About Us

About the Role

As the Senior Accountant you will have a direct impact on accounting and reporting activities for a fast-growing, public biotech.

Reporting to the Director, Accounting, you will be responsible for (i) assisting with monthly and quarterly close activities such as preparation of journal entries, reconciliations, financial analyses, supporting documentation and financial statements, (ii) assisting with systems implementations, including potential new ERP, (iii) assisting with management and execution of our independent audit and Sarbanes-Oxley activities, and (iv) supporting other activities such as clinical trial accruals and collaboration arrangements. You must have experience working with public biopharma companies and/or public accounting experience to be successful in this role.

This is an exciting opportunity to assist with the continued build-out of the accounting and financial reporting processes and have a significant impact on the future success of the company. We are building a culture of individuals who hold our core principles at the center of our operations, with the goal to elevate the care of our patients’ lives. We are open to you working remotely.

Key Responsibilities

• Complete monthly and quarterly account reconciliations to ensure accurate reporting and ledger maintenance including but not limited to cash, accounts receivable, accounts payable, general ledger, fixed assets, payroll, prepaids, and purchasing.
• Assists with the Sarbanes-Oxley activities including updating system documentation, testing controls, remediating control deficiencies and coordination efforts with the auditors.
• Assists with completion of audit requests related to the annual audit and quarterly reviews.
• Assists with the implementation of accounting systems, policies, and procedures.
• Keeps up to date on overall activities of the team, identifying problem areas and taking corrective actions.
• Prepares specialized analyses in support of all business functions.
• Potential management of future team members including but not limited to activities of mentoring, training and embodying a continuous improvement mindset.
• Assists with specific projects and initiatives unique to a fast-growing biotechnology start-up, such as system implementations, updates and business process improvements and other ad hoc projects.

Experience

• CPA or CMA license preferred.
• Bachelor’s degree (B.A.) or equivalent.
• At least 5 years of related experience and/or training with 1-2 years of biotechnology or life science industry experience required.
• Working knowledge of all aspects of accounting and financial reporting.
• Flexible, personable team-player, comfortable in a fast-paced, small company environment.
• Ability to identify errors and root causes of errors, develop workable solutions or alternatives.
• Ability to work with all levels of management.
• Strong organizational, problem-solving, and analytical skills; able to manage priorities and workflow.
• Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm.

Pulmovant is a Roivant-backed clinical-stage biotechnology company developing innovative therapies for patients suffering from pulmonary diseases. Pulmovant’s first program, mosliciguat is designed to provide an effective, once-daily, inhaled treatment option for patients with pulmonary hypertension (PH). Mosliciguat is a novel, potential first-in-class, sGC activator with a differentiated mechanism that may have broad applicability across the PH spectrum.

Mosliciguat has been extensively characterized across a robust Phase 1 program with 170 participants dosed to date including patients with PH in the Phase 1b ATMOS study which has produced highly compelling and clinically meaningful efficacy data, as well as a favorable safety profile. Pulmovant recently completed enrollment in the Phase 2 PHocus study evaluating mosliciguat in patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD), with topline data expected in the second half of 2026. Mosliciguat is also being evaluated in the Phase 2 PHactor study in combination with inhaled treprostinil in patients with PH-ILD.

As part of the Roivant family of companies, Pulmovant leverages the power of collaboration and innovation to drive progress.

For more information, please visit https://www.pulmovant.com.

About Roivant:

Roivant specializes in developing transformative medicines at an accelerated pace through the launch of nimble biopharmaceutical and health technology entities, each meticulously tailored to address a specific medical need. Since its inception in 2014, Roivant has achieved the following critical milestones in support of its vision: built over 20 Vants; 12 consecutive positive Phase 3 trials; 8 FDA approvals; 5 successful IPOs; >$6B in capital raised; >$10B in global pharma partnerships and proceeds; and continued pipeline expansion across various modalities and therapeutic areas through in-licensing and acquisition of novel product candidates and technology platforms.  In addition to a robust clinical stage pipeline, Roivant also incubates discovery-stage companies and health technology startups complementary to its biopharmaceutical business.

Position: Senior Director / Head of Biometrics

Summary:

Pulmovant is seeking an accomplished biostatistician to lead the Biometrics function. This individual will own and build the Biostatistics and Statistical Programming functions, providing strategic and operational leadership across all of Pulmovant’s clinical development programs.

This is a high-impact opportunity at a pivotal moment for the company. With enrollment recently completed in the Phase 2 PHocus study of mosliciguat in PH-ILD and topline results expected in the second half of 2026, the Head of Biometrics will play a critical role in shaping the analysis, regulatory strategy, and registrational path for a potential first-in-class inhaled sGC activator. The successful candidate will partner closely with Clinical Development, Clinical Operations, Data Management, Regulatory Affairs, and external CROs to deliver high-quality, regulatory-grade biometrics deliverables and to scale a fit-for-purpose function as the pipeline advances.

Key Duties and Responsibilities 

• Lead, build, and oversee the Biostatistics and Statistical Programming functions, establishing standards, processes, and infrastructure to support a growing pipeline.
• Serve as the senior biostatistical leader across Pulmovant’s programs, including the Phase 2 PHocus and PHactor studies of mosliciguat in PH-ILD, and future late-stage and registrational studies.
• Provide strategic statistical input into protocol design, sample size justification, statistical analysis plans (SAPs), and integrated analyses (ISS/ISE) supporting regulatory submissions.
• Review data quality, completeness, and key derivations
• Review and provide feedback and QC on TLF shells and outputs
• Ensure deliverables meet SAP specifications and quality standards
• Confirm readiness of TLR package for internal/external use
• Partner with Clinical Development, Regulatory Affairs, and Clinical Operations to define endpoints, estimands, and analysis strategies aligned with FDA, EMA, and other global health authority expectations.
• Oversee CRO biostatistics and statistical programming deliverables, ensuring quality, timeliness, and adherence to CDISC (SDTM/ADaM), FDA, and ICH E9/E9(R1) standards.
• Lead preparation of biometrics components of regulatory submissions (IND, EOP2, NDA/MAA) and represent Pulmovant in interactions with FDA and other agencies.
• Drive innovative analytical approaches, including adaptive designs, Bayesian methods, and use of historical or external controls where appropriate for a rare-disease setting.
• Build and lead a high-performing team of biostatisticians and statistical programmers; mentor staff and shape the talent strategy as Pulmovant scales.
• Support data monitoring committees (DMCs), trial steering committees, and key opinion leader engagements.
• Contribute to publications, scientific communications, and conference presentations of clinical trial results.

Education and Experience 

• PhD in Biostatistics, Statistics, or a closely related quantitative field (MS with extensive industry experience may be considered).
• 12+ years (Senior Director) or 15+ years (Vice President) of biostatistics experience in the biopharmaceutical industry, including significant time leading biostatistics across late-stage development and regulatory submissions.
• Demonstrated experience leading both Biostatistics and Statistical Programming functions, including oversight of CRO partners.
• Track record of leading biostatistical strategy through successful regulatory interactions and submissions (IND, NDA/BLA, MAA); FDA submission experience required.
• Prior experience in pulmonary, cardiovascular, rare disease, or interstitial lung disease therapeutic areas is strongly preferred; experience with PH or PH-ILD a plus.
• Experience working in a small or mid-cap biotech and operating effectively in a lean, fast-paced environment.

Essential Skills and Abilities 

• Deep expertise in statistical methodology for clinical trials, including adaptive designs, longitudinal/mixed models, survival analysis, missing data, and estimands per ICH E9(R1).
• Working knowledge of statistical programming in SAS and R; expert understanding of CDISC (SDTM, ADaM) standards and submission deliverables.
• Strong regulatory acumen and ability to translate complex statistical concepts into clear narratives for regulators, executives, and clinical partners.
• Proven leadership and people-management skills; ability to attract, develop, and retain top biometrics talent.
• Excellent written and verbal communication skills, with comfort presenting to executives, regulators, DMCs, and external KOLs.
• Strategic mindset paired with a hands-on willingness to operate at all levels in a small-company setting.
• Strong cross-functional collaboration skills with Clinical Development, Clinical Operations, Data Management, Regulatory, and Medical Affairs.
• Proficient in vendor and CRO management, with proven ability to drive quality and timelines.
• High personal integrity, scientific rigor, and unwavering commitment to patients.

