development team leader and other cross-functional colleagues, including CROs to deliver sound, efficient development strategies and operational plans
• Represent Regulatory Affairs on assigned cross-functional development teams.
• Lead and manage the development and preparation of high-quality global submissions (including IND, CTAs, NDAs, and MAAs) for early and late-stage programs in collaboration with the regulatory and project teams to support and accelerate clinical development and regulatory approval, as applicable
• Lead communication with global Health Authorities (HA), such as FDA and EMA, including, planning and preparing for formal meetings with regulatory agencies and interpreting HA feedback from these interactions.
• Develops and executes, or oversees global regulatory strategy for long-term planning, including the potential to accommodate expedited development needs
• Anticipate issues and guide cross-functional teams on risk mitigation strategies for any development challenges Provides insight and guidance on the implementation of current regulations and assesses regulatory risk based on precedence
• Ensure adherence to current regulations associated with regulatory activities
• Works strategically with all regulatory functions to develop detailed, actionable submission plans, tracks major submission deliverables, and ensures 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

Requirements

• Bachelor's degree in life-sciences or related scientific discipline; advanced degree preferred Manager:
• Must have minimum of 12 years in Regulatory affairs strategy with significant experience in the immunology and inflammation therapeutic area
• 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
• 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

Salary Range:  220K – 254K plus bonus and equity.

Company Overview

Tango Therapeutics is a biotechnology company dedicated to discovering novel drug targets and delivering the next generation of precision medicine for the treatment of cancer.

Using an approach that starts and ends with patients, Tango leverages the genetic principle of synthetic lethality to discover and develop therapies that take aim at critical targets in cancer.

This includes expanding the universe of precision oncology targets into novel areas such as tumor suppressor gene loss and their contribution to the ability of cancer cells to evade immune cell killing.

The Tango labs and offices are located at 201 Brookline Avenue, in the Fenway area of Boston, Massachusetts.

Summary 

The Senior MSL is a U.S. field-based role within Medical Affairs, reporting to the Executive Director, Medical Affairs. This role will be a core member of Tango’s growing field medical team during a critical phase of development.

The Senior MSL will be responsible for high‑quality scientific exchange, trial execution support, medical education, and insight generation across priority solid tumor indications, with an initial focus on pancreatic cancer (PDAC), non-small cell lung cancer (NSCLC), and our evolving pipeline programs.

This role is ideal for an individual who wants to operate at the intersection of clinical development, external scientific engagement, and launch readiness in a late-emerging biotech environment, where individual impact is high and scientific accountability matters.

Your role

      Primary Focus: Solid tumors (pancreatic cancer (PDAC), non-small cell lung cancer (NSCLC)

      Scientific Exchange & External Engagement

What You Bring

      Education & Experience

• 8 years of relevant experience with a bachelor’s degree, 6 years with a master’s degree, or 3 years with an advanced scientific or medical degree (e.g., PharmD, PhD, MD) Candidates with advanced clinical degrees (e.g., NP, PA) and significant oncology Medical Science Liaison experience will also be considered.
• Experience in PDAC, GI malignancies, or NSCLC strongly preferred
• Prior experience supporting clinical-stage or pre-launch oncology assets highly valued

      Skills & Attributes

• Strong scientific acumen with the ability to engage deeply on complex biology and emerging clinical data
• Demonstrated strength in insight generation, synthesis, and communication
• Comfortable operating in a fast-moving, high-accountability biotech environment
• Excellent collaboration skills across matrixed teams
• Strong understanding of U.S. clinical research and healthcare environments

      Compliance & Technical Requirements

• Working knowledge of FDA, OIG, ICH, GCP, PhRMA Code, and applicable compliance standards
• Commitment to compliant, ethical scientific exchange
• Proficiency in standard business and field tools (CRM, MS Office, virtual engagement platforms)

Work Environment

• Field-based role in California, with residence required within assigned territory
• ~ 50% domestic travel expected, with significant time spent with external scientific partners

Why Join Tango Medical Affairs?

• Be part of a Medical Affairs team built for a transition from mid-stage to late-stage development
• Contribute directly to trial success, data readiness, and future regulatory and commercialization pathways
• Expand and establish Tango as a credible clinical scientific leader in precision oncology
• Work in a lean, collaborative environment where your scientific judgment and execution matter

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

#LI-Remote

About the Role >>> Associate Director, GCP Quality Assurance   

As the Associate Director, GCP Quality Assurance, reporting to the Senior Director GCP Quality Assurance, you will be partnering with Clinical Development/Operations, Pharmacovigilance and Safety in cross-functional study teams to drive GCP/GVP compliance. This will include identifying and communicating clinical trial-related risks and opportunities for process improvement, as well as reviewing / approving study-related documents and plans and supporting audits.  

This hybrid role is based out of either our San Francisco, CA or Cambridge, MA office and requires up to 20% travel. 

Your work will primarily encompass: 

• Performs internal and external audits as assigned to ensure compliance with GCP/GVP regulations and guidelines 
• Provide GCP/GVP auditing activities, including audit preparation, execution, report preparation, and follow-up to any findings/observations, including corrective and preventive actions (CAPAs), communicate audit results to internal stakeholders  
• Partner with QA leadership during regulatory authority inspections and drive  GxP inspection readiness activities 
• Oversees quality aspects related to clinical study start-up, execution, and close-out by providing leadership, guidance, and direction to staff consistent with GCP/GVP 
• Prepare for health authority inspections, suppliers and or clinical sites 
• Oversee clinical compliance and quality within the context of cross-functional study teams 
• Continue to improve/refine Olema’s risk-based GCP compliance approach globally 
• Manage Quality Management System (QMS) including, but not be limited to, the following activities: QA review/approval of deviations, CAPAs and change controls 
• Draft, review, and approve policies, procedures, and work instructions 

Ideal Candidate Profile >>> Key Requirements 

A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role. 

Knowledge: 

• Bachelor’s Degree or higher in a scientific discipline 
• Strong understanding of clinical trials and pharmacovigilance reporting  
• In-depth knowledge of and ability to interpret and apply GCP, EU, FDA, and ICH regulations and guidelines 
• Understanding of industry quality management tools, quality systems (e.g., QMS, eTMF, EMRs, EDC, etc.) 

Experience: 

• A minimum of 8 years of relevant experience in Quality Assurance or related role in a pharmaceutical, biotechnology, or related environment 
• Demonstrated experience leading and/or conducting internal and external QA audits developing and executing risk-based audit plans 
• Demonstrated ability to develop and foster positive, collaborative relationships with internal staff as well as with external, third-party vendors 
• Hands-on experience with regulatory inspections and inspection readiness activities 
• Experience writing and reviewing SOPs 
• Experience using QMS (Veeva systems preferred) 
• Knowledge and experience in Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP) regulations. In addition, preferred Good Laboratory Practice (GLP) experience 
• Ability to interpret and apply GCP, EU, FDA, and ICH regulations and guidelines 

Attributes: 

• Excellent verbal and written communication skills 
• Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members 
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines 
• Excellent planning, organization, and time management skills including the ability to support and prioritize multiple projects 
• Ability to work hands-on and be a strong individual contributor 

The base pay range for this position is expected to be $190,000 - $205,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits. 

#LI-CK1

The Opportunity:

This is a unique opportunity for a Clinical Operations Professional who has innate leadership and organizational skills, technical expertise in clinical drug development in an industry setting and a drive to promote excellence. As an Associate Director (AD) Clinical Operations Enablement & Knowledge Systems, you will be a key member of the Clinical Operations Excellence team. You will be responsible for building and scaling the Clinical Operations “knowledge ecosystem”—including how information is structured, accessed, and applied—to enable consistent, efficient, and high-quality study execution across roles and programs. This is an execution-focused role that strengthens the capabilities of the Clinical Operations organization.

• The ideal candidate is a Clinical Operations leader who combines deep study execution experience with the ability to design scalable, user-centered systems that enable others to perform at their best.

• Lead the design and deployment of a scalable Clinical Operations knowledge ecosystem, including playbooks, toolkits and structured resources that enable consistent high quality study execution.

• Develop role-based enablement frameworks aligned to Clinical Operations responsibilities, study activities, and key transition points.

• Design and deliver multi-modal learning solutions (e.g., live sessions, on-demand modules, short-form videos, playbooks, and interactive resources) to maximize accessibility and adoption.

• Apply adult learning principles and user-centered design to ensure content is practical, engaging, and immediately applicable.

• Apply knowledge of Clinical Operations workflows and regulatory context (e.g., GCP, ICH) to ensure learning content is relevant, practical, and aligned with real-world study execution (this role does not own SOP development, GxP training, or inspection readiness activities).

• Support the successful onboarding of new Clinical Operations team members.

• Design and deliver targeted, “just-in-time” learning tools and experiences (e.g., checklists, quick guides, decision aids) to support critical activities and study milestones.

• Align learning and knowledge resources to key study lifecycle stages (e.g., study start-up, conduct, database lock, close-out).

• Define and implement a scalable structure for Clinical Operations knowledge, including how resources, tools, and guidance is organized, accessed, and maintained.

• Create intuitive, role-based pathways for accessing information across study lifecycle stages.

• Establish standards for maintaining and continuously improving operational knowledge.

• Own day-to-day planning, coordination, and delivery of learning activities, ensuring timeline, quality and outcomes are met.

• Track adoption, effectiveness and impact of learning and knowledge initiatives.

• Use feedback and performance insights to identify capability gaps and continuously improve tools, resources, and learning solutions.

• Evolve learning materials and resources to maintain alignment with Clinical Operations and cross-functional partner growth and needs.

• Partner with Clinical Operations and cross-functional team members to improve processes that will impact clinical trial management, quality and efficiency.

• Line management responsibilities including hiring, performance management, career development, and mentorship.

• This role does not own SOP authoring, GxP training delivery, or inspection readiness activities, but partners with relevant functions to ensure alignment.

• Participate in other Clinical Operations Excellence and Clinical Operations Activities as appropriate.

Required Skills, Experience and Education:

• RN or Bachelor’s degree in biological sciences or health-related field required.

• 11+ years direct Clinical Operations experience in the pharmaceutical or biotech industry, Relevant indirect experiences may also meet the requirement.

