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/).

About Sony Music Entertainment

At Sony Music Entertainment, we fuel the creative journey. We’ve played a pioneering role in music history, from the first-ever music label to the invention of the flat disc record. We’ve nurtured some of music’s most iconic artists and produced some of the most influential recordings of all time.

Today, we work in more than 70 countries, supporting a diverse roster of international superstars, developing and independent artists, and visionary creators. From our position at the intersection of music, entertainment, and technology, we bring imagination and expertise to the newest products and platforms, embrace new business models, employ breakthrough tools, and provide powerful insights that help our artists push creative boundaries and reach new audiences. In everything we do, we’re committed to artistic integrity, transparency, and entrepreneurship.

Sony Music Entertainment is a member of the Sony family of global companies.

The Global Philanthropy, Social Impact & Environment (PSIE) is seeking an Environmental Social Governance (ESG) Specialist. The ideal candidate will have a strong background in administration, data analysis, and stakeholder engagement. As an ESG Specialist, you will play a crucial role in supporting our environmental and social initiatives, ensuring compliance with ESG goals, and communicating progress to internal and external stakeholders.

What you'll do:

Administration

• Work closely with the EVP on day-to-day administration and calendar management for ESG tasks, meetings, and workstreams
• Support the creation and maintenance of team project boards and keep the team on task
• Manage ESG calendar and proactively liaise with internal/external stakeholders for scheduling
• Own ESG meeting agendas and minutes with prompt distribution, meticulous archive management, and task scheduling
• Conduct internal and external research on ESG topics to assist with stakeholder engagement, reporting, benchmarking, and best practices
• Coordinate deliverables, timelines, and communication between internal teams and external partners to ensure alignment on ESG initiatives

• Develop branded ESG presentation templates and standardized slide formats (e.g., SMG, PSIE) to support consistent internal and external communication
• Create, update, and maintain ESG external decks used for stakeholder engagement, reporting, and executive briefings
• Translate complex ESG concepts into clear, visually compelling presentation materials for cross‑functional and leadership audiences

Operations

• Support the rollout of the Environmental Framework, including cross-departmental task force efforts
• Assist with ongoing environmental data collection efforts and maintain the highest level of integrity, accuracy, and transparency in GHG credit accounting practices
• Support ESG system implementation, data migration, and reporting
• Co-develop data collection training materials
• Conduct stakeholder outreach, including program info sessions and system training
• Assist with stakeholder initiatives such as employee-led ERGs, as well as label and regional OpCo target execution efforts
• Collaborate with broader Philanthropy department to support Sustainability related initiatives/ activations

• Organize, maintain, and quality‑check ESG documentation, including GEMS materials, program frameworks, and sustainability records
• Review strategic ESG documents (e.g., GM 2030 materials) and provide feedback to senior leadership and global teams to support alignment and decision‑making
• Record and maintain documentation of green initiatives, sustainability language, and program updates to support reporting and internal visibility
• Track progress across ESG workstreams and ensure accurate, up‑to‑date documentation for internal and external reporting cycles

Who you are:

• 2-5 Years of experience in corporate sustainability
• Bachelor’s degree in Environmental Studies, Environmental Policy Economics, Business, Accounting or Data Analytics preferred
• This role will handle sensitive and highly confidential information. Trustworthiness is essential with high emotional intelligence and ability to build relationships a major plus.
• Thrives in a fast-paced environment
• Strong bias for planning ahead and on-time execution
• Strong analytical background, comfort with complex data-oriented products & structured problem-solving capabilities
• Meticulous attention to detail
• Ability to translate complex information into presentations
• Strong cross-functional presentation and communication skills
• Flexibility and ability to prioritize multiple responsibilities.
• Experience with ESG regulations (SEC Climate Disclosure, California's SB 253, SB 261, CSRD, SSBJ, Extended Producer Responsibility, etc.)
• Experience with ESG framework (GRI, SASB, TCFD, etc)
• Experience with ESG reporting for corporate entities, with a strong understanding of how ESG data is organized, reviewed, and communicated for external reportings, audits, or stakeholder inquiries
• Exposure to communications and engagement campaigns, such as coordinating internal communications, developing background materials for campaigns, assisting with stakeholder engagement strategies, or supporting cross-functional collaboration between. ESG communications and external partners.
• The role requires expertise in ESG regulations and carbon accounting, with responsibilities including client engagement, staff supervision, and project management

What we give you:

• You join an inclusive, collaborative and global community where you have the opportunity to channel your passion every day  
• A modern office environment designed to foster productivity, creativity, and teamwork empowering you to bring your best 
• An attractive and comprehensive benefits package including medical, dental, vision, life & disability coverage, and 401K + employer matching 
• Voluntary benefits like company-paid identity theft protection and resources for pets, mental health and meditation resources, industry-leading fertility coverage, fully paid leave for childbirth or bonding, fully paid leave for caregivers, programs for loved ones with developmental disabilities and neurodiversity, subsidized back-up child and elder care, and reimbursement for adoption, surrogacy, tuition, and student loans 
• Investment in your professional growth and development enabling you to thrive in our vibrant community.  
• The space to accelerate progress, positively disrupt, and create what happens next  
• Time off for a winter recess

Sony Music is committed to providing equal employment opportunity for all persons regardless of age, disability, national origin, race, color, religion, sex, sexual orientation, gender, gender identity or expression, pregnancy, veteran or military status, marital and civil partnership/union status, alienage or citizenship status, creed, genetic information or any other status protected by applicable federal, state, or local law.

Summary:

A hands-on role providing both strategic and operational activities. This role develops and executes multi-product global regulatory CMC strategies for investigational products and leads the preparation and filing of regulatory CMC submissions. Manages interactions with Health Authorities for CMC topics. Provides regulatory CMC guidance to various cross-functional teams and ensures all applicable global regulatory requirements are considered and incorporated into product development. Conducts routine regulatory surveillance and communicates new/changing regulations.  

Essential Functions:

• Leads the preparation and review of CMC sections of global regulatory submissions, as well as the interactions and responses with regulatory agencies
• Member of technical development teams which require experienced interpretation of applicable EMA/FDA/ICH/Global regulations to ensure CMC compliance
• Defines CMC content (data and documentation) requirements for regulatory submissions and compiles/reviews this content for conformance with established requirements
• Provides CMC regulatory guidance to cross-functional teams and key stakeholders
• Manages regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP investigations throughout development
• Leads projects with cross-functional teams and acts as the primary regulatory CMC contact for assigned products and projects
• Represents company in Health Authority meetings and leads or supports CMC preparation activities for meetings with Health Authorities on CMC related matters
• Stays abreast of current and evolving regulatory CMC requirements, applies this knowledge to assigned projects, and shares knowledge and experience with others to support their development
• Participates in the design, development and implementation of department strategies, providing recommendations in area of expertise

Requirements:

Bachelor’s Degree in a scientific discipline (e.g. Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices). Minimum 10 years of experience working in vaccine or biotech industry, or in a related field, or the equivalent combination of education and experience. Other combinations of education and/or experience may be considered.

• Prior experience preparing/authoring CMC DS sections:
• BLA highly preferred.
• Post-approval supplements/variations highly preferred.
• INDs/IMPDs.
• Prior development or manufacturing experience is a plus.
• Computer software skills (LIMS, SAP, TrackWise, Veeva will be used).
• Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency.
• Excellent interpersonal skills to communicate difficult concepts.

• Strategic thinking and strong problem-solving skills
• Collaborates and communicates in an open, clear, complete, timely, and consistent manner
• Strong sense of planning and prioritization, and the ability to work with all levels of management
• Advanced knowledge in regulatory (FDA, EMA, Health Canada and ICH) guidelines

Legend Biotech is seeking a Director, Thought Leader Liaison & Strategic Alliances, Northeast as part of the Commercial team based in Somerset, NJ.

Role Overview

The Director, Thought Leader Liaison (TLL) is a senior individual contributor responsible for shaping and advancing the organization’s thought leader engagement strategy across the cell therapy landscape. This role operates at an enterprise level, cultivating high-impact relationships with national and regional experts to inform strategy, accelerate adoption, and elevate the organization’s scientific and clinical presence.
Unlike the Associate Director TLL role, which is primarily focused on execution within a defined scope, the Director TLL role is distinguished by breadth of influence, strategic insight generation, and executive-level engagement. The Director TLL serves as a trusted scientific partner to external experts and an internal advisor to senior leadership—translating complex field insights into actionable enterprise strategy.

Key Responsibilities

Strategic Thought Leader Engagement

• Lead relationships with top-tier national and regional thought leaders in cell therapy, oncology, and transplant.
  
• Design and execute long-term engagement strategies aligned to enterprise priorities and lifecycle needs.
  
• Serve as a credible scientific partner in discussions spanning clinical practice, research trends, operational challenges, and future innovation.
  

Enterprise-Level Insight Generation

• Synthesize insights across engagements to identify emerging trends, unmet needs, and strategic opportunities.
  
• Translate field insights into clear, executive-ready narratives that inform strategy, messaging, evidence generation, and education.
  
• Proactively identify gaps between internal strategy and external reality, elevating recommendations to leadership.
  

Executive & Cross-Functional Partnership

• Act as a strategic advisor to Medical Affairs, Clinical Development, Commercial, Marketing, Market Access, and Clinical Education.
  
• Support executive-level meetings, advisory boards, and strategic initiatives requiring deep scientific and field expertise.
  
• Influence internal decision-making without direct authority through credibility, data, and perspective.
  

Scientific Credibility & External Presence

• Represent the organization with a high level of scientific rigor and professionalism in external forums.
  
• Contribute to the shaping of advisory boards, peer-to-peer forums, and scientific exchange models.
  
• Ensure compliant, balanced, and ethical engagement with thought leaders at all times.
  

Standards Setting & Capability Elevation (Non-Managerial)

• Serve as a role model for advanced TLL capabilities, including insight quality, engagement depth, and strategic thinking.
  
• Contribute to the evolution of insight frameworks, engagement models, and performance standards.
  
• Provide informal mentoring and best-practice sharing across the TLL team without direct supervisory responsibility.
  

Requirements

• Minimum: Bachelor’s Degree from accredited college or university.
• Advanced degree also considered.
• Minimum of a bachelor’s degree in a related field required; MD, PharmD, PhD or other related graduate degree preferred.
  
• 10-15 years of pharmaceutical or biologics industry experience in sales, marketing, key account management, or medical engaging with thought leaders or influential HCPs required.
  
• 4 years of relevant Multiple Myeloma, Cell Therapy, or Oncology experience required.
  
• Deep expertise in oncology, cell therapy, transplant, or related therapeutic areas.
  
• Demonstrated success influencing senior internal and external stakeholders.
  
• Proven ability to translate complex scientific dialogue into actionable strategic insight.
  
• Able to work cross-functionally with internal and external stakeholders to innovate, collaborate, and deliver results.
  
• Valid driver's license.
  
• Ability to travel 75 – 85%.
  
• Required to exercise sound judgment and discretion, independently assess and resolve complex situations and shift priorities as the need arises.
  
• Possess excellent oral and written communication skills.
  
• Able to coordinate multiple projects with overlapping deadlines and complete tasks autonomously.
• Challenges the status quo, looks for/adopts best practices, embraces change.
  
• Must demonstrate flexibility, while maintaining a sense of urgency.
• Demonstrated ability to access and understand challenges and educational needs of stakeholders and accounts within the assigned geography.
  
• Proven customer focus.
  
• Demonstration of strong in-person and virtual presentation and engagement skills.
  
• Superior clinical skills and business acumen with the proven ability to excel in a technically complex and ambiguous environment.
  
• Experience working with CAR-T or other cell and gene therapies.
  
• Proven track record of shaping strategy through field-derived insights.
  
• Demonstrated ability to identify critical activities and tasks and adjusts priorities to meet organizational goals and objectives.
  
• Demonstrated ability to read situations quickly, anticipate and adjust for problems and roadblocks.
  
• Proficient in Microsoft Office (Word, Excel, Outlook, PowerPoint).

#Li-JK1

#Li-Hybrid

The Opportunity:

This newly created role represents a unique opportunity to shape the future of patient engagement at Revolution Medicines. The Omnichannel Strategy & Operations Team is seeking a forward-thinking, digitally fluent marketing leader to drive patient non-personal promotion (NPP) across our oncology portfolio.

The Senior Manager, Omnichannel Marketing (Portfolio Patient NPP) will lead the design and execution of innovative patient omnichannel capabilities and campaigns that support brands and disease state education. The Senior Manager will oversee the creation and management of omnichannel-ready content derivatives—ensuring cohesive, high-impact patient engagement across channels.  This role also offers the opportunity to build and scale best-in-class digital engagement models in close partnership with our Brand Patient Leads, Insights, and IT teams.

In addition to leading campaign execution, this individual will partner to identify measurement opportunity, optimize performance through data-driven insights, and identify emerging digital technologies that accelerate market readiness and enhance the patient experience.

Note: Branded & Unbranded Patient Marketing strategy, imperatives, objectives & content will be created by the brand aligned Patient Marketing Business Lead.

Key Responsibilities:

• Lead the Patient Non-Personal Promotion (NPP) Omnichannel Operations across oncology launches while identifying & designing integrated omnichannel engagement opportunities aligned to patient journey insights and brand objectives.

• Partner with Patient Marketing Business Lead(s) to understand the Patient engagement Strategy, Objectives and market research (per Asset/Tumor)

• Translate brand objectives and market research into engaging and effective Patient NPP campaigns to meet patients’ needs and preferences while ensuring consistent messaging across multiple channels.

• Develop and execute comprehensive Patient NPP marketing plan for all oncology launch products and indications, including creating strategic proposals and actionable options for effectively targeting patients. For example, what is the approach, channel, optimal media usage & measurement?

• Leverage existing or derivative assets.

• This includes vendor management to achieve transparent & optimal performance.

• Analyze and interpret Patient NPP campaign performance data to derive actionable insights and optimize future NPP initiatives.

• Partnering with the Insights team, present marketing performance insights and recommendations to Commercial Leadership Team.

• Collaboratively work with cross functional omnichannel partners to think strategically to solve/impact key business solutions/opportunities and present these complex ideas with clarity. For example: what hypothesis should we be testing for patients to engage more optimally? Specifically- Channels, Tactics, Orchestration, Impact/Measure, Cos

• Offer targeted digital solutions and strategies to enhance Patient, NPP, product & Disease State education launch strategies and reach the right patients/caregivers.

• Identify and evaluate new marketing technology platforms that support future readiness and patient engagement models.

• NPP Content Owner the PRC weekly team to manage & move assets from creation to execution as needed for NPP channels.

• Collaborate closely with cross-functional stakeholders (Medical Affairs, Market Access, Commercial, Legal) to ensure alignment of Patient NPP brand strategy and execution is compliant.

• Manage Patient NPP Omnichannel tactics marketing budgets effectively to ensure efficient resource allocation.

Required Skills, Experience and Education:

• Bachelor’s degree required; MBA or advanced degree strongly preferred.

• Minimum of 6-8 years of progressive experience in marketing within the pharmaceutical or biotech industry, including oncology product experience.

• Demonstrated examples of experience in Digital Marketing, Media Channel Marketing or Personal Promotion Marketing experience.

• Track record of being a collaborative team player, building positive partnerships, and adaptive to meet the needs of a growing business.

• Experience managing external vendors, budgets, and promotional reviews in a regulated environment

• Strong analytical skills and ability to interpret complex datasets to drive marketing decisions.

• Proven ability to influence cross-functional teams and stakeholders without direct authority.

• Strong analytical skills and ability to interpret complex datasets to drive marketing decisions.

• Thorough knowledge of current digital marketing platforms, media channels, and regulatory considerations.

Preferred Skills:

• Experience launching targeted oncology therapies or rare disease products.

• Experience optimizing Branded & Unbranded Patient NPP channels and/or journeys.

• Familiarity with modular content management, dynamic content creation, or AI-enhanced promotional tools.

• Experience in a high-growth, pre-commercial environment. 

  #LI-Hybrid  #LI-SS2

Legend Biotech is seeking an Executive Director, Pipeline Clinical Lead as part of the Clinical Development team based in Somerset, NJ.

Role Overview

The Pipeline Clinical Lead is a senior clinical development leader accountable for the scientific and medical direction of early stage clinical programs. This role provides strategic and operational leadership across first in human through proof of concept studies, with accountability for clinical strategy, trial design, execution, interpretation, and regulatory interactions.

The Pipeline Clinical Lead will lead and develop a team of physicians and scientists, work closely with cross functional partners, and collaborate with external development partners and investigators. Deep expertise in clinical trial design, regulatory frameworks, and compliance in drug development—ideally within cell therapy—is essential.

This role requires strong scientific judgment, leadership presence, and a hands on approach in a fast paced, entrepreneurial environment, with a clear focus on patient safety and clinical impact.

Key Responsibilities

Clinical Development Leadership

• Serve as clinical science lead for early stage programs (pre IND through Phase 1/2), including study design, execution, data interpretation, and reporting.
• Define and integrate clinical strategies, including PK/PD, biomarkers, diagnostics, and translational approaches, particularly for cell and gene therapies.
• Provide clinical input into asset selection, review of preclinical data, and development path decisions.

Regulatory & Compliance

• Lead or support IND preparation and amendments, clinical sections of regulatory submissions, and responses to health authority questions.
• Represent the clinical function in pre IND, IND, and (as applicable) BLA/MAA interactions with regulatory agencies.
• Champion patient safety, ethical conduct, and compliance with GCP, corporate policies, and global healthcare regulations.