Pulmovant provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

We will not accept unsolicited resumes nor outreach from agencies. Please do not send agency resumes to our website or Roivant Sciences and affiliated employees. Thanks!

Reports To: Head of Global Medical Operations

About This Role:

The Associate Director, Global Medical Operations provides operational oversight within Global Medical Affairs and partners closely with global and regional medical teams. This role supports the planning and execution of key medical activities, including global advisory boards, global congress activities, medical insights infrastructure, grants and giving governance, external expert engagement, digital medical solutions, and key internal medical meetings. 

This is a hands-on, execution focused role that ensures seamless coordination and high-quality delivery across Medical Operations. We’re looking for a collaborative, adaptable professional who thrives in a fast paced, emerging biotech environment—someone who can juggle priorities, pivot quickly, and build strong cross functional relationships. 

What You'll Do: 

• Lead planning and execution of Global Advisory Boards, with support from a local vendor and in collaboration with Legal/Compliance, ensuring compliant business needs assessment review, logistics coordination, cross border regulatory requirements, contracting, FMV alignment, and final insights documentation
• Partner with Global Scientific Communications to oversee end-to-end global congress logistics—including booth operations, symposia support, onsite coordination, and operational deliverables—across an annual schedule of 3–4 global congresses.
• Partner with IT to manage the global insights process and digital framework, enabling structured insights capture, analysis, dashboard reporting, and cross functional dissemination across all regions to support global strategy development. 
• Support Global Grants & Giving governance, including review workflows, due diligence documentation, and compliance alignment. 
• Provide operational support for External Expert Engagement, in collaboration with Legal/Compliance, ensuring FMV standards, compliant contracting, and tracking of local regulatory requirements. 
• Partner with IT to collaborate and operationally support digital medical initiatives, including SharePoint governance, dashboard development, process optimization, and workflow automation. 
• In conjunction with Global Medical Training, manage logistics and operations for the All Medical Summit Meetings twice annually, ensuring seamless planning, cross functional coordination, and high quality execution. 
• Partner closely with Finance, Legal/Compliance, IT, Global Scientific Communications, and regional medical teams to ensure integrated, compliant, and efficient execution of medical operations. 
• Contribute as a hands on, collaborative member of the Global Medical Operations team, fostering a culture of teamwork, transparency, and operational excellence. 

Required Skills:

• Bachelor’s degree required. 
• 8-10 years in Medical Affairs or Medical Operations; emerging biotech experience strongly preferred. 
• Demonstrated hands-on experience executing medical operations activities. 
• Strong understanding of global medical compliance, HCP engagement standards, FMV principles, and congress operations. 
• Experience collaborating extensively with Legal/Compliance, Finance, IT, Global and Scientific Communications. 
• Proven ability to multitask, adapt quickly, and operate effectively in a fastmoving, environment. 
• Excellent communication, organizational, and project management skills. 
• A collaborative, solutions-oriented working style and the ability to build strong, positive relationships across teams. 

Preferred Skills:

• Emerging biotech experience strongly preferred. 

Additional Information: 

The base compensation range for this role is: $200,000 - $240,000. Compensation is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.

Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. We are pioneering a transformational approach to treating cancer by harnessing the ability of the human immune system to recognize and attack diverse cancer cells in each patient. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, which may be a promising option for patients with cancer.

Overview

The Lifecycle leader (LCL) is responsible for shaping the program vision, strategic context, and lifecycle plan (LCP) across indications globally. The LCL oversees the development and execution of the LCP in line with the company strategy.  They are able to navigate complex program challenges, the commercial and development landscape and assess and prioritize development in future indications.

Essential Functions and Responsibilities

• The LCL is responsible for shaping the program's cross-functional vision, strategic context, and lifecycle plan (LCP) for both current and future business opportunities.
• The LCL, in partnership with the Program Manager, will work with leadership & SMEs (subject matter experts) to build out appropriate internal ways of working to enable best practices around development of data driven recommendations, decision making and communication.
• As the single point of accountability in a cross-functional team, the LCL ensures timely delivery and manages the associated execution plan and milestones, closely aligning them with the approved LCP.
• The LCL oversees integration across Iovance involving multiple stakeholders to ensure optimal program execution in line with program strategy and LCP.
• Collaborating with functional team leaders, the LCL fosters alignment across the different sub -teams to ensure execution will achieve team and corporate goals (Commercial Team, Development Team, Regulatory Team etc.)
• Serving as a point of triage, the LCL facilitates clear decision-making by incorporating cross-functional input to address high-impact issues. This involves co-creating solutions to complex challenges in real time.
• The LCL leads the team in framing program needs and develops a range of options and recommendations for presentation to the Executive Leadership Team (ELT). The LCL ensures transparent communication with senior leadership, highlighting relevant scenarios, assumptions, and risks to inform decision-making and trade-offs. The LCL also represents the enterprise mindset and ensures all relevant functional perspectives have been considered.
• The LCL ensures the inclusion of subject matter experts (SMEs) and situational members in discussions, guided by a predefined agenda set with guidance from the Program Manager.
• The LCL is accountable to the ELT for program recommendations and frames them within the context of the broader portfolio.
• The LCL is accountable for day-to-day management of the program to ensure all established deliverables with high program impact remain on track and in line with program strategy.
• The LCL is responsible for ensuring the health of the team, creating a highly functional environment with collaborative ways of working where debate and honest feedback are encouraged
• Other responsibilities to consider: Risk identification and mitigation planning; ensuring financial stewardship of approved and recommended projects; clear communication throughout organization of key milestones, deliverables and progress; ensure appropriate resourcing of functions to achieve program goals and vision.

Additional Responsibilities:

• May work with Development and Commercial Teams to define the disease area strategy and to execute a business plan with clear deliverables and resource needs. This includes defining priorities and an approach to leveraging external opportunities in close collaboration with Business Development and academic experts.
• Advocates on behalf of Iovance and effectively communicates scientific/medical/clinical concepts in both written and oral communication to both internal and external stakeholders.
• Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
• Perform miscellaneous duties as assigned. 

Required Education, Skills, and Knowledge

• Bachelor's degree in a scientific discipline; advanced or professional degree highly desirable (e.g., PhD, MD, or MBA).
• 15+ years of bio-pharmaceutical industry experience with at least 5 years of relevant work experiences in the biotech/pharmaceutical industry as a Lifecycle Leader or Program Team Leader.
• Must demonstrate strong knowledge of the overall drug development process relevant to biotech/ pharmaceutical companies; commercial launch experience and a depth of experience with drug development is required.
• Experience working with or on program strategy teams required.

Preferred Education, Skills, and Knowledge 

• Strong leadership skills from leading cross-functional teams in a matrix organization, with highly collaborative instincts and a track record of resolving conflicts within the team.
• Ability to communicate clearly and effectively with clinical scientists, biologists, manufacturing experts, as well as with regulatory and commercial colleagues at all levels of the organization.
• High degree of organizational awareness and understanding of change management and leading innovation.
• Possess significant depth and breadth of experience across phases of drug development that enable you to immediately bring considerable strategic value to a project.
• Possess understanding of drug development experience and understand what it takes to shepherd an asset through its lifecycle.

The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation.

Physical Demands and Activities Required

• Must be able to remain in a stationary position standing or sitting for prolonged periods of time.
• Must be able to move about inside an office and exert up to 10 pounds of force occasionally or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects.
• Must have visual acuity to perform activities such as: preparing and analyzing data and figures, viewing a computer screen, and extensive reading.
• This position requires repetitive motion, substantial movements (motions) of the wrist, hands, and/or fingers.
• Must be able to communicate with others to exchange information. 

