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Job Title: AD or Director, Regulatory Affairs Strategy Location: Florham Park, NJ (10 days onsite per month) Type: 12-month contract Must haves: Must be local for hybrid schedule - fully remote is NOT an option. Must have Module 5 expertise. Must have regulatory strategy experience in IND/NDA development, not just life cycle management. Must have regulatory strategy experience in IND/NDA development, not just life cycle management. Overview Support the Regulatory Affairs (Executive Director) in developing and executing regulatory strategies for antiviral programs globally or within specific regions Requirements Bachelor's degree in a scientific discipline such as life sciences, pharmacy, bioscience; advanced degree preferred. 7+ years of experience in regulatory affairs within the pharmaceutical or biotech industry, with a focus on antiviral products preferred. Demonstrated ability to work effectively in a cross-functional team environment. Strong knowledge of regional regulatory requirements and guidelines, including FDA regulations and ICH guidelines. Excellent communication and interpersonal skills. Responsibilities Assisting in preparing presentations, reports, and strategic documents for leadership discussions. Maintaining and tracking project timelines, action items, and regulatory deliverables to ensure smooth execution. Organizing and documenting meeting minutes and action items to support the leader’s strategic planning. Contributing to the preparation and submission of regulatory documents related to antiviral programs to regulatory authorities. Conducting research on regulatory trends, competitor strategies, and market intelligence to provide background insights. Assist in Coordinating with Global Regulatory Counterparts to Align Regional Strategies and Submissions with Global Development Plans and Regulatory Strategy Plans ESTABLISH DELIVERABLES & PERFORMANCE EXPECTATIONS Preparation of Type C/B/D Meetings for antivirals in clinical development (as needed) Contributions to and finalization of regulatory strategy plans and implementation for antivirals in development (including 2 new IND applications and 1 NDA) Knowledge of and Compliance with FDA, EMEA, PMDA guidances Performance will be monitored via regular review by the Executive Director and feedback on the strategist's work. This will include review of meeting minutes, timelines and draft submission packages. Performance metrics will include completion of regulatory submissions, adherence to timelines, and the quality of submissions The Executive Director, Regulatory Affairs will review and approve completed work. Benefits System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan. #LI-LM1

Senior Regulatory Affairs Manager. Support global regulatory teams and/or in-country dealers/representatives with regulatory registrations of IVD products. Supports North America regulatory activities.

Job Description Company introduction: Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. The Company is headquartered in London, UK, with offices in New York City in the US. We focus on developing novel treatments that have the potential to improve the lives of those who are suffering with mental health conditions and who are not helped by current treatments. We are pioneering a new paradigm for treating mental health conditions focused on rapid and durable responses through the development of our investigational COMP360 synthetic psilocybin treatment, potentially a first in class treatment. COMP360 has Breakthrough Therapy designation from the US Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD) due to the pressing unmet need in this area. We are currently in phase 3 for TRD, have completed phase 2 studies for both post-traumatic stress disorder (PTSD) and anorexia nervosa and are planning a further late-stage study in PTSD. We envision a world where mental health means not just the absence of illness but the ability to thrive. - Compass Pathways. Job Overview: The Senior Director, Clinical Safety and Pharmacovigilance plays a key leadership role in driving our patient safety and shaping risk management strategies across global clinical development. This position offers the opportunity to champion pharmacovigilance excellence, proactively manage safety signals, and steer impactful medical monitoring in an innovative, science-led environment. Location: Remote on the East Coast, United States or hybrid in our NYC office. Reports to: Vice President, Clinical Safety and Pharmacovigilance. Roles and responsibilities (Include but are not limited to): • Serve as drug safety SME for Compass clinical development programs and as primary Sponsors medical contact or medical monitor for assigned Phase 1-3 studies, • Lead safety activities, benefit-risk strategies, and safety signal management for assigned studies and compounds, • Oversee aggregate safety review documents, safety labelling, and safety sections of clinical trial documents and regulatory filings, ensuring compliance with global regulations, • Oversee and manage vendors/CROs supporting Safety/PV functions, • Identify, evaluate, and manage safety signals through comprehensive data analysis author safety signal assessments and aggregate reports, • Prepare, coordinate, and submit safety reports (PSURs, DSURs, CIOMS, etc.) to regulatory authorities ensure ongoing compliance with local and international regulations, • Develop, maintain, and provide training on SOPs, PV processes, and procedures in accordance with Good Pharmacovigilance Practices (GVP), • Collaborate with cross-functional teams (clinical operations, regulatory affairs, medical affairs) to address safety issues and develop effective risk minimization strategies, • Manage and develop PV scientists and mentor/supervise colleagues as positive change agents, • Represent Compass at