Cross Functional & External Collaboration

• Partner closely with Clinical Operations, Biostatistics, Regulatory Affairs, Early Discovery,
• Manufacturing, Biomarkers, and Pharmacovigilance to ensure integrated program delivery.
• Collaborate with external development partners, academic investigators, KOLs, and study sites.
• Act as a credible scientific and clinical representative for programs in internal governance and external forums.

People & Matrix Leadership

• Provide direct line management and mentorship for Medical Directors, Clinical Research Scientists, Medical Writing, Clinical Program management and other clinical staff as applicable.
• Lead effectively in a matrix environment, anticipating cross functional needs and proactively resolving conflicts or risks.
• Contribute clinical leadership to business development, due diligence, and partnership activities when required.

Requirements

• MD or MD PhD (or equivalent) with US board certification or international equivalent.
• ≥8 years of clinical development experience in industry and/or academia, with demonstrated leadership in hematology/oncology.
• Proven experience designing and executing clinical trials from first in human through registrational stages.
• Prior involvement with IND submissions; experience with BLA/MAA filings and health authority meetings strongly preferred.
• Cell therapy and/or CAR T clinical development experience highly desirable IT Skills.
• Strong scientific judgment with the ability to navigate complex clinical and regulatory challenges.
• Demonstrated ability to lead cross functional and geographically distributed teams in a matrix environment.
• Excellent written and oral communication skills, including protocol writing, regulatory documents, publications, and senior level presentations.
• Highly collaborative, influential leader with the ability to represent programs with credibility and confidence.
• Hands on, execution oriented mindset with strong organizational and analytical skills.
• Willingness to travel up to 15–20%.

#Li-AS1

#Li-Hybrid

Legend Biotech is seeking a Head, Business Operations and Alliance Management as part of the Commercial team based in Bridgewater, NJ.

Role Overview

Reporting directly to the President, Carvykti BU, this role serves as the BU’s Strategy & Execution Lead, driving alignment, execution, and operational effectiveness across Commercial, GMS, Quality, and Medical Affairs. A core responsibility is managing Legend’s strategic alliances—ensuring strong governance, seamless communication, and proactive issue resolution so both organizations deliver on joint CAR‑T objectives.

The role also leads BU‑wide engagement and communication, fostering clarity, connection, and cultural cohesion across global teams. In parallel, it drives capability building, strengthening organizational readiness, talent development, and cross‑functional effectiveness to support Carvykti’s rapid growth and strategic priorities.

Key Responsibilities

Alliance Management:

• Lead governance of current and future alliances, ensuring transparent communication, shared accountability, and timely escalation.
• Coordinate joint steering committees, joint working teams, and governance bodies to ensure compliance with collaboration agreements and delivery on shared milestones.
• Maintain a strong relationship with partner organizations (e.g., Janssen) and serve as a central connective point between Carvykti BU functional stakeholders and alliance partners.
• Proactively identify risks, misalignments, or emerging strategic opportunities within collaborations and drive resolution or acceleration initiatives.
• Ensure open communication channels across both organizations and consistent partnership health tracking.

Engagement & Communication:

• Drive engagement initiatives and forums - town halls, BU business reviews, culture initiatives, leader communications, and cross‑functional alignment sessions.
• Serve as a strategic advisor to the BU President on messaging, engagement cadence, and organizational pulse.
• Design and lead BU‑level internal communications strategy, ensuring clarity, transparency, and alignment from the President through LT‑1 and field/operational teams.

Innovation & Strategy Acceleration:

• Partner with BU President & LT to shape and drive BU strategic initiatives, including transformation, digital capability scaling, operational innovation, and cross‑functional initiatives.
• Monitor industry trends (CAR‑T evolution, regulatory updates, partnership models) and translate insights into BU priorities.

Capability Building:

• Support BU‑wide capability strategy (technical, leadership, and operational), to ensure teams are equipped for current and future needs across Commercial, GMS, Quality, and Medical Affairs.
• Build mechanisms to measure capability maturity and organizational effectiveness.
• Partner with HRBP, OD, and Functional Heads to design learning ecosystems and talent acceleration pathways.
• The Head, Business Operations and Alliance Mgmt. exercises independent decision-making authority across strategic and operational domains, including project scope, timelines, resource allocation, and vendor selection. Decisions related to significant budget changes, strategic shifts, or major collaborations require higher-level approvals. This role is expected to proactively identify issues, propose solutions, and guide cross-functional execution with minimal oversight.

Requirements

• Advanced degree (MBA, MS) preferred; background in cell therapy, biotech, strategy, or operations strongly desirable.
• 10+ years’ in Pharma / Biotech with experience in alliance management, strategy execution, business operations and cross-functional leadership.
• Demonstrated success managing high‑complexity external partnerships and governance structures.
• Experience working with or leading within matrix organizations across Commercial, GMS, Quality, and Medical Affairs is highly desirable.
• Proven track record in driving organizational capability building, communication strategies, or enterprise‑level initiatives.
• Strong written and verbal communication skills; executive‑level presence.
• Strategic systems thinker with ability to distill complexity and drive clarity.
• Exceptional stakeholder management and influence.
• Strong program management, change management, and problem‑solving capability.
• High agility, ability to manage ambiguity, and proactive issue resolution.
• Culturally intelligent and globally collaborative.

#Li-JK1

#Li-Hybrid

Legend Biotech is seeking a Manager, Competitive Intelligence as part of the Commercial team based in Somerset, NJ.

Role Overview

The of Competitive Intelligence (CI) will serve as a strategic thought partner responsible for generating actionable insights that inform decision-making across R&D, commercial, and corporate strategy functions. This individual will lead proactive and on-demand CI initiatives, including competitor monitoring, landscape assessments, early signal detection, conference surveillance, and strategic analysis that supports pipeline development, lifecycle management, and long-term planning. The ideal candidate is a highly analytical, collaborative, and business-oriented professional with strong communication skills and a deep understanding of the biopharmaceutical landscape.

Key Responsibilities

Strategic Intelligence & Insight Generation

• Lead competitive intelligence activities across assigned therapeutic areas, platforms, and/or programs, delivering high-quality, actionable insights to senior leadership and cross-functional stakeholders.
• Conduct comprehensive landscape assessments, including scientific, clinical, regulatory, and commercial dimensions.
• Monitor competitors’ pipelines, clinical data, regulatory actions, collaborations, and market events to identify emerging threats, opportunities, and early signals.
• Monitor new entrants and startup tracking: Monitoring early innovation signals, investments, and disruptive players
• Synthesize complex data into clear narrative insights and strategic recommendations.

Conference Coverage & Surveillance

• Lead end-to-end conference CI planning and execution, including surveillance plans, abstract triage, onsite (or virtual) monitoring, rapid-readouts, and post-conference summaries.
• Coordinate cross-functional stakeholders to ensure aligned priorities and actionable outputs.

Data & Analysis Leadership

• Build and maintain CI frameworks, dashboards, market landscapes, and tracking systems to support continuous monitoring.
• Manage internally created CI dashboard and in some cases external CI vendors and ensure high-quality deliverables aligned with business needs.
• Develop and implement CI best practices, tools, and standardized processes.

Cross-Functional Partnership

• Serve as CI lead for R&D, commercial, BD, and strategy teams; participate in team meetings and strategic discussions as an insights partner.
• Partner with forecasting, medical affairs, and commercial strategy to ensure cohesive interpretation of external environment dynamics.
• Required to make decisions on a day-to-day operations for their tasks, and technicalities related to CI mostly. 

Requirements

• Master’s in life sciences, business, or related field
• 3+ years of experience in pharmaceutical/biotech competitive intelligence, strategy, consulting, market research.
• Strong scientific and clinical acumen in relevant therapeutic areas; hematology/oncology and Autoimmune experience preferred (if applicable).
• Demonstrated track record of delivering strategic insights and influencing decision-making.
• Strong analytical and strategic thinking abilities.
• Excellent written and verbal communication skills; ability to distill complex information into clear insights.
• Highly proficient in CI methodologies, secondary research, data interpretation, and triangulation.
• Skilled at working in fast-paced, cross-functional environments with tight timelines.
• High integrity and ability to manage sensitive/confidential information.
• Familiarity with CI tools, databases, and information platforms (e.g., Evaluate, Cortellis, Datamonitor, Alphasense, and clinical databases). 

#Li-

#Li-

Legend Biotech is seeking an Associate Director, Operations Program Lead as part of the Clinical Operations team based in Somerset, NJ.

Role Overview

The Operations Program Lead (OPL), Clinical Operations is accountable for accelerated operational delivery of 1-2 priority cell therapy development programs across all phases. This position is responsible for leading, managing and providing operational oversight for quality delivery within budget across all Legend Pipeline studies for 1-2 assets.

This individual must be able to work and lead in a small, fast-paced environment while also wearing multiple hats at any given time as the needs of the organization change and evolve. This position requires a high-performing contributor with strong leadership and stakeholder management skills. This individual will collaborate with the cross functional team to develop operationally feasible program timelines and identify clinical trial operational risks and develop mitigation strategies to ensure accelerated and cost-efficient quality clinical trial execution.  In addition, the position will ensure program consistency across studies, drive research and operational excellence through process improvement, and represent the clinical trial operation function at internal and external meetings.

This position will oversee 1-2 contractor Clinical Trial Associates (CTA).

Key Responsibilities

Direct end-to-end clinical trial management: 

• Direct end-to-end clinical trial operations activities domestically and globally: i.e. lead and take ownership in all aspects of Study Operations for CAR-T Studies in a matrix environment.
• Responsible for the overall success of the clinical study programs
• Ensures the assigned clinical trials are executed in compliance with FDA and ICH/GCP guidelines/regulations and SOPs. Ensures audit-ready condition of clinical trial documentation including central clinical files.
• Report on all aspects of the study progress at a granular level to stakeholders and senior leaders. Effective, consistent & regular tracking of project (s). Prepare and present project reports as required. Plans, executes, and leads study-specific meetings as needed (e.g., Senior and Mid-level management Study Management Meetings).
• Supports the Development of strategic plans for clinical trial operations, ensuring alignment with the company's overall goals and objectives.
• Collaborate with the cross-functional "core" teams to integrate clinical operations strategies into broader development plans.
• Define project timelines & deliverables, by working closely with the cross-functional core program team for end-to-end execution of clinical trials.
• Collaborates in the preparation and/or review of study-related documents (e.g., study protocols, informed consents and amendments, Study Operations Plan, Monitoring Plan, Pharmacy Manual, Informed Consent, Laboratory Manual, CRF Completion Guidelines, study tools/worksheets and other study-specific documents or manuals).

Clinical Trial Operations Efficiency and optimization:

• The OPL will drive clinical Operations excellence by playing a critical role in Clinical Trial Operations Efficiency and optimization.
• Work with cross-functional teams and external vendors to identify clinical trial operational risks and develop mitigation strategies to ensure quality delivery of the clinical trial to support optimal and efficient clinical trial execution. 
• The position involves working closely with the clinical development team and collaboration with cross-functional teams, including safety, study monitoring and coordinators, data management, biostatistics, bio analytics, tech ops, manufacture, supply chain, regulatory, project management, medical affairs, finance, legal and quality.
• Create and Manage study trial execution RACI to support overall trial execution and operational excellence.
• Contribute to Clinical Operations functional initiatives and institution of best practices.

Resource Management and Direct High Performing team:

• Manage and build a high-performing clinical operations support structure. Duties include hiring, onboarding, training, and development of staff to manage studies.
• Lead, develop and manage study operation manual, new work-streams, SOPs, study template, tracking tools, dashboards to support optimal clinical operation performance.
• Provides study-specific training and leadership to clinical research staff, including CRO, sites and other study personnel to support clinical trial execution and optimization.

Direct and Support Vendor Partnership

• Oversee vendor selection process, management, of Contract Research Organizations (CROs) and vendors involved in clinical trial Operation (CRO, Central Lab, etc).
• Participates in CRO and vendor study related calls and meetings, holds team members accountable for actions, escalates issues and oversees all aspects of daily study operations. Ability to identify issues and risks. Develops and manages mitigations and/or escalate risks appropriately.
• Negotiates vendor contracts / budgets and presents to the executive study team for approval.
• Review and confirm CRO and site payment invoices.
• Lead vendor performance assessment for continuous process improvement
• Management/oversight of external vendor deliverables reports and budgets.
• Collaborate within Clinical Operations and with study leadership team to create preferred vendor list for clinical development.

Leadership Skills

• Has critical thinking skills for problem solving and have the lateral and strategic thinking capacity to drive the study(ies) and understand the upstream, downstream, and lateral implications of decisions that affect study outcomes and timelines.
• Adaptable / flexible, self-starter (willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism)
• Excellent team player: willingness and ability to fill functional gaps in a small organization.
• Comfortable multi-tasking in a fast-paced small company startup environment and able to adjust workload based upon changing priorities.

Key Relationships

• The Operations Program Lead in Clinical Operations works closely with the asset Core Team and cross-functional teams such as safety, study monitoring, data management, biostatistics, bioanalytics, manufacturing, supply chain, regulatory, project management, medical affairs, and quality.
• Mentoring and management of a CTA.

Requirements

• Minimum degree requirements of a bachelor’s degree (BA, BS) in scientific or health care discipline. Advance Degree Preferred.
• Oncology and/or Immunology clinical trial operations therapeutic experience required. 10+ years of pharmaceutical, biotech or CRO related/ oncology clinical research experience.
• Experience leading the operational planning and oversight of clinical trials as the point of accountability for operational delivery. (CAR-T trials experience is a plus).
• Demonstrated ability to deliver ambitious trial acceleration timelines within a competitive clinical trial landscape.
• Phase 1 clinical trial operational experience is preferred.
• Experience and knowledge of end-to-end management of clinical trial conduct, knowledge of the pharmaceutical industry and an understanding of clinical drug development, clinical trials operations and FDA/ICH regulatory requirements are essential.
• This position requires experience and leading study/project management to create study project plans, and end-to end-study timelines for execution of clinical trials.
• Demonstrated ability to multi-task and manage high performance demands.
• Excellent organizational skills, ability to manage multiple tasks and meticulous attention to detail.
• CRO/Vendor oversight experience required.
• Project Management (biotech) experience a plus.
• Regulatory authority inspection experience a plus.
• Ability to travel as necessary (approximately 10 – 15 %); both domestically and internationally.
• Effective oral, written and interpersonal communication skills.
• Strong communication and presentation skills.
• Forward and critical thinker.
• SOP development experience preferred.
• Strong organizational and project management skills, and the ability to multitask.
• Computer literacy required (MS word, MS excel, MS PowerPoint and MS Project).
• Excellent working knowledge GCP, FDA and ICH Guidelines.

#Li-AS1

#Li-Hybrid

Legend Biotech is seeking a Sr. Medical Science Liaison as part of the Medical Affairs team based Remotely in the Mid Atlantic Territory.

Role Overview

The Senior Medical Science Liaison (MSL) is a field‑based scientific expert within U.S. Medical Affairs, responsible for fostering credible, compliant, and non‑promotional scientific exchange with healthcare professionals (HCPs), investigators, and other external stakeholders in hematology/oncology.

This role serves as a key scientific partner across academic and community settings, supporting Legend Biotech’s marketed and pipeline assets through evidence‑based dialogue, clinical trial support, medical education, and generation of actionable medical insights. The Senior MSL operates with a high degree of autonomy, contributes to territory and national medical strategy execution, and may mentor or support the development of junior MSL colleagues.

Key Responsibilities

Scientific Engagement & External Partnerships

• Develop and maintain long‑term, peer‑to‑peer scientific relationships with key opinion leaders (KOLs), investigators, and other relevant healthcare stakeholders within the assigned territory.
• Deliver fair‑balanced, scientifically rigorous medical information in response to unsolicited requests, consistent with PhRMA Code, FDA regulations, and company SOPs.
• Serve as a trusted scientific resource on disease state, mechanism of action, clinical data, and emerging evidence related to Legend Biotech and relevant competitive landscapes.

Clinical Research & Development Support

• Act as the primary field‑based medical contact for investigators and research staff involved in company‑sponsored and investigator‑initiated studies.
• Support clinical trial feasibility, site identification, site initiation, and enrollment discussions in collaboration with Clinical Development and Clinical Operations.
• Provide education and support related to protocol concepts, safety reporting, and adverse event (AE) management, as appropriate and compliant.

Medical Strategy Execution & Insights

• Execute Medical Affairs strategies and tactics at the territory level in alignment with national medical plans.
• Collect, synthesize, and communicate high‑quality medical insights related to clinical practice, unmet needs, treatment paradigms, and competitive intelligence.
• Translate field insights into actionable recommendations for internal stakeholders to inform medical, clinical, and research strategies.

Scientific Exchange & Medical Education

• Support and participate in scientific congresses, symposia, advisory boards, and investigator meetings.
• Interpret scientific data presented at meetings and communicate key findings, trends, and implications to cross‑functional partners.
• Contribute to the development and continuous improvement of medical resources, training materials, and scientific content.

Cross‑Functional Collaboration & Leadership

• Collaborate effectively with internal partners including Medical Affairs, Clinical Development, Commercial (as appropriate), Regulatory, and strategic alliance teams while maintaining appropriate medical independence.
• Collaborate with alliance partners on field-based strategies and tactics
• Mentor and provide informal leadership support to newly hired or less experienced MSLs, as needed.
• Demonstrate strong judgment, adaptability, and professionalism in complex and evolving environments.