Mental: Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines. 

Work Environment 

This job operates in a professional workplace or remote office environment and requires standard office equipment and keyboards. Employees who work remotely are expected to maintain their workspace and environment safely and free from safety hazards.

#LI-remote

About Us

About the Role

As the Associate Director, Pharmacovigilance, you will work closely with the Safety team to support ongoing clinical trials.

This role is critical in ensuring patient safety and regulatory compliance throughout the drug development lifecycle. Day to day, you will work closely with safety physicians, clinical teams, and external stakeholders to manage safety data and contribute to safety oversight. You must have experience reviewing adverse events, safety signals, and coordinate/contribute to the Safety Review Committee (SRC) and Drug Safety Monitoring Boards (DSMB) meetings. You must have experience supporting clinical pharmacovigilance activities and working with DSMBs in order to be successful in this role.

This is a unique role that will allow you to work collaboratively with the growing pharmacovigilance team that is working closely with cross functional teams to help Dianthus elevate the care of our patients' lives. We are building a culture of individuals who hold our core principles at the center of our operations, with the goal to elevate the care of our patients' lives. We are open to you working remotely within the United States.

Key Responsibilities

Safety Data Review

• Oversee pharmacovigilance activities for assigned clinical programs, ensuring alignment with global regulatory requirements and internal SOPs.
• Review, evaluate, and provide managerial oversight of adverse event (AE) reports, including serious adverse events (SAEs), ensuring accurate assessment and timely submission to regulatory authorities and ethics committees.
• Ensure quality and accuracy of safety data review within the safety database and direct reconciliation efforts with clinical databases to maintain data integrity.

Cross-functional Communication & Collaboration

• Contribute to the development of safety sections within clinical documents, including protocols, investigator brochures, and clinical study reports.
• Manage and oversee the scheduling, planning, and facilitation of DSMB and SRC meetings, including preparation of agendas, meeting materials, guided discussions, documentation of minutes, and follow-up on action items.
• Contribute strategically to the preparation of aggregate safety reports such as the DSUR.
• Partner with safety physicians on signal detection, emerging safety issues, risk assessments, and benefit–risk evaluations.
• Serve as a subject matter expert to internal stakeholders and external partners on safety-related topics, providing guidance and ensuring consistent communication.

Documentation & Compliance

• Ensure organizational compliance with global pharmacovigilance regulations (FDA, EMA, ICH) and company policies.
• Manage and oversee pharmacovigilance-related quality events, including change controls, deviations, and CAPAs, ensuring timely resolution and documentation.
• Supervise and ensure accurate documentation of DSMB and SRC meetings and maintain records within designated systems and repositories.

Experience

• Education: PharmD or RN degree required.
• Experience in pharmacovigilance or in clinical development within biotech or pharmaceutical industry.
• Proven experience reviewing adverse events and working closely with safety physicians.
• Hands-on experience supporting DSMBs and SRCs and preparing safety deliverables.
• Proficiency in Microsoft Office Suite and Microsoft Teams, with the ability to leverage these tools for efficient communication, scheduling, and documentation
• Strong knowledge of global PV regulations (FDA, EMA, ICH guidelines).
• Excellent analytical, organizational, and communication skills.
• Ability to thrive in a fast-paced, start-up environment and manage multiple priorities.
• Fluency with Argus safety database
• Familiarity with rare disease or oncology programs.
• Prior experience in a start-up or small biotech setting.

Location: SF Bay Area

The Role and The Team: 

We are looking for a collaborative, self-driven sales leader to join our team.  You will be responsible for developing, driving and executing the commercial strategy within the defined US territory and supporting our global expansion. In this sales role you will develop deep customer relationships within academic, Biotech, Pharma and Government accounts,  establish the Seer technology for unbiased proteomics as the market leader, support the build out of Seer’s commercial organization and meet or exceed the commercial targets set for the company. This role will be field and home-office based. 

Responsibilities and goals: 

• Develop a territory and account-based sales plan for the territory 
• Execute the plan for the territory to meet or exceed company goals 
• Deliver presentations on the Seer technology to customers in seminars and smaller meetings 
• Consult customers on the value of Seer technology for deep, unbiased proteomics to ensure the delivery of an exceptional customer experience
• Partner across the company to communicate the needs of customers to drive future product developments and market expansion
• Manage and drive the sales process within a complex sales environment
• Utilize, update and manage the CRM system
• Effectively manage and deliver an accurate forecast for the sales territory
• Drive prospecting and develop new leads in the region to expand the customer base and open up new markets
• Support the expansion of the commercial organization as needed to meet the company goals 

Background and Qualifications: 

• Deep knowledge of biomarker discovery and life science markets 
• 8+ years or equivalent of proven life science capital sales experience and success 
• Highly adaptable and independent professional
• Strong desire to build customer relationships for long term engagement
• Ideal candidate will be based in the region they support 

Education: 

• Life science degree is required 
• MBA or similar business degree desired 

At Seer, base pay is one part of our total compensation package and is determined within a range. This provides the opportunity to progress as you grow and develop within a role. The base pay range for this role is between $140,000 and $160,000, and will depend on the candidates education, skills, qualifications, experience, and location. This position is also eligible for bonus, benefits, and participation in Company’s stock option plan.   

#LI-REMOTE

Position Summary:

The Associate Director, Market Access Marketing will play a key role in supporting the launch of atacicept in a dynamic environment. This role will be responsible for executing market access marketing initiatives, including leading coverage assessments, advancing payer and market research, developing high-quality payer-facing materials, and supporting field team readiness. The Associate Director will work collaboratively with National and Regional Account Directors, Trade & Distribution, Patient Hub, Marketing, Commercial Operations, HEOR, Medical Affairs, and external partners to ensure access strategies are aligned, compliant, and effectively executed in support of launch objectives. The ideal candidate is a strategic, execution-oriented marketer who is highly organized, adaptable, and motivated to contribute to deliver strong launch execution and support the organization as it evolves beyond launch.

Responsibilities:

• Lead hands-on execution of market access marketing initiatives in support of the launch of atacicept.
• Translate access strategy into high-quality, payer-facing marketing materials, including payer value stories, access tools, and resources to support engagement with national and regional payers.
• Lead coverage assessments and competitive access analyses to inform payer trends, access strategies, and evolving market dynamics.
• Deliver training of field-based Market Access teams and ensure readiness with access materials.
• Partner cross-functionally with National & Regional Account Directors, Trade & Distribution, Patient Hub, Marketing, Commercial Operations, HEOR, and Medical Affairs to ensure alignment, consistency, and timely delivery of access-related initiatives.
• Drive launch readiness by managing access marketing deliverables, timelines, and review processes, ensuring materials are accurate, compliant, and available to support launch milestones.
• Manage agencies and external vendors, providing clear direction and oversight to ensure high-quality, on-time execution of access marketing initiatives.
• Operate effectively in a dynamic, pre-commercial environment, adapting priorities and approaches as launch plans and organizational needs evolve.
• Contribute insights from launch execution to inform future indication expansion and lifecycle access strategies, in partnership with cross-functional stakeholders.

Qualifications:

• Bachelor’s degree required; advanced degree (MBA, MPH, PharmD, or related field) strongly preferred.
• 7+ years of relevant experience in pharmaceutical/biotech market access, payer marketing, or related commercial function.
• 4+ years of experience in Market Access Marketing, Patient Support Services, and/or Payer Account Management
• Demonstrated success developing and executing payer-focused marketing tools, preferably in support of a product launch.
• Strong knowledge of the S. payer landscape, reimbursement pathways, and key access drivers across payer segment.
• Thorough understanding of Medical, Legal, and Regulatory (MLR) review processes and experience managing materials through approval.
• Highly organized and detail-oriented, with the ability to manage multiple access marketing workstreams, timelines, and stakeholders simultaneously.
• Proven project management, prioritization, and agility skills in fast-paced, evolving environments.
• Experience managing external vendors and agencies of record, with accountability for quality, timelines, and outcomes.
• Strong collaboration and communication skills, with the ability to influence across functions and levels in a matrixed organization.