Health Authority inspections, DMC meetings, and provide input to R&D publication strategy, • Maintain thorough and accurate documentation of safety data, supporting timely and quality submissions and presentations, • Ensure all responsibilities are performed efficiently, accurately, and cost-effectively in line with current global regulatory and quality standards, • Accountable for compliance with ethical and scientific standards, regulatory requirements, and the Compass Quality Management System, ensuring participant safety, data integrity, and accuracy throughout the trial process, • MD/DO/MBBS required with considerable experience in the pharmaceutical industry, predominantly in the drug safety/medical monitoring function track record of successful product launch, • Extensive industry experience in CNS, ideally psychiatry, • Demonstrated working knowledge of cGCP, ICH, and other relevant clinical development EU/US regulations and processes, • Experience/in-depth understanding of clinical trial/drug development from a regulatory perspective, • Excellent written and oral English communication and presentation skills and interpersonal skills to engage internal and external leaders proactively, • Proven ability to work effectively on a team in a collaborative environment Please note that the base salary range is a guideline, and individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location. Base pay is one part of the Total Package that is provided to compensate and recognise employees for their work and any role at Compass, regardless of the location, is eligible for additional discretionary bonuses and equity. 【Base salary per annum】:$260,000—$320,000 USDBenefits & Compensation: For an overview of our benefits package and compensation information, please visit "Working at Compass". Equal opportunities: Reasonable accommodation We are committed to building a workplace where everyone's wellbeing matters. If you need reasonable accommodation during the interview process to be at your best, please let our recruiting team know. UK applicants We are proud of our commitment to diversity and equality (pursuant to the Equality Act 2010). We do not discriminate based upon race, religion or belief, colour, nationality, ethnic or national origin, gender, pregnancy or maternity, marital or civil partner status, sexual orientation, gender reassignment, age or disability. US applicants Compass Pathways is proud to be an equal opportunity employer. All employment decisions are based on business needs, job requirements, and individual qualifications, without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, and related medical conditions), ethnicity, age, disability, sexual orientation, gender identity, gender expression, military service, genetic information, familial or marital status, or any other status, category, or characteristic protected by applicable law. Sponsorship: Unfortunately, we cannot sponsor employment visas and can only accept applications if you have employment rights in the country to which you are applying. Data Privacy: All data is confidential and protected by all legal and data privacy requirements, please see our recruitment Privacy Notice to learn more about how we process personal data.

Job Description Regulatory Affairs Associate – Managed Long Term Care (MLTC) Compensation: $150K–$170K per year Job Type: Monday through Friday, 9:00 AM to 5:00 PM. This role will be fully onsite for the first 90 days during the probationary period. After that, the position transitions to a hybrid schedule: 3 days in the office and 2 days remote. Our client, is seeking a Regulatory Affairs Associate to support and coordinate compliance activities within its health plan operations. This position plays a critical role in ensuring regulatory alignment across various programs, contracts, and legal matters, including CMS, DOH, OIG, and OMIG compliance. Responsibilities • Draft, review, and negotiate provider and organizational agreements in accordance with internal policies and compliance standards., • Lead and manage data collection and submissions for external audits, surveys, and government requests., • Oversee provider contracting processes and manage follow-up communications., • Administer Fair Hearing (FH) cases, including calendar management, case prep, documentation, and hearing attendance., • Handle regulatory reports and provide updates on ongoing cases and investigations., • Participate in Special Investigation Unit (SIU) functions, including compliance reporting and internal investigations., • Update HIPAA-related policies and procedures to ensure compliance with current regulations., • Maintain awareness of and ensure adherence to OIG and OMIG compliance practices and requirements., • Review state and federal plan contracts to ensure consistency with regulatory standards., • Distribute and interpret CMS and DOH updates, memos, and official regulatory guidance., • Coordinate document production in response to legal matters or litigation requests., • Maintain internal databases related to provider credentials and other compliance documentation., • Draft and revise internal policies, procedures, manuals, and member-facing plan materials., • Juris Doctor (JD) from an accredited institution, • Must be a Licensed Attorney, • Minimum of 3 years’ experience in managed care compliance, credentialing, or contracting, • Familiarity with MLTC, MAP, Medicaid, and Medicare program regulations, • Demonstrated leadership or supervisory experience, • Strong legal and analytical skills related to contract review and compliance oversight, • Medical, • Dental, • Vision, • 403B with employer match, • Life insurance, • Flexible Spending Account, • Employee Assistance Program (EAP), • Pet insurance, • Tuition Reimbursement Program If you're excited about the potential of this role, we’d love to hear from you!