• Minimum of 5 years of line management experience.

• Strong working knowledge of FDA Regulations, ICH Guidelines, and GCP.

• Demonstrated experience successfully developing and authoring Clinical Operations and cross-functional handbooks, guidances or process templates in support of clinical operations or clinical study team management.

• Experience with leading organizational change efforts.

• Minimum of 6 years of cross-functional study management or related leadership experience in life sciences.

• Demonstrated experience building or scaling learning programs, knowledge systems, or operational frameworks within Clinical Operations.

• Experience translating complex clinical workflows into practical tools, guidance, or training materials.

• Strong systems thinking and ability to design scalable, user-friendly solutions.

• Experience in selection and management of external resources (e.g., CROs, vendors, contractors).

• Thrives in a collaborative team setting that demonstrates flexibility required to maintain a fast pace and is driven by a desire to deploy innovative approaches and technologies in a high-energy environment.

• Be solution-oriented by anticipating obstacles and difficulties, and proactively providing risk assessment and mitigation strategies to achieve project goals.

• Ability to deal with time demands, incomplete information, or unexpected events.

• Outstanding organizational skills with the ability to multi-task and prioritize.

• Excellent interpersonal, verbal and written communication skills.

• High sense of priority and commitment to excellence in the successful execution of deliverables.

• Ability to contribute with a mind on quality, diligence, timeliness and fiscal responsibility, make and drive decisions, multi-task, prioritize tasks, anticipate challenges, and execute on goals as a member of the Clinical Operations Excellence team.

• Decision-making skills.

• Comfortable in a fast-paced company environment and able to adjust workload based upon changing priorities.

• Demonstrate proficiency in Microsoft Office Suite (Outlook, MS Word, Excel, PowerPoint); MS Project and/or Smartsheet a plus.

• Travel may be required (~25%).

Preferred Skills:

• Experience deploying AI-enabled solutions to support Clinical Operations activities.

• Familiarity working with in-house or vendor systems/portals (e.g., eTMF, EDC, IRT, CTMS).

• Oncology experience, early and/or late stage, strongly preferred.

• Experience in start-up, management, and close-out of clinical trials, including authoring clinical study and regulatory documentation.

• Knowledge and/or familiarity with Ex-US region(s) clinical trial operations. 

  #LI-Hybrid  #LI-DN1

The Oncology MSL role is an exciting opportunity to work at a well-established pharmaceutical company that is poised to have a first in class oncology product in a platform extending across multiple therapeutic areas. This role is a chance to join a high performing team that is well-respected in the cross-functional Oncology Business Unit. This will cover the West Territory.

The MSL will represent Corcept to the highest ethical and professional standards and in accordance with guidelines, directions, and policies.

Responsibilities:

• Engage in clinically meaningful scientific discussions with thought leaders in gynecological oncology and other malignancies to enhance their knowledge of Corcept and the role of cortisol modulation in oncology
• Proactively communicate and educate health care professionals on disease states where cortisol modulation may play a role. Provide responsive support when appropriate requests are made. Engage in scientific exchange on Corcept’s non-clinical and clinical trial data as well as the clinical development plan
• Develop and maintain strong working relationships with thought leaders, patient advocacy organizations, and oncology associations (like GOG and ASCO as well as regional organizations) within the oncology community
• Capture, analyze, and communicate insights and intelligence from the medical and scientific community in a compliant manner to help inform decisions by Corcept. Communications will clearly and effectively frame insights in a usable manner
• Support company-sponsored clinical trials, investigator-initiated studies (IIS), scientific communications, publications, clinical and scientific education, advisory boards, and congresses
• Maintain the highest standards of scientific, clinical, and technical expertise in relevant therapeutic area(s)
• Demonstrates teamwork and collaboration within Medical Affairs (MA) as well as cross-functionally with Clinical Development, Clinical Operations, Market Access, Marketing, Commercial, Data Analytics, etc. Exchanges ideas and knowledge compliantly among Oncology functions
• Travel required – approximately 50-60% of the time

Preferred Skills, Qualifications and Technical Proficiencies:

• Demonstrates strong scientific oncology acumen: therapeutic landscapes, NCCN guidelines, clinical trial data, oncology cooperative groups, NCI/NCCN cancer centers, etc.
• Exemplifies the following core competencies: intellectual curiosity, managing change, teamwork and collaboration, communication, achieving results, decision-making, and clinical and scientific expertise
• Demonstrates strong business acumen: has working knowledge of the multi-disciplinary functions involved in a company's drug development process, e.g., research, development, clinical operations, biostatistics, regulatory, commercial, etc.
• Exhibits excellent project management skills: can prioritize multiple tasks and goals and ensure the timely, on-target, and within-budget accomplishment of projects
• Identifies resources to accomplish priorities and works with the MA team to ensure resources are available
• Understands change management and demonstrates adaptability in priorities, goals, and territory
• Has proven effective interpersonal and communication skills
• Provide feedback to the MA trainer and MA Senior Director to ensure an atmosphere of quality improvement and excellence
• Demonstrates strong experience with PowerPoint, Word, and Excel; must be able to create and edit content with minimal assistance and an eye for accuracy and detail
• Experienced with Veeva CRM (or other CRM) and Veeva Vault, as well as SharePoint and/or BOX is preferred
• Must maintain a driving record in accordance with Corcept vehicle policy

Preferred Education and Experience:

• PhD, advanced degree in medical science (MD, PharmD, MSN, PA, NP) required
• 1-3+ years MSL experience; 2+ years in oncology

 _#LI-Remote

The pay range that the Company reasonably expects to pay for this position is $206,370 – $242,820; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education.

 Applicants must be currently authorized to work in the United States on a full-time basis.

The Opportunity:

We are seeking an experienced clinical science drug developer to serve as Senior Director of Clinical Development in support of Revolution Medicines’ clinical-stage molecule(s). In this critical role, you will support various clinical science deliverables and enable effective and efficient execution of the clinical development plan for a molecule(s) within its particular indication(s). The scope of activities spans early-stage clinical research to pivotal studies including regulatory submissions. You will play a vital role in leading the clinical science aspects of the Clinical Development Plan (CDP) strategy, driving the development of transformative therapies for patients.

• Lead clinical science aspects of the clinical development strategy and clinical documentation.

  Represent the clinical development plan on appropriate teams, sub-teams and forums; oversee training of study site personnel, act as primary point-of-contact for questions/enquires regarding the CDP at a program level, oversee the conduct of medical/safety data reviews and study reporting.

• Potential assignment to complex and high-priority strategic studies for Revolution Medicines’ molecules, with expectation to perform responsibilities with independence and clear self-directed leadership.

• Cross-functionally align efforts seamlessly with scientific, regulatory, and commercial objects while executing upon the clinical development plan.

• Lead, mentor, and contribute to a high-performing cross-functional team of clinical development professionals, fostering a culture of collaboration, innovation, and excellence.

• Oversee all aspects of clinical trial design and execution, including site selection, patient recruitment, data management, and regulatory compliance.

• Establish and maintain strong relationships with clinical investigators, regulatory agencies, and key stakeholders.

• Gather, analyze and interpret clinical data, providing strategic insights to inform critical decisions and guide program development.

• Manage clinical development timelines effectively, ensuring efficient resource allocation and achievement of milestones.

• Stay abreast of the latest scientific advancements and regulatory trends in the field of clinical development.

• Potential to manage multiple direct reports

Required Skills, Experience and Education:

• A PhD, PharmD or equivalent is required. The years of experience are based on clinical development or similar relevant experience.

• Minimum 10+ years experience in clinical development required (Pharma R&D experience outside of a clinical development role also considered pending transferability of skills and responsibilities).

• Extensive experience working with the principles and techniques of data analysis, interpretation, and clinical relevance as related to the pharmaceutical/biotech industry.

• Experience in independent generation of trial design, protocol writing/ICF (writing or amendment), constructing appropriate CRF and coordinating cross-functionally.

• In-depth therapeutic area experience/expertise, and relevant clinical trial experience (or clear ability to adapt with transferable skills).

• Strong knowledge of medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMA and other relevant guidelines and regulations is required.

• Proven ability to work effectively and efficiently within cross-functional teams involved in the drug development process; proven ability to efficiently integrate multiple perspectives into the CDP.

• Experience authoring regulatory briefing packs, write responses to Health Authority questions, and proven ability to contribute to strategic approach and cross-functional coordination in support of regulatory activities/interactions.

• Demonstrated success in driving various aspects of cross-functional study level strategy, e.g. study design, supporting feasibility and timelines/budget projections, protocol amendment requirements. Ability to drive relevant discussion at key internal decision-making bodies/governance.

• Proven ability to build and maintain strong relationships and contribute to interactions with external key opinion leaders to optimize clinical programs (e.g. advisory boards, individual engagements, steering committees, etc.).

  Experience in (or clear ability) investigator engagement to optimize clinical trial conduct. Includes presenting at investigator meetings.

• Strong orientation to teamwork. Excellent leadership, communication, and interpersonal skills with the ability to inspire, motivate and mentor across a diverse team.

• Experience in mentoring other clinical scientists. Experience or clear potential as an effective line manager.

• Expertise in building and maintaining strong relationships with internal and external stakeholders.

• Superb strategic thinking and analytical skills, with the ability to make data-driven decisions in a fast-paced environment. Able to recognize trade-off decisions and can determine priorities and goals.

• Strong written and business presentation skills is required.

• Passion for innovation and a commitment to developing therapies that make a meaningful difference in patients' lives.

• Demonstrated strong leadership presence.

• Has demonstrated adaptability and flexibility.

• Anticipates needs, assesses and manages business and organizational risks.

Preferred skills:

• Has made significant contributions to clinical development plan conception, conduct and delivery, including successful alignment with scientific governance.

• Experience in ongoing enhancements/development of core and sub-team processes, structures, systems, tools and other resources in the pharmaceutical/biotech industry.

• Has led clinical development contributions to major regulatory submissions (e.g. (s)NDA, (s)BLA, PIP/PSP, label negotiation, Breakthrough Therapy Designation, Accelerated Review) is a major plus.