Job Title: Senior Scientific Communications Manager        

Location: Remote          

Role Overview: We’re looking for a Senior Scientific Communications Manager to join our growing biotech team. This is a hands-on role for someone who enjoys turning complex scientific and clinical information into clear, accurate, and useful communications for a variety of audiences.

At a small startup, this person will wear multiple hats. You’ll help shape our scientific story externally and internally, while also building and supporting core Medical Information capabilities. That means creating high-quality scientific materials and helping ensure that medical inquiries are addressed in a timely, accurate, balanced, and compliant way.

This role is a great fit for someone who is scientifically strong, highly organized, comfortable with ambiguity, and excited to build processes in a fast-moving environment.

Key Responsibilities: 

Scientific Communications

• Develop and refine clear, compelling scientific messaging across programs and stages of development
• Draft and manage scientific content such as:
• slide decks
• congress materials
• medical Information letters
• medical affairs and training materials
• FAQs and background documents
• external sci comm projects (e.g. webinars, podcast, product theaters, symposia)
• Translate preclinical, translational, and clinical data into audience-appropriate communications
• Partner cross-functionally with Medical Affairs, Clinical Development, Regulatory, and company leadership to ensure scientific accuracy and message consistency
• Help prepare materials for advisory boards, investigator meetings, and scientific congresses
• Contribute to the development of the company’s scientific narrative as programs advance

Medical Information

• Help build and maintain core Medical Information content and processes in an early-stage company environment
• Develop, review, and update standard medical response documents and reference materials
• Research and synthesize literature and internal data to support responses to unsolicited medical inquiries
• Ensure responses are accurate, balanced, evidence-based, and compliant with internal and external requirements
• Partner with Medical Affairs, Regulatory, and Pharmacovigilance to support appropriate documentation and escalation of medical inquiries, adverse events, and product complaints, as applicable
• Maintain a library of response letters, FAQs, and scientific references
• Identify trends in incoming medical questions and share insights with internal stakeholders
• Support training of internal teams on scientific messaging and Medical Information processes
• Help manage external Medical Information vendors or agency partners, when applicable

Other Requirements: the ability to travel at least twice yearly to company all hands meetings and optionally to scientific conferences where you feel your presence is of value

Qualifications: 

• Advanced degree in life sciences preferred
• Approximately 5+ years of relevant experience in scientific communications, medical communications, medical affairs, medical information, or a related biotech/pharma function
• Experience in dermatology or immunology strongly preferred
• Strong scientific writing and editing skills, with the ability to tailor content to different audiences
• Solid understanding of drug development, clinical research, and interpretation of scientific data
• Experience supporting scientific communications deliverables such as presentations and congress materials
• Experience developing or reviewing Medical Information content is strongly preferred
• Strong attention to detail and commitment to scientific accuracy and compliance
• Able to work independently, manage multiple priorities, and adapt quickly in a startup setting
• Experience working with vendors, medical writers, or outsourced contact center/Med Info partners
• Collaborative, practical, and comfortable working across functions with limited structure

Qualifications:

• Required BA/BS in related discipline, a combination of relevant education and applicable job experience may be considered
• Advanced degree in life sciences preferred
• Experience in the dermatology or immunology therapeutic areas highly preferred
• 5+ years of relevant experience in publications, medical affairs, scientific communications, or medical writing within biotech, pharma, or a medical communications environment
• Knowledge of ICMJE recommendations, Good Publication Practice guidelines, and standard publication planning processes
• Strong experience managing scientific publications, including manuscripts, abstracts, and posters
• Demonstrated experience working with and managing external medical writing vendors or publications agencies
• Strong understanding of publication planning, congress execution, and scientific data communication
• Excellent project management skills with the ability to manage multiple complex deliverables simultaneously
• Strong written and verbal communication skills, including the ability to provide thoughtful editorial and strategic feedback
• High attention to detail and commitment to scientific accuracy, quality, and compliance
• Ability to work cross-functionally and build strong relationships in a collaborative, fast-paced environment
• Ability to operate with autonomy and help build processes where structure is still evolving
• The ability to travel twice yearly to company all hands meetings and optionally to scientific conferences where presence is of value

Compensation:

• An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.
• The anticipated salary range for candidates, who will work remotely is $161,000 to $187,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Oruka is a multi-state employer and this salary range may not reflect positions that work in other states.

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

Job Title: Senior Publications Manager         

Location: Remote          

Role Overview: We are looking for a Senior Publications Manager to lead publication planning and execution across our clinical and scientific programs. This role will be responsible for driving high-quality, timely development of manuscripts, abstracts, posters, and related scientific communications in close partnership with internal cross-functional teams and external medical writing vendors.

This is a highly collaborative, hands-on role for someone who understands the strategic importance of publications in biotech and can manage multiple deliverables across a fast-moving environment. The right person will be comfortable building processes, partnering with subject matter experts, and ensuring scientific outputs are accurate, compliant, and aligned with broader medical affairs and development objectives.

This role is ideal for someone who enjoys both strategy and execution and is excited to help build the publications function within a growing biotech company.

Key Responsibilities: 

Publications Strategy and Planning

• Lead development and execution of publication plans aligned with company strategy, clinical milestones, and medical affairs objectives
• Partner with Medical Affairs, Clinical Development, Biostatistics, Regulatory, and other internal stakeholders to identify publication opportunities and priorities
• Help define publication strategy across manuscripts, abstracts, posters, congress presentations, and other scientific outputs
• Maintain visibility into timelines, dependencies, and milestone-driven deliverables across programs
• Track relevant congress deadlines and publication opportunities to support proactive planning

Publication Development and Execution

• Manage end-to-end development of scientific publications, including:
• manuscripts
• review articles
• abstracts
• posters
• oral presentations
• encore materials, as appropriate
• Coordinate author review, internal review, and approval workflows to support on-time delivery
• Ensure materials accurately reflect scientific data and are consistent with agreed messaging and publication objectives
• Partner with internal subject matter experts to shape content direction, interpret data, and resolve comments efficiently
• Support preparation for scientific congresses by driving abstract and poster development from concept through final delivery
• Oversee publication timelines, status trackers, and document version control

Vendor and Agency Management

• Serve as the primary point of contact for external medical writing vendors and publications agencies
• Manage vendor scope, timelines, budgets, and deliverable quality
• Provide clear direction and feedback to vendors to ensure content meets scientific, stylistic, and strategic expectations
• Review drafts critically for scientific accuracy, clarity, completeness, and consistency
• Help establish productive, scalable ways of working with external writing partners
• Monitor vendor performance and help identify opportunities to improve efficiency, quality, and collaboration

Process and Compliance

• Help build and refine publications processes
• Ensure publication activities are conducted in accordance with internal policies, publication standards, and applicable industry guidelines
• Support documentation of publication decisions, authorship rationale, and review history as needed
• Contribute to publication governance, tracking, and planning tools that improve transparency and execution
• Promote high standards for scientific integrity, authorship practices, and publication quality

Qualifications:

• Required BA/BS in related discipline, a combination of relevant education and applicable job experience may be considered
• Advanced degree in life sciences preferred

• Experience in the dermatology or immunology therapeutic areas highly preferred.
• 5+ years of relevant experience in publications, medical affairs, scientific communications, or medical writing within biotech, pharma, or a medical communications environment
• Knowledge of ICMJE recommendations, Good Publication Practice guidelines, and standard publication planning processes.
• Strong experience managing scientific publications, including manuscripts, abstracts, and posters
• Demonstrated experience working with and managing external medical writing vendors or publications agencies
• Strong understanding of publication planning, congress execution, and scientific data communication
• Excellent project management skills with the ability to manage multiple complex deliverables simultaneously
• Strong written and verbal communication skills, including the ability to provide thoughtful editorial and strategic feedback
• High attention to detail and commitment to scientific accuracy, quality, and compliance
• Ability to work cross-functionally and build strong relationships in a collaborative, fast-paced environment
• Ability to operate with autonomy and help build processes where structure is still evolving
• The ability to travel twice yearly to company all hands meetings and optionally to scientific conferences where presence is of value

Compensation:

• An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.
• The anticipated salary range for candidates, who will work remotely is $161,000 to $187,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Oruka is a multi-state employer and this salary range may not reflect positions that work in other states.