Job Description About Cleerly We're Cleerly – a healthcare company that's revolutionizing how heart disease is diagnosed, treated, and tracked. We were founded in 2017 by one of the world's leading cardiologists and are a growing team of world-class engineering, operations, medical affairs, marketing, and sales leaders. We raised $223M in Series C funding in 2022 which has enabled rapid growth and continued support of our mission. In December 2024 we received an additional $106M in a Series C extension funding. Most of our teams work remotely and have access to our offices in Denver, Colorado, New, York, New York, Dallas, Texas, and Lisbon, Portugal with some roles requiring you to be on-site in a location. Cleerly has created a new standard of care for heart disease through value-based, AI-driven precision diagnostic solutions with the goal of helping prevent heart attacks. Our technology goes beyond traditional measures of heart disease by enabling comprehensive quantification and characterization of atherosclerosis, or plaque buildup, in each of the heart arteries. Cleerly's solutions are supported by more than a decade of performing some of the world's largest clinical trials to identify important findings beyond symptoms that increase a person's risk of heart attacks. At Cleerly, we collaborate digitally and use a wide variety of systems. Our people use Google Workspace (GMail, Drive, Docs, Sheets, Slides), Slack, Confluence/Jira, and Zoom Video, prior experience in these areas is a plus. Role or department specific technology needs may vary and will be listed as requirements in the job description. While we are mostly a remote company, travel is required for some team meetings and cross function projects typically once per month or once per quarter, for some roles like sales or external facing roles travel could be up to 90% of the time. About the Opportunity As Senior Manager, Regulatory Affairs, you will oversee regulatory activities and personnel to support Cleerly's product development, global market access and compliance objectives. You will help contribute to Cleerly's regulatory team in the areas of regulatory strategy, regulatory intelligence, and regulatory operations including submissions. You will build a team of regulatory professionals, ensuring high-quality execution of Cleerly's regulatory strategy, submissions; provide guidance to cross-functional teams, and adherence to evolving global regulatory requirements. This role combines hands-on regulatory expertise with leadership responsibilities, contributing to departmental strategy and talent development. You will support inspections and/or audits from health authorities, support and/or lead global regulatory and compliance initiatives and provide regulatory and compliance guidance while helping to develop, lead and manage the regulatory team. Responsibilities Digital Health & SaMD Regulatory Leadership • Lead the regulatory strategy for Cleerly's AI and Software as a Medical Device (SaMD). This includes authoring and managing submissions for key markets (e.g., FDA 510(k), De Novo; EU CE Marking under MDR)., • Collaborate closely with R&D and product teams to ensure regulatory requirements are integrated into the design and development of our Cleerly's software and AI medical devices., • Develop and maintain a robust regulatory intelligence program to monitor, analyze, and communicate changes in the global regulatory environment., • Establish and manage the Ad Promo review process to ensure all commercial and marketing materials are compliant, truthful, and non-misleading., • Drive the optimization of regulatory workflows and information systems. This includes refining submission templates, managing regulatory documentation within the Quality Management System (QMS), and implementing efficient process management tools., • Champion a culture of regulatory compliance throughout the organization., • Your expertise will be crucial during internal and external audits (e.g., FDA inspections, Notified Body audits), ensuring our operations are consistently inspection-ready. People Leadership & Team Management: • Manage and mentor regulatory staff, providing coaching, feedback, and professional development., • Delegate responsibilities effectively, balancing oversight with empowerment of team members., • Conduct performance reviews and contribute to talent management practices. Other Responsibilities • Maintain knowledge of industry trends, regulatory changes, and emerging best practices by reviewing relevant resources regularly., • Contribute to the development and maintenance of Regulatory Affairs working practices and Standard Operating Procedures., • Performs other duties as required or assigned to enable effective functioning of the Regulatory Affairs department. Requirements • Minimum 10 years of medical device experience in a regulatory affairs role required., • Minimum 5 years' experience directly related to AI/ML-based medical devices or software as a medical device (SAMD)., • Minimum 5 years' direct people management experience preferred (e.g., leading individual contributors or project teams) preferred., • Experience in global regulatory submittals and applications for medical devices required (AI/ML SaMD preferred)., • Experience in supporting External 3rd Party Audits and Inspections required., • Education: B.S. or higher degree in a Life Science, Engineering or related discipline., • Regulatory Affairs Certification (RAC) preferred., • Demonstrated experience in developing regulatory strategy for novel software (SaMD) or AI/ML-driven medical devices is required.", • Experience with the De Novo classification process and/or Breakthrough Device Designation program is highly desirable.", • Proven ability to collaborate with and influence cross-functional technical teams (e.g., data science, engineering) to achieve regulatory objectives, • Demonstrated knowledge and experience in the identification and interpretation of global regulations, guidelines, and compliance. Must be able to independently coordinate and oversee interdisciplinary project team in quality and timely delivery and compilation and retention of submission documents. *Total Target Compensation (TTC): Total Cash Compensation (including base pay, variable pay, commission, bonuses, etc.). Each role at Cleerly has a defined salary range based on market data and company stage. We typically hire at the lower to mid-point of the range, with the top end reserved for internal growth and exceptional