Compliance & Operational Excellence

• Adhere to all company policies, SOPs, and external regulations, including PhRMA Code, FDA guidance, and internal compliance standards.
• Maintain accurate and timely documentation of field activities, insights, and metrics using approved systems and tools.
• Manage territory operations effectively, including planning, prioritization, and travel logistics.

Requirements

• Advanced terminal degree (PharmD, PhD, MD, DO) or other advanced clinical degree (e.g., NP, PA) with relevant clinical experience.
• Minimum of 3-5 years of Medical Science Liaison experience in a therapeutic area aligned with hematology/oncology, immunology or CAR-T therapy; or 3-5 years of hematology/oncology clinical experience.
• Strong foundational knowledge of clinical research, trial design, and drug development processes.
• Demonstrated ability to engage in high‑level scientific exchange with expert clinicians and researchers.
• Excellent verbal, written, and presentation skills, with the ability to communicate complex scientific concepts clearly.
• Proven ability to work independently while collaborating effectively in a matrix organization.
• Valid U.S. driver’s license and ability to travel extensively, including overnight and occasional weekend travel.
• Residence within the assigned territory or within reasonable commuting distance.
• Core Competencies:
  • Scientific and Clinical Acumen
  • Strategic Thinking and Problem Solving
  • Insight Generation and Communication
  • Stakeholder Relationship Management
  • Emotional Intelligence and Professional Presence
  • Adaptability and Change Management
  • Compliance Mindset and Ethical Judgment
  • Digital and Technical Proficiency

#Li-JK1

#Li-Remote

Legend Biotech is seeking a Project Manager, External Engagement (Contractor) as part of the Commercial team based in Bridgewater, NJ.

Role Overview

Reporting to Executive Director, External Engagement, the Project Manager will run and manage multiple projects in a proactive manner. Leverage project management tools and processes, including detailed timelines, milestones and daily tracking to ensure projects are delivered to company goals and commitments. Be prepared to report on project progress and status through weekly reporting or at the request of Leadership.

Key Responsibilities

• Define scope, goals, and deliverables of each assigned project that support business goals in collaboration with senior management and stakeholders.
• Develop full-scale project plans and associated communications documents.
• Identify and anticipate potential risks and establish plans to proactively address such potential risks.
• Effectively and proactively communicate project modifications to the impacted parties with explanations of new responsibilities, deadlines, target dates, etc.
• Coordinate with members of the Legal, Compliance, and Medical Affairs departments to ensure concurrence with budgetary, and other legal and compliance requirements.
• Develop and implement procedures, as needed, for project monitoring to include team meetings, action item follow-up, meeting minutes, and identifying new actions and resolutions.
• Coordinate with internal resources to assist with project management and execution.
• Manage workflow requirements and documentation related to the projects.
• Interface with executives/department leads for strategy and budgeting purposes.
• Efficiently manage and maintain a system of problem resolution (i.e., change in project requirements, missed deadlines, etc.). Facilitate resolution of project conflicts by consulting with project teams and stakeholders and developing innovative solutions.
• Weekly Reporting.

Requirements

• Bachelor’s Degree from accredited college or university.
• Two to four years project management experience, or combination of education and experience.
• Two + years’ experience in the pharma/biotechnology industry.
• Initiative-taker.
• Excellent people skills with the ability to lead, engage in focused and clear interactions with stakeholders from a variety of levels, functions, and companies.
• Strong familiarity with project management software, such as Microsoft Project
• Exceptional planning, organization, and execution skills.
• Strong quantitative and analytical skills.
• Demonstrated ability to identify, prioritize, provide resolution options, and escalate critical issues to Executive Leadership, as necessary.
• Demonstrated ability to manage timelines.
• Ability to anticipate and solve problems while analyzing complex issues and environments.
• Demonstrated excellence in project management, while effectively managing multiple projects/priorities.
• Strong oral and written communication skills and an ability to communicate complex concepts in a concise, simplified manner.
• Demonstrated ability to work with and coordinate demands from multiple internal and external stakeholders.
• Ability to effectively prioritize and execute in a high-pressure, milestone-driven, and rapidly changing environment is crucial.
• Exhibition of the highest degree of ethical standards and trustworthiness.

#Li-JK1

#Li-Hybrid

#Contract

Legend Biotech is seeking a Sr. Director, Clinical Operations Capabilities and Standards as part of the Clinical Operations team based in Somerset, NJ.

Role Overview

The Sr. Director, Clinical Operations Capabilities and Standards will be responsible for providing strategic leadership and oversight for foundational and centralized trial operations support towards cost-effective scalability of the Clinical Operations department. 

Among other responsibilities, this position will establish, oversee and grow Clinical Operations capability pillars that include Clinical Trial Planning and Analytics, Clinical Trial Operational Technologies, Vendor Alliance Management, Site Contracts & Payments, and Sample & Imaging Management Operations; including managing and developing staff within each pillar.

This position will also be the company subject-matter expert for clinical operations standards applied across the portfolio of Legend IND clinical trials.

Key Responsibilities

Oversee the development and strengthening of the following clinical operations capabilities and functions, with leads/teams in each of these areas:

Clinical Trial Planning & Analytics:

• Clinical Trial Planning and Analytics (CTP&A) is accountable for end‑to‑end clinical trial feasibility activities, supporting protocol optimization, country and site selection, enrollment forecasting, and risk mitigation across clinical programs.
• This function provides data‑driven feasibility insights to enable informed decision‑making during early study planning and partners closely with Clinical Operations Leads, Clinical Development, cross-functional stakeholders and external vendors to ensure trials are designed and placed for successful execution.
• This function is responsible for predictive trial performance modeling to enable proactive implementation of contingency plans

Clinical Trial Operational Technologies:

• The Clinical Trial Operations Technology function is responsible for the strategic ownership, governance, and optimization of clinical trial operations systems that enable compliant, efficient, and inspection‑ready execution of clinical trials.
• This function serves as the business owner for core clinical systems (e.g., CTMS, eTMF, and related platforms), ensuring alignment with clinical operations needs, regulatory requirements, and the company’s development portfolio. The position partners closely with Clinical Operations Leads, Quality, Regulatory, Data Management, IT, and CROs/external vendors.
• Areas of focus for capability building include leveraging technology to enable cost-efficient trial budget builds and ongoing costs optimization during study execution, enabling tools for targeted clinical operations risk management and technology-enabled eTMF oversight.

Vendor Alliance Management:

• Vendor Alliance Management is responsible for the strategic and operational oversight of external clinical operations vendors and CRO partners supporting clinical trials, including coordination of vendor due diligence for vendor qualification. Ensures vendors deliver high‑quality services in compliance with GxP and contractual expectations, while enabling efficient study execution across one or more clinical programs.
• Vendor Alliance Management is the primary interface between internal Clinical Operations Program Leads and external service providers, with accountability for vendor governance, performance management via objective metrics, issue escalation, and continuous improvement.

Site contracts and Payments

• Site Contracts & Payments is responsible for creating and overseeing a scalable and effective operating model for site contracting visibility, investigator payment operations, serving as a central point of accountability for improving operational control, process effectiveness, financial discipline, vendor performance consistency, and sponsor-CRO-site workflow alignment.

Sample and Imaging Management Operations

• Sample and Imaging Management is responsible for end-to-end sample and imaging oversight across Legend pipeline studies. To strengthen visibility, accountability, and coordination across sites, CROs, central labs, specialty labs, imaging vendors.
• Sample and Imaging Management focuses on system‑level consistency and risk reduction, mitigating against loss of patient data, enabling acceleration of data cleaning and reducing site burden for participation in clinical trials.
• Lead business owner for clinical operations standards and practices, including functional owner for clinical operational related SOPs and guidance documents.
• Performs other duties as required.

Key Relationships

• The Head of Clinical Operations Capabilities and Standards works closely with all applicable internal cross-functional leaders and teams as well as external vendors for the clinical operations capability building and strengthening.

Requirements

• Minimum degree requirements of a bachelor’s degree (BA, BS) in scientific or health care discipline. Advance Degree Preferred.
• 12+ years of progressive experience in pharmaceutical or biotechnology clinical operations, with demonstrated leadership responsibility across global clinical development programs.
• Significant experience in establishing, scaling, or transforming centralized Clinical Operations capabilities, including one or more of the following:
  • Clinical Trial Planning & Analytics / Feasibility
  • Clinical Trial Operational Technologies (e.g., CTMS, eTMF, analytics platforms)
  • Vendor Alliance Management
  • Site Contracts and Investigator Payments
  • Sample and Imaging Management Operations
• Proven expertise in end‑to‑end clinical trial conduct, including early‑phase through late‑phase trials, with strong understanding of protocol development, feasibility, start‑up, execution, and close‑out.
• Demonstrated strategic CRO and vendor oversight experience, including governance models, performance metrics, financial oversight, issue escalation, and continuous improvement.
• Experience acting as a functional or enterprise‑level clinical operations subject‑matter expert, defining standards, operating models, and best practices applied across multiple studies or programs.
• Strong background collaborating with Quality, Regulatory, Clinical Development, Data Management, Biostatistics, Medical Writing, Pharmacovigilance, Translational/Bioanalytical, Medical Affairs, Procurement, Legal and IT functions in a matrixed global environment.
• Experience participating in and/or supporting regulatory authority interactions (e.g., FDA inspections) related to clinical operations processes, vendors, systems, or trial conduct is strongly preferred.
• Demonstrated success leading, developing, and retaining high‑performing teams, including functional leaders.
• Willingness to travel as required (approximately 10%).
• Deep knowledge of clinical trial operations frameworks, including industry best practices and regulatory expectations (ICH‑GCP, FDA, and global health authorities).
• Strong capability in clinical operations operating model design, including centralization, standardization, governance, and scalability.
• Demonstrated leadership in clinical operations technology enablement, including business ownership of systems (e.g., CTMS, eTMF), data quality oversight, technology‑enabled risk management, and inspection readiness.
• Expertise in vendor and alliance management, including development of governance structures, KPI frameworks, financial oversight, and performance optimization.
• Understanding of clinical trial sample, imaging, and data flows, with ability to design operational controls that reduce patient data risk, site burden, and cycle times.
• Ability to translate portfolio‑level strategy into executable clinical operations capabilities, standards, and guidance.
• Proven strategic and critical thinking skills, with a data‑driven mindset and ability to anticipate operational risks and mitigation strategies.
• Strong experience developing, authoring, and governing clinical operations SOPs, standards, and guidance documents.
• Exceptional communication, presentation, and stakeholder influence skills, with the ability to engage senior leadership and cross‑functional teams.
• High proficiency with clinical operations–relevant technologies and tools, including MS Office (Excel, PowerPoint, Word) and enterprise clinical systems; ability to leverage analytics for operational decision‑making.

#Li-AS1

#Li-Hybrid

Legend Biotech is seeking a Program Lead, Cell and Gene Therapy as part of the Global Manufacturing and Supply team based in Raritan, NJ.

Role Overview

The program Lead will be responsible for developing and executing the internal commercial manufacturing strategy for iLVV (in vivo Lentiviral Vector). This role will lead strategic planning, drive execution, propose options to senior leadership, of the commercial manufacturing introduction activities across late-stage and commercial programs, ensuring technical excellence, regulatory readiness, operational execution, and seamless cross-functional alignment. The position requires close collaboration with cross-functional teams including R&D, process development, MSAT, global facility & engineering, Quality, procurement, regulatory affairs, and finance.

Key Responsibilities

Strategic Leadership

• Define and drive the internal commercial manufacturing strategy for iLVV.
• Evaluate internal/external options for iLVV commercial manufacturing, and seek stakeholder feedback.
• Present options and recommendations to senior leadership for decision-making.
• Provide clear, concise, and timely updates to senior management regarding program progress, risks, and strategic considerations.
• Motivate and inspire cross-functional teams, building momentum, alignment, and ownership.
• Make decisive, data-driven, and sometimes tough decisions to advance program objectives under aggressive timelines.

Planning & Execution:

• Develop detailed business and implementation plans and timeline for late stage clinical and commercial manufacturing to deliver launch milestones.
• Oversee facility fitness and readiness and ensure alignment with stakeholders on commercial tech transfer and production timelines.

Cross-Functional Collaboration

• Partner with R&D for process development and technology transfer.
• Work closely with engineering and Somerset facility teams for infrastructure planning.
• Drive decision-making that balances scientific rigor, speed, risk, and business impact.
• Coordinate with regulatory and quality teams to ensure compliance with global standards.
• Collaborate with finance to manage budgets and cost projections.

Process Development & Transfer

• Working with MSAT to drive commercial process transfer activities from development to manufacturing.
• Coordinate generation of process descriptions, control strategies, equipment requirements and Bill of Materials.
• Drive establishment of raw material requirements, QC method readiness and facility fit.
• Ensure robust scale-up and validation of vector manufacturing processes.

Manufacturing Site & Operational Readiness

• Ensure manufacturing facilities are prepared for the new product including capacity, equipment, utilities, and staffing.
• Partner with Supply Chain to secure long-lead materials, single-use components, and critical suppliers.
• Oversee line-of-business readiness: QA, QC, MSAT, warehouse, digital systems, labeling, analytics.
• Align on operational procedures (SOP updates, batch records, deviations/corrective actions).

Quality and Compliance

• Ensure compliance with applicable global GMP, ICH, and regulatory expectations.
• Support CMC submissions, PPQ documentation, change controls, and validation packages.
• Collaborate with Quality to ensure inspection readiness and audit support.

Continuous Improvement & Lifecycle Management

• Identify opportunities to optimize manufacturing robustness, cost, and yield post-launch.
• Implement lessons learned, knowledge management systems, and NPI best practices.
• Support product lifecycle changes such as process improvements, site expansions, and supply chain enhancements.

Requirements

Education

BS is required, Ph.D. preferred in Biotechnology, Biochemical Engineering, or related field.

Experience

• Minimum 10+ years in biopharmaceutical manufacturing. Viral vector late processes development/manufacturing experience is required.
• Proven experience in facility scale and layout planning, and commercial process transfer and validation.
• Strong understanding of cGMP requirements and regulatory frameworks for cell and gene therapy products.

Skills

• Strategic thinking and ability to build consensus among peers and influence senior leadership.
• Excellent project management and cross-functional leadership skills.
• Strong communication and stakeholder management capabilities.
• Ability to thrive in a fast-paced, evolving environment.
• Highly goal-oriented, ownership-driven, and laser-focused on execution.
• Comfortable navigating ambiguity and making quick, high-impact decisions.

#Li-BZ1

#Li-Hybrid

Job Summary

The Vice President of Marketing will lead the enterprise marketing strategy and commercialization planning across our growing ophthalmic portfolio. As a key member of the Commercial Leadership Team, this executive will drive brand performance, launch excellence, and market expansion to accelerate revenue growth.

Operating in a fast-paced, high-growth environment, this leader will build and scale a high-performing marketing organization. The successful candidate will design innovative omnichannel engagement strategies, shape differentiated brand positioning, and leverage data-driven analytics to maximize adoption of our therapies across HCP and consumer audiences.

Core Responsibilities

Strategic Leadership & Portfolio Management

• Lead enterprise brand strategy, end-to-end lifecycle management, and launch readiness across the company’s product portfolio.
• Drive strategic positioning, pricing, and market expansion initiatives to maximize long-term growth and commercial performance.
• Partner with Executive Leadership, Sales, Market Access, Medical Affairs, and other critical functions to ensure strategic alignment and commercialization success.

Commercial Execution & Analytics

• Develop and execute integrated omnichannel marketing strategies across digital, field, and media platforms to accelerate brand awareness and adoption.
• Establish clear forecasting models, investment/resource allocation strategies, and KPIs to optimize ROI and overall business impact.
• Utilize market research, competitive intelligence, prescription data, and CRM analytics (e.g., Salesforce, Tableau) to inform agile decision-making.
• Build and maintain strategic relationships with KOLs, industry partners, and external stakeholders, leading medical education and congress strategies.

Team Building & Organizational Excellence

• Lead, mentor, and scale a high-performing marketing team, fostering a culture of accountability, innovation, and executional excellence.
• Direct agency and vendor partnerships to ensure the delivery of high-quality, differentiated promotional campaigns and customer-facing materials.

Qualifications & Requirements

• Bachelor’s degree in Marketing, Business, Life Sciences, or a related field required; MBA or advanced degree preferred.
• 12+ years of progressive commercial leadership experience in the pharmaceutical or biotech industry, with a strong preference for direct experience in ophthalmic pharmaceuticals/eye care.
• Proven track record of successful brand leadership, go-to-market strategy, product launches, and scaling brands through high-growth commercialization phases.
• Deep understanding of omnichannel marketing, customer engagement, and ROI-driven resource allocation.
• Exceptional executive communication and stakeholder management skills.
• Proficiency with CRM systems and commercial analytics platforms.

Position Type 

• Remote

Travel

• Up to 25%

Overview

Want to make a difference in the world? Join a team of innovative professionals who put customers first and align a federal civilian agency’s mission and priorities with modern enterprise system solutions.