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

About Us

About the Role

The Senior Medical Director, Clinical Development will be the clinical and medical strategic lead of one or more clinical trials for DNTH212.

Reporting to the SVP, Clinical Development, you will steer the preparation, review and execution of clinical study synopses and protocols, investigator brochures, and clinical study reports; review SAPs and TLF shells, guide the evaluation of emerging clinical trial data, oversee/guide the data interpretation and data mining, and ensure assigned studies are conducted according to GCPs and SOPs. You will act as a the medical monitor in close collaboration with the CRO medical and clinical monitors, ensure timely recruitment in collaboration with clinical operations, oversee/guide in conducting literature searches and reviews, meta-analyses, and publishing data. You must have experience with Rare Diseases or Rheumatology within the biotechnology or pharmaceutical industries.  

This is a unique opportunity to join a growing organization with an expanding pipeline and lead clinical strategy for auto-immune indications. We are building a culture of individuals who hold our core principles at the center of our operations, with the goal to elevate the care of our patients’ lives. We are open to you working remotely.

Key Responsibilities

• Providing clinical leadership and strategic medical input for all clinical deliverables in the assigned project or section of a clinical program.
• Leading development of clinical sections of trial and program level regulatory documents.
• Driving execution of the program and/or clinical trial in partnership.
• Supporting the Senior Vice President, Clinical Development by providing medical input into Clinical Development Plan (CDP) and Clinical Trial Protocol (CTP) reviews and contributing to/driving development of disease clinical standards for new disease areas.
• Literature review, KOL interactions, attending scientific meetings, and presenting the clinical development plan to the relevant internal stakeholders to help shape the new indication selection process.
• Leading the protocol development for the new selected indication/s, working closely with the relevant external and internal stakeholders.
• As a medical specialist, supporting and leading interactions with external and internal partners and decision boards.
• Medical monitoring of the assigned clinical trial/s, data and safety review and working closely with the clinical operations, and external partners to oversee conduct of the assigned clinical trial/s.
• Working closely with the internal and external stakeholders as well as the clinical sites, and investigators to help ensure timely recruitment.

Experience

• MD with board certification in US, with clinical experience in Immunology or Rheumatology.
• 8+ years of previous experience in clinical research in the CRO/ biotech/ pharma setting preferred. Experience in rare diseases, neurology is highly preferred.
• Proven ability to work with cross functional teams, study vendors and clinical trial sites.
• Strong business communication skills, written and verbal, and comfortable with giving presentations internally and externally.
• Knowledge – thorough understanding of GCP/regulatory requirements.
• Proactiveness – the ability to identify challenges and risks and implement appropriate actions with some supervision.
• Motivation – highly motivated and self-starter; able to organize and perform complex tasks with minimal supervision.
• Collaboration – to coordinate activities of internal cross-functional study team as well as external vendors as applicable.
• Open-mindedness – listen to ideas from others and seek guidance when applicable; inform manager as situations arise to brainstorm and seek best solutions.

Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. We are pioneering a transformational approach to treating cancer by harnessing the ability of the human immune system to recognize and attack diverse cancer cells in each patient. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, which may be a promising option for patients with cancer.

Overview

The Senior Clinical Trial Manager (CTM) in the Research Alliances team will independently lead and is accountable for the planning, execution, management, and reporting of clinical projects supporting Iovance commercial activities, including Expanded Access Programs (intermediate EAP, single-patient and Ex-US Access Programs) and Phase 4 post marketing studies.  In addition, the Sr. CTM/CTM will provide operational leadership for studies within a growing portfolio of Investigator Sponsored collaborations and other non-clinical collaborative research initiatives involving lifileucel and Proleukin. This position works very closely with external vendors, HCPs, as well as multiple Iovance teams: Commercial, Medical Affairs, Regulatory, Safety, Clinical, Biometrics, Quality, Legal, Quality, Supply Chain & Logistics and Manufacturing. 

The ideal candidate will have clinical operations experience within the pharma/biotech arena, be self-motivated, and able demonstrate the ability to manage complex programs independently while collaborating effectively in a dynamic, agile, and evolving organization.

Essential Functions and Responsibilities

• Oversee the timely activation, execution, and management of Expanded Access Programs (EAPs) that support commercial launch activities at authorized treatment centers 
• Leads the activities for the timely activation, execution, and management of Post Marketing study
• Oversee the timely activation, execution, and management of ISTs/non-clinical research projects
• Ensure Sunshine Act reporting data for lifileucel and Proleukin products across Research Alliances programs are collected
• Works closely with Legal to initiate CDAs, clinical trial and service agreements, amendments and change orders for EAPs, Phase 4, Investigator-Sponsored and non-clinical collaborations.
• Manages external contract research organizations involved with EAPs and Phase 4 who will have responsibility for site interaction, site monitoring, patient schedule management, data collection/management, central IRB interaction, and clinical site contracts.
• Oversee drug supplies, co-therapies, and lab supplies for clinical and non-clinical collaboration studies and EAPs.
• Reports to Iovance teams on study status, activity and site/vendor performance. Develops and maintains dashboards and trackers to communicate progress and risks.
• Ensure that Investigative sites submit monthly enrollment logs, safety listings, database transfers and quarterly reports or as required in the study agreements.
• Responsible for the writing and updating workflows, manuals, consent forms, and technical documents to support EAPs, Phase 4, ISTs/collaborations and non-clinical studies.
• Organizes and documents decisions of routine meetings with internal teams, CROs and Investigator/research teams.
• Collect and maintain essential regulatory documents.
• Contribute and lead process improvements by updating or developing SOPs and Work Instructions.  
• Performs additional job-related duties as required to support successful program execution.
• Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
• Perform other miscellaneous duties as assigned. 

Travel - 15% of the time.

Required Education, Skills, and Knowledge

• Bachelor’s degree in health or science-related area with 7+ (Sr. CTM) or 5+ (CTM) years of clinical operations experience in the pharmaceutical or biotech area. Or an equivalent combination of education and relevant experience
• Demonstrated ability to independently initiate and manage Expanded Access Programs and Phase 1–4 clinical trials
• Proven track record of building and maintaining effective relationships with investigative sites and site personnel
• Excellent written and verbal communication skills, with the ability to collaborate across internal and external stakeholders
• Demonstrated ability to work independently, adapt to changing priorities, and manage multiple programs in a dynamic, result-driven environment
• Knowledge of US and Global Regulations and Guidance (ICH-GCP, FDA-CFR)
• Experience in data collection, review and monitoring Phase 1-4 clinical studies
• Demonstrated experience leading phase 1-4 clinical trials and supporting ISTs.
• Demonstrated success in managing clinical studies within timeline and budget.
• Strong interpersonal communication (verbal and written) with the ability to build strong relationships with peers and partners within and across functional teams to engage in high performance.
• In-depth knowledge of Microsoft Office, including MS Word, MS Excel, MS PowerPoint, and MS Outlook
• Previous experience with EDC systems (eClinical, Medidata RAVE, InForm), and electronic Trial Master File systems
• Requires working knowledge of Good Clinical Practices, Food and Drug Administration regulatory reporting requirements, and the regulations and laws governing the pharmaceutical industry (e.g., compliance, Sunshine Act)

Preferred Education, Skills, and Knowledge 

• Oncology/immunotherapy experience
• Phase 4, Expanded Access Program experience

The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodation may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request accommodation.

The physical demands described here represent those an employee may encounter while performing the essential functions of this job. Reasonable accommodation may be provided to enable individuals to perform these functions.