performance. Actual pay depends on factors like experience, technical depth, geographic location, and alignment with internal peers. Working at Cleerly takes HEART. Discover our Core Values: • H: Humility- be a servant leader, • E: Excellence- deliver world-changing results, • A: Accountability- do what you say; expect the same from others, • R: Remarkable- inspire & innovate with impact OUR COMPANY IS AN EQUAL OPPORTUNITY EMPLOYER. We do not discriminate on the basis of race, color, national origin, ancestry, citizenship status, protected veteran status, religion, physical or mental disability, marital status, sex, sexual orientation, gender identity or expression, age, or any other basis protected by law, ordinance, or regulation. By submitting your application, you agree to receive SMS messages from Cleerly recruiters throughout the interview process. Message frequency may vary. Message and data rates may apply. You can STOP messaging by sending STOP and get more help by sending HELP. For more information see our Privacy Policy (). All official emails will come from @cleerlyhealth.com email accounts. #Cleerly

Job Description Our client, a distinguished leader in the pet care sector, is looking for a seasoned Senior Regulatory Affairs Specialist with pesticide expertise. This strategic position presents an exceptional opportunity to become part of an expanding regulatory department during a pivotal period, featuring clear advancement opportunities as executive leadership prepares for future transitions. In this role, you will serve as the key regulatory expert for pesticide products throughout North America, ensuring regulatory excellence while facilitating product innovation in the pet care market. This position uniquely combines technical regulatory mastery, interdisciplinary teamwork, and authentic career progression within a highly regarded company. Cross-Functional Collaboration & Advisory: • Deliver specialized consultation to R&D, Marketing, Sales, and Executive teams regarding pesticide regulatory requirements, • Participate in docket evaluation committees to assess public information related to pesticides, • Review and validate marketing materials and product labeling for regulatory compliance, • Direct the development and submission of complete regulatory packages, encompassing toxicological and regulatory elements, • Establish comprehensive knowledge of testing methodologies, procedures, and criteria necessary for successful Agency clearances, • Oversee adverse event monitoring, categorization, and reporting to federal, state, and international regulatory bodies, • Research and address compliance challenges, inquiries, or concerns from internal departments, clients, and governmental authorities, • Maintain regulatory adherence for all pesticide formulations (topical treatments, collars, shampoos) throughout North America (United States, Canada, Mexico), • Administer federal and state product registrations, modifications, renewals, and labeling compliance under FIFRA guidelines, • Function as the principal contact with EPA and state regulatory authorities, • Pesticide Expertise: Demonstrated experience leading dossier development and new pesticide product registration (full ownership responsibility, not supportive roles), • Education: Bachelor's degree in Chemistry, Biology, Entomology, or equivalent scientific discipline, • Technical Skills: Excellent analytical and critical thinking capabilities; advanced proficiency in Microsoft Office applications, • Systems Proficiency: Operational experience with National Pesticide Information Retrieval System (NPIRS) and Pesticide Product and Label System (PPLS), • Experience: 5+ years minimum in Regulatory Compliance/Affairs within EPA-regulated product industries, with specific FIFRA experience, • Communication: Outstanding written and oral communication abilities, capable of interpreting complex regulatory frameworks and counseling stakeholders, • Travel: Flexibility to travel approximately 5% for business requirements, • Regulatory Knowledge: Extensive understanding of U.S. federal and state pesticide registration standards, regulations, and procedures Health & Wellness: • Employee Assistance Program (EAP) providing mental health resources, • Comprehensive Medical, Dental, and Vision coverage, • Wellness initiatives and programs, • Hybrid work arrangements (fully remote options available for exceptional candidates), • Pet-friendly workplace environment (dogs and cats encouraged!), • Relaxed, inclusive organizational culture, • Pet insurance discounts, • Healthcare Flexible Spending Account (FSA), • Paid parental leave benefits Pet bereavement leave, • Annual performance-based bonus eligibility, • Base Compensation: $135,000 - $150,000 (commensurate with experience and qualifications), • Relocation sign-on bonus up to $5,000 for candidates moving independently Equal Employment Opportunity and Non-Discrimination Policy Equal Employment Opportunity Statement: Both Keller Executive Search and our clients are Equal Opportunity Employers. For all positions, whether with Keller Executive Search or our clients, qualified applicants will receive consideration for employment without regard to race, skin color, religion, sex, sexual orientation, gender identity, gender expression, national origin, age, protected veteran status, disability, genetic information, or any other legally protected status. Commitment to Diversity: Keller Executive Search and its clients are committed to fostering a diverse and inclusive work environment where all individuals are valued and respected. Reasonable Accommodations: Both Keller Executive Search and our clients are committed to providing reasonable accommodations to individuals with disabilities and pregnant individuals. We engage in an interactive process to determine effective, reasonable accommodations. Compensation Information: For client positions, compensation information is available in the job post. If not provided, it will be shared during the interview process in accordance with applicable laws. When required by law, salary ranges will be included in job postings. Actual salary may depend on skills, experience, and comparison to current employees in similar roles. Salary ranges may vary based on role and location. Compliance with Laws: Both Keller Executive Search and our clients comply with federal, state, and local laws governing nondiscrimination in employment. This policy applies to all employment terms and