Esri is the place for you to do your best work amid a supportive culture that encourages creativity, collaboration, and passion for each project. You’ll be part of a high performing team that helps federal civilian agencies (such as NASA, Department of Energy, EPA, Department of Commerce, CDC, and Veterans Affairs) apply geospatial science and leading-edge analytical technologies to discover unique patterns, trends, and solutions hidden within complex scientific and business problems. As an Account Manager at Esri, the global leader in geospatial science and GIS, you will apply your selling skills to address a huge transformation in technological capabilities across the public sector that includes Artificial Intelligence (AI) and Machine Learning (ML), Kubernetes, digital twin, data science, big data, Microsoft Fabric; distilling IoT-generated data into actionable intelligence, cloud computing, and more.

Responsibilities

• Deliver results. Successfully execute the account management and sales processes for all opportunities. Use whiteboard sessions and other techniques to support visual storytelling and propose solutions that best meet the need of the customer.
• Understand our customers. Demonstrate industry knowledge and its relevance to the application of GIS. Identify key stakeholders and business drivers for an organization. Understand customer budgeting and acquisition processes. Use solution selling skills to understand the needs and business challenges of customers.
• Build relationships. Prospect, develop, and implement location strategies for organizations. Maintain a healthy pipeline of business growth opportunities for new and existing customers. Leverage social media and other avenues to build your professional network. Participate and present at trade shows, workshops, and seminars.
• Learn and grow. Clearly articulate the strength and value of Esri technology as it relates to the industry. Consistently conduct research and pursue professional development to anticipate customer needs and trends that may impact them.
• Collaborate with others. Leverage your domain knowledge when working with teams across Esri to define and execute account strategies. Be motivated and resourceful and take initiative to resolve issues.

Requirements

• 5+ years of enterprise sales and/or relevant consulting or program management experience
• 3+ years of experience working in or supporting the federal government/public sector
• Experience creating partnerships, and establishing yourself as a trusted advisor with customers
• Understanding and execution of the sales process, account management, account planning and opportunity strategy creation
• Demonstrated knowledge of enterprise systems and new technology trends, and the ability to translate this into solutions for customers
• Able to negotiate, present, and support visual storytelling across all levels of an agency
• Ability to travel domestically 25-50%
• Bachelor’s degree in business administration, GIS, environmental/earth, social and/or health science, or a related field
• Visa sponsorship is not available for this posting. Applicants must be authorized to work for any employer in the U.S.

Recommended Qualifications

• Understanding of GIS, Esri technology, and environmental and earth sciences as they relate to one another
• Understanding of environmental, earth and, health sciences
• General knowledge of data science or spatial analysis and how it is used for problem solving and uncovering patterns and trends within organizations
• Knowledge of public sector fiscal year, budgeting, and procurement cycles
• Master’s degree in business administration, GIS, environmental/earth, social and/or health science, or a related field

Questions about our interview process? We have answers.

#LI-KH3

#LI-ONSITE

PrizePicks is seeking a strategic and execution-oriented Chief Communications Officer to lead our internal and external communications strategy. Reporting directly to the CEO, the CCO will shape how PrizePicks is understood by employees, players, regulators, media, partners, and the broader public. This leader will ensure the world knows that PrizePicks is a fast-growing, innovative, responsible, and consumer-first entertainment company.

What you’ll own:

• Corporate Narrative & Brand Positioning: Develop and refine the corporate story and ensure consistent messaging across all channels. 
• Media & Public Relations: Build a world-class PR function and elevate executive visibility.
• Internal Communications & Culture: Align employees around company priorities and support change management. 
• Crisis & Reputation Management: Lead crisis communications planning and response.
• Government & Regulatory Messaging: Partner with Legal/Public Affairs to ensure consistent compliance messaging. 

What success looks like:

• PrizePicks is recognized as a premier consumer entertainment brand.
• Share of voice and media sentiment improve year-over-year.
• Strong internal alignment on strategy and performance.

What you bring:

• 15+ years of progressive communications leadership experience.
• Experience scaling communications at a high-growth consumer, tech, gaming, or entertainment company. 
• Strong understanding of regulated industries preferred.
• Proven crisis management experience.
• Exceptional executive presence and board-level influence.

Where you’ll live:

• This is a hybrid position based at our PrizePicks headquarters in Atlanta, GA. #LI-Hybrid

The hourly rate for this position is $19.00 an hour. 

Summary

We are seeking a Legal Assistant to join our Veteran Affairs' group. As a Legal Assistant you must be highly organized and able to work on a varied caseload, take pride in what you do, and assist the attorney in preparing documents and correspondence as needed. 

Responsibilities

• Perform administrative duties, such as scheduling calendar hearings and deadlines, organizing case files, and managing logistics
• Maintain pleadings and discovery indexes
• Organize exhibits, documents, evidence, briefs, and appendices
• Implement and improve upon administrative processes for more efficient workflow
• Collect, examine, and organize evidence and other legal documents for attorney review and case preparation
• Draft and proofread correspondence and legal documents, such as pleadings and contracts
• Research regulations, laws, and legal articles to assist with the preparation of reports, case files, and legal advice
• Manage client billing by preparing, finalizing, and sending out bills, as well as resolving billing issues in cooperation with the billing attorney
• Communicate with clients and witnesses to schedule meetings, interviews, and hearings
• Manage, organize, and maintain documents in paper or electronic filing systems
• Provide general administrative assistance, such as maintaining the attorney’s calendar and making travel arrangements

Qualification

• High school diploma or GED
• Associate’s Degree in Paralegal Studies, Bachelor’s Degree, or a Paralegal Certificate (preferred)
• Prior experience as a case manager in a Veteran Affairs department (preferred)
• At least 1 year of working legal, medical, or social services experience (preferred)
• Highly organized with the ability to multitask, prioritize, handle a fast-paced environment, and manage workload with a great attitude and minimal supervision
• Strong written and verbal communication skills, including good presentation skill
• This role is on-site, which gives you the chance to be fully immersed in the work and gain direct experience alongside the team. We’ve found that being in the office helps new team members get up to speed quickly and feel more connected.

#LI-EM1

About Nucleus Global

Nucleus Global is a global leader in the medical communications space with locations across Europe, US, and APAC and a portfolio of 90-plus clients. It forms part of the Inizio Medical group, which includes Ashfield MedComms, ApotheCom, and MEDiSTRAVA. Its unique position as part of this international network, which includes three of the world’s top medical communications companies, gives it a key advantage over its commercial competitors in terms of the scale of its reach and depth of its expertise.

About the Role

Are you ready to take the next step in your medical communications career? We’re looking for a Senior Account Executive to join our talented, collaborative team supporting a high-profile medical affairs account.

In this role, you’ll be a key player in bringing scientific stories to life — helping our clients communicate their research clearly, accurately, and with impact. You’ll work alongside experienced Client Services leaders to keep projects running smoothly, ensuring every deliverable is high-quality, on time, and within budget.

From developing project timelines to managing budgets and financial reconciliations, you’ll take ownership of the details that make our partnerships successful. Most importantly, you’ll help build trusted relationships with both clients and colleagues — because great science deserves great teamwork.

This position is remote.

About You

You’re organized, proactive, and passionate about making a difference through scientific communication. You thrive in a fast-paced environment and love seeing your projects come to life.

• Bachelor’s degree required (Life Sciences preferred)
• 3+ years of experience in project management or a similar role
• Background in medical communications or the pharmaceutical industry, with experience managing medical affairs projects
• Proficient in Veeva (required)
• Skilled at juggling multiple projects while keeping timelines, budgets, and quality on track
• Confident using Microsoft Office, especially Excel for tracking and managing project finances
• Excellent communication skills — written, verbal, and interpersonal
• A true team player who builds positive, productive relationships

Benefits:

• Health coverage
• Retirement
• PTO

In addition to a great benefits package, we are happy to talk flexible working. We are also known for our friendly and informal working environment with Friday socials across our offices, regular wellbeing weeks, and Town Hall events. We offer excellent opportunities for career and personal development, including opportunities to transfer your skills to our other offices around the world.

Our Pledge

At Nucleus Global, we are committed to encouraging a culture of diversity, inclusion and belonging where everyone can bring each facet of themselves to work each day. We believe that strength in diversity and inclusivity is a driver of our success.

Nucleus Global is not accepting unsolicited résumés from search firms for this employment opportunity. Regardless of past practice, all résumés submitted by search firms to any employee of Nucleus Global and its affiliated companies by email, the Internet or in any form — without a current signed fee agreement for that position (as authorised by the Recruitment Manager) — will be deemed the sole property of Nucleus Global, and no fee will be paid in the event you are hired as a result of the referral or through other means.

Nucleus Global is part of Inizio Medical. Inizio is a strategic partner for health and life sciences with a full suite of medical, marketing, advisory and engagement services

About Nucleus Global

Nucleus Global is a global leader in the medical communications space with locations across Europe, US, and APAC and a portfolio of 90-plus clients. It forms part of the Inizio Medical group, which includes Ashfield MedComms, ApotheCom, and MEDiSTRAVA. Its unique position as part of this international network, which includes three of the world’s top medical communications companies, gives it a key advantage over its commercial competitors in terms of the scale of its reach and depth of its expertise.

About the role

We have and exciting opportunity for an experienced Account Director to join the group working a large on a medical affairs account. This role would suit a candidate who enjoys being a strategic leader, multi-tasking, and is motivated to drive and develop the business.

Here's what you'll be doing:

As Account Director you will be responsible for supervising a range of communications projects. Using your project management / leadership skills and scientific expertise you will deliver a range of scientific services to clients, including scientific and strategic consultation, project planning for new and existing drug therapies, satellite symposia, conferences, medical education projects in both web and multimedia formats and future launch planning. You will research information from a variety of sources in order to provide expertise in therapy area(s) and product(s) and as a primary client liaison point, you will be responsible for maintaining excellent relations with clients, meeting and surpassing client needs and guaranteeing high business standards. You may also have line management responsibility.

About you:

To succeed, you must have a Bachelor’s degree, preferably in life sciences (advanced degree, preferred). You will also have a wealth of experience in a medical communications agency or pharmaceutical marketing environment working on medical affairs projects. In addition, a proven track record of exceptional staff, project and client management experience is required. To be successful you would needed to have developed strategic communication plans and programs in a previous role. You should have good financial understanding and have had experience with budgeting. You will also be able to work well within a team and demonstrate strong written and verbal communication skills.

Benefits:

• Health coverage
• Retirement
• PTO

In addition to a great benefits package, we are happy to talk flexible working. We are also known for our friendly and informal working environment with Friday socials across our offices, regular wellbeing weeks, and Town Hall events. We offer excellent opportunities for career and personal development, including opportunities to transfer your skills to our other offices around the world.

Our Pledge

At Nucleus Global, we are committed to encouraging a culture of diversity, inclusion and belonging where everyone can bring each facet of themselves to work each day. We believe that strength in diversity and inclusivity is a driver of our success.

Nucleus Global is not accepting unsolicited résumés from search firms for this employment opportunity. Regardless of past practice, all résumés submitted by search firms to any employee of Nucleus Global and its affiliated companies by email, the Internet or in any form — without a current signed fee agreement for that position (as authorised by the Recruitment Manager) — will be deemed the sole property of Nucleus Global, and no fee will be paid in the event you are hired as a result of the referral or through other means.

Nucleus Global is part of Inizio Medical. Inizio is a strategic partner for health and life sciences with a full suite of medical, marketing, advisory and engagement services.

A Strategic Account Director (SAD) acts as the day-to-day strategic advisor to the client and ensures that our work is strategically on-target and delivered within budget and timelines. SADs are also responsible for generating revenue to be delivered on through leading and managing a team of internal resources to maximize effectiveness and efficiency for the client and the company.

Essential Functions and Summary of Responsibilities

Big Picture for Clients

• Understand the business challenges your client is facing and what strategic questions they are or should be asking
• Help clients define and achieve their business goals
• Prepare annual strategic/tactical plans for each client and individual campaign/project plans as needed throughout the year
• Manage and strengthen client relationships
• Propose, sell to clients, and oversee ideas and projects that are tied to clients’ objectives
• Continuously offer unsolicited ideas to increase the effective of clients’ brand and company activities

Big Picture for Precision AQ

• Understand revenue generation and recognition, and contribute to Precision AQ's profitability through good management
• Serve as an advocate and strong representative for Precision AQ
• Identify and cultivate new business opportunities
• Periodically report to company leadership on the condition of client-Precision AQ relationships

Day-to-Day for Clients

• Initiate and oversee Precision AQ activities on behalf of and in support of clients
• Manage day-to-day client-Precision AQ communication on strategy (ideas, recommendations, approaches to consider) and planning
• Become a partner to each client, functioning as an extension of the client’s team by taking ownership and accountability for their business

Day-to-Day for Precision AQ

• Closely manage clients’ budget and team efficiency to maximize return for clients and Precision AQ
• Build up your team by celebrating successes, listening to them, learning and improving from mistakes, and sharing information with other teams along the way
• Mentor, train, and coach team members to facilitate growth and development

For You, Precision AQ, and Clients

• Stay abreast of developments (eg, science, competitors, regulations) in clients’ industries
• Keep honing marketing and strategy expertise to better serve clients and Precision AQ
• Network and connect to grow your influence and add value

We seek highly motivated people with outstanding professional credentials, business accomplishment, and leadership. In addition, we place high value on relevant personal qualities: resourcefulness, tenacity, independence, energy, and self-confidence.

Qualifications

• Bachelor’s degree, ideally with a concentration in advertising, marketing, communications, or journalism; other majors will be considered
• Advanced degree (PhD, MD, or PharmD) in life sciences, pharmacy, medicine, and/or advanced degree in management, marketing, or business desirable/preferred
• A minimum of five (5) years of pharmaceutical/biotech marketing or medical affairs experience or medical communications agency experience, with experience successfully managing and growing $1M+ pharma/healthcare accounts

Skills

• Microsoft Office (Word, Excel, PowerPoint, Outlook)
• PowerPoint design proficiency
• Thorough understanding of the objectives, as well as the strategic and tactical activities of pharmaceutical/biotech marketing, particularly in the area of medical communications
• Demonstrated proficiency in acting as a trusted strategic/business advisor to marketers and other managers
• Proficiency in leading and managing employees, growing client relationships, and managing expanding business opportunities
• Ability to thrive and succeed in a fast-paced environment
• Strong communication and presentation skills
• Strong time management skills to work effectively within demanding timelines
• Ability to interact in a professional manner with clients and thought leaders in a variety of therapeutic areas
• Ability to understand and interpret market dynamics, scientific information and clinical and preclinical data
• Ability to interpret and act on business metrics and financial information

A Strategic Account Director (SAD) acts as the day-to-day strategic advisor to the client and ensures that our work is strategically on-target and delivered within budget and timelines. SADs are also responsible for generating revenue to be delivered on through leading and managing a team of internal resources to maximize effectiveness and efficiency for the client and the company.

Essential Functions and Summary of Responsibilities

Big Picture for Clients

• Understand the business challenges your client is facing and what strategic questions they are or should be asking
• Help clients define and achieve their business goals
• Prepare annual strategic/tactical plans for each client and individual campaign/project plans as needed throughout the year
• Manage and strengthen client relationships
• Propose, sell to clients, and oversee ideas and projects that are tied to clients’ objectives
• Continuously offer unsolicited ideas to increase the effective of clients’ brand and company activities

Big Picture for Precision AQ

• Understand revenue generation and recognition, and contribute to Precision AQ's profitability through good management
• Serve as an advocate and strong representative for Precision AQ
• Identify and cultivate new business opportunities
• Periodically report to company leadership on the condition of client-Precision AQ relationships

Day-to-Day for Clients

• Initiate and oversee Precision AQ activities on behalf of and in support of clients
• Manage day-to-day client-Precision AQ communication on strategy (ideas, recommendations, approaches to consider) and planning
• Become a partner to each client, functioning as an extension of the client’s team by taking ownership and accountability for their business

Day-to-Day for Precision AQ

• Closely manage clients’ budget and team efficiency to maximize return for clients and Precision AQ
• Build up your team by celebrating successes, listening to them, learning and improving from mistakes, and sharing information with other teams along the way
• Mentor, train, and coach team members to facilitate growth and development

For You, Precision AQ, and Clients

• Stay abreast of developments (eg, science, competitors, regulations) in clients’ industries
• Keep honing marketing and strategy expertise to better serve clients and Precision AQ
• Network and connect to grow your influence and add value

We seek highly motivated people with outstanding professional credentials, business accomplishment, and leadership. In addition, we place high value on relevant personal qualities: resourcefulness, tenacity, independence, energy, and self-confidence.

Qualifications

• Bachelor’s degree, ideally with a concentration in advertising, marketing, communications, or journalism; other majors will be considered
• Advanced degree (PhD, MD, or PharmD) in life sciences, pharmacy, medicine, and/or advanced degree in management, marketing, or business desirable/preferred
• A minimum of five (5) years of pharmaceutical/biotech marketing or medical affairs experience or medical communications agency experience, with experience successfully managing and growing $1M+ pharma/healthcare accounts

Skills

• Microsoft Office (Word, Excel, PowerPoint, Outlook)
• PowerPoint design proficiency
• Thorough understanding of the objectives, as well as the strategic and tactical activities of pharmaceutical/biotech marketing, particularly in the area of medical communications
• Demonstrated proficiency in acting as a trusted strategic/business advisor to marketers and other managers
• Proficiency in leading and managing employees, growing client relationships, and managing expanding business opportunities
• Ability to thrive and succeed in a fast-paced environment
• Strong communication and presentation skills
• Strong time management skills to work effectively within demanding timelines
• Ability to interact in a professional manner with clients and thought leaders in a variety of therapeutic areas
• Ability to understand and interpret market dynamics, scientific information and clinical and preclinical data
• Ability to interpret and act on business metrics and financial information

Are you a board-certified physician looking for a flexible, remote opportunity to apply your clinical expertise? We are seeking experienced physicians to conduct independent case reviews for the Department of Veterans Affairs (VA). This role involves evaluating medical cases to assess quality of care, adherence to standards, and opportunities for improvement.