• Ability to remain in a stationary position for extended periods
• Ability to move about within an office or remote workspace and exert up to 10 pounds of force occasionally
• Visual acuity sufficient for preparing and analyzing data, viewing computer screens, and extensive reading
• Repetitive motion involving wrists, hands, and/or fingers
• Ability to communicate effectively to exchange information
• Cognitive: Ability to engage in analytical, conceptual, and problem‑solving activities in a dynamic business environment 

Work Environment

This role operates in a professional office or remote work environment and requires routine use of standard office equipment and technology. Employees working remotely are expected to maintain a safe workspace free from recognized hazards.

#LI-remote

About Us

About the Role

The Director, Clinical Quality Assurance (QA), will be responsible for end-to-end quality oversight of global clinical trials to ensure compliance with applicable regulatory requirements and internal standards.

Reporting to the Sr. Director, Clinical QA, you will provide independent quality oversight of clinical development programs, ensuring that clinical trial conduct, data integrity, and sponsor oversight activities meet expectations of global regulatory authorities (e.g. ICH, FDA, EMA, MHRA, etc.)

You will partner cross-functionally with Clinical Operations, Clinical Development, Data Management, Pharmacovigilance, Bioanalytical, CMC, and Regulatory Affairs teams, while working closely with other functions of the Quality Unit (e.g. Clinical Quality Systems and Quality Systems and Compliance) to ensure the global GCPs are met for our clinical studies and to support inspection readiness and quality system alignment. Your role will be integral in assuring Dianthus is always inspection ready. You must possess experience and skill collaborating and influencing CRO’s, laboratories, and other clinical vendors in order to be successful in this role.

This is a unique opportunity to join a rapidly growing organization and have a significant impact at Dianthus. We are building a culture of individuals who hold our core principles at the center of our operations, with the goal to elevate the care of our patients’ lives. We are open to you working remotely.

Key Responsibilities

• Provide proactive, risk-based quality oversight for global clinical trials across all phases (e.g. Phase I, II, and III).
• Serve as the primary QA lead for clinical development programs, ensuring quality is embedded from study design through close-out.
• Ensure compliance with ICH E6 (R3) GCP and applicable global regulations (e.g. FDA, EMA, MHRA, etc.)
• Provide expert guidance on quality risk management, issue escalation, and mitigation strategies.
• Establish and maintain robust sponsor oversight frameworks for CROs and other third-party vendors.
• Ensure effective oversight of delegated activities, including monitoring, data management, and safety management.
• Collaborate with the Quality Unit to assess vendor qualification, performance metrics, and compliance trends.
• Lead and execute a risk-based GCP audit program, including investigator site audits, clinical vendor/CRO audits, and clinical process/system audits.
• Align audit strategy with clinical milestones and BLA readiness.
• Oversee audit findings, CAPAs, and effectiveness checks, ensuring timely and sustainable resolution.
• Ensure data integrity principles (ALCOA++) are embedded across clinical programs.
• Partner with the Director/Sr. Director of Clinical Quality Systems and the Sr. Director of Quality Systems and Compliance to support inspection readiness activities, provide audit insights and risk signals, contribute to inspection strategy and preparation.
• Participate in regulatory inspections as a QA subject matter expert.
• Act as a trusted advisor to Clinical Development and Operations leadership.
• Drive a culture of quality, compliance, and continuous improvement.
• Provide QA input and conduct QC of protocols, amendments, CSRs, and regulatory submission components.
• Provide quality oversight of bioanalytical activities, including review of bioanalytical method validation documentation to ensure alignment with regulatory expectations and clinical program needs.
• Lead or contribute to quality governance forums and risk review boards.
• Identify and assess systemic quality risks and compliance gaps
• Ensure appropriate classification and management of protocol deviations, serious breaches, and inspection findings.
• Escalate critical risks to senior leadership with clear, risk-based recommendations.
• Additional duties may be identified by functional management based on current project/business objectives.
• Some travel (approx. 20%) is required for company meetings and support of audits or regulatory inspections (e.g. in support of Sr. Director Quality Compliance as needed).

Experience

• BS or MS degree in life sciences or related field required.
• 12+ years of experience in GxP with minimum of 5+ years in GCP within the biotech or pharmaceutical industry.
• Deep knowledge of GCP regulations and guidance’s (e.g. ICH, FDA, EMA, MHRA, etc.)
• Significant experience supporting global clinical trials (e.g. Phase I, II and III).
• Demonstrated experience supporting or leading submissions and regulatory inspections (e.g. BLA, PMA, BIMO).
• Deep expertise of Sponsor oversight and CRO/vendor management responsibilities.
• Deep expertise in data integrity principles and risk-based quality management.
• Demonstrated experience in clinical audit strategies including investigator site audits, audit execution, and CAPA management.
• Experience working with or managing eQMS platforms and quality processes.
• Knowledge of Clinical Quality Systems.
• Experience with project management processes / tools to support in meetings, assist with project planning, and facilitate completion of tasks.
• Proven ability to lead strategically while remaining hands-on in a fast-paced biotech environment and risk-based thinking is critical.
• Proven capability to drive alignment and influence stakeholders across global, cross-functional organizations.
• Ability to translate regulatory expectations into practice, risk-based solutions.
• Excellent communication skills with the ability to engage senior leadership and regulatory inspectors.

We are seeking a highly motivated and results-driven Business Development Manager – West to join our dynamic team at Quantum-Si to uncover and create new business opportunities for Quantum-Si’s next generation protein sequencing products. The ideal candidate will be a self-starter with a hunger for success, capable of driving prospecting efforts and closing deals to achieve sales targets. This role offers the opportunity to work with cutting-edge technologies and make a significant impact in the life sciences community.   

As part of our team, your core responsibilities will be:  

• Prospecting and lead generation:  

• Aggressively hunt, identify, and research potential clients across academia, bio/pharma, biotech, and industry. 

• Conduct proactive outbound prospecting activities, including cold calling, email outreach, tradeshows and regional events. 

• Qualify leads based on their needs, budget, and purchasing authority. 

• Nurture relationships through regular follow ups and engagement. 

• Closing business: 

• Develop and maintain a robust sales pipeline of qualified opportunities. 

• Manage opportunities closely, provide strong forecasting updates, and deliver accurate insights into revenue and adoption.  

• Track and prioritize opportunities to ensure timely and efficient sales cycles. 

• Create and execute effective sales strategies to close capital deals, exceed sales targets, drive consumable revenue growth. 

• Negotiate pricing, terms, and contracts with clients to ensure mutually beneficial agreements that achieve optimal outcomes for both parties. 

Qualifications 

Baseline skills/experiences/attributes: 

• Bachelor’s degree in life science preferred.  

• 4+ years of quota carrying outside sales.   

• Capital sales experience in the research and tools space market with a focus on Proteomics and DNA sequencing. 

• Strong relationships in Pharma, biotech and academic research organizations is desired.  

• Demonstrated track record in lead generation and prospecting.  

• Proven track record of meeting and exceeding sales targets year over year.   

• Strong desire to win business and establish long-term customer relationships.   

• Confident energetic “Hunter” mentality.   

• Highly adaptable and independent.   

• Thrives in a rapidly growing start-up environment. Can pivot when necessary, with a positive attitude.   

• Excellent verbal, written, and computer skills.   

• Take initiative with a strong growth mindset.   

• Mastery of Miller Heiman Strategic and Conceptual selling. 

• Ability to travel smart and maximize commercial productivity in each trip traveled.  Required travel: 60-80% 

• Work is accomplished in a proactive manner without considerable direction.  Able to independently create and develop resolution to complex problems while meeting objectives/goals. 

• Ideally located in San Francisco area or San Diego area, other locations along the west coast will be considered 

Ideally, you also have these skills/experiences/attributes (but it’s ok if you don’t!): 

• Graduate degree in life sciences strongly preferred.  