• Proven ability to present the clinical development aspects of a program(s) to key major reference health authorities (FDA, EMA, others.) by teleconference or in-person. Has led Health Authority interaction(s).

• Proven ability to set out the clinical development strategy for CTA/EC submissions and responses to health authority questions.

• Has demonstrated collaborate behaviors on enterprise-level strategic initiatives with a variety of internal and external partners and stakeholders - including clinical investigators/clinicians, scientists and key opinion leaders (KOLs), as well as internal groups, including other groups in development, research, business development, commercial, legal, etc. - resulting in demonstrable outcomes that have further enhanced strategic goals.

• Influential and inspiring leader, with proven ability to bring teams and individuals along with them.

• Has demonstrated courage and conviction in past positions and responsibilities. Demonstrated skills in conflict resolution. 

  #LI-Hybrid  #LI-SH1

About the Role

Join us in advancing our pipeline to address a number of diseases across therapeutic categories including eye care, dermatology, and other diseases with high unmet needs.

This role will be focused on the development of clinical strategies for assigned programs and is responsible for ensuring effective and efficient execution of the clinical development plan

Let’s talk about some of the key responsibilities of the role:

• A leader with influence to present and collaborate with cross-functional team members to synthesize clinical data.
• Primary author for assigned clinical trial protocols, collaborating with and leading with other functions required for protocol development.
• Contributes or reviews clinical, regulatory, and relevant study documents, including Investigator Brochures, Clinical Study Reports, Statistical Analysis Plans, Operation Manuals, Investigational New Drug Applications/Clinical Trial Applications, case report forms, and data tables listings and figures.
• Educates internal and external team members on protocol execution.
• Primary point of contact to address or properly triage inquiries from site, CRO personnel, and site monitors, regarding study protocol, informed consent, and patient-specific questions.
• Reviews, finalizes, and updates information/data entered in clinical trial registries.
• Participates in development of Clinical Development Plan.
• Partners with data management on resolution of all clinical queries to sites.
• May participate in health authority interactions, as well as interactions with site Institutional Review Boards/ethics committees.
• Contributes to scientific abstracts for submissions to scientific conferences and publications for peer-reviewed journals.
• Creates, reviews, and/or presents clinical slides for internal meetings and external forums.
• Collaborates with biostatistics to develop data tables, listings, and figures.
• Identifies and tracks any potential safety events within a given study, or across studies for assigned programs.
• Conducts medical data review.
• Provides clinical development input to proposed revisions of SOPs and guidance documents.

Factors for Success:

• Advanced clinical/science degree preferred (PharmD, PhD, OD, MD).
• 10+ years minimum experience, with 3+ years of pharma/biotech experience or demonstrates relevant equivalent clinical research experience (Clinical Scientist) and 5+ years of experience with clinical trials. Eye care experience preferred.
• Experience authoring clinical trial protocols and/or study results and conclusions, applying creative thinking and adaptability for early development programs
• In-depth understanding of drug development.
• Working knowledge of basic biostatistics
• Experience working with techniques of data analysis, interpretation, and assessment of clinical relevance.
• Well-versed in medical aspects of Good Clinical Practice, International Council for Harmonization, Food and Drug Administration, European Medicines Agency, National Institute for Health and Care Excellence and other relevant guidelines and regulations.
• Has demonstrated, through past experience, abilities to competently manage the majority of clinical science deliverables associated with assigned clinical studies.
• Strong presentation skills: effective at summarizing and presenting the key considerations and decision points.
• Confident and competent when interacting with varying levels of internal/external management, key opinion leaders, etc.
• Excellent teamwork and negotiation skills: knows how to complete deliverables by working effectively with others internally and externally; can effectively drive discussions and decisions toward desired end results.
• Able to work in a fast-paced dynamic organization.
• Demonstrated ability to be flexible and adaptable to change, to move between projects easily, and provide support/expertise where needed.
• Tarsus Competencies:
  • Decision Making - Identifies, analyzes, and resolves issues or challenges effectively and efficiently. Demonstrates creativity, decisiveness, and the capacity to implement solutions in a structured and outcome-oriented manner. Navigates uncertainty when there’s not a blueprint for success. Owns their decisions and actions.
  • Collaboration and Team Building - Builds strong relationships and networks. Is curious about and respectful of different points of view. Cultivates a safe space for discussion readily engaging in group dialogue and debate. Puts the team first.
  • Outcome Driven - Clearly defines mutual expectations of self and others in a team setting. Adapts to changing business needs. Is determined and resourceful in finding solutions, even when faced with obstacles. Takes appropriate actions, including calculated risks, to ensure obligations are met. 

A Few Other Details Worth Mentioning:

• The position will be based in our beautiful Irvine office, complete with onsite gym, pool, snacks, drinks, and occasional catered meals. We provide a hybrid work environment. Remote work is an option.
• We are passionate about our culture! Our Tarsans live our values of commitment to patients, empowerment to champion innovation, and teamwork to amplify impact!
• This position reports directly to the COO.
• Some travel may be required – up to 50%

At Tarsus, we understand the importance of attracting and retaining top talent. The expected base pay range for this position is $165,000 - $231,000 plus bonus, stock equity, and comprehensive benefits. The base pay range reflects the target range for this position, but individual pay will be determined by additional factors such as job-related skills, experience and relevant education or training. Our benefits include health, dental and vision insurance benefits to ensure your well-being. We believe in work-life balance and offer generous paid time off, including vacation, holidays, and personal days. For more details regarding Tarsus benefits, please visit: https://eb.alliant.com/26tarsusbenefitssnapshot.

#LI-Hybrid

#LI-Remote

Job Title: Executive Medical Director, Clinical Development         

Location: Remote OR Hybrid 3 days/week if located near office in either Waltham, MA or Menlo Park, CA will be required.          .          

Role Overview: The Executive Medical Director of Clinical Development plays a key role in leading the design, execution, and oversight of clinical trials at an asset level, ensuring high-quality data generation to support the safety and efficacy of our pipeline products.  This role involves leading and developing a team and contributing to and influencing clinical development strategy across an asset, including study design, implementation, and data interpretation, while working cross-functionally to align clinical activities with overall development plans.  The Executive Medical Director collaborates closely with internal and external stakeholders to ensure trial execution meets regulatory, scientific, and business objectives in a fast-paced environment.  The role reports to the Vice President of Clinical Development. 

Key Responsibilities:

• Strategic Leadership:
• Drives the clinical development strategy for one or more assets
• Identifies critical clinical development milestones and ensures team alignment and accountability toward meeting timelines
• Provides leadership to the clinical team’s contribution to clinical study reports, key clinical documents, and regulatory submissions
• Directly manages and/or mentors Medical Directors, Clinical Scientists and other team members as appropriate
• Clinical Trial Design and Oversight:
• Leads and contributes to the development of clinical trial protocols, including patient selection criteria, study endpoints, and data collection methods
• Oversees the conduct of clinical trials, ensuring adherence to protocols and good clinical practice (GCP) guidelines, working closely with CROs and external partners to ensure efficient execution
• Reviews and interprets clinical data to assess the safety and efficacy of the investigational drug, driving timely, data-driven decisions
• Manages the clinical contribution to documents required during development (including but not limited to: Clinical Study Protocols, Investigator Brochures, Clinical Study Reports)
• Medical Expertise:
• Provides deep medical and scientific expertise in the therapeutic area, disease state, and potential drug effects 
• Reviews clinical data to identify and analyze safety concerns and adverse events, working with the pharmacovigilance team on continual benefit-risk assessment
• Stays current with relevant medical literature and clinical trial methodologies

• Contributes medical expertise to external interactions, including KOL engagement, advisory boards, and regulatory interactions as appropriate

• Cross-Functional Collaboration:
• Works closely with other functions including clinical operations, regulatory affairs, medical affairs, biometrics, pharmacovigilance, pre-clinical and project management teams to ensure alignment between clinical strategy and execution in a fast-paced environment
• Presents clinical data to internal and external stakeholders as appropriate
• People Leadership & Team Development:
• Leads and develops a high-impact team
• Provides coaching, mentorship, and performance management
• Fosters a culture of accountability, collaboration, and scientific rigor
• Supports hiring and resource planning in partnership with leadership

Qualifications:

• Medical degree (MD) ideally with board certification in a relevant specialty
• Extensive experience in clinical research and development, including within the pharmaceutical industry with progression of career demonstrating clinical leadership
• Proven people leadership experience, including managing and developing direct reports in small or growing teams
• Strong understanding of clinical trial design, GCP guidelines, and regulatory requirements, ideally with Phase 2 and 3 clinical study experience
• Excellent communication, leadership, and analytical skills
• Demonstrated ability to contribute to and influence clinical strategy while driving hands-on execution 

Experience working in a small or emerging biotech environment, with comfort operating in a fast-paced setting

Compensation:

• An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.
• The anticipated salary range for candidates is $331,000 to $368,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Oruka is a multi-state employer and this salary range may not reflect positions that work in other states.

We're looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day.

The Opportunity:

We are seeking an experienced clinical science drug developer to serve as Senior Medical Director of Clinical Development in support of Revolution Medicines’ molecule(s) in clinical or late pre-clinical development. In this critical role, you will support various clinical science deliverables and enable effective and efficient execution of the clinical development plan for a molecule(s) within its particular indication(s). The scope of activities spans early-stage clinical research and may extend to studies supporting regulatory submissions including Breakthrough-Therapy-Designation (BTD) or Accelerated Approvals (AA). You will play a vital role in leading the clinical science aspects of the Clinical Development Plan (CDP) strategy, driving the development of transformative therapies for patients.

• Lead clinical science and medical aspects of the clinical development strategy and clinical documentation. Represent the clinical development plan on appropriate teams, sub-teams and forums; oversee training of study site personnel, act as primary point-of-contact for questions/enquires regarding the CDP at a program level, oversee the conduct of medical/safety data reviews and study reporting.

• Potential assignment to complex and high-priority strategic studies for Revolution Medicines’ molecules, with expectation to perform responsibilities with independence and clear self-directed leadership.

• Cross-functionally align efforts seamlessly with scientific, regulatory, and commercial objects while executing upon the clinical development plan.