This is an ideal opportunity for physicians seeking part-time, flexible work that complements their clinical practice.

Position Details:

• Job Type: Part-time
• Location: Fully remote (U.S. only)
• Schedule: Flexible—complete cases at your convenience within 5 calendar days
• Case Volume: Varies monthly—no fixed predictions by specialty or case type

Key Responsibilities:

1. Medical Case Audits & Quality Reviews

• Conduct objective medical case reviews using standardized assessment criteria
• Evaluate the timeliness and appropriateness of care provided
• Identify quality improvement opportunities

1. Performance Improvement & Specialty Case Reviews

• Review cases initiated for non-standardized performance improvement reasons
• Assess medical decision-making and compliance with best practices

1. Medical Advisory Opinions

• Provide expert medical opinions
• Analyze complex clinical scenarios from an impartial, evidence-based perspective

Qualifications & Requirements:

To be eligible for this role, you must meet the following criteria:

• Active, unrestricted physician license in any U.S. state or territory
• Board certification in a specialty recognized by the American Board of Medical Specialties
• Minimum of 5 years of clinical experience in your specialty
• Minimum of 2 years of recent clinical practice relevant to case reviews
• Actively engaged in direct patient care (minimum 20 clinical hours per month)
• Hospital privileges in your specialty
• Fluent in English (strong reading and writing skills required)

Open Positions by Specialty:

• Nephrology    Nephrology
  Nephrology    Nephrology Transplant Qualified

Why Join Us?

✔ Fully remote work—complete cases on your own schedule
✔ Flexible hours— ability to complete reviews within 5 days on your own time
✔ No court appearances—your reviews remain confidential
✔ Make a meaningful impact—help improve healthcare standards for veterans

How to Apply:

If you meet the qualifications and are interested in joining our team, apply today!

Are you a board-certified physician looking for a flexible, remote opportunity to apply your clinical expertise? We are seeking experienced physicians to conduct independent case reviews for the Department of Veterans Affairs (VA). This role involves evaluating medical cases to assess quality of care, adherence to standards, and opportunities for improvement.

This is an ideal opportunity for physicians seeking part-time, flexible work that complements their clinical practice.

Position Details:

• Job Type: Part-time
• Location: Fully remote (U.S. only)
• Schedule: Flexible—complete cases at your convenience within 5 calendar days
• Case Volume: Varies monthly—no fixed predictions by specialty or case type

Key Responsibilities:

1. Medical Case Audits & Quality Reviews

• Conduct objective medical case reviews using standardized assessment criteria
• Evaluate the timeliness and appropriateness of care provided
• Identify quality improvement opportunities

1. Performance Improvement & Specialty Case Reviews

• Review cases initiated for non-standardized performance improvement reasons
• Assess medical decision-making and compliance with best practices

1. Medical Advisory Opinions

• Provide expert medical opinions
• Analyze complex clinical scenarios from an impartial, evidence-based perspective

Qualifications & Requirements:

To be eligible for this role, you must meet the following criteria:

• Active, unrestricted physician license in any U.S. state or territory
• Board certification in a specialty recognized by the American Board of Medical Specialties
• Minimum of 5 years of clinical experience in your specialty
• Minimum of 2 years of recent clinical practice relevant to case reviews
• Actively engaged in direct patient care (minimum 20 clinical hours per month)
• Hospital privileges in your specialty
• Fluent in English (strong reading and writing skills required)

Open Positions by Specialty:

• Gastroenterology / Hepatology    Gastroenterology with ERCP capability
  Gastroenterology / Hepatology    Hepatology
  Gastroenterology / Hepatology    Hepatology Transplant Qualified

Why Join Us?

✔ Fully remote work—complete cases on your own schedule
✔ Flexible hours— ability to complete reviews within 5 days on your own time
✔ No court appearances—your reviews remain confidential
✔ Make a meaningful impact—help improve healthcare standards for veterans

How to Apply:

If you meet the qualifications and are interested in joining our team, apply today!

The Opportunity:

• Manage planning, preparation (including authoring when appropriate), coordination, and submission of regulatory documents to global National Health Authorities that meet ICH and FDA standards, and other local or regional regulatory requirements.

• Such submissions may include Clinical and Preclinical content. 

• Assist and keep detailed timelines for regulatory activities and submissions. 

• Perform regulatory research to assess regulatory implications and inform business strategy for drug development and approval.

• Assess and communicate risks. 

• Ensure that there are no significant interruptions to the business due to regulatory compliance issues. 

• Correspond and collaborate across the organization at all levels, across functional groups, and with executive management. 

• Support NDA filing activities and assist with developing regulatory process supporting the filing. 

• Prepare and manage routine submissions and related activities. 

• Develop regulatory strategies to inform associated budgets, tools and specialized support necessary for efficient operations. 

• Stay abreast of changes in the regulatory environment and guidelines (e.g., FDA, ICH) in areas relevant to company projects.

Required Skills, Experience and Education:

• Bachelor’s degree or equivalent in Regulatory Science or related degree in Life Science or Health Science fields.  

• Three (3) years of experience in Regulatory Affairs department at a drug or biologics company.  

• Employer will accept a Master's degree or equivalent in Regulatory Science or related degree in Life Science or Health Science fields and one (1) year of experience in Regulatory Affairs department at a drug or biologics company.

• Work experience to include:

• Manage the preparation and submission of initial IND (Investigational New Drug) application and subsequent amendments;

• Manage the development of regulatory submissions in eCTD (electronic Common Technical Document) format;

• Interpret and apply FDA (Food and Drug Administration), ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use), EMA (European Medicines Agency), or PMDA (Pharmaceuticals and Medical Devices Agency) regulations to oncology drug development;

• Manage global regulatory health authority filings and subsequent amendments.

• Successful completion of background checks and employment history verification required.  

• 100% remote position reporting to Revolution Medicines, Inc. in Redwood City, CA.  Candidate may live anywhere in the continental U.S.

Are you a board-certified physician looking for a flexible, remote opportunity to apply your clinical expertise? We are seeking experienced physicians to conduct independent case reviews for the Department of Veterans Affairs (VA). This role involves evaluating medical cases to assess quality of care, adherence to standards, and opportunities for improvement.

This is an ideal opportunity for physicians seeking part-time, flexible work that complements their clinical practice.

Position Details:

• Job Type: Part-time
• Location: Fully remote (U.S. only)
• Schedule: Flexible—complete cases at your convenience within 5 calendar days
• Case Volume: Varies monthly—no fixed predictions by specialty or case type

Key Responsibilities:

1. Medical Case Audits & Quality Reviews

• Conduct objective medical case reviews using standardized assessment criteria
• Evaluate the timeliness and appropriateness of care provided
• Identify quality improvement opportunities

1. Performance Improvement & Specialty Case Reviews

• Review cases initiated for non-standardized performance improvement reasons
• Assess medical decision-making and compliance with best practices

1. Medical Advisory Opinions

• Provide expert medical opinions
• Analyze complex clinical scenarios from an impartial, evidence-based perspective

Qualifications & Requirements:

To be eligible for this role, you must meet the following criteria:

• Active, unrestricted physician license in any U.S. state or territory
• Board certification in a specialty recognized by the American Board of Medical Specialties
• Minimum of 5 years of clinical experience in your specialty
• Minimum of 2 years of recent clinical practice relevant to case reviews
• Actively engaged in direct patient care (minimum 20 clinical hours per month)
• Hospital privileges in your specialty
• Fluent in English (strong reading and writing skills required)

Open Positions by Specialty:

• Radiology / Imaging    Diagnostic Radiology
  Radiology / Imaging    Interventional Radiology
  Radiology / Imaging    Nuclear Medicine

Why Join Us?

✔ Fully remote work—complete cases on your own schedule
✔ Flexible hours— ability to complete reviews within 5 days on your own time
✔ No court appearances—your reviews remain confidential
✔ Make a meaningful impact—help improve healthcare standards for veterans

How to Apply:

If you meet the qualifications and are interested in joining our team, apply today!

Are you a board-certified physician looking for a flexible, remote opportunity to apply your clinical expertise? We are seeking experienced physicians to conduct independent case reviews for the Department of Veterans Affairs (VA). This role involves evaluating medical cases to assess quality of care, adherence to standards, and opportunities for improvement.

This is an ideal opportunity for physicians seeking part-time, flexible work that complements their clinical practice.

Position Details:

• Job Type: Part-time
• Location: Fully remote (U.S. only)
• Schedule: Flexible—complete cases at your convenience within 5 calendar days
• Case Volume: Varies monthly—no fixed predictions by specialty or case type

Key Responsibilities:

1. Medical Case Audits & Quality Reviews

• Conduct objective medical case reviews using standardized assessment criteria
• Evaluate the timeliness and appropriateness of care provided
• Identify quality improvement opportunities

2. Performance Improvement & Specialty Case Reviews

• Review cases initiated for non-standardized performance improvement reasons
• Assess medical decision-making and compliance with best practices

3. Medical Advisory Opinions

• Provide expert medical opinions
• Analyze complex clinical scenarios from an impartial, evidence-based perspective

Qualifications & Requirements:

To be eligible for this role, you must meet the following criteria:

• Active, unrestricted physician license in any U.S. state or territory
• Board certification in a specialty recognized by the American Board of Medical Specialties
• Minimum of 5 years of clinical experience in your specialty
• Minimum of 2 years of recent clinical practice relevant to case reviews
• Actively engaged in direct patient care (minimum 20 clinical hours per month)
• Hospital privileges in your specialty
• Fluent in English (strong reading and writing skills required)

Open Positions by Specialty:

We are currently hiring physicians who are board certified with the American Board of Medical Specialties in the following specialties:

Cardiology
•    Cardiology – Electrophysiology (EP) 
•    Cardiology – Invasive 
•    Cardiology – Transplant Qualified 
________________________________________
Cardiothoracic & Thoracic Surgery
•    Cardio-Thoracic Surgery 
•    Thoracic Surgery 
________________________________________
General & Subspecialty Surgery
•    Colo-Rectal Surgery 
•    Neurosurgery 
•    Orthopedics – Spine 
________________________________________
Radiology & Imaging
•    Diagnostic Radiology 
•    Interventional Radiology 
•    Nuclear Medicine 
________________________________________
Gastroenterology & Hepatology
•    Gastroenterology (with ERCP capability) 
•    Hepatology 
•    Hepatology – Transplant Qualified 
________________________________________
Nephrology
•    Nephrology 
•    Nephrology – Transplant Qualified 

Why Join Us?

✔ Fully remote work—complete cases on your own schedule
✔ Flexible hours— ability to complete reviews within 5 days on your own time
✔ No court appearances—your reviews remain confidential
✔ Make a meaningful impact—help improve healthcare standards for veterans

How to Apply:

If you meet the qualifications and are interested in joining our team, apply today!

Are you a board-certified physician looking for a flexible, remote opportunity to apply your clinical expertise? We are seeking experienced physicians to conduct independent case reviews for the Department of Veterans Affairs (VA). This role involves evaluating medical cases to assess quality of care, adherence to standards, and opportunities for improvement.

This is an ideal opportunity for physicians seeking part-time, flexible work that complements their clinical practice.

Position Details:

• Job Type: Part-time
• Location: Fully remote (U.S. only)
• Schedule: Flexible—complete cases at your convenience within 5 calendar days
• Case Volume: Varies monthly—no fixed predictions by specialty or case type

Key Responsibilities:

1. Medical Case Audits & Quality Reviews

• Conduct objective medical case reviews using standardized assessment criteria
• Evaluate the timeliness and appropriateness of care provided
• Identify quality improvement opportunities

1. Performance Improvement & Specialty Case Reviews

• Review cases initiated for non-standardized performance improvement reasons
• Assess medical decision-making and compliance with best practices

1. Medical Advisory Opinions

• Provide expert medical opinions
• Analyze complex clinical scenarios from an impartial, evidence-based perspective

Qualifications & Requirements:

To be eligible for this role, you must meet the following criteria:

• Active, unrestricted physician license in any U.S. state or territory
• Board certification in a specialty recognized by the American Board of Medical Specialties
• Minimum of 5 years of clinical experience in your specialty
• Minimum of 2 years of recent clinical practice relevant to case reviews
• Actively engaged in direct patient care (minimum 20 clinical hours per month)
• Hospital privileges in your specialty
• Fluent in English (strong reading and writing skills required)

Open Positions by Specialty:

• Cardiology    Cardiology-Invasive
  Cardiology    Cardiology-Transplant Qualified
• Why Join Us?

✔ Fully remote work—complete cases on your own schedule
✔ Flexible hours— ability to complete reviews within 5 days on your own time
✔ No court appearances—your reviews remain confidential
✔ Make a meaningful impact—help improve healthcare standards for veterans

How to Apply:

If you meet the qualifications and are interested in joining our team, apply today!

The Opportunity:

The Vice President, Regulatory Affairs will manage several key U.S. based regulatory functions and report to the SVP of Regulatory and Quality. The position is responsible for expanding and leading a large, high functioning regulatory group and ensuring global alignment.

• Provide ethical and mission-driven leadership of the Regulatory Affairs functions. Embody and practice the company’s mission-driven culture. Ensure that our core values guide our strategic vision and our day-to-day decision making.

• Provide a vision for the Regulatory Affairs organization and develop a plan to achieve it. Design and rapidly scale a group to meets the needs of an explosive pipeline in areas of high unmet medical need and intense industry competition.

• Influence decision-making of senior leadership and ensure globally aligned regulatory decision-making.

• Collaborate closely and form effective relationships with other functional heads and regional counterparts to ensure high quality, cross-functionally sound decision-making.

• Collaborate with peer leaders and management to ensure regulatory considerations are integrated upstream appropriately, e.g., target product profiles, clinical development plans, financial planning.

• Ensure consistency in approach (one playbook) and that learning occurs across staff and disciplines.

• Continue to build the Regulatory Affairs group, strategizing with other leaders to maximize enterprise-wide impact locally and globally.

• Actively lead the function and support team member career development.

Required Skills, Experience and Education: 

• Local to San Francisco Bay Area or able to travel to headquarters frequently and for adequate durations (up to 25%).

• BA/BS degree in life sciences or related disciplines.

• At least 15 years of experience in drug development regulatory affairs.

• Minimum of 10 years of experience in regulatory leadership or executive role.

• Significant oncology experience.

• Expertise in navigating global regulatory environments in a commercial setting.

• Ability to successfully work in a fast-paced, demanding and highly cross-functional environment.

• Experience scaling an organization rapidly.

• Clearly understands the role of regulatory science in drug development and global commercialization, and is comfortable with ambiguity, risk, and optimizing for business needs.

Preferred Skills:

• Advanced degree in life sciences enabling technical fluency in oncology.

• Prior senior regulatory executive in oncology drug development at a medium or large pharmaceutical enterprise but who also understands the startup environment.

#LI-Hybrid  #LI-GL1 

Position Description

The Director, Regulatory Labeling, Advertising & Promotion (LAP) is responsible for leading global product labeling and U.S. advertising and promotion regulatory activities across the company’s portfolio. This role provides strategic and operational leadership to ensure labeling and promotional materials are scientifically accurate, compliant with regulatory requirements, and aligned with corporate and commercial objectives.

The position serves as a key regulatory partner to Clinical Development, Medical Affairs, Commercial, Legal, and Safety, and plays a central role in labeling strategy, lifecycle management, and promotional material review in a highly regulated environment, for cell and gene therapy products.

This is a full-time hybrid position (3 days a week) in our Somerville – Assembly Row, Massachusetts office.

Job Duties and Responsibilities

Core Responsibilities:

Labeling

• Lead the development, negotiation and lifecycle maintenance of global and US product labeling, including pre- and post- approval updates.
• Drive development and maintenance of Company Core Data Sheets (CCDS) and Company Core Safety Information (CCSI), ensuring alignment with global regulatory expectations.
• Establish and operationalize labeling strategies that result in clear, concise, compliant and scientifically robust product labels.
• Provide regulatory leadership for labeling-related interactions with Health Authorities, including briefing documents and responses to inquiries.
• Ensure final labeling content meets internal standards and regulatory authority requirements prior to submission or implementation.

Advertising and Promotion

• Oversee regulatory review of US promotional and select non-promotional materials. across channels, ensuring compliance with FDA regulations and enforcement trends
• Serve as the regulatory lead and reviewer for Medical-Legal-Regulatory (MLR) review.
• Partner with Commercial, Medical Affairs and Legal to proactively identify and mitigate regulatory risk in promotional strategy and execution.
• Monitor and interpret FDA enforcement actions and policy developments related to advertising and promotion, translating insights into internal guidance and best practices.
• Develop submission strategy for efficient and appropriate health authority review of promotional materials; and ensure the compliant and timely submission of promotional materials to Health Authorities.
• Create and manage promotional submissions documents in the electronic database and partner with Regulatory Operations on submissions.

Governance, Process and Compliance

• Support or co‑lead the Labeling Review Committee (LRC) and provide regulatory oversight of labeling governance processes.
• Develop, maintain, and improve SOPs, workflows, tools, and training related to labeling and Ad/Prom review.
• Ensure inspection readiness and documentation compliance for labeling and promotional activities.
• Drive consistency and operational excellence across labeling and Ad/Prom processes globally.