conditions, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training. Workplace Harassment: Both Keller Executive Search and our clients expressly prohibit any form of workplace harassment based on race, skin color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status. E-Verify Participation: Keller Executive Search and/or our clients may participate in E-Verify. Information about E-Verify participation will be provided during the application process where applicable. Privacy and Pay Equity: California Residents: For more information about the categories of personal information we collect for recruiting and employment purposes, please review our Privacy Policy at . Colorado, Nevada, New York City, California, and Washington Residents: Compensation information is available in the job post or will be provided during the interview process if not initially available. Both Keller Executive Search and our clients are committed to pay equity and conduct periodic pay equity analyses in accordance with applicable laws. State-Specific Information: Rhode Island: We do not request or require salary history from applicants. Connecticut: We provide wage range information upon request or before discussing compensation. 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Job Description The START Center for Cancer Research (“START”) is the world’s largest early phase site network, fully dedicated to oncology clinical research. Throughout our history, START has provided hope to cancer patients in global community practices by offering access to cutting edge trials throughout the US and Europe. Today, with over 1,300 studies completed, and with research facilities in the United States and in Spain, Portugal, and Ireland, START’s mission is to accelerate the development of new anticancer drugs that will improve the quality of life and survival for patients with cancer and lead to its eventual cure. To date, over 43 therapies conducted at START locations have obtained FDA/EMA approval. Incredibly, while Academic Medical Centers (AMCs) conduct 80% of cancer trials, such trials reach only 20% of the patient population – leaving the majority of patients who are treated in community practices and hospitals without access to a clinical trial when their care journey calls for one. START serves the many – by bringing cancer trials to physicians and their patients in community hospitals and practices when hope is needed most. START represents the world’s largest roster of Principal Investigators (PIs) across its eight clinical trial sites. Committed to accelerating passage from trials to treatments, START delivers hope to patients, families, and physicians around the world. As an example, in San Antonio, where START was founded, START treated the first patient ever with Keytruda – the most effective cancer drug in medical history. We are hiring a motivated Data Coordinator who will collect, enter/transcribe, and transmit/submit clinical data for assigned investigational drug studies. This position is onsite at our NYC-Long Island Location (450 Lakeville Road, Entrance A, Lake Success, NY 11042). The hourly rate for this role is $24-$27 per hour. However, hourly rate may vary depending on multiple individualized factors including market location, job related knowledge, skills, and experience. Essential Responsibilities • Collect, enter/transcribe, and transmit/submit clinical data in paper and/or electronic case report forms (CRFs), including correction and query resolution for assigned investigational drug studies., • Receive and request patient records/data from the study team as required to complete CRFs for assigned studies., • Review patient data for completeness and accuracy for assigned studies., • Coordinate and schedule monitor visits for assigned studies. This includes exit meetings with monitors to review data or queries., • Identify lab facilities used for assigned studies and communicate to the Regulatory Affairs staff so that lab certifications can be requested for the study file., • Review and utilize protocols as guides for study activities for assigned studies., • Assure that data entry remains current for all assigned studies., • Attend meetings as required for assigned studies. This includes, but is not limited to, site initiation meetings, monitor exit meetings, close-out visit meetings, and audit preparation meetings., • Be available and on-site, if required, during audits for assigned studies., • Bachelor’s degree or equivalent experience in lieu of degree., • Ability to accurately perform data review and CRF completion in its entirety with minimal direction., • Familiarity with medical terminology., • Travel required up to 10% of the time., • Sitting for extended periods of time., • Comprehensive health coverage: Medical, dental, and vision insurance provided, • Robust retirement planning: 401(k) plan available with employer matching, • Financial security: Life and disability insurance for added protection, • Flexible financial options: Health savings and flexible spending accounts offered, • Well-being and work-life balance: Paid time off, flexible schedule, and remote work choices provided, • Plus, we work to maintain the best environment for our employees, where people can learn and grow with the company. We strive to provide a collaborative, creative environment where everyone feels encouraged to contribute to our processes, decisions, planning, and culture. More about The START Center for Cancer Research Deeply rooted in community oncology centers globally, The START Center for Cancer Research provides access to specialized preclinical and early-phase clinical trials of novel anti-cancer agents. START clinical trial sites have conducted more than a thousand early-phase clinical trials, including for 43 therapies that were approved by the FDA. START represents the world’s largest roster of Principal Investigators (PIs) across its eight clinical trial sites. Committed to accelerating passage from trials to treatments, START delivers hope to patients, families, and physicians around the world. Learn more at STARTresearch.com. Ready to be part of a team changing the future of cancer treatment? Join us in our mission to conquer cancer, one clinical trial at a time. Your expertise and dedication can help us bring hope and healing to patients worldwide. Please submit your application online. We are an equal opportunity employer that welcomes and encourages diversity in the workplace. We do 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.