• Channel sales experience 

The estimated base salary range for this role is: $150,000 - $180,000. Compensation decisions are dependent on several factors including, but not limited to, level of the position, an individual’s skills, knowledge and abilities, location where the role is to be performed, internal equity, and alignment with market data. Additionally, all full-time employees are eligible for our discretionary bonus program and equity as part of the compensation package.   

Quantum-Si does not accept agency resumes. 

Quantum-Si is an E-Verify and equal opportunity employer regardless of race, color, ancestry, religion, gender, national origin, sexual orientation, age, citizenship, marital status, disability or Veteran status. All your information will be kept confidential according to EEO guidelines. 

Position Overview:

Beam is seeking a highly talented and motivated Senior Directory, Gene Therapy Operations (Apheresis) leader to join our growing Commercial Patient Operations team. The Senior Director, Gene Therapy Operations will be responsible for leading Gene Therapy Operations, Apheresis team- the team responsible for 1) treatment center onboarding, training and qualification. 2) Patient Scheduling and Coordination for Apheresis and Drug Product Delivery. 3) Cell collection optimization support. 4) Drug Product storage, thawing, and administration support. The leader will be responsible for defining the strategy and scope and building their team, leading treatment center activation and patient coordination. This leader and their team must have a patient-centric and customer-focused approach to drive commercial launch readiness and execution for Beam’s lead asset, ristocel, an ex vivo autologous hematopoietic stem cell-based gene therapy for the treatment of severe sickle cell disease (SCD). This is a high impact role for Beam’s potential first product commercialization. The successful candidate plays a critical role in building and establishing commercial operations readiness for the company.

Responsibilities:

• Develop and mentor a high performing Gene Therapy Operations, Apheresis team that is focused on delivering an excellent patient and stakeholder experience for commercial gene therapy from scheduling through infusion process.
• Develop and execute the strategic initiative and process for Treatment Center Qualification, training and ongoing support for patient coordination, scheduling, communication, cell collection support, and drug product infusion support.
• Drive Workflow & Training development: Design training to qualify apheresis and treatment centers, leading treatment center activation and certification processes and providing ongoing operational oversight post-activation.
• Quality & Compliance oversight: Ensuring compliance with regulatory standards (FACT, AABB), managing quality records (deviations, CAPAs, change controls) and overseeing the end-to-end process for patient apheresis and product delivery. Ensure COC/COI and assist in the implementation of ISBT-128 ST-018, as needed.
• Partner with Quality and Patient Operations team to build a robust treatment center network including center selection, qualification, training and ongoing support. Lead field team providing onsite support.
• Provide Apheresis expertise to support various internal activities and external facing training development.
• Create and conduct Apheresis and Cell therapy lab on-boarding, assessments, training, and collection support and other areas as needed.
• Build metrics program that will drive data collection and analysis in support of optimizing collection procedures, efficiency, and quality.
• Actively engage in the identification, sharing, and adaptation of best practices cross-functionally and between centers and identify and champion industry working group initiatives that will improve overall cell and gene therapy industry and treatment experience of our patients.
• Work closely across functions to ensure Chain of Identify and Chain of Custody are maintained throughout the patient journey.

Qualifications:

• Bachelor's degree or the combination of education and business experience required.
• Advanced degree preferred (e.g., MBA, RN, MPH, etc.)
• Minimum 10+ years (18+ years) of healthcare or related experience, including significant experience within the biotech industry (especially with cell and gene therapy products).
• Strong direct apheresis experience within the last 5 years.
• Strong preference for experience within Sickle Cell Disease and autologous cell & gene therapy.
• Qualification in Apheresis (QIA) certification preferred.
• Ability to work independently with very limited supervision.
• Ability to navigate and be successful in a fast-paced, highly matrixed work environment.
• Detail-oriented, able to assess and assimilate data and communicate objectively.
• Experience in commercial gene or cell therapy is greatly preferred.
• Good knowledge of GCPs, GMPs, AABB, FACT/JACIE, FDA, EMEA, MHRA, regulations.
• Effective teaching, training, planning, and problem-solving abilities.
• Willingness to travel domestically (30-50% of time).
• Strong team player that has patient focused approach and is solution oriented.
• Excellent listening, communication and interpersonal skills foster team spirit.
• Excellent people management skills and a strong track record of developing people/talent and organizational capability.
• A passion for addressing the critical unmet medical needs of patients.

About Us

About the Role

We are building our Clinical team and need two Senior Clinical Trail Associates who are open to owning end-to-end processes. You will report directly to the respective Senior Director, Clinical Development Operations global leads.

As the Senior Clinical Trial Associate (Sr. CTA)/ Sr. Associate, you will play a crucial role in the Clinical Development Operations (CDO) department to support the planning, execution, and management of clinical trials in accordance with regulatory requirements and industry best practices.  In this role, you will collaborate with cross functional study teams, clinical Research Organizations (CROs), and other external vendors to ensure the successful delivery of clinical study activities.

You must have experience supporting global clinical study teams in order to be successful. Experience in rare diseases is ideal, however not required. We are looking for someone who can grow with our organization and will continue to support your ongoing development. We are building a culture of individuals who hold our core principles at the center of our operations, with the goal to elevate the care of our patients’ lives. We are open to you working remotely.

Key Responsibilities

• Provides support to assigned clinical studies, taking on various responsibilities to support project and study deliverables.
• Coordinates, attends and may lead study team meetings; ensures appropriate meeting scheduling and documentation, including creation, distribution and filing of meeting agendas and minutes.
• Maintains and generates applicable study trackers and documents (for example: action-decision log, storyboard, patient enrollment and IRB approvals).
• Monitors clinical trial insurance and license agreements across studies and work with vendors to ensure current agreements.
• Supports the development and review of study documents, including study manuals.
• Maintains knowledge and acts as team super-user or subject matter expert for study-related systems and processes.
• Manages deliverables and navigates changing priorities.
• Supports the clinical team with coordination and preparation for investigator meetings, PI calls, conferences as well as internal clinical meetings.
• Supports management of the Trial Master File according to Sponsor Oversight plan to ensure accuracy and completeness.
• Assists with study budget oversight, including invoice tracking, reconciliation and collaboration with cross-functional teams and vendors.
• Participates in vendor selection and management meetings (e.g., CROs, IVRS, Central Labs, etc).

Experience

• BA/BS degree or equivalent, relevant work experience.
• Minimum of 5 years’ experience working on clinical studies in pharmaceutical, biotech, or CRO setting preferred. Prior CTA experience required.
• Excellent interpersonal and communication skills with ability to work collaboratively across functional teams.
• Strong organizational and time management skills, and strong attention to detail.
• Knowledge of global regulatory and compliance requirements for clinical research.
• Experience with essential documentation for Trial Master Files required.
• Knowledge of drug development, clinical operation processes, medical terminology, and procedures according to FDA GCP/ICH regulatory guidelines.
• Excellence with MS Office products Word, Excel, SharePoint, PowerPoint.
• Experience working with clinical trial systems (CTMS, IRT, EDC) preferred.
  
  

About this opportunity:

Freenome is looking for a Vice President, Digital Health, as a key member of our rapidly developing Commercial team. The ideal candidate will be a visionary leader with hands-on experience in defining and designing a cohesive digital platform strategy that enables and scales cutting-edge diagnostic solutions within complex healthcare ecosystems, enhancing interactions with patients and providers. This role offers a unique opportunity to bring the digital infrastructure necessary for this game-changing early disease detection technology to be seamlessly integrated into clinical practice.

In this role, you will be instrumental in bridging the gap between Freenome's cutting-edge science and its practical application in physician offices and health systems, ultimately maximizing patient adherence and test utilization. You will contribute to guiding and refining company-level strategy. Your commitment to innovation and seamless user experience will significantly contribute to our growth and our mission to outpace cancer with early detection.

This role will report to the Chief Commercial Officer and will serve as a vital part of the Commercial Leadership Team. This is a remote role with the requirement to travel up to 30% of the time.