Cross-Functional Leadership

• Act as a strategic regulatory advisor to Clinical, Safety, Medical Affairs, Commercial, Quality, and Regulatory Strategy teams.
• Lead and mentor internal staff and manage external vendors or consultants as needed.
• Contribute to broader regulatory strategy discussions.

Essential/Required Qualifications:

• Minimum of 10 years of regulatory experience in biotech or pharmaceutical companies.
• Experience supporting FDA interactions related to labeling and promotional compliance
• Experience with MLR review and developing Company Core Data Sheets
• Prior experience in cell and gene therapy or rare disease is strongly preferred.
• Proven ability to lead cross-functional teams and to operate in a matrixed organization, including leadership without direct authority.
• Advanced degree preferred (PharmD, PhD, MD, JD or equivalent degree)
• Excellent written and verbal communication skills.

Preferred Qualifications:

• Prior experience in cell and gene therapy or rare disease is strongly preferred.
• Ability to influence without authority and partner effectively with senior leaders.
• Strong attention to detail and accuracy with sound judgement and risk-based decision making.
• Entrepreneurial and self-directed, able to prioritize work to meet targets and timelines, motivates others, demonstrates tact and diplomacy, and has a flexible and positive solution-oriented approach.

Key Competencies:

• Deep understanding of FDA regulations and guidance governing labeling and promotional materials.
• An aptitude for problem-solving and ability to quickly understand new science and technology and to resolve issues and conflicts.

Are you a board-certified physician looking for a flexible, remote opportunity to apply your clinical expertise? We are seeking experienced physicians to conduct independent case reviews for the Department of Veterans Affairs (VA). This role involves evaluating medical cases to assess quality of care, adherence to standards, and opportunities for improvement.

This is an ideal opportunity for physicians seeking part-time, flexible work that complements their clinical practice.

Position Details:

• Job Type: Part-time
• Location: Fully remote (U.S. only)
• Schedule: Flexible—complete cases at your convenience within 5 calendar days
• Case Volume: Varies monthly—no fixed predictions by specialty or case type

Key Responsibilities:

1. Medical Case Audits & Quality Reviews

• Conduct objective medical case reviews using standardized assessment criteria
• Evaluate the timeliness and appropriateness of care provided
• Identify quality improvement opportunities

1. Performance Improvement & Specialty Case Reviews

• Review cases initiated for non-standardized performance improvement reasons
• Assess medical decision-making and compliance with best practices

1. Medical Advisory Opinions

• Provide expert medical opinions
• Analyze complex clinical scenarios from an impartial, evidence-based perspective

Qualifications & Requirements:

To be eligible for this role, you must meet the following criteria:

• Active, unrestricted physician license in any U.S. state or territory
• Board certification in a specialty recognized by the American Board of Medical Specialties
• Minimum of 5 years of clinical experience in your specialty
• Minimum of 2 years of recent clinical practice relevant to case reviews
• Actively engaged in direct patient care (minimum 20 clinical hours per month)
• Hospital privileges in your specialty
• Fluent in English (strong reading and writing skills required)

Open Positions by Specialty:

• Surgery Specialties Bariatric Surgery
• Surgery Specialties Cardio-Thoracic Surgery
• Surgery Specialties Colo-Rectal Surgery
• Surgery Specialties Neurosurgery
• Surgery Specialties Orthopedics-Spine
• Surgery Specialties Thoracic Surgery
   

Why Join Us?

✔ Fully remote work—complete cases on your own schedule
✔ Flexible hours— ability to complete reviews within 5 days on your own time
✔ No court appearances—your reviews remain confidential
✔ Make a meaningful impact—help improve healthcare standards for veterans

How to Apply:

If you meet the qualifications and are interested in joining our team, apply today!

About the Role

Verkada is entering a transformative phase of growth in the public sector. To accelerate this momentum in 2026 and beyond, we are seeking a strategic, high-impact Director of Public Sector Business Development. This is a foundational hire responsible for building an integrated public sector business development function that aligns sales strategy and business development across both federal and state public sectors.

You will be the architect of Verkada’s touchpoints with key government stakeholders, ensuring that our cloud-based physical security solutions—from AI-powered cameras to integrated access control—are the standard for modern government infrastructure.

What You'll Do

Strategic Leadership & Revenue Acceleration

• Develop the Playbook: Create and execute a comprehensive government sales strategy initially focused on U.S. Federal and SLED markets, with expansion into international territories as Verkada scales.
• Bridge Policy & Sales: Partner directly with the Public Sector Sales organization to unlock procurement pathways, navigate agency-specific requirements, and support account-level strategy.
• Thought Leadership: Position Verkada as the leading provider in physical security modernization, educating policymakers on the benefits of cloud-native safety technology.

External Partner & Association Management

• Partner Engagement: Identify, hire, manage partners, procurement-focused partners, lobbyists, consultants, and advisors to deliver high ROI by navigating complex contracting vehicles for priority targets like the VA, DoW, and major school systems (e.g., NYC Public Schools).
• High-ROI Engagement: Curate Verkada’s presence in elite organizations such as NASCIO, NASTD, Major Cities Chiefs Association, and the National Governors Association.

Relationship-Building, Strategy & Compliance

• Build relationships with key government stakeholders and technology leaders to advocate for funding (e.g., school safety grants) and appropriations that favor the adoption of modernized cloud-based physical security platforms.
• Partner with legal, government affairs, and policy functions to monitor the evolving legislative and appropriations landscape relating to issues that impact Verkada’s platform and product roadmap, including but not limited to physical security and cybersecurity mandates, AI governance, data privacy (CCPA/GDPR), data security programs (such as FedRAMP and similar state programs), and (NDAA/FedRAMP) that impact our product roadmap.
• Partner with Legal to ensure all activities meet the highest standards of ethics and disclosure requirements.

What You Bring

• Experience: 10+ years in public sector sales, government funding, appropriations, and procurement, and/or public sector business development.
• Industry Background: Must come from a technology (SaaS/Cloud/Hardware) or a highly regulated industry (e.g., Aerospace, Defense, Telecom, or FinTech).
• Procurement Expertise: Deep understanding of the "mechanics" of government buying—you know how to influence a specification before the RFP is released.
• Travel Readiness: Willingness to travel 50% of the time to engage with stakeholders in Washington D.C., state capitals, and international markets.
  • This role requires regular travel, estimated to be more than 50% of the time, including both domestic and international destinations as needed. The successful candidate must be comfortable with frequent travel to support business operations, customer and partner engagements and team collaboration. 
• The "Builder" Mindset: You are comfortable starting with a blank slate and flying “solo” without a team under you for support, and regularly “rolling up your sleeves” to get the work done and achieve results.
• Cross-Functional Expert:  Effective development of public sector sales strategy does not happen in a silo; it requires clear and concise communication skills while managing constant cross-functional work across internal and external teams.

US Employee Benefits

Verkada is committed to fostering a workplace environment that prioritizes the holistic health and wellbeing of our employees and their families by offering comprehensive wellness perks, benefits, and resources. Our benefits and perks programs include, but are not limited to:

• Healthcare programs that can be tailored to meet the personal health and financial well-being needs - Premiums are 100% covered for the employee under at least one plan and 80% for family premiums under all plans
• Nationwide medical, vision and dental coverage
• Health Saving Account (HSA) with annual employer contributions and Flexible Spending Account (FSA) with tax saving options
• Expanded mental health support
• Paid parental leave policy & fertility benefits
• Time off to relax and recharge through our paid holidays, firmwide extended holidays, flexible PTO and personal sick time
• Professional development stipend
• Wellness/fitness benefits
• Healthy lunches provided daily
• Commuter benefits

Additional Information

• You must be independently authorized to work in the U.S. We are unable to sponsor or take over sponsorship of an employment visa for this role, at this time

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

About the Role

We are seeking an experienced, strategic, and highly collaborative Director/Senior Director, Legal (North America) to support our North American region.

The Director/Senior Director, Legal (North America) will serve as the primary commercial legal partner for our agency in North America, focusing heavily on high-volume commercial contract negotiation, and providing strategic and operational legal counsel across all areas of our business. This role will partner closely with business leaders, commercial finance, content and technology teams, data/privacy experts, and the VP, Global Legal & Business Affairs to ensure efficient contract execution, manage legal risks, and enable business growth across our North American operations.

The role is based in New York and reports to the VP, Global Legal and Business Affairs, who is based in Los Angeles.

Responsibilities:

• Leading drafting, review, and negotiation of a high-volume of commercial contracting in North America, including client MSAs and SOWs, technology licensing and reseller agreements, influencer and media partnerships, SaaS/vendor agreements and agency/client service contracts. 
• Acting as the primary legal point of contact for our commercial finance and business teams to respond to RFPs and RFIs from our clients and participating actively in client pitches to help our business win.
• Partnering with the VP, Global Legal and Business Affairs to streamline the North American pipeline and develop and build a strong and efficient team to support client contracting across the region.
• Managing a small team of lawyers and contract managers in North America, ensuring operational efficiency and consistency with global standards.
• Develop standardized contract templates and tools that improve process efficiency and legal protection.
• Advise on other aspects of our North America business as required, including litigation (where necessary in conjunction with external counsel), operating with a high degree of independence.
• Working closely with peers in our other three key regions (Latin America; Europe, Middle East and Africa; and Asia Pacific) to develop consistent standards, tools, and processes across the Legal and Business Affairs team.

About You

The essentials:

• Juris Doctor (JD) degree from an accredited law school.
• Active bar membership in at least one U.S. jurisdiction, New York or California preferred, with ability to register/registration as an in-house counsel in New York required.
• 6+ years of progressive legal experience, including in-house and/or major law firm experience, with a strong emphasis on commercial contract review, drafting, and negotiation (advertising, production, digital media, technology, and data contract experience strongly preferred).
• Proven ability to work with cross-functional teams and independently manage a high-volume workload in fast-paced, innovative environments.
• Strong legal drafting and negotiation skills.
• Excellent commercial judgment with a strategic mindset.
• Ability to translate complex legal issues into pragmatic business advice.
• Superior interpersonal and communication skills, both written and verbal.
• Experience managing legal teams or supervising attorneys.
  
  

At Monks, we believe in fostering an environment where a diversity of perspectives can thrive. We proactively work to design hiring processes that promote equity and inclusion while mitigating bias. We celebrate diversity and are committed to building a team that reflects the communities we serve. We welcome and encourage qualified applicants, from all backgrounds, who are excited to contribute to our mission.  

This role is subject to our Return to Office (RTO) policy. If you reside within a commutable distance of one of our office locations, you will be expected to work from the office a set number of days per week. The specific details, including the number of required office days, will be in accordance with the company’s then-current RTO policy, which is subject to change from time to time.

#LI-MB3

#LI-Hybrid

About the Opportunity

Our commercial team is growing and looking for a Clinical Account Manager based in Nashville/Raleigh
to help support our growth. You will play a critical role in supporting Cleerly’s growth and
success of current clients/partners by making sure they understand our product offerings and
helping patients get Cleerly scans. Reporting to the Regional Director of Sales, this role will be
working with clinical partners to find expansion opportunities as well as to provide ongoing
clinical education to grow existing Cleerly accounts.

You will be responsible for identifying growth opportunities, maintaining relationships with
existing high-value partners, and representing Cleerly as a leader in the industry to positively
impact the lives of millions. The ideal candidate is highly motivated, has a clinical background, is
client focused, result-oriented, and mission-driven. You will work with clinics to ensure that they
are extremely successful with Cleerly’s cardiovascular diagnostic technology by proactively
supporting, educating, and providing high customer satisfaction. This is a customer- facing role
with a primary focus on spending time with customers including Cardiologists. This is a
field-based role, but you must be based in or near Nashville/Raleigh, as it will be a key market in
your assigned territory. 

Responsibilities

• Manage and maintain relationships with clinical partners to make sure they understand
  Cleerly and how Cleerly helps Providers in their treatment decisions for patients.

• Account development - Experience building and supporting strong clinical programs is
  preferred.

• Clinical / technical proficiency - Quick learner able to grasp new clinical/technical
  information and then disseminate to customers.

• Develop relationships with key account stakeholders, to include admin, admin support,
  key cardiologists, key referring physician practices, and key strategic personnel to drive
  awareness of Cleerly’s offerings and promote adoption.

• Customer-focused mentality.

• Drive new product and technology introductions for existing customers.

• Develop a qualified lead funnel within the existing base. Regular activities consist of
  formal presentations, peer-to-peer education, new physician training, and driving
  physician education.

• Use Salesforce.com to manage administrative tasks.

• Travel to various provider sites within a territory 50-80% of the time including the following states: NC, TN

Requirements

• Degree from accredited college/university.
• 5+ years of related sales or clinical experience (PA, NP, DNP or RN).
• Prior experience in medical device, cardiology pharmaceuticals, cardiology
  radio-pharmaceuticals, hospital, or medical software is highly desired.
• Highly coachable with the ability to learn and communicate complex programs and value
  propositions.
• Strong interpersonal and relationship-building skills, polished communications, the ability
  to manage multiple customer and internal company interactions.
• Effective project management skills while embracing change and driving solutions in
  otherwise chaotic environments.
• Exceptional written and verbal communication skills.
• A hard-worker, self-motivator with can-do approach and bias for action.
• Highly responsive with the ability to interpret appropriate next step actions.
• Ability to collaborate cross-functionally with both internal and external stakeholders
  across a vast geographic region.
• Experience with introducing new cardiovascular technologies into hospitals is highly
  desired.
• Ability to accurately assess and understand different stakeholders needs/wants. Process
  cross functional agendas and adjust strategy to achieve desired outcomes.
• Grit, high integrity, values-based work ethic.

The base salary range for this role is aligned to market benchmarks and determined by experience, skills, and internal equity.

This role is eligible for annual On Target Commission, resulting in the following base salary and Total Target Compensation (TTC) ranges:

• Base Salary: $130,000 - $140,000
• Commission: $90,000
• TTC: $220,000 - $230,000

*Total Target Compensation (TTC): Total Cash Compensation (including base pay, variable pay, commission, bonuses, etc.) Additionally, stock options, paid benefits, and employee perks are part of your total rewards.

Team Description:

Join the Quality Team at Neuralink, a group of dedicated professionals building and sustaining world-class quality and compliance frameworks from the group up. The Quality team focuses on exceeding regulatory requirements and industry best practices to enable safe and fast development of Neuralink’s innovative technologies.

Job Description and Responsibilities:

Neuralink is seeking a Document Control Specialist with strong organization skills to support document control-related activities company-wide. This role will serve as a foundational resource for organizing and managing critical documentation across the preclinical, manufacturing, engineering, quality, and regulatory departments. This position will support the maintenance, development, and scaling of processes, archiving, and compliance tracking—ensuring traceability, version control, and readiness for audits and submissions in a highly regulated environment.  Additionally, you will be expected to:

• Sustain and improve document control systems across Neuralink in alignment with FDA regulations (e.g., 21 CFR Part 11, 21 CFR 58, 21 CFR 812) and other GxP requirements
• Organize GxP files (including study records, lab data, equipment logs, and audit documentation) into a traceable, trackable, and searchable system
• Maintain archives for GxP studies and ensure proper retention, deprecation, and re-indexing as needed (including leading archive re-indexing projects to correct/improve indexing)
• Assist in SOP development, revisions, periodic reviews, and maintenance of tables of contents
• Assist with the maintenance of various study trackers, training assignments, master schedule(s), and the glossary
• Facilitate the completion of deviations and  investigations
• Manage document lifecycles: versioning, deprecation of obsolete documents, and routing/approval workflows
• Support the Regulatory department by organizing regulatory filings (e.g., new study submissions and supplements), managing uploads to the eTMF, and preparing routine submission documents (cover letters, annual reports)

Required Qualifications:

• Meticulous attention to detail and exceptional organizational skills
• Excellent verbal and written communication skills
• Strong multitasking abilities in a dynamic, fast-paced, and constantly changing environment
• Proficiency with Google Suite (Docs, Sheets, etc.) and standard document management tools
• Working knowledge of medical, scientific, and regulatory terminology

Preferred Qualifications:

• Bachelor's Degree in a relevant field, such as life sciences, engineering, technical writing/communications, regulatory affairs, or equivalent
• Relevant experience working in highly regulated environments, such as the medical device or pharmaceutical industries

Expected Compensation:

At Neuralink, your base pay is one part of your total compensation package. The anticipated hourly rate for this position is expected to be within the below range. Your actual base pay will be determined by your job-related skills, experience, and relevant education or training.

Texas Hourly Range:

$21 – $35/Hr USD

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 critical  in translating Neuralink’s BCI technology for clinical use!

Job Description and Responsibilities:

As a Clinical Program Manager, you will be the primary architect of Neuralink’s human clinical trial operations, transforming high-level strategy into rigorous, executable clinical programs. We are seeking a high-autonomy leader who thrives on ambiguity and drives projects to completion with surgical precision. In our hyper-dynamic environment, you aren't just managing timelines—you are building the infrastructure for the future of neurotechnology. You will be expected to:

Strategic Oversight & Relationship Management

• Act as the Principal Lead for complex clinical programs, owning end-to-end delivery and ensuring all milestones align with broader organizational objectives.
• Cultivate High-Stakes Partnerships across internal engineering and regulatory teams, as well as external vendors, strategic partners, and world-class clinical research sites.
• Champion Stakeholder Readiness by overseeing the training and credentialing of cross-functional teams, ensuring every contributor is equipped to operate within the trial’s rigorous requirements.