Job Description Human Factor Lead Type: Part-Time Hours Per Week: 25 hours + (Could be more) Note: For the right candidate the goal is to convert Number of Positions: 1 Work Style: Remote Hours in Work Week: EST Targeted Start Date: Monday, June 2nd Estimated End Date: End of September 2025 Expenses: Reimbursed by approval of HM Work Schedule: 9am - 5pm OT: Potentially, approved by HM Interview Process: Up to 2 Teams interviews, 30 mins each Pre-Hire Onboarding Requirements: Background Check and Onboarding - NO DRUG SCREEN, NO PCP Job Description: Reporting to the Medical affairs (MA), this role defines work roles and oversees human factors, user experience, and preclinical activities for direct reports and extended core-team team members. Ensures MA function has necessary skills and resources to execute on develop projects as part of business goals and associates are compliant in following procedures. The Senior Manager will lead a Human Factor reviews and all related activity including management, schedule, and verifications. In this key strategic and technical leadership role, additional responsibilities will be to ensure collaboration with peer leaders across R&D, Quality, Marketing, Clinical and Scientific Affairs, Operations, R&D and Regulatory functions as well as any other key stakeholders including those external to . This person must ensure compliance with ethics, quality policies, procedures, and practices through appropriate communication, training, and education of sound quality assurance principles. They must also ensure compliance with all local, state, federal, and safety regulations, policies, and procedures. Guide completion of major programs, including Human Factors Validation in support of new product development and sustaining engineering. Collaborate with peer leaders in product development as well as technology development efforts. Partner internally and externally to implement best practices, regulatory standards and guidelines to generate high quality information to ensure innovative device design to meet unmet medical needs in alignment with the mission. Manage the human factors activities defined in program goals such as: user interface, user experience, Instructions for Use (IFU), formative studies, and summative studies. Help shape the overall vision and strategy for human factors engineering within and support preclinical, clinical tests. Advise and inform the leadership staff to develop strategy, tactics, and execution of development plans. Provide expert guidance, technical & process insight for core teams to overcome challenges and meet business expectations for product development. Create a team culture that supports open communication, collaboration across teams and empowerment to employees Experience and Education Minimum of a Bachelors degree in Human Factors/Ergonomics Engineering, Applied Science in Industrial Engineering, Industrial and Systems Engineering, Engineering Psychology, Bioengineering, Biomedical Engineering, or a closely related technical or scientific degree is required. 8+ years demonstrated experience (based on own subject matter expertise) in human factors engineering or equivalent user-based test experience. Established expertise in areas including risk management, user needs research such as: translating HF+UXD findings into user-needs/requirements, user risk, and/or design solutions related to the user interfaces, management of human factors and usability engineering file. Strong experience with relevant medical device standards, including IEC 62366-1, ISO 13485, ISO 14971, FDA Guidance for Design Controls. 8+ years of experience in product development; Medical Device experience highly desired. Masters degree in Human Factors/Ergonomics Engineering, Applied Science in Industrial Engineering, Industrial and Systems Engineering, Engineering Psychology, Bioengineering, Biomedical Engineering, or a closely related technical or scientific degrees are preferred. Excellent verbal and writing skills as well as presentation expertise to senior level leadership. Advanced leadership, interpersonal and influencing skills. Organizational awareness and ability to garner support at all levels for a course of action. Strong experience with relevant medical device standards, including IEC 62366-1, ISO 13485, ISO 14971, FDA Guidance for Design Controls. Demonstrated breadth and depth of technical, organizational and leadership capabilities, including strengths in most of the competency areas listed below and solid product development knowledge and expertise.

Job DescriptionAssociate General Counsel Fully Remote | Fast-Growing Biotech/Pharma Company Compensation: $200,000 – $300,000 Base + More Join a mission-driven biotech company transforming the future of rare autoimmune disease treatment. We’re developing innovative therapies for patients who need them most—and we’re looking for a strategic legal partner to help guide our growth. About the Role We’re adding an Associate General Counsel to our dynamic legal team. Reporting directly to the General Counsel, you’ll be a key business partner across the company, providing practical legal advice, driving compliance initiatives, and ensuring that we move fast while staying grounded in ethics and integrity. This is an opportunity to do meaningful work at the intersection of science, law, and business—where your impact will be felt across patients, employees, and the broader healthcare community. What You’ll Do * Keep Us Compliant: Navigate the complex biotech regulatory landscape and ensure we’re ahead of the curve on evolving laws. * Strengthen Our Culture of Integrity: Develop and deliver engaging training on compliance topics—from our Code of Conduct to anti-bribery and anti-kickback rules—while continuously refining company policies. * Be a Deal-Maker: Draft, review, and negotiate critical agreements (clinical trial, licensing, manufacturing, research collaborations, vendor, and more). * Enable Commercial Success: Partner with the commercial team to review promotional materials, advertising, and other go-to-market initiatives. * Protect and Empower: Spot legal risks early, propose smart solutions, and balance business agility with compliance. * Collaborate Across Teams: Work side-by-side with colleagues in R&D, Regulatory Affairs, Quality, HR, Finance, and Commercial to deliver clear, actionable guidance. * Be a Trusted Advisor: Foster trust at every level of the organization, championing ethical business practices and sound judgment. What You’ll Bring * JD (or equivalent) with active bar membership in good standing. * 10+ years of legal experience in biotech, pharma, or life sciences (in-house or at a top firm advising clients in these sectors). * Deep knowledge of the regulations shaping the biotechnology industry. * Proven success drafting and negotiating complex agreements. * Familiarity with global privacy frameworks (e.g., GDPR). * A reputation for providing clear, business-oriented legal counsel in fast-moving environments. * Exceptional communication and relationship-building skills—you can talk science with scientists, strategy with executives, and compliance with employees. * Impeccable ethics, attention to detail, and the ability to juggle multiple priorities without losing focus. Why Join Us? This isn’t just another legal role. It’s a chance to help shape a high-growth biotech company as it brings life-changing medicines to market. You’ll work with passionate, driven colleagues in a collaborative environment where your voice matters and your work has a direct impact on patients’ lives. If this sounds like something you are interested in, apply today!