• Lead, mentor, and contribute to a high-performing cross-functional team of clinical development professionals, fostering a culture of collaboration, innovation, and excellence.

• Oversee all aspects of clinical trial design and execution, including site selection, patient recruitment, data management, and regulatory compliance.

• Establish and maintain strong relationships with clinical investigators, regulatory agencies, and key stakeholders.

• Gather, analyze and interpret clinical data, providing strategic insights to inform critical decisions and guide program development.

• Manage clinical development timelines effectively, ensuring efficient resource allocation and achievement of milestones.

• Stay abreast of the latest scientific advancements and regulatory trends in the field of clinical development.

• Potential to manage multiple direct reports.

Required Skills, Experience and Education:

• MD (oncology training preferred) with 7+ years of experience in clinical development in the pharmaceutical/biotech industry and/or academic/other clinical trial setting; some experience in and understanding of early phase drug development preferred.

• Extensive experience working with the principles and techniques of data analysis, interpretation, and clinical relevance as related to the pharmaceutical/biotech industry.

• Experience in independent generation of trial design, protocol writing/ICF (writing or amendment), constructing appropriate CRF and coordinating cross-functionally.

• In-depth therapeutic area experience/expertise, and relevant clinical trial experience (or clear ability to adapt with transferable skills).

• Strong knowledge of medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMA and other relevant guidelines and regulations is required.

• Proven ability to work effectively and efficiently within cross-functional teams involved in the drug development process; proven ability to efficiently integrate multiple perspectives into the CDP.

• Experience authoring regulatory briefing packs, write responses to Health Authority questions, and proven ability to contribute to strategic approach and cross-functional coordination in support of regulatory activities/interactions.

• Demonstrated success in driving various aspects of cross-functional study level strategy, e.g. study design, supporting feasibility and timelines/budget projections, protocol amendment requirements. Ability to drive relevant discussion at key internal decision-making bodies/governance.

• Proven ability to build and maintain strong relationships and contribute to interactions with external key opinion leaders to optimize clinical programs (e.g. advisory boards, individual engagements, steering committees, etc.).

• Experience in (or clear ability) investigator engagement to optimize clinical trial conduct. Includes presenting at investigator meetings.

• Strong orientation to teamwork. Excellent leadership, communication, and interpersonal skills with the ability to inspire, motivate and mentor across a diverse team.

• Experience in mentoring other clinical scientists. Experience or clear potential as an effective line manager.

• Expertise in building and maintaining strong relationships with internal and external stakeholders.

• Superb strategic thinking and analytical skills, with the ability to make data-driven decisions in a fast-paced environment. Able to recognize trade-off decisions and can determine priorities and goals.

• Strong written and business presentation skills is required.

• Passion for innovation and a commitment to developing therapies that make a meaningful difference in patients' lives.

• Demonstrated strong leadership presence.

• Has demonstrated adaptability and flexibility.

• Anticipates needs, assesses and manages business and organizational risks.

Preferred skills:

• Has made significant contributions to clinical development plan conception, conduct and delivery, including successful alignment with scientific governance.

• Experience in ongoing enhancements/development of core and sub-team processes, structures, systems, tools and other resources in the pharmaceutical/biotech industry.

• Has led or supported clinical development contributions to major regulatory submissions (e.g. IND for First-in-Human studies, EOP2 briefing books (Type C/D); PIP/PSP, label negotiation, Breakthrough Therapy Designation, Accelerated Review is a major plus.

• Proven ability to present the clinical development aspects of a program(s) to key major reference health authorities (FDA, EMA, others.) by teleconference or in-person. Has led Health Authority interaction(s).

• Proven ability to set out the clinical development strategy for CTA/EC submissions and responses to health authority questions.

• Has demonstrated collaborative behaviors on enterprise-level strategic initiatives with a variety of internal and external partners and stakeholders - including clinical investigators/clinicians, scientists and key opinion leaders (KOLs), as well as internal groups, including other groups in development, research, business development, commercial, legal, etc. - resulting in demonstrable outcomes that have further enhanced strategic goals.

• Influential and inspiring leader, with proven ability to bring teams and individuals along with them.

• Has demonstrated courage and conviction in past positions and responsibilities. Demonstrated skills in conflict resolution.

#LI-Hybrid  #LI-SH1

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers.  The company’s R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies. As a new member of the Revolution Medicines team, you will join other outstanding Revolutionaries in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.

The Opportunity:

As an Associate Director, you will be responsible for the following:

• Lead and/or support development and implementation of GCP systems and inspection readiness.

• Lead and/or support the development and continuous improvement of Clinical Policies/ SOPs/ WIs/ Templates/etc. using knowledge and experience with clinical study management, International Conference on Harmonization (ICH) Guidelines, Good Clinical Practices (GCP) and regulatory requirements.

• SME for Clinical Operations GCP guidance, best industry practices, SOPs, and audit responses.

• Contribute to the development and management of business and compliance metrics to assess and continuously improve RevMed oversight and inspection readiness throughout the clinical trial lifecycle.

• Support Clinical Operations Inspection Readiness activities with clinical study teams; key participation in Mock/Regulatory Authority inspections.

• Contribute to the development and execution of Clinical Operations training programs to deliver RevMed standards, GCP, and regulatory requirements.

• Partner cross-functionally and with QA on quality initiatives, continuous improvement of GCP systems, and internal audits.

• Line management responsibilities including hiring, performance management, career development, and mentorship.

• Participate in other Clinical Operations Activities per the business need.

Required Skills, Experience and Education:

• Bachelor’s degree in biological sciences or health-related field required.

• 10+ years direct Clinical Compliance, and/or Clinical Quality Assurance experience in the pharmaceutical or biotech industry. Relevant Clinical Operations experiences may also meet the requirement.

• Strong working knowledge of FDA Regulations, ICH Guidelines, and GCP.

• Demonstrated experience successfully developing and authoring Clinical and cross-functional SOPs ensuring compliance with GCP and regulatory requirements.

• Experience with development and monitoring of oversight activities.

• Knowledge and/or familiarity with Ex-US region(s) e.g. EMA, MHRA, PDMA.

• Ability to perform complex assessments & investigations, draw relevant conclusions, and implement appropriate solutions.

• Strong analytical, negotiation, and persuasion skills.

• Ability to deal with time demands, incomplete information, or unexpected events.

• Outstanding organizational skills with the ability to multi-task and prioritize.

• Excellent interpersonal, verbal, and written communication skills.

• Decision-making skills.

• Comfortable in a fast-paced company environment and able to adjust workload based upon changing priorities.

• Demonstrate proficiency in Microsoft Office Suite (Outlook, MS Word, Excel, PowerPoint); MS Project and/or Smartsheet a plus.

• Travel may be required (~25%).

Preferred Skills:

• Line Management experience.

• Oncology experience, early and/or late stage, strongly preferred.

• RN or Master’s degree in biological sciences or health-related field preferred.

• Strong working knowledge of ex-US regulations and requirements. 

  #LI-Hybrid  #LI-DN1

The Opportunity:

The Senior Director, Global Patient Safety Science provides safety science and pharmacovigilance support to all products across the RevMed portfolio, which includes early and late phase development activities as a member of the Global Patient Safety team. The individual will be responsible for safety oversight and input into all aspects of study management across the portfolio.  This position may have individual reporting to it depending on the program / portfolio being led. The Senior Director of Safety Science serves as the lead for multiple or large complex strategically important developmental programs. Works closely with the other functions as part of a flexible matrix team to conduct robust safety assessments and safety risk management activities.

The Senior Director, Global Patient Safety Science will develop and maintain an expert understanding of the safety profile of the assigned product(s) as well as an understanding of the relevant strategic context (e.g., disease under study, safety profile of competitors, mechanism of action, etc.) and is accountable for oversight of benefit/risk safety profile of allocated products through the product lifecycle.

Specifically, you will be responsible for:

• Responsible for safety surveillance and risk management activities including, but not limited to medical review of ICSRs, routine review of safety data, and pertinent scientific literature articles. Contribute to the review of assessments for safety signals or in response to Regulatory Authority requests.

• Providing medical safety input into the design and conduct of pharmacoepidemiology and observational studies

• Plan and interpret safety data analyses, prepare and present safety data summaries to internal and external stakeholders.

• Acquire and contribute knowledge of relevant drug class and/or competitor safety issues.

• Lead the development of safety surveillance strategy, identify potential clinical safety issues, and recommend appropriate risk mitigation measures.

• Establish and maintain collaborative working relationships with all key stakeholders (e.g., clinical study teams, safety CROs, business partners) which require expert contribution to the development of the product safety strategy.

• Accountable for risk management activities including preparation and maintenance of relevant sections of clinical trial protocols, IBs (including the reference safety information section), ICFs, DSURs, RMPs, CCDS, and labelling, as required.

• Contribute to regulatory authority submissions (Investigational New Drug applications, New Drug Applications, Marketing Authorization Applications, etc.).

• Developing response strategies in collaboration with safety committee members, providing medical-scientific input to regulatory documents for safety-related requests from health authorities and other external parties.

• Drives risk minimization strategies and takes accountability for the medical-scientific content in the Risk Management Plans, including risk minimization measures, risk minimization action plans and REMS programs, as relevant.

• Accountable for the safety components of study reports (i.e., CSRs), aggregate reports (DSUR, PSUR/PBRER, PADER) and other regulatory documents.

• Participate in internal and external Data Monitoring Committees through review of safety data, insights and leadership and development of DMC Charters.

• Lead representative for Safety Science during Health Authority meetings.

• Reviews publications, including abstracts, manuscripts, and speaker presentations.

• Trains and mentors Safety Scientists.

• Consistently comply with all governing laws, regulations, RevMed standard operating procedures (SOPs) and other guidelines.

Required Skills, Experience and Education:

• 10 or more years of drug development experience in the pharmaceutical or related industry, of which at least 6 years include prior Safety Science experience, which includes performance of medical review, safety surveillance/signal detection, and other related risk management activities.

• A relevant postgraduate qualification (e.g., MD, PharmD, PhD/MSc in a Life sciences discipline, or other post-graduate health professional qualifications).