Operational Excellence & Scalability

• Engineer Scalable Frameworks to expand clinical operations across diverse global geographies, prioritizing safety, quality, and regulatory compliance at every inflection point.
• Lead Commercial & Financial Negotiations with trial sites, driving contract execution, budget optimization, and long-term financial planning to maximize trial efficiency without compromising site engagement.
• Drive Data Intelligence by leading the synthesis and analysis of clinical data to provide actionable insights for program refinement.

Compliance & Regulatory Stewardship

• Navigate Global Regulatory Landscapes to secure study approvals and maintain impeccable standing with Institutional Review Boards (IRB), Research Ethics Committees (REC), and relevant governing bodies.
• Enforce Rigorous Quality Standards, maintaining an expert-level command of Good Clinical Practices (GCP), international regulatory requirements, and site-specific Standard Operating Procedures (SOPs).
• Foster a Culture of Accountability, proactively identifying operational risks and implementing mitigation strategies to ensure the integrity of the clinical program.

Required Qualifications: 

Strategic Leadership & Clinical Expertise

• Extensive Industry Tenure: 7+ years of progressive leadership experience in clinical research, specifically within Class III medical devices, neurology, or high-complexity life sciences.
• Clinical Architecture: Advanced proficiency in clinical study design, endpoint selection, and the development of robust data analysis plans for first-in-human or pivotal trials.
• Regulatory Mastery: Deep technical knowledge of Global Good Clinical Practice (GCP) and international regulatory standards (e.g., ISO 14155, MDR, FDA 21 CFR Part 812).

Data Intelligence & Analytical Rigor

• Quantitative Fluency: Professional experience leveraging statistical methods or programming languages (Python, R) to drive data-led decision-making and trial optimization.
• Complex Problem Solving: Proven track record of interpreting multi-dimensional datasets and translating complex scientific findings into executive-level strategy.
• Meticulous Precision: A high-level of organizational rigor with the ability to manage competing high-priority workstreams in a fast-paced, high-stakes environment.

Communication & Interdisciplinary Integration

• Cross-Functional Catalyst: Demonstrated success leading integration between neural engineering, clinical neurosurgery, and regulatory affairs to achieve unified program goals.
• Scientific Diplomacy: Exceptional written and verbal communication skills, with the ability to distill complex technical and clinical concepts for diverse audiences, from internal engineers to external ethics committees.
• Operational Autonomy: A self-starting leader who initiates critical workstreams independently and maintains a relentless focus on deadline accuracy and operational efficiency.

Mission-Critical Mindset

• High-Stakes Resilience: A documented history of thriving in high-pressure, rapidly evolving environments where pivots are frequent and the margin for error is razor-thin.
• Advocacy & Influence: Strong presence and "scientific diplomacy" skills, with the ability to represent Neuralink’s clinical vision to world-class neurosurgeons, key opinion leaders (KOLs), and global health authorities

Preferred Qualifications: 

Advanced Academic & Technical Background

• Advanced Degree: PhD, MD, or Master’s degree in a relevant field (e.g., Neuroscience, Biomedical Engineering, Clinical Research, or Biological Sciences).
• Neurotech Specialization: Direct experience managing clinical trials for Class III active implantable medical devices (AIMDs), specifically Brain-Computer Interfaces (BCI) or Neuromodulation systems.
• Computational Fluency: Advanced proficiency in Python or R for automated data visualization, clinical dashboarding, or sophisticated statistical modeling.

Strategic Clinical Leadership

• First-in-Human (FIH) Mastery: Proven success in leading Early Feasibility Studies (EFS) and navigating the unique safety and ethical rigors of pioneering human trials.
• Global Expansion Experience: Experience scaling clinical operations across international jurisdictions, including familiarity with O-US regulatory bodies and localized clinical trial infrastructure.
• Financial Stewardship: Demonstrated expertise in multi-million dollar budget management, including sophisticated resource allocation and vendor contract optimization.

Innovation & Process Design

• Clinical Systems Architecture: Experience implementing and optimizing Clinical Trial Management Systems (CTMS), Electronic Data Capture (EDC), and eTMF platforms for high-growth environments.
• Agile Clinical Operations: Ability to apply "lean" or "agile" methodologies to clinical trial workflows, reducing cycle times while maintaining absolute compliance.
• Interdisciplinary Synthesis: A rare ability to translate high-level engineering specifications into clinical protocols that are both scientifically rigorous and operationally feasible for surgical teams.

A Strategic Account Manager (SAM) is the first line of support to the Strategic Account Director. In this position, the SAMs will manage projects under the direction of the Strategic Account Director, and having mastered the responsibilities outlined below, eventually assume their own book of business as a Strategic Account Director (StrAcctDir).

The SAM will work hand-in-hand with the StrAcctDirs to meet and exceed their goals through support and execution of their core responsibilities:

Big Picture for Clients

• Understand the business challenges your client is facing and what strategic questions they are or should be asking
• Help clients define and achieve their business goals
• Prepare annual strategic/tactical plans for each client and individual campaign/project plans as needed throughout the year
• Manage and strengthen client relationships
• Propose, sell to clients, and oversee ideas and projects that are tied to clients’ objectives
• Continuously offer unsolicited ideas to increase the effectiveness of clients’ brand and company activities

Big Picture for Precision AQ

• Understand revenue generation and recognition, and contribute to Precision AQ’s profitability through good management
• Serve as an advocate and strong representative for Precision AQ
• Identify and cultivate new business opportunities (even if it means just passing them along internally)

Day-to-Day for Clients

• Initiate and oversee Precision AQ activities on behalf of and in support of clients
• Manage day-to-day client-Precision AQ communication on strategy (ideas, recommendations, approaches to consider) and planning
• Become a partner to each client, functioning as an extension of the client’s team by taking ownership and accountability for their business

Day-to-Day for Precision AQ

• Closely manage clients’ budget and team efficiency to maximize return for clients and Precision AQ
• Work with the internal team to exceed clients’ expectations
• Mentor, train, and coach team members to facilitate growth and development

Additional Responsibilities

• Stay abreast of developments (eg, science, competitors, regulations) in clients’ industries
• Keep honing marketing and strategy expertise to better serve clients and Precision AQ
• Network and connect to grow your influence and add value

Support of the StrAcctDir may include tasks, such as: assisting in the preparation of annual strategic/tactical plans for clients and Precision AQ, addressing ad hoc client requests and needs, reviewing and finalizing materials for distribution to the client or other external parties, participating in and/or leading calls with clients or healthcare practitioners, preparing content as necessary to fulfill client requirements, traveling to and attending and supporting live meetings with clients and/or healthcare practitioners, and more. The day-to-day activities of a SAM will vary greatly depending on client needs, account size, product status, and Precision AQ needs and may include assuming an independent lead role on individual projects as well as responsibility for a modest revenue goal.

Desired Skills
We seek highly motivated people with outstanding professional credentials, business accomplishment, and leadership. In addition, we place high value on relevant personal qualities: resourcefulness, tenacity, independence, energy, and self-confidence.

Qualifications

• Bachelor’s degree required; Advanced degree (PhD, MD or PharmD) in life sciences, pharmacy, medicine, and/or advanced degree in management, marketing or business is preferred
• Minimum of 3 years of experience in account management, overseeing both client relationships and internal teams within the medical communications or a related industry. Prior exposure to medical affairs, publications, and/or peer-to-peer marketing is strongly preferred.
  
  

Skills

• PowerPoint design proficiency
• Strong strategic and analytical background
• Ability to interact in a professional manner with clients and leaders with scope in a variety of therapeutic areas
• Ability to understand and interpret market dynamics, scientific information, and clinical and preclinical data
• Ability to interpret business metrics and financial information

A Strategic Account Manager (SAM) is the first line of support to the Strategic Account Director. In this position, the SAMs will manage projects under the direction of the Strategic Account Director, and having mastered the responsibilities outlined below, eventually assume their own book of business as a Strategic Account Director (StrAcctDir).

The SAM will work hand-in-hand with the StrAcctDirs to meet and exceed their goals through support and execution of their core responsibilities:

Big Picture for Clients

• Understand the business challenges your client is facing and what strategic questions they are or should be asking
• Help clients define and achieve their business goals
• Prepare annual strategic/tactical plans for each client and individual campaign/project plans as needed throughout the year
• Manage and strengthen client relationships
• Propose, sell to clients, and oversee ideas and projects that are tied to clients’ objectives
• Continuously offer unsolicited ideas to increase the effectiveness of clients’ brand and company activities

Big Picture for Precision AQ

• Understand revenue generation and recognition, and contribute to Precision AQ’s profitability through good management
• Serve as an advocate and strong representative for Precision AQ
• Identify and cultivate new business opportunities (even if it means just passing them along internally)

Day-to-Day for Clients

• Initiate and oversee Precision AQ activities on behalf of and in support of clients
• Manage day-to-day client-Precision AQ communication on strategy (ideas, recommendations, approaches to consider) and planning
• Become a partner to each client, functioning as an extension of the client’s team by taking ownership and accountability for their business

Day-to-Day for Precision AQ

• Closely manage clients’ budget and team efficiency to maximize return for clients and Precision AQ
• Work with the internal team to exceed clients’ expectations
• Mentor, train, and coach team members to facilitate growth and development

Additional Responsibilities

• Stay abreast of developments (eg, science, competitors, regulations) in clients’ industries
• Keep honing marketing and strategy expertise to better serve clients and Precision AQ
• Network and connect to grow your influence and add value

Support of the StrAcctDir may include tasks, such as: assisting in the preparation of annual strategic/tactical plans for clients and Precision AQ, addressing ad hoc client requests and needs, reviewing and finalizing materials for distribution to the client or other external parties, participating in and/or leading calls with clients or healthcare practitioners, preparing content as necessary to fulfill client requirements, traveling to and attending and supporting live meetings with clients and/or healthcare practitioners, and more. The day-to-day activities of a SAM will vary greatly depending on client needs, account size, product status, and Precision AQ needs and may include assuming an independent lead role on individual projects as well as responsibility for a modest revenue goal.

Desired Skills
We seek highly motivated people with outstanding professional credentials, business accomplishment, and leadership. In addition, we place high value on relevant personal qualities: resourcefulness, tenacity, independence, energy, and self-confidence.

Qualifications

• Bachelor’s degree required; Advanced degree (PhD, MD or PharmD) in life sciences, pharmacy, medicine, and/or advanced degree in management, marketing or business is preferred
• Minimum of 3 years of experience in account management, overseeing both client relationships and internal teams within the medical communications or a related industry. Prior exposure to medical affairs, publications, and/or peer-to-peer marketing is strongly preferred.
  
  

Skills

• PowerPoint design proficiency
• Strong strategic and analytical background
• Ability to interact in a professional manner with clients and leaders with scope in a variety of therapeutic areas
• Ability to understand and interpret market dynamics, scientific information, and clinical and preclinical data
• Ability to interpret business metrics and financial information

Senior Strategic Account Directors (SrSADs) are responsible for generating revenue to be delivered on through leading and managing a team of internal resources to maximize effectiveness and efficiency for the client and the company. In addition to acting as the day-to-day strategic advisor to clients and ensuring our work is strategically on-target and delivered within budget and timelines, an PRECISION AQ SrSAD also provides oversight, coaching, and mentorship to Strategic Account Directors (SADs), Strategic Account Managers (SAMs), and Strategic Account Associates (SAAs) within their books of business. They also support department and company initiatives, as requested, lead and participate in new business opportunities and pitches, and support strategic planning within and outside of their books of business.

Summary of Responsibilities

Big Picture for Clients

• Understand the business challenges your client is facing and what strategic questions they are or should be asking
• Help clients define and achieve their business goals
• Prepare annual strategic/tactical plans for each client and individual campaign/project plans as needed throughout the year
  • Support strategic planning within and outside of current book of business (ie, supporting other teams, as needed)
• Manage and strengthen client relationships
• Propose, sell to clients, and oversee ideas and projects that are tied to clients’ objectives
• Continuously offer unsolicited ideas to increase the effective of clients’ brand and company activities

Big Picture for PRECISION AQ

• Understand revenue generation and recognition, and contribute to PRECISION AQ’ profitability through good management
• Serve as an advocate and strong representative for PRECISION AQ
• Identify, cultivate, and participate in new business opportunities
• Periodically report to company leadership on the condition of client-PRECISION AQ relationships
• Support and participate in department- and company-level initiatives, as requested

Day-to-Day for Clients

• Initiate and oversee PRECISION AQ activities on behalf of and in support of clients
• Manage day-to-day client-PRECISION AQ communication on strategy (ideas, recommendations, approaches to consider) and planning
• Become a partner to each client, functioning as an extension of the client’s team by taking ownership and accountability for their business

Day-to-Day for PRECISION AQ

• Closely manage clients’ budget and team efficiency to maximize return for clients and PRECISION AQ
• Build up your team by celebrating successes, listening to them, learning and improving from mistakes, and sharing information with other teams along the way
• Mentor, train, and coach team members to facilitate growth and development, with direct emphasis on development and coaching/mentorship of junior account team staff

For You, PRECISION AQ, and Clients

• Stay abreast of developments (eg, science, competitors, regulations) in clients’ industries
• Keep honing marketing and strategy expertise to better serve clients and PRECISION AQ
• Network and connect to grow your influence and add value

Desired Skills
We seek highly motivated people with outstanding professional credentials, business accomplishment, and leadership. In addition, we place high value on relevant personal qualities: resourcefulness, tenacity, independence, energy, and self-confidence.
SrSADs have achieved a high level of proficiency and expertise with managing clients and the team, demonstrating consistent revenue growth, client relationships that travel with them, sound fiscal management, and successful project management. In addition, they should have a consistent track record of achieving or surpassing revenue and profitability targets.

Qualifications

• Education: Bachelor's degree
  • Advanced degree (PhD, MD, or PharmD) in life sciences, pharmacy, medicine, and/or advanced degree in management, marketing, or business desirable/preferred
• Work Experience: A minimum of seven (7) years of pharmaceutical/biotech marketing or medical affairs experience or medical communications agency experience, with experience successfully managing and growing $2.5M+ pharma/healthcare accounts

Skills

• Microsoft Office (Word, Excel, PowerPoint, Outlook); Internet
• PowerPoint design proficiency

Competencies

• Thorough understanding of the objectives, as well as the strategic and tactical activities of pharmaceutical/biotech marketing, particularly in the area of medical communications
• Demonstrated proficiency in acting as a trusted strategic/business advisor to marketers and other managers
• Proficiency in leading and managing employees, growing client relationships, and managing expanding business opportunities
• Ability to thrive and succeed in a fast-paced environment
• Strong communication and presentation skills
• Strong time management skills to work effectively within demanding timelines
• Ability to interact in a professional manner with clients and thought leaders in a variety of therapeutic areas
• Ability to understand and interpret market dynamics, scientific information and clinical and preclinical data
• Ability to interpret and act on business metrics and financial information

Senior Strategic Account Directors (SrSADs) are responsible for generating revenue to be delivered on through leading and managing a team of internal resources to maximize effectiveness and efficiency for the client and the company. In addition to acting as the day-to-day strategic advisor to clients and ensuring our work is strategically on-target and delivered within budget and timelines, an PRECISION AQ SrSAD also provides oversight, coaching, and mentorship to Strategic Account Directors (SADs), Strategic Account Managers (SAMs), and Strategic Account Associates (SAAs) within their books of business. They also support department and company initiatives, as requested, lead and participate in new business opportunities and pitches, and support strategic planning within and outside of their books of business.

Summary of Responsibilities

Big Picture for Clients

• Understand the business challenges your client is facing and what strategic questions they are or should be asking
• Help clients define and achieve their business goals
• Prepare annual strategic/tactical plans for each client and individual campaign/project plans as needed throughout the year
  • Support strategic planning within and outside of current book of business (ie, supporting other teams, as needed)
• Manage and strengthen client relationships
• Propose, sell to clients, and oversee ideas and projects that are tied to clients’ objectives
• Continuously offer unsolicited ideas to increase the effective of clients’ brand and company activities

Big Picture for PRECISION AQ

• Understand revenue generation and recognition, and contribute to PRECISION AQ’ profitability through good management
• Serve as an advocate and strong representative for PRECISION AQ
• Identify, cultivate, and participate in new business opportunities
• Periodically report to company leadership on the condition of client-PRECISION AQ relationships
• Support and participate in department- and company-level initiatives, as requested

Day-to-Day for Clients

• Initiate and oversee PRECISION AQ activities on behalf of and in support of clients
• Manage day-to-day client-PRECISION AQ communication on strategy (ideas, recommendations, approaches to consider) and planning
• Become a partner to each client, functioning as an extension of the client’s team by taking ownership and accountability for their business

Day-to-Day for PRECISION AQ

• Closely manage clients’ budget and team efficiency to maximize return for clients and PRECISION AQ
• Build up your team by celebrating successes, listening to them, learning and improving from mistakes, and sharing information with other teams along the way
• Mentor, train, and coach team members to facilitate growth and development, with direct emphasis on development and coaching/mentorship of junior account team staff

For You, PRECISION AQ, and Clients

• Stay abreast of developments (eg, science, competitors, regulations) in clients’ industries
• Keep honing marketing and strategy expertise to better serve clients and PRECISION AQ
• Network and connect to grow your influence and add value

Desired Skills
We seek highly motivated people with outstanding professional credentials, business accomplishment, and leadership. In addition, we place high value on relevant personal qualities: resourcefulness, tenacity, independence, energy, and self-confidence.
SrSADs have achieved a high level of proficiency and expertise with managing clients and the team, demonstrating consistent revenue growth, client relationships that travel with them, sound fiscal management, and successful project management. In addition, they should have a consistent track record of achieving or surpassing revenue and profitability targets.