Job Description Company introduction: Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. The Company is headquartered in London, UK, with offices in New York City in the US. We focus on developing novel treatments that have the potential to improve the lives of those who are suffering with mental health conditions and who are not helped by current treatments. We are pioneering a new paradigm for treating mental health conditions focused on rapid and durable responses through the development of our investigational COMP360 synthetic psilocybin treatment, potentially a first in class treatment. COMP360 has Breakthrough Therapy designation from the US Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD) due to the pressing unmet need in this area. We are currently in phase 3 for TRD, have completed phase 2 studies for both post-traumatic stress disorder (PTSD) and anorexia nervosa and are planning a further late-stage study in PTSD. We envision a world where mental health means not just the absence of illness but the ability to thrive. - Compass Pathways. Job overview: The Associate Director, Clinical Sciences is accountable for the scientific leadership and operational excellence of protocol strategy and clinical document development across assigned assets, ensuring robust clinical rationale, endpoint strategy, and patient-centered design aligned with regulatory and launch objectives. The role partners closely with Clinical Operations, Statistics & Data Management, Medical Affairs, Regulatory Sciences, Clinical Safety, and HEOR to deliver high-quality protocols, IB/ICF content, and key clinical components of NDAs, enabling timely, compliant, and insight-driven decision making. Location: Hybrid in our New York City office or remote on the East Coast in the United States. Reports to: Vice President, Clinical Development. Roles and responsibilities (Include but are not limited to): • Lead authorship and scientific integrity of clinical protocols, synopses, amendments, and key trial documents, integrating disease biology, patient journey insights, and regulatory feedback for psychiatric indications, • Lead SOPs, templates, and scalable processes that implement quality and velocity across the development portfolio, • Define study objectives, endpoints, inclusion/exclusion criteria, and statistical considerations in partnership with Statistics, aligning with target product profile and pivotal-readiness standards, • Drive cross-functional protocol development forums, ensuring timely input from all relevant functions, and resolving scientific and operational trade-offs with clear decision logs, • Contribute to NDA/MAA clinical components, including clinical summaries, study reports, and responses to regulatory queries, • Ensure evidence plans anticipate payer and access needs by partnering with HEOR/RWE to harmonize endpoints, PROs, and real-world relevance from protocol inception, • Champion patient-centric design, incorporating feasibility data, KOL feedback, and ethical considerations into procedures, visit schedules, and burden-reduction strategies, • Maintain scientific oversight during study execution, supporting medical monitoring, protocol deviations/clarifications, CSR quality, and interpretation of clinical signals across programs, • Lead cross-functional readiness for key milestones (protocol finalization, database lock, regulatory interactions), establishing operating rhythms and documentation standards consistent with Compass values and governance, • Partner with Medical Affairs to align on publication plans and scientific communication points derived from protocol design and study outcomes, • PhD in neuroscience, pharmacology, or related life sciences field, or MD/PharmD with equivalent clinical development experience, • Required industry experience in biopharma/biotech clinical development with demonstrated leadership in protocol authorship and late-stage study design; CNS experience strongly preferred, • Preferable NDA/MAA experience, including contributing to Module 2/5 clinical sections, data narratives, and regulatory interaction support, • Proven capability to translate biology and patient insights into clear study objectives, endpoints, and operationally feasible designs in psychiatry/neurology, • Strong cross-functional collaboration; skilled at guiding teams through complex scientific choices and change, • Excellent scientific writing, data interpretation, and communication skills, with a track record of high-quality clinical documents and timely milestone delivery Please note that the base salary range is a guideline, and individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location. Base pay is one part of the Total Package that is provided to compensate and recognise employees for their work and any role at Compass, regardless of the location, is eligible for additional discretionary bonuses and equity. 【Base salary per annum】:$200,000—$280,000 USDBenefits & Compensation: For an overview of our benefits package and compensation information, please visit "Working at Compass". Equal opportunities: Reasonable accommodation We are committed to building a workplace where everyone's wellbeing matters. If you need reasonable accommodation during the interview process to be at your best, please let our recruiting team know. UK applicants We are proud of our commitment to diversity and equality (pursuant to the Equality Act 2010). We do not discriminate based upon race, religion or belief, colour, nationality, ethnic or national origin, gender, pregnancy or maternity, marital or civil partner status, sexual orientation, gender reassignment, age or disability. US applicants Compass Pathways is proud to be an equal opportunity employer. All employment decisions are based on business needs, job requirements, and individual qualifications, without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, and related medical conditions), ethnicity, age, disability, sexual orientation, gender identity, gender expression, military service, genetic information, familial or marital status, or any other status, category, or characteristic protected by applicable law. Sponsorship: Unfortunately, we cannot sponsor employment visas and can only accept applications if you have employment rights in the country to which you are applying. Data Privacy: All data is confidential and protected by all legal and data privacy requirements, please see our recruitment Privacy Notice to learn more about how we process personal data.