• Mentor, and lead a high-performing Safety Science team.

• Excellent ability to evaluate, interpret and present scientific data with clarity.

• Proven success in creating and sustaining strong relationships with internal and external business partners across an organization to create positive partnerships.

• Experience with interacting and leading with Regulatory Authorities (i.e. FDA, EMA) at type C, B, pre-BLA/MAA meetings, Advisory Committee meetings, or other scientific advice forums.

• Strong analytical and strategic thinking, problem-solving, and decision-making skills.

• Excellent communication, collaboration, and team management abilities.

• Extensive understanding of pharmacovigilance and risk management.

• Strong clinical leadership and experience.

• Outstanding emotional intelligence.

Preferred Skills:

• Demonstrated ability to lead and influence in a global matrix environment.

• 4+ years of experience in Oncology clinical development.

• Proficiency in managing regulatory interactions, BLA/MAA experience.

• Strong organizational and time management skills, with the ability to prioritize and manage multiple tasks effectively.

• Excellent influence and collaboration/teamwork capabilities.

• Strong interpersonal and communication (written and verbal) skills. 

  #LI-Hybrid  #LI-SH1

The Opportunity:

This is a unique opportunity for a Clinical Operations Professional who has innate leadership and organizational skills, technical expertise in clinical oncology drug development in an industry setting, and experience in overseeing clinical trials. As an Associate Director, you will be responsible for the Contract Research Organization (CRO) oversight, execution, and management of Revolution Medicines (RevMed) clinical trials.

Responsibilities:

• Adhere to Clinical Standard Operating Procedures (SOP) and Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) Guidelines.

• Global experience in end-to-end execution of different phases of clinical trials.

• Accountable for study delivery goals. Oversee the successful management of all aspects of clinical trials within timelines and designated program budgets.

• Guide assessment, selection, engagement, management, and oversight of appropriate vendors.

• Responsible for making decisions that balance risk/benefit with clear understanding of impact on the study and project; takes action to mitigate risk where appropriate.

• Lead risk management and quality efforts to ensure study compliance and continual inspection readiness. Lead/contribute to ways of working and process improvement initiatives.

• Provide proactive and consistent oversight of CRO and vendor performance Support Clinical Operations Program and / or Indication Lead with key study level status updates, with a particular focus on delivery to corporate and project level objectives.

• Contributions to the strategy and execution of the Clinical Development Plan (CDP) for assigned clinical programs which include timelines, budget, and resource requirements. Ability to identify critical path activities and articulate and mitigate risks to clinical trial conduct.

• Responsible for successful planning and deployment of Clinical Operations staff (potentially including Clinical Program Managers/Clinical Trial Managers/Clinical Trial Assistants, and consultants) for project and non-project related tasks.

• Lead line management responsibilities that include hiring, performance management, career development, and mentorship.

• Manage/oversee CROs and selected study vendors; ensuring all vendors strive to achieve the predetermined program milestones according to budget and timeline, as well as evaluate vendor performance using metrics and KPIs.

• Lead cross functional team meetings and collaborate with other functional groups within the company (e.g., Clinical Development, Regulatory, QA, Finance, Legal, etc.) to achieve clinical study goals.

• Ensure clinical trials maintain an inspection readiness state throughout the lifecycle of the trial.

• Oversee the improvement of processes that will impact clinical trial management and deliverables including contingency plans by maintaining a highly effective Clinical Operations team and building strong relationships with functional leaders.

Required Skills, Experience and Education:

• RN or Bachelor’s or Master’s degree in biological sciences or health-related field required.

• 11+ years direct Clinical Operations experience in the pharmaceutical or biotech industry. Relevant indirect experiences may also meet the requirement.

• Minimum of 5 years of project and first-line management experience.

• Experience in oncology.

• Experience in leading and managing global phase 1-3 clinical trials within designated timelines, resources, and budgets.

• Strong working knowledge of FDA Regulations, ICH Guidelines, and GCP.

• Experience with vendor management and CRO oversight.

• Ability to perform complex analysis, draw relevant conclusions, and implement appropriate solutions.

• Ability to pivot, be solution-oriented with consideration to long-term impact on clinical trials, responsibilities, and inspection-readiness.

• Strong analytical, negotiation, and persuasion skills.

• Ability to deal with time demands, incomplete information, or unexpected events.

• Outstanding organizational skills with the ability to multi-task and prioritize.

• Excellent interpersonal, verbal, and written communication skills.

• Decision-making skills.

• Comfortable in a fast-paced company environment and able to adjust workload based upon changing priorities.

• Demonstrate proficiency in Microsoft Office Suite (Outlook, MS Word, Excel, PowerPoint); MS Project and/or Smartsheet a plus.

• Travel may be required (~25%).

• Demonstrated experience leading in the matrix environment to deliver projects, develop clinical plans and manage change.

• In-depth knowledge of either study management or data management and knowledge of essential global regulatory guidelines and ICH/GCP.

• Proven experience working with investigators, external experts and regulatory agencies and oversight of Contract Research Organizations and third-party vendors including realigning with CRO partners when deliverables are at risk, negotiating solutions and leading After Action Reviews to share lessons learned.

• Excellent project management skills and budget management skills.

Preferred Skills:

• Proven success working with vendor systems/portals (e.g., eTMF, EDC, IRT, CTMS)

• Oncology experience, early and/or late stage, strongly preferred.

• Knowledge and/or familiarity with Ex-US region(s) clinical trial operations

• Experience in working with cooperative group studies and investigator sponsored trials preferred. 

  #LI-Hybrid  #LI-DN1

The Opportunity:

The Senior Director, Pipeline & Product Communications will lead the strategy, development, and execution of integrated communications across the company’s pipeline and product candidate portfolio. This role is accountable for shaping how Revolution Medicines’ pipeline and product narratives are understood by external stakeholders, including scientific and medical audiences, patients and advocates, media, and the broader healthcare ecosystem.

Reporting to the Head of Communications, this leader will serve as a trusted strategic advisor to cross-functional partners across R&D, Medical Affairs, Regulatory, Commercial, Market Access, Patient Advocacy, Legal, and Investor Relations. The role requires deep expertise across the full product lifecycle, from early clinical development through regulatory milestones and launch readiness, and the ability to translate complex science into clear, differentiated, and credible narratives.

This is a high-impact leadership role for a communications professional who thrives at the intersection of science, strategy, people leadership, and reputation management. Key Responsibilities include but not limited to:

• Own and lead the integrated pipeline and product communications strategy across all stages of development, ensuring clear differentiation, scientific credibility, and alignment with corporate and business priorities.

• Direct communications for major clinical and regulatory milestones, including data readouts, congress presentations, trial initiations, filings, approvals, and pre-launch milestones, in close partnership with R&D, Medical Affairs, Regulatory, and Legal.

• Serve as the senior communications advisor for launch readiness, shaping pre-launch and launch narratives across earned media, disease education, patient engagement, and stakeholder communications, with clear linkage to future commercial strategy.

• Lead disease awareness and patient advocacy communications, ensuring responsible education, strong patient advocacy group partnerships, and integration of patient voice into pipeline and product storytelling.

• Provide strategic counsel on value, access, and product-related issues, anticipating reputational risk and leading communications response to safety updates, competitive dynamics, and external scrutiny.

• Drive scientific and medical thought leadership, positioning Revolution Medicines and its leaders as credible voices through publications, congress presence, executive visibility, and media engagement.

• Build and lead a high-performing pipeline and product communications team, setting direction, developing talent, and ensuring consistent, high-quality execution.

• Oversee agency partners and measurement frameworks, using insights to evaluate impact, optimize performance, and scale communications effectiveness.

Required Skills, Experience and Education:

The successful candidate will be a seasoned communications leader with a proven track record of building and leading integrated pipeline and product communications strategies in complex, science-driven organizations.

• 15+ years of experience in biotech or pharmaceutical communications, including deep experience in pipeline and product communications in-house and/or at a leading agency.

• Bachelor’s degree required in Communications or similar; advanced degree preferred

• Demonstrated success supporting clinical development, regulatory milestones, and product launches, ideally in precision oncology or a similarly complex therapeutic area.

• Proven people management experience, including leading teams and developing talent.

• Strong leadership presence with the ability to influence senior stakeholders and lead cross-functional initiatives.

• Deep understanding of the U.S. healthcare environment, including regulatory policy, R&D, pricing, and access.

• Exceptional storytelling and writing skills, with the ability to translate complex science for diverse audiences.

• Demonstrated experience managing sensitive issues and high-profile communications.

• Track record of building relationships with top-tier scientific, medical, and industry media.

Preferred Skills:

• Deep familiarity with precision oncology, including competitive landscapes, combination strategies, and evolving standards of care.

• Proven success leading communications for major regulatory milestones, including FDA approvals, advisory committee meetings, and high-stakes data readouts.

• Strong issues-management experience relating to global trial access and expanded access.

• Track record of coordinating with corporate patient advocacy and patient advocacy organizations and integrating patient voice into pipeline and product storytelling.

• History of leading large-scale disease education or awareness campaigns that shift understanding of disease complexity or heterogeneity.

• Background spanning both product and corporate communications, enabling integrated decision-making across asset narratives and enterprise reputation. 

  #LI-Hybrid  #LI-YG1

The Opportunity:

This is a unique opportunity for a Clinical Operations Professional who has innate leadership and organizational skills, technical expertise in clinical oncology drug development in an industry setting, and experience in overseeing clinical trials. As an Associate Director, you will be responsible for the Contract Research Organization (CRO) oversight, execution, and management of Revolution Medicines (RevMed) clinical trials.

Responsibilities:

• Adhere to Clinical Standard Operating Procedures (SOP) and Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) Guidelines

• Oversee the successful management of all aspects of clinical trials within timelines and designated program budgets.

• Strategic thought partner on the development, management, and execution of the Clinical Development Plan (CDP) for assigned clinical programs which includes timelines, budget, and resource requirements. Ability to identify critical path activities and articulate and mitigate risks to clinical trial conduct.

• Responsible for successful planning and deployment of Clinical Operations staff (potentially including Clinical Program Managers/Clinical Trial Managers/Clinical Trial Assistants, and consultants) for project and non-project related tasks.