Qualifications

• Education: Bachelor's degree
  • Advanced degree (PhD, MD, or PharmD) in life sciences, pharmacy, medicine, and/or advanced degree in management, marketing, or business desirable/preferred
• Work Experience: A minimum of seven (7) years of pharmaceutical/biotech marketing or medical affairs experience or medical communications agency experience, with experience successfully managing and growing $2.5M+ pharma/healthcare accounts

Skills

• Microsoft Office (Word, Excel, PowerPoint, Outlook); Internet
• PowerPoint design proficiency

Competencies

• Thorough understanding of the objectives, as well as the strategic and tactical activities of pharmaceutical/biotech marketing, particularly in the area of medical communications
• Demonstrated proficiency in acting as a trusted strategic/business advisor to marketers and other managers
• Proficiency in leading and managing employees, growing client relationships, and managing expanding business opportunities
• Ability to thrive and succeed in a fast-paced environment
• Strong communication and presentation skills
• Strong time management skills to work effectively within demanding timelines
• Ability to interact in a professional manner with clients and thought leaders in a variety of therapeutic areas
• Ability to understand and interpret market dynamics, scientific information and clinical and preclinical data
• Ability to interpret and act on business metrics and financial information

Vice President, Value Demonstration and Economic Modeling (VDEM)

Are you looking to work with a dynamic team of industry leading professionals in the HEOR space?  Are you interested in leading teams pointed at Value Demonstration and Economic Modeling studies that quantify the value of healthcare interventions? Our HEOR team is hiring a Vice President to lead a team of interdisciplinary research professionals conducting client studies in the biopharma space, operating as a thought leader, problem solver and consultative expert.

About You

• You are an experienced health economics and outcomes research leader who has experience leveraging a broad range of models to answer key research questions for pharmaceutical and biotech clients (e.g., budget impact, cost consequence, cost effectiveness).
• You have a demonstrated track record in economic modeling, as well as possess a solid understanding of key concepts and principles related to evidence synthesis and comparative effectiveness, as well as critical US payer requirements, including CMS, ICER, and private payers.
• You can clearly explain the rationale, methods/results, and strategy for studies to project teams, clients, and external stakeholders.
• You understand strengths and limitations of alternative approaches and propose applications/solutions of new or existing methods tailored to a specific research question.

About The Role

The Vice President (VP), VDEM is responsible for the growth and development of VDEM services and talent as part of the core Evidence Generation and overall HEOR leadership teams. The VP creates new business, cultivates key client relationships, oversees a growing delivery team, and finds opportunities to improve and grow current business.

Essential functions of the job include but are not limited to:

• Actively participate in and contribute to the senior leadership of the business including setting business strategy, participating in initiatives that encourage colleague engagement and satisfaction, promoting business growth, and ensuring operational and methodological excellence
• Collaborate across multiple business units on business strategy and execution
• Provide leadership and direction as part of the core Evidence Generation and overall HEOR leadership team delivering high-quality evidence-strategy planning, economic modeling, real-world evidence, and related services to biopharmaceutical industry clients globally
• Coordinate prioritization, resource allocation, and delivery for VDEM projects with resource and project leaders
• Contribute to business growth within existing HEOR services and expansion of HEOR-related service lines
• Achieve revenue and sales targets through direct client engagement, and support research and scientific leads in client management, project delivery, and sales activities
• Build new business opportunities and maintain long-term partnerships with clients, proactively identifying and proposing technical and strategic solutions
• Manage multiple assigned accounts simultaneously and related revenue
• Manage communications to support department and business unit goals and objectives
• Identify, develop and retain talent both inside and outside of the existing VDEM team
• Partner with colleagues and business leaders on staffing-decision recommendations (level to hire/when to hire) based on capacity models, utilization, and business pipeline
• Coach, mentor, and develop VDEM staff including overseeing new-employee onboarding and providing career development planning and opportunities
• Empower employees to take responsibility for their career development and goals

 Required Experience

• 10-12+ years of experience, at least four in a consulting environment
• Postgraduate degree - PhD, MD, or PharmD preferred; Master’s degree in a subject related to health services research (e.g., health economics, public policy, health policy, epidemiology, biostatistics, or public health), with relevant experiences considered.
• Strong knowledge of the biopharmaceutical industry and payer-evidence requirements
• Proven record of leadership experience in high-impact HEOR publications, business development, consulting, and/or leadership, including a proven track record of success.
• Expert review and interpretation of data outputs and results, and develop/deliver publications and/or presentations
• Experience with development of pharmacoeconomic models, with specific understanding of value-demonstration modeling, including but not limited to:
• Possesses expert understanding of the biopharmaceutical industry, medical affairs, and requirements for payer and health-technology assessment, evidenced by a track record of relevant publications
• Demonstrates sufficient understanding of relevant methods to be able to oversee studies involving model development/validation (budget impact, cost effectiveness, cost consequence, other), and utility modelling/mapping (trial-based analyses)
• Clearly explains the rationale, methods/results, and strategy for studies to project teams, clients, and external stakeholders
• Understands strengths and limitations of alternative approaches and proposes applications/solutions of new or existing methods tailored to a specific research question
• Strong strategic and technical writing skills

• Knowledge of the interconnectedness of the variety of commercialization services that a life sciences company needs to successfully launch a project. 

Vice President, Value Demonstration and Economic Modeling (VDEM)

Are you looking to work with a dynamic team of industry leading professionals in the HEOR space?  Are you interested in leading teams pointed at Value Demonstration and Economic Modeling studies that quantify the value of healthcare interventions? Our HEOR team is hiring a Vice President to lead a team of interdisciplinary research professionals conducting client studies in the biopharma space, operating as a thought leader, problem solver and consultative expert.

About You

• You are an experienced health economics and outcomes research leader who has experience leveraging a broad range of models to answer key research questions for pharmaceutical and biotech clients (e.g., budget impact, cost consequence, cost effectiveness).
• You have a demonstrated track record in economic modeling, as well as possess a solid understanding of key concepts and principles related to evidence synthesis and comparative effectiveness, as well as critical US payer requirements, including CMS, ICER, and private payers.
• You can clearly explain the rationale, methods/results, and strategy for studies to project teams, clients, and external stakeholders.
• You understand strengths and limitations of alternative approaches and propose applications/solutions of new or existing methods tailored to a specific research question.

About The Role

The Vice President (VP), VDEM is responsible for the growth and development of VDEM services and talent as part of the core Evidence Generation and overall HEOR leadership teams. The VP creates new business, cultivates key client relationships, oversees a growing delivery team, and finds opportunities to improve and grow current business.

Essential functions of the job include but are not limited to:

• Actively participate in and contribute to the senior leadership of the business including setting business strategy, participating in initiatives that encourage colleague engagement and satisfaction, promoting business growth, and ensuring operational and methodological excellence
• Collaborate across multiple business units on business strategy and execution
• Provide leadership and direction as part of the core Evidence Generation and overall HEOR leadership team delivering high-quality evidence-strategy planning, economic modeling, real-world evidence, and related services to biopharmaceutical industry clients globally
• Coordinate prioritization, resource allocation, and delivery for VDEM projects with resource and project leaders
• Contribute to business growth within existing HEOR services and expansion of HEOR-related service lines
• Achieve revenue and sales targets through direct client engagement, and support research and scientific leads in client management, project delivery, and sales activities
• Build new business opportunities and maintain long-term partnerships with clients, proactively identifying and proposing technical and strategic solutions
• Manage multiple assigned accounts simultaneously and related revenue
• Manage communications to support department and business unit goals and objectives
• Identify, develop and retain talent both inside and outside of the existing VDEM team
• Partner with colleagues and business leaders on staffing-decision recommendations (level to hire/when to hire) based on capacity models, utilization, and business pipeline
• Coach, mentor, and develop VDEM staff including overseeing new-employee onboarding and providing career development planning and opportunities
• Empower employees to take responsibility for their career development and goals

 Required Experience

• 10-12+ years of experience, at least four in a consulting environment
• Postgraduate degree - PhD, MD, or PharmD preferred; Master’s degree in a subject related to health services research (e.g., health economics, public policy, health policy, epidemiology, biostatistics, or public health), with relevant experiences considered.
• Strong knowledge of the biopharmaceutical industry and payer-evidence requirements
• Proven record of leadership experience in high-impact HEOR publications, business development, consulting, and/or leadership, including a proven track record of success.
• Expert review and interpretation of data outputs and results, and develop/deliver publications and/or presentations
• Experience with development of pharmacoeconomic models, with specific understanding of value-demonstration modeling, including but not limited to:
• Possesses expert understanding of the biopharmaceutical industry, medical affairs, and requirements for payer and health-technology assessment, evidenced by a track record of relevant publications
• Demonstrates sufficient understanding of relevant methods to be able to oversee studies involving model development/validation (budget impact, cost effectiveness, cost consequence, other), and utility modelling/mapping (trial-based analyses)
• Clearly explains the rationale, methods/results, and strategy for studies to project teams, clients, and external stakeholders
• Understands strengths and limitations of alternative approaches and proposes applications/solutions of new or existing methods tailored to a specific research question
• Strong strategic and technical writing skills

• Knowledge of the interconnectedness of the variety of commercialization services that a life sciences company needs to successfully launch a project. 

Job Summary of the Director, Market Development

The Director, Market Development reports directly to the Chief Marketing Officer and is a senior leader within the Commercial organization. The role owns and leads development of the market development strategy for their respective market that accelerates growth across priority segments and ensure fulfilment of Axogen’s mission and business purpose. This role leads the planning and execution of integrated marketing programs that strengthen Axogen’s brand perception, drive surgeon demand and adoption and influence customer behavior to change entrenched clinical behaviors and ensure progression toward standard‑of‑care status.

Requirements of the Director, Market Development

• Bachelor’s degree required; Advanced educational degree desirable.
• Minimum of 10 years of progressive experience in marketing and product management within the medical device, surgical implant, or biotech industry.
• Conceptual and applied understanding of strategy, and the strategic planning process.
• Demonstrated success in developing and scaling new market opportunities, preferably involving disruptive or paradigm‑shifting technologies.
• Strong technical and clinical acumen with the ability to shape evidence generation supporting adoption and reimbursement.
• Proven experience leading market change, measuring penetration, and driving uptake across adopter segments from early adopters to early majority.
• Experienced people leader with a strong record of talent development and employee engagement.
• Ability to make decisions with imperfect data and establish performance measures to enable course correction.
• Strong interpersonal, written, and verbal communication skills with the ability to influence across multiple stakeholder groups.
• Ability to manage multiple priorities in a fast‑paced environment, on time and within budget.
• Willingness to travel domestically up to 35%, with some international travel expected.

Responsibilities of the Director, Market Development

The specific duties of the Director, Market Development include but are not limited to:

Market Strategy & Direction

• Develop and execute market development strategies that change entrenched clinical behavior and overcome inertia in standards of care.
• Apply a strong strategic and analytical mindset to convert market data, trends, and insights into actionable growth strategies and measurable outcomes.
• Drive strategic market segmentation, targeting, and positioning to accelerate adoption and penetration of Axogen’s nerve repair algorithm and their inclusion in clinical guidelines and achievement of standard of care status.
• Ensure all strategies are translated into the Axogen sales and sales management process, and are monitored, managed and adapted based on objective criteria.
• Identify, size, and prioritize growth opportunities across new markets, new segments, and evolving customer needs.
• Translate evolving and unmet customer needs into portfolio requirements.

 Marketing Program Execution & Commercial Enablement

• Lead the planning and execution of integrated marketing programs that drive surgeon demand and adoption, influence customer behavior and strengthen Axogen brand perception.
• Define and enable compelling, market specific value propositions by partnering with sales leadership to build effective selling models, processes, and training that equip the field to confidently and consistently communicate clinical, economic, and quality‑of‑life value through practical, execution ready tools.
• Apply process‑driven launch excellence planning and program management disciplines to ensure scalable execution of new product and clinical indication launches with measurable impact.

 Insights & Analytics Leadership

• Develop deep understanding of customer journeys across clinical markets and identify interventions that drive behavior change.
• Leverage analytical capabilities to extract insights from market data, VOC, and performance metrics.
• Establish and monitor KPIs to evaluate effectiveness of market development initiatives and inform course correction.
• Share insights across marketing, sales, medical affairs, HEOR, and R&D to influence enterprise decision making

KOL, Society & Advocacy Ecosystem Leadership

• Establish and lead a comprehensive Key Opinion Leader (KOL) and professional society engagement strategy across priority markets, building and sustaining senior‑level relationships with influential clinical leaders, academic centers, and society leadership.
• Partner closely with Medical Affairs to advance advisory boards, peer‑to‑peer programs, congress engagement, and scientific collaboration, ensuring KOL insights directly inform marketing strategy, evidence generation, and long‑term portfolio planning.

 Leadership & Collaboration

• Lead, mentor, and develop high performing market development leaders and teams.
• Build organizational capabilities in strategic marketing, analytics, customer insight, and execution excellence.
• Foster a collaborative, cross functional leadership culture aligned with Axogen values and mission.

Location

111 West Oak Ave., Tampa, FL  33602

#LI-AC1

Benefits/Compensation

The Opportunity:

Reporting to the Senior Director, U.S. Forecasting, the Director, U.S. Forecasting will be responsible for developing and executing forecasting models and analyses that support product strategy, performance management, and operational planning.

This role focuses on building and maintaining short-term demand forecasts and patient-based models across U.S. oncology assets, enabling manufacturing, supply chain, and commercial decision-making. The Director will partner closely with cross-functional stakeholders to align on forecast inputs, assumptions, and outputs, while ensuring high-quality, timely deliverables.

As a key contributor within the U.S. Forecasting function, this individual will execute forecasting processes in alignment with the broader U.S. forecasting strategy and contribute to ongoing improvements in forecasting capabilities, tools, and data integration.

This position is based at our Redwood City, CA headquarters, with flexibility for remote candidates willing to travel regularly to the office.

Responsibilities include:

• Develop, maintain, and refine short-term demand forecasts across U.S. oncology products, including SKU-, dose-, and channel-level projections to support supply chain and commercial planning.

• Build and manage patient-based forecasting models incorporating oncology-specific dynamics such as incidence, biomarker segmentation, lines of therapy, treatment duration, and market evolution.

• Conduct scenario, sensitivity, and risk analyses to evaluate key business drivers and inform near-term decision-making.

• Translate complex data, assumptions, and model outputs into clear, actionable insights to support launch planning, performance tracking, and operational readiness.

• Partner cross-functionally with Commercial, Finance, Market Access, Medical Affairs, Supply Chain, and Manufacturing to gather inputs, validate assumptions, and ensure alignment on forecast outputs.

• Support development of production and inventory strategies by providing accurate and timely forecast updates and analyses.

• Integrate real-world data, secondary data sources (e.g., IQVIA), and competitive intelligence into forecasting models to enhance accuracy and responsiveness.

• Execute forecasting activities in alignment with U.S. Forecasting strategy and methodologies established by senior leadership, ensuring consistency and rigor.

• Support enhancements to forecasting processes, tools, and data infrastructure, including model standardization and automation initiatives.

• Maintain clear and transparent documentation of forecasting methodologies, assumptions, and data sources.

• Manage external vendors and data partners to ensure delivery of high-quality inputs and analyses.

• Escalate key risks, assumptions, and forecast variances to senior leadership with clear summaries and recommendations.

• Stay current on Revolution Medicines’ portfolio, competitive landscape, and evolving oncology market dynamics.

Required Skills, Experience and Education:

• Bachelor’s degree in business, life sciences, statistics, or economics required; advanced degree (MBA, MS, MPH, or PhD) preferred.

• 8+ years of experience in pharmaceutical, biotechnology, or consulting roles, including at least 5 years in forecasting, analytics, or demand planning.

• Demonstrated experience building and maintaining patient-based and/or demand-based forecasting models supporting commercial and operational decision-making.

• Strong understanding of forecasting methodologies, including patient-based modeling, scenario analysis, and data-driven forecasting approaches.

• Experience working with oncology data and/or oncology markets preferred.

• Proficiency in analytics and visualization tools (e.g., Excel, Tableau, Power BI or equivalent).

• Experience working with secondary data sources (e.g., IQVIA) and integrating multiple data streams into forecasting models.

• Strong analytical and problem-solving skills, with the ability to synthesize complex data into actionable insights.

• Demonstrated ability to collaborate effectively across cross-functional teams and contribute to decision-making processes.

• Strong organizational skills and attention to detail, with the ability to manage multiple priorities in a fast-paced environment.

• Effective communication skills, including the ability to clearly present analyses and insights to diverse stakeholders.

Preferred Skills:

• Experience in oncology forecasting, including patient flow modeling and treatment dynamics.

• Experience supporting product launches or pre-commercial forecasting.

• Familiarity with supply chain or manufacturing planning processes.

• Experience working in a fast-paced, growth-stage biotechnology organization.

• Experience managing vendors or external analytics partners. 

  #LI-Hybrid #LI-SS2