What you’ll do:

Digital Health Platform Strategy & Design

• Platform Strategy and Design: Define and drive the long-term vision and design, while informing the architecture for Freenome's digital health platform. This includes performing Voice of the Customer (VOC), maintaining industry and competitor awareness, incorporating innovative/pioneering thinking (true innovation), and integrating advisory committee feedback to support the long-term vision of rules-based medicine programs.
• Partner with the product team to inform the design, architecture, and development of critical platform features and functions, commercial and clinical requirements, such as patient identification, education modules, provider engagement tools, EHR integration, and adherence management systems.
  
• Define and establish strategic ecosystem partnerships that expand Freenome’s access and distribution footprint.
• Partner with Product, RWD, and Medical Affairs to ensure Freenome Digital Health (FDH) enables real-world data collection and linkage to support clinical validity, clinical utility, and HEOR evidence generation for future indication expansion and test improvements.
• Build executive‑level relationships with health system leaders, population health teams, and digital transformation groups to drive adoption of FDH across health systems and integrated delivery networks.
  

Program Performance & Engagement

• Overall Commercial Performance Achievement: Accountable for the achievement of digital health performance goals, ensuring the platform effectively drives utilization, adherence, and customer satisfaction.
• Commercial Performance Metric and Goal Development: Define, track, and manage key performance indicators (KPIs) and goals for all digital health programs.
• KOL and Advisory Committee Engagement: Lead KOL and Advisory Committee engagement for program development, design validation, and establishing program credibility with clinical and technical stakeholders.
• Medical Affairs Partnership: Proactively partner with Medical Affairs to align the digital platform with the publication strategy, ensuring features support evidence design and development needs.
• Continuous Improvement: Evaluate program effectiveness and work with the Product and technical teams to continuously improve program function and scope.
  

Clinical Integrity

• Interoperability and Integration: Act as a primary interface with health-system IT leaders, clinical operations, and informatics teams to scope and negotiate integration requirements.
• Clinical Strategy Representation: Represent Freenome’s clinical strategy in discussions around interoperability, FHIR/HL7 capabilities, ordering modules, clinical decision-support, and results workflows.
• Customer Education: Create crisp education/messaging on the clinical and economic impact of Freenome tests, and help inform customer decision-making to improve population health initiatives.
• Clinical Understanding: Demonstrate a keen understanding of how PCPs and specialists evaluate risk, order tests, and interpret results.
• Ensure clinical messaging and customer-facing workflows align with established medical guidelines and align FDH with health system quality metrics such as HEDIS.
  

Must haves:

• Bachelor's degree in a technical or relevant field.
• 15+ years of progressive commercial or product leadership experience in diagnostics, pharmaceuticals, or biotech, with significant focus on digital health, health IT, or clinical informatics.
• 10+ years in senior leadership roles, with direct responsibility for launching and scaling digital health platforms for clinical use.
• Demonstrated ability to build executive-level relationships with C-suite leaders and key decision-makers across health systems and provider networks.
• Deep expertise in healthcare data standards (FHIR, HL7), EHR integration, and clinical decision support systems.
• Proven track record of identifying and negotiating strategic partnership opportunities that expand distribution, access, and ecosystem impact.
• Strong entrepreneurial mindset and passion for pioneering new digital solutions in a complex, regulated environment.
• Demonstrated ability to closely collaborate with Product and Engineering to design, build and commercialize digital platforms.
• Ability to craft and clearly convey the company’s story compellingly to diverse audiences.
  

Nice to haves:

• Advanced degree (MBA, PhD, CGC, MS in Health Informatics, or similar).
• Experience with AI/ML-driven decision support tools and rules-based clinical programs.
• Experience in oncology or preventative screening.
• SF Bay Area residency is a plus but not mandatory.
  

Benefits and additional information:

The US target range of our base salary for new hires is $293,550 - $383,775. You will also be eligible to receive equity, cash bonuses, and a full range of medical, financial, and other benefits depending on the position offered.  Please note that individual total compensation for this position will be determined at the Company’s sole discretion and may vary based on several factors, including but not limited to, location, skill level, years and depth of relevant experience, and education. We invite you to check out our career page @ freenome.com/job-openings/ for additional company information.  

Freenome is proud to be an equal-opportunity employer, and we value diversity. Freenome does not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.

Applicants have rights under Federal Employment Laws.  

• Family & Medical Leave Act (FMLA)
• Equal Employment Opportunity (EEO)
• Employee Polygraph Protection Act (EPPA)

#LI-REMOTE

About this opportunity:

Freenome is looking for a strategic, high-energy Director of Downstream Marketing to lead the commercial launch and market expansion of our blood-based cancer screening tests. As the first dedicated downstream leader, you will be the bridge between our breakthrough science and the healthcare providers, systems, and patients we serve.

You will own the go-to-market (GTM) execution, demand generation, and sales enablement strategies that turn our clinical evidence into a market-leading commercial brand.

This role will report to the VP, Marketing and  is a remote or hybrid/onsite role with minimal travel requirements. 

What you’ll do:

• Commercial Launch and Campaign Execution: Execute Go-to-Market (GTM) tactics for new products and indications by delivering integrated campaigns and cross-channel collateral and sales enablement tools that translate complex early-detection science into compelling messaging for PCPs and health system stakeholders.
• Customer acquisition and digital marketing: Develop and optimize digital marketing campaigns to drive system, HCP and patient acquisition. Oversee paid media strategy, SEO/SEM, email marketing, and conversion optimization. Use data to continuously test, refine, and scale campaigns based on performance.
• Sales Enablement & Field Support: Partner closely with the Sales and L&D teams to develop high-impact collateral, training modules, and "objection-handling" tools that accelerate the sales cycle.
• Brand Stewardship: Ensure a consistent, high-integrity brand voice across all physician-facing and patient-facing touchpoints.
• Market Intelligence: Monitor the competitive landscape (Liquid Biopsy, Cologuard, etc.) to refine our positioning and maintain Freenome’s competitive edge.
• Agency & Budget Management: Manage external creative and media agencies to deliver high-ROI campaigns while maintaining a disciplined marketing budget.
• External Stakeholder Relations: Build relationships with industry/market thought leaders, customers, societies, internal stakeholders and provide key insights to cross-functional teams.
• Provider Marketing & ABM: Design and execute Account-Based Marketing (ABM) strategies to engage referring physicians and healthcare professionals (HCPs). Partner with field teams to identify target segments and develop tailored content that drives referrals and builds brand trust.
  

Must haves:

• Bachelor’s degree in a business, life sciences, or related field.
• 10+ years of experience in marketing, with at least 5 years specifically in downstream/commercial marketing within the molecular diagnostics, biotech, or medical device space.
• Ability to translate dense clinical data (Sensitivity, Specificity, NPV) into a narrative that a busy physician can understand in 30 seconds.
• Drive to thrive in the "center of the wheel," working across Sales, Medical Affairs, and Product Management to ensure everyone is aligned on the commercial mission.
• Demonstrated data-driven decision making. You don't just "run ads"; you measure conversion rates, CAC (Customer Acquisition Cost), and physician engagement metrics to iterate constantly.
  

Nice to haves:

• Experience launching a PCP-focused diagnostic test is a significant plus.
• Familiarity with the reimbursement landscape and how it affects downstream adoption.
• MBA or advanced degree in life sciences preferred.
  

Benefits and additional information:

The US target range of our base salary for new hires is $197,200 - $281,400. You will also be eligible to receive equity, cash bonuses, and a full range of medical, financial, and other benefits depending on the position offered.  Please note that individual total compensation for this position will be determined at the Company’s sole discretion and may vary based on several factors, including but not limited to, location, skill level, years and depth of relevant experience, and education. We invite you to check out our career page @ freenome.com/job-openings/ for additional company information.  

Freenome is proud to be an equal-opportunity employer, and we value diversity. Freenome does not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.

Applicants have rights under Federal Employment Laws.  

• Family & Medical Leave Act (FMLA)
• Equal Employment Opportunity (EEO)
• Employee Polygraph Protection Act (EPPA)

#LI-REMOTE