• Lead line management responsibilities that include hiring, performance management, career development, and mentorship.

• Manage/oversee CROs and selected study vendors; ensuring all vendors strive to achieve the predetermined program milestones according to budget and timeline, as well as evaluate vendor performance using metrics and KPIs.

• Lead team meetings and collaborate with other functional groups within the company (e.g., Clinical Development, Regulatory, QA, Finance, Legal, etc.) to achieve clinical study goals.

• Ensure clinical trials maintain an inspection readiness state throughout the lifecycle of the trial.

• Oversee the improvement of processes that will impact clinical trial management and deliverables including contingency plans by maintaining a highly effective Clinical Operations team and building strong relationships with functional leaders.

Required Skills, Experience and Education:

• RN or Bachelor’s or Master’s degree in biological sciences or health-related field required.

• 11+ years direct Clinical Operations experience in the pharmaceutical or biotech industry. Relevant indirect experiences may also meet the requirement.

• Minimum of 5 years of project and first-line management experience.

• Experience in leading and managing global phase 1-3 clinical trials within designated timelines, resources, and budgets.

• Strong working knowledge of FDA Regulations, ICH Guidelines, and GCP.

• Experience with vendor management and CRO oversight.

• Ability to perform complex analysis, draw relevant conclusions, and implement appropriate solutions.

• Ability to pivot, be solution-oriented with consideration to long-term impact on clinical trials, responsibilities, and inspection-readiness.

• Strong analytical, negotiation, and persuasion skills.

• Ability to deal with time demands, incomplete information, or unexpected events.

• Outstanding organizational skills with the ability to multi-task and prioritize.

• Excellent interpersonal, verbal, and written communication skills.

• Decision-making skills.

• Comfortable in a fast-paced company environment and able to adjust workload based upon changing priorities.

• Demonstrate proficiency in Microsoft Office Suite (Outlook, MS Word, Excel, PowerPoint); MS Project and/or Smartsheet a plus.

• Travel may be required (~25%).

Preferred Skills:

• Proven success working with vendor systems/portals (e.g., eTMF, EDC, IRT, CTMS).

• Oncology experience, early and/or late stage, strongly preferred.

• Knowledge and/or familiarity with Ex-US region(s) clinical trial operations.

• Experience in working with cooperative group studies and investigator sponsored trials preferred. #LI-Hybrid  #LI-DN1

The Opportunity:

We are seeking an experienced clinical scientist to serve as Associate Director, Clinical Science in support of Revolution Medicines’ late-stage clinical programs.  In this role, you will independently lead defined clinical science workstreams within pivotal and supportive studies and support execution of the registrational clinical development strategy for assigned molecule(s) and indication(s). The Associate Director plays a critical role in ensuring high-quality clinical data review, protocol consistency, and submission-readiness for late-stage programs. This position operates with substantial autonomy within assigned scope and collaborates closely with more senior clinical science team members and the study Medical Director to ensure medically sound and regulatory-aligned execution. Furthermore:

• Independently lead defined clinical science workstreams within pivotal and registration-enabling studies (e.g., endpoint strategy, data review oversight, CSR section ownership, data consistency initiatives).

• Contribute substantially to protocol development, CRF design, ICF updates, and alignment of data standards with downstream regulatory requirements.

• Drive ongoing clinical data review activities, including plausibility review, query trend analysis, and preparation for database lock.

• Accountable for assigned clinical science deliverables supporting regulatory submissions, including CSR sections, briefing package content, and health authority response inputs.

• Support preparation of regulatory documentation and responses to health authority questions.

• Collaborate closely with Biostatistics, Data Management, Medical Writing, Medical Directors, Pharmacovigilance, and Clinical Operations to ensure alignment and submission readiness.

• Participate in study team meetings and represent Clinical Science in sub-team discussions.

• May serve as Clinical Science lead for smaller or supportive studies, based on experience and study complexity.

• Mentor Senior Clinical Scientists and Clinical Scientists as appropriate.

• Proactively identify risks, propose mitigation strategies, and escalate significant issues as appropriate to Directors or Senior Directors.

• Contribute to cross-functional discussions to support eSective and eSicient study execution.

Required Skills, Experience and Education:

• Bachelor’s Degree (life sciences preferred); Advanced Clinical/Science Degree is a plus (e.g., PharmD, PhD, MSN, MPH, etc.).

• 5+ years of clinical development or relevant experience within a pharmaceutical, biotech, or academic clinical research setting; late-stage development experience preferred.

• Demonstrated experience contributing to pivotal or registration-enabling studies.

• Strong knowledge of GCP, ICH, FDA, EMA, and other relevant regulatory guidelines.

• Experience contributing to protocol development, CRF design, and regulatory documentation.

• Strong analytical skills and experience interpreting clinical trial data.

• Proven ability to work eSectively in cross-functional teams and integrate multiple perspectives.

• Excellent written and verbal communication skills.

• Strong organizational skills and ability to manage multiple deliverables.

Preferred Skills:

• Experience contributing to NDA/BLA/MAA submission components.

• Experience supporting health authority interactions.

• Demonstrated ability to lead defined study-level initiatives.

• Experience mentoring junior clinical science staffs.

#LI-Hybrid  #LI-SH1

The Opportunity:

This internship provides foundational training in clinical supply chain operations, documentation practices, and systems used to support global clinical trials. The intern will develop a working understanding of how supply chain activities directly impact study execution, compliance, and patient safety. As a Clinical Supply Chain Intern, you will gain hands-on exposure to the operational backbone that supports global clinical trials. You will work closely with the Clinical Supply Chain team to understand how investigational product (IP) is planned, documented, distributed, and maintained in compliance with GxP and regulatory standards.

By the end of the internship, the intern will be able to:

• Understand the role of clinical supply chain in clinical trial execution.

• Identify key elements of batch documentation relevant to clinical supply.

• Understand temperature excursion processes and documentation requirements.

• Review depot-level shipment documentation for completeness and compliance.

• Organize and centralize shipment documentation within a TMF structure.

• Apply GxP principles and inspection-ready documentation practices.

Required Skills, Experience and Education:

• Currently pursuing a degree in Supply Chain, Life Sciences, Pharmacy, Engineering, or related field.

• Interest in biotechnology, pharmaceutical operations, or clinical development.

• Strong attention to detail and organizational skills.

• Proficiency in Microsoft Excel and general document management tools.

• Strong communication skills and willingness to learn in a regulated environment.

• Excellent organizational, communication, and problem-solving skills.

• Ability to work independently while collaborating effectively across functions and with external partners. 

  #LI-Hybrid  #LI-AP1

The Opportunity:

The Clinical Operations Summer Intern will support a strategic initiative focused on optimizing study-level execution and operational alignment to the Clinical Operations Handbook (V2.0). The intern will conduct a structured review of active clinical studies to assess consistency, tool utilization, and workflow execution from protocol finalization through site activation.

Key Responsibilities

• Select 1–2 active clinical studies for detailed assessment.

• Evaluate use of RAID logs, Study Dashboards, Vendor Oversight Plans, and Startup Timelines.

• Document end-to-end workflows from protocol finalization to site activation.

• Identify gaps, redundancies, and inconsistencies in process execution.

• Conduct structured interviews with COLs and CTAs.

• Shadow CSET meetings to observe dashboard and RAID utilization.

• Review Smartsheet tools and Egnyte folder structures.

• Compare real-world execution against Clinical Operations Handbook processes.

Deliverables

• Current-state workflow maps with annotated pain points.

• Tool consistency matrix across selected studies.

• Prioritized, actionable process improvement recommendations.

• Updated mock dashboard or tracker templates (if applicable).

Impact

• Reduce variability in study-level execution.

• Clarify ownership and functional handoffs.

• Improve dashboard clarity for leadership review.

• Strengthen inspection readiness through documented alignment.

Required Skills, Experience and Education:

• Pursuing a Bachelor’s or Master’s degree in Life Sciences, Public Health, Clinical Research, Business, or related field.

• Excellent communication skills.

• Interest in clinical trial operations and process optimization.

Preferred Skills:

• Strong analytical and organizational skills.

• Proficiency in Microsoft Office; familiarity with Smartsheet a plus. 

  #LI-Hybrid  #LI-AP1

The Opportunity:

This is a unique opportunity as a junior Clinical Trial Assistant in Clinical Operations, initially reporting to the Associate Director/Director Clinical Operations, you will be responsible for acting as a central contact for the clinical study teams and assist with the clinical execution and management to support RevMed clinical trials.

Responsibilities:

• Assisting in the review, distributing, and archiving of study specific documents and reports (plans, training materials, study guides, manuals etc.).

• Assisting with updating and maintaining clinical systems and any reporting tools.

• Support maintenance of the trial master files (TMF) if applicable, or work with CRO to audit and resolve discrepancies.

• Create, maintain, and track information for key study related activities.

• Assisting in the preparation of meeting materials, scheduling meetings, for internal clinical operation team meetings.

• Working with cross functional study teams, and vendors to assist in the coordination of clinical trial activities.

• Support other clinical operations activities as appropriate.

Required Skills, Experience and Education:

• Currently enrolled at an accredited college/university as a rising senior or higher in a Bachelor’s degree in biological sciences or related health related field.

• Thrives in a collaborative team setting and is driven by a desire to deploy innovative approaches and technologies in a high-energy environment.

• Excellent written and verbal communication and interpersonal skills.

• Demonstrate proficiency in Microsoft Word, Excel and PowerPoint and other software platforms.

• Demonstrated ability to multi-task, prioritize options. 

  #LI-Hybrid  #LI-AP1

The Opportunity:

The Senior Director of Economic Modeling is responsible for defining and executing the economic modeling strategy to produce high quality health economic models & modeling strategies across Rev Meds portfolio.  This is an exceptional opportunity to contribute to the advancement of healthcare by providing evidence that can shape the future of patient care in Oncology.

Key Strategic Responsibilities:

• Lead the development of strategic and operational plans for health economic modeling within Global HEOR & RWE (e.g., early and submission cost-effectiveness / utility models, budget impact models, and country adaptations) while ensuring alignment with Integrated Evidence Plans and appropriate Global stakeholders.

• Partner with Global HEOR & RWE Executive Directors on core health economic modeling plans to support HTA, payer, and other access stakeholder assessments, submissions, negotiations, including associated value/HTA deliverables and publications to meet business and access objectives.

• Provide strategic, methodological and analytical leadership to teams and countries for adaptation of economic models for local HTA submissions

• Lead the development of an approach to monitor, educate and integrate evolving HTA guidelines, payer requirements, and methodologic advancements related to economic modeling.

• Lead the development of robust governance, compliance, and readiness for all economic modeling activities by adhering to processes, guidelines, and project management standards.

• Represent Rev Med in global external working groups regarding modeling standards and innovation (e.g., ISPOR Special Interest groups).

Key Operational Responsibilities:

• Support design and development of economic models from start to finish for products across Rev Meds portfolio.

• Direct statistical analyses of real-world data and clinical trial data (in collaboration with biostatistics) to generate inputs including treatment effects, survival extrapolations, resource use, and health utility estimates.

• Design evidence synthesis, including network meta-analysis (NMA), and matching adjusted indirect comparisons (MAIC) to inform comparative effectiveness.

Required Skills, Experience and Education:

• Advanced degree (Masters or PhD) in health economics, econometrics, biostatistics, mathematics, engineering or related field (DrPH, PharmD).

• Minimum of 15 years with a Masters (or 13+ years with a PhD/PharmD/DrPH) of relevant experience in economic modeling in the pharmaceutical, biotech, or consulting setting.

• Hands on experience in developing cost-effectiveness, budget impact models as well as NMA/MAIC.

• Track record of high impact publications in economic modeling for global access decision-makers.

• Experience supporting HTA submissions and payer evidence generation.

• Strong written and interpersonal communication skills, with an ability to present complex technical information clearly.

• Proven leadership

  • Ability to influence others without direct reporting relationships.

• Comfortable working in a global team across time zones.

Preferred Skills:

• Experience in oncology economic modeling is highly desirable, especially related to gastrointestinal and thoracic malignancies. 

  #LI-Hybrid  #LI-GL1

The Opportunity:

Revolution Medicines is seeking a Sr. Financial Analyst/Finance Manager to support our growing needs in Development and R&D Finance. The successful candidate will have experience with clinical trials, R&D accruals process, month-end close, financial reporting, SOX, and audit support. This position is based out of our headquarters in Redwood City, CA.

• Reporting to the Associate Director, FP&A and will serve as a business partner to Clinical Operations and cross-functional partner to Accounting, Finance, and Procurement.

• Prepare month-end clinical trial accruals, including review of CRO reports, patient costs, and site payments.

• Prepare monthly and quarterly reconciliations for accrued clinical and related prepaid accounts.

• Contribute to Identify, design, and implement process improvements to streamline clinical trial accruals, reducing manual effort and improving accuracy and timeliness.

• Review contracts and amendments to analyze and determine impact on clinical accruals.

• Prepare contract analysis to assess new contracts against existing budget.

• Work with external CROs and vendors to ensure that expenses are accurately accounted for.

• Ensure and maintain proper documentation and internal controls around clinical trial accruals for SOX compliance.

• Partner with the accounting team to support monthly and quarterly close activities.

• Support the annual audit and quarterly reviews through preparation of audit schedules and other documentation as requested by external auditors.

• Perform variance analysis of actuals versus budget, investigate and explain key discrepancies, and identify underlying business drivers.

• Prepare actuals vs budget dashboard monthly to provide financial visibility to business partners.

• Review purchase requests against budgeted amount and account coding.

• Prepare ad hoc financial analysis and special projects as needed.

Required Skills, Experience and Education:

• Bachelor's degree in finance, Accounting, or related field.

• 4+ years’ experience in a similar role in biotechnology industry.

• Experience in reviewing clinical contracts (i.e. CRO contracts, Site contracts, protocols, etc.).

• Highly proficient in Excel and strong attention to detail.

• Prior ERP and financial systems experience: Netsuite, etc.

• Strong work ethic and ability to adjust workload based on changing priorities.

Preferred Skills:

• CPA or MBA.

• Biotech or Big 4 Accounting experience.

• Prior experience with clinical trial accruals.

• Adaptive Planning (Office Connect) experience a plus.

• Coupa experience a plus. 

  #LI-Hybrid  #LI-YG1

The Opportunity:

The GxP Systems Administrator will be responsible for the day-to-day support and administration of application platforms that enable our Research & Development (R&D) functions. The ideal candidate will have hands-on experience administering and configuring GxP-compliant SaaS systems (particularly Veeva Vault), including basic security updates, object configuration, and lifecycle and workflow management, along with a strong understanding of regulatory requirements in a life sciences environment.

This individual will play a key role in handling user requests, provisioning accounts, troubleshooting issues, and supporting the implementation and maintenance of new GxP applications and systems. Strong technical skills, attention to detail, and the ability to communicate effectively across functional teams are essential for success in this role. As a member of the Information Sciences team, the GxP Systems Administrator will report directly to the Senior Manager, GxP Business Systems and collaborate closely with CSV, Quality, and other R&D stakeholders to ensure systems are effectively managed and remain in a validated state. Key responsibilities include:

• Administer and support GxP systems that enable R&D functions in compliance with applicable regulations and standards (e.g., 21 CFR Part 11, Annex 11, GAMP 5).

• Manage user access for GxP (and occasional non-GxP) systems, including provisioning, modification, and deactivation of accounts per company procedures.

• Troubleshoot and resolve support requests and incidents related to GxP systems using ServiceNow, ensuring timely, accurate documentation and adherence to defined SLAs.

• Collaborate with cross-functional teams (e.g., Quality, Regulatory, Clinical, IT) to support business operations and ensure compliance.

• Perform routine system activities such as periodic user access reviews, audit trail reviews, and other steady-state tasks per company procedures and regulatory standards.

• Support the implementation and maintenance of new GxP systems, including validation activities and system documentation (e.g., specifications, user guides, administration procedures).

• Participate in change control, impact assessments, and release management for validated systems.

• Maintain a working understanding of applicable GxP regulations and guidelines (e.g., 21 CFR Part 11, Annex 11, GAMP 5) and ensure data integrity principles (ALCOA+) are applied in day-to-day system administration and operations.

Required Skills, Experience and Education:

• Bachelor’s degree with a minimum of 2 years experience in Information Technology/Computer Science supporting GxP-regulated environments, in pharma, life sciences or related industries.

• Veeva Vault Platform Administrator certification required (or ability to obtain within 6 months of hire), with demonstrated hands-on experience administering and configuring Veeva Vault applications (e.g., QualityDocs, QMS and RIM).

• Experience supporting or administering Veeva Vault systems.

• Basic understanding of GxP regulatory expectations and industry guidelines (e.g., GAMP 5, FDA, EU).

• Knowledge of user management, including security access controls, policies, and permissions.

• Experience providing system support preferably using ServiceNow, including troubleshooting and resolving user issues.

• Efficient time management, with the ability to support multiple systems simultaneously.

• Strong written and verbal communication skills and the ability to present complex information.

• Ability to work effectively in a dynamic and fast-paced environment.

• Experience with applications supporting life science research and development.

Preferred Skills:

• Direct experience administering and configuring Veeva Vault (Quality, RIMS), eTMF (Trial Interactive), DocuSign Part 11, ComplianceWire, and similar GxP systems.

• Working knowledge of Computer System Validation (CSV) principles and deliverables, Software Development Life Cycle (SDLC) processes, and 21 CFR Part 11 compliance, with applied experience in validation documentation and ensuring regulatory adherence.

• Familiarity with Active Directory and Azure Entra.

• Basic scripting or automation skills (e.g., Python, PowerShell) to support system efficiency.

• Experience collaborating with Quality and Regulatory teams within a GxP environment. 

  #LI-Hybrid  #LI-YG1

Opportunity: 

The Senior Clinical Data Manager is responsible for all aspects of the data management process from the development of project documentation, system set-up, User Acceptance Testing (UAT), routine data review through database lock of clinical trials.  The Sr/CDM has a broad, fundamental knowledge of the data management process and can plan, manage and coordinate all Data Management activities for assigned study(ies) with minimal guidance. This person may have project level oversight of junior data managers and/or Clinical Data Associates (CDAs).  The core duties and responsibilities of the Sr/CDM are delineated below. Specifically, you will be responsible for:

• Represents data management in study team meetings, able to facilitate and provide data management updates and/or input when appropriate.

• Manages data management timelines to coordinate and synchronize deliverables with the overall study timelines.

• Generates and/or reviews/approves study documents (e.g. Data Management Plans, Case Report Forms, DB build specifications, data transfer specifications, SAE and/or external data reconciliation plans, coding conventions, laboratory data handling plan, study protocols).

• Reviews protocols for appropriate data capture including electronic Case Report Form (eCRF) design and external data vendors’ systems.

• Provides oversight of database set-up/migrations/updates including coordinating and performing UAT

• Leads the development of internal Data Review Plan and coordinates cross functional team data listing review.

• Coordinates the internal medical coding review.

• Performs ad hoc and scheduled data listing review and generates/resolves queries in EDC.

• Performs external data reconciliation against EDC.

• Performs Serious AE reconciliation according to SOPs and guidelines, as applicable.

• Executes and/or distributes data management metrics, listings, and reports.

• Provides oversight of data management CRO/service providers including manages and monitors the progress of data management activities with CROs and/or other service providers on assigned studies; build effective relationships with CRO/service provider counterparts.

• Reviews and provides feedback to the clinical team on other study documents e.g., Clinical Monitoring plans and vendor specifications.

• Provides training on the EDC system and/or CRF completion guidelines and EDC system to internal or external study team members, as needed.

• Proactively identifies potential study issues/risks and recommends/implements solutions.

• Maintains study DM related documents/files for inspection readiness.

• Provides DM support to Statisticians and Statistical Programmers in production of clinical trial reports and other deliverables.

• Assists with the training of new employees and/or contractors (e.g., clinical data associates and/or junior clinical data managers working on the studies).

• Participates in CRO/vendor selection process for outsourced activities.

• Supports budget and resource planning across assigned projects.

• Participates in the development, review and implementation of departmental SOPs, templates, and processes.

• Participates in department or cross-functional initiatives (as needed).

• Contributes to a professional working environment through exemplifying RevMed Core Values.

Required Skills, Experience and Education:

• Bachelor’s degree in health sciences, Life Sciences, Mathematics, Computer Sciences, or health-related field.

• At least five (5) years for Sr. CDM of Data Management experience in the pharmaceutical or biotechnology industry, depth and exposure to DM related tasks considered in lieu of minimum requirement.

• Requires solid knowledge of clinical data management principles, clinical trials process and regulatory requirements.

• Good working knowledge of ICH, FDA, and GCP regulations and guidelines.

• Strong well-rounded technical skills (EDC systems, MS Word, Excel, PowerPoint).

• Knowledge of industry standards (CDISC, SDTM, CDASH).

• Experience with web-based Electronic Data Capture (EDC), clinical data management systems and industry wide thesauri, such as MedDRA and WHO Drug.

• Excellent verbal/written and interpersonal skills required for working successfully in a cross-functional team environment.

• Ability to handle multiple projects and prioritize effectively, well organized and detail oriented.

• Proven ability to work both independently and in a team setting.

Preferred Skills:

• Bachelor's degree in health sciences, Life Sciences, or health-related field

• CRO/Service provider management experience.

• Prior oncology/solid tumor experience highly desired

• Knowledge of industry standards (CDISC, SDTM, CDASH).

• Working knowledge of statistical programming packages (e.g. SAS) is a plus.

#LI-Hybrid  #LI-JC1

The Opportunity:

The Senior Director of Clinical Data Management provides high-level leadership for data management functions within clinical research, focusing on strategic development, operational execution, and regulatory compliance to ensure data integrity for clinical trials. Key responsibilities include leading and managing data management teams, establishing and enforcing data management policies and procedures, overseeing departmental budgets, collaborating with cross-functional teams and vendors, and ensuring data management processes meet regulatory standards. This role requires extensive experience in clinical data management, strong leadership and communication skills, expertise in clinical trial methodologies, and a deep understanding of regulatory requirements including submissions and data management systems.

Required Skills, Experience and Education:

• Define and implement the overall vision, strategy, and goals for the clinical data management department, including developing and enforcing departmental SOPs.

• Lead, manage, and develop data management teams, handling resource planning, staff training, and performance reviews.

• Develop and monitor KPIs for data quality and operational performance.

• Manage relationships with Contract Research Organizations (CROs) and other data management vendor partners, ensuring they meet quality and performance standards.

• Forecast, manage, and provide oversight for departmental budgets, including internal and external expenditures.

• Ensure data integrity, quality, and compliance with regulatory requirements (e.g., FDA, ICH, GCPs) and internal company policies.

• Experience with global trials and regulatory submissions (FDA, EMA).

• In-depth understanding of industry standards related to clinical data management (e.g., medical dictionary coding).

• Guide data management activities for regulatory submissions and represent the department during regulatory inspections and internal audits.

• Serve as a key liaison and collaborate effectively with cross-functional teams (e.g., Clinical, Quality, Regulatory) and key external stakeholders.

• Extensive experience in clinical data management and systems, with proven leadership experience in oncology therapeutic area.

• Proficient knowledge of EDC systems (e.g., Medidata Rave), CDISC standards, and clinical trial processes.

• Drive innovation and continuous process improvement within data management by implementing new technologies and advanced systems to enhance productivity and efficiency.

• Demonstrated ability to lead, motivate, and develop teams.

• Excellent communication and interpersonal skills to effectively collaborate with diverse teams and stakeholders.

• Strong problem-solving and decision-making abilities to resolve complex issues and drive solutions.

• MS, BS/BA degree, or other suitable qualification with relevance to the field.

• 17 or more years’ direct experience in clinical data management in the biotechnology OR Pharmaceutical industry.

Preferred Skills:

• A degree in life science, health informatics, or a related field.

• Exposure to real-world data (RWD) and decentralized trial models.

• Automation and digital transformation initiatives to improve data quality and efficiency (e.g., IXRS, AI/ML tools, RBQM platforms). #LI-Hybrid  #LI-DN1

The Opportunity:

We are seeking a highly motivated and scientifically rigorous Director of Biostatistics to our Medical Analytics and Exploratory Data Science Biostatistics group. This role will provide strategic and hands-on statistical leadership for exploratory data analyses, scientific publications, real-world evidence (RWE), post-marketing research, and health economics and outcomes research (HEOR) initiatives. The successful candidate will serve as a key statistical leader and individual contributor, partnering closely with cross-functional teams to generate high-quality evidence that advances our oncology pipeline and supports medical and scientific strategy.

• Provide statistical leadership for exploratory data analyses using existing clinical trial data, real world data studies, post-marketing research, and HEOR projects.

• Serve as a primary statistical contact for assigned projects, working collaboratively with clinical development, medical affairs, safety, statistical programming, regulatory affairs and commercial.

• Lead the design, analysis, and interpretation of complex statistical models, including survival analysis, machine learning, and casual inference methodologies.

• Contribute to and implement policies, standards, and procedures to ensure consistency and quality in statistical practices.

• Manage relationships with external partners, such as contract research organizations (CROs), ensuring adherence to timelines, budgets, and quality standards.

• Mentor and provide technical guidance to junior statisticians, fostering scientific rigor, innovation, and professional growth.

• Contribute to regulatory and payers/HTA agencies interactions, scientific publications, abstracts, and internal decision-making through clear and effective communication of statistical results.

Required Skills, Experience and Education:

• Ph.D. or M.S. in Statistics/Biostatistics, a minimum of 8 years (for Ph.D.) and 12 years (for M.S.) of experience in biotech/pharma industry as a statistician.

• Solid knowledge of statistical methodologies for oncology, including survival analysis and causal inference.

• Hands-on experience in exploratory analysis of oncology trials.

• Proven ability to independently lead statistical aspects of complex, cross-functional projects.

• Strong understanding of regulatory requirements related to biostatistical activities and clinical trials.

• Excellent verbal and written communication skills are required.

• Excellent interpersonal and project management skills are essential.

• Proficiency in SAS and/or R.

Preferred Skills:

• Knowledge of RWD and health economics and outcomes research (HEOR) in oncology is a plus.

• Familiarity with machine learning or advanced modeling approaches applied to biomedical or observational data. 

  #LI-Hybrid  #LI-SH1

The Opportunity:

The Director, Global Regulatory Affairs Project Management is an integral part of the global Regulatory Affairs organization and is responsible for translating global regulatory strategies into actionable execution plans.  This role applies advanced project management expertise and operational leadership to guide cross-functional teams, supporting planned and ongoing drug marketing applications across RevMed programs.  The role partners closely with Global Regulatory Science and Global Filing and Registration and contributes to the broader Global Regulatory Affairs function at RevMed.  This position reports to the Senior Director, Global Regulatory Affairs Project Management.

The ideal candidate will have an in-depth understanding of oncology drug development and demonstrated hands-on regulatory project management experience supporting early- and late-stage registrational programs, including the execution of global new drug marketing applications, in alignment with corporate objectives. 

Core Responsibilities:

• Project manage regulatory submissions from initiation through submission, supporting the definition of scope, timelines, prioritization, resource needs, and key deliverables.

• Develop, maintain, and track comprehensive submission timelines for INDs / CTAs, NDAs / MAAs, amendments, agency interactions, and other key global regulatory activities.

• Partner with Global and Regional Regulatory Science Leads to advance global regulatory strategies for assigned molecules across indications.

• Facilitate Global Regulatory Teams and meetings to ensure coordinated development and execution of high-quality, timely global regulatory deliverables at the study level.

• Partner with Global Filing Leads on planning, resourcing, and execution of new drug marketing applications for global agency submissions, interactions, and approvals.

• Drive the operational planning, coordination, and tracking of new drug marketing application submission activities across cross-functional Filing Teams (including Regulatory, Medical Writing, Nonclinical, Clinical, Safety, Biostatistics, CMC / Pharmaceutical Development and Manufacturing, etc. and external consultants), supporting the Global Filing Lead’s strategic vision.

• Coordinate with global partners to maintain consistent regulatory program plans, ensuring alignment, compliance, and continuity across regions.

• Proactively identify operational risks, gaps, and bottlenecks; propose and implement solutions, including process improvements and outsourcing strategies, as appropriate.

• Build and maintain submission dashboards; communicate status, risks, and mitigation strategies to senior management and key stakeholders.

• Support the development, implementation, and continuous improvement of global regulatory project management processes, templates, tools, dashboards, analytics, and best practices.

• Champion innovation and operational excellence, identifying opportunities to streamline regulatory project management and enhance submission preparation efficiency and scalability.

Required Skills, Experience and Education:

• Bachelor’s degree in a life sciences or related discipline; advanced degree preferred.

• 15+ years of pharma / biotech industry experience, including 8-10 years of regulatory project management experience. Hands-on U.S. drug marketing application experience required.

• Strong working knowledge of global regulatory regulations, guidelines, and submission pathways; familiarity with nonclinical, clinical, and CMC (bio)pharmaceutical development.

• In-depth knowledge of CTD structure and dossier component management, including coordination across cross-functional filing team contributors and senior leadership.

• Exceptional project management skills with proven ability to manage multiple complex programs under compressed timelines in a fast-paced, cross-functional environment that values both speed and quality.

• Excellent communication and interpersonal skills, with demonstrated ability to influence, manage group dynamics, and balance functional, team, and leadership objectives.

• Ability to think both strategically and tactically and present recommendations to senior leadership and key stakeholders.

• High proficiency with project management tools including Smartsheet and Microsoft Project, and familiarity with WBS management, timeline development, and critical path analysis; experience with OnePager, Office Timeline, and Veeva RIM is a plus.

Preferred Skills:

• Experience supporting global regulatory filings including Japan, Canada, and EU / UK submissions.

• Oncology drug development experience.

• Experience with complex oncology clinical trial designs (e.g., combination studies, multi-cohort expansions, basket or umbrella master protocols). 

  #LI-Hybrid #LI-JC1