Job Description About Cleerly We're Cleerly – a healthcare company that's revolutionizing how heart disease is diagnosed, treated, and tracked. We were founded in 2017 by one of the world's leading cardiologists and are a growing team of world-class engineering, operations, medical affairs, marketing, and sales leaders. We raised $223M in Series C funding in 2022 which has enabled rapid growth and continued support of our mission. In December 2024 we received an additional $106M in a Series C extension funding. Most of our teams work remotely and have access to our offices in Denver, Colorado, New, York, New York, Dallas, Texas, and Lisbon, Portugal with some roles requiring you to be on-site in a location. Cleerly has created a new standard of care for heart disease through value-based, AI-driven precision diagnostic solutions with the goal of helping prevent heart attacks. Our technology goes beyond traditional measures of heart disease by enabling comprehensive quantification and characterization of atherosclerosis, or plaque buildup, in each of the heart arteries. Cleerly's solutions are supported by more than a decade of performing some of the world's largest clinical trials to identify important findings beyond symptoms that increase a person's risk of heart attacks. At Cleerly, we collaborate digitally and use a wide variety of systems. Our people use Google Workspace (GMail, Drive, Docs, Sheets, Slides), Slack, Confluence/Jira, and Zoom Video, prior experience in these areas is a plus. Role or department specific technology needs may vary and will be listed as requirements in the job description. While we are mostly a remote company, travel is required for some team meetings and cross function projects typically once per month or once per quarter, for some roles like sales or external facing roles travel could be up to 90% of the time. About the Opportunity We are seeking an accomplished Staff Product Manager to lead the release and launch of Cleerly's AI-powered products for cardiovascular health. The Product Manager will collaborate with cross-functional teams to define product requirements, prioritize features, and deliver innovative AI solutions that directly impact the diagnostic and prognostic care pathways for heart disease. This role requires a focus on understanding clinical needs, designing effective solutions, and making informed trade-offs to balance customer demands with technical feasibility. The Product Manager will be a primary contributor to product definition and will be responsible for prioritizing and articulating new opportunities in the marketplace and defining the product roadmap in alignment with the overall business objectives. Responsibilities • Lead the product roadmap for innovation products aligning with market demand, customer needs and company goals., • Engage with internal and external stakeholders, such as clinicians and AI scientists, to shape the product vision and direction; establish the voice of the customer funnel., • Write clear business and functional requirements that support development efforts while ensuring clinical relevance and regulatory alignment., • Understand the domain of diagnostic and prognostic care pathways for heart disease to guide product decisions., • Prioritize features and balance trade-offs between performance, feasibility, and business impact., • Collaborate with AI, regulatory, and engineering teams on implementation, from design and development reviews to launch, ensuring timely and high-quality delivery., • Work closely with product management and leadership teams to develop and support the go-to-market strategy., • Define, track, and interpret key product metrics to drive future product iteration, inform decisions and drive continuous improvement., • 10-12+ years in product and portfolio management, with hands-on experience developing and launching SaMD, or AI-driven healthcare solutions., • Bachelor's degree in Engineering, Biomedical Engineering, or a related technical field (MS or PhD a plus)., • Proven track record of leading the roadmap planning, end-to-end development, launch, and iteration of complex products in fast-paced or startup environments., • Deep understanding of clinical workflows and advanced imaging techniques, particularly in cardiology and radiology., • Track record of managing products through the full lifecycle, from concept to launch and beyond, while anticipating future needs and problems in the roadmap., • Strong research and analytical skills, a deep understanding of customer needs, and an ability to represent the customer as a stakeholder in detailed design team meetings., • Skilled at breaking down complex, ambiguous, or changing problems into clear product strategies and functional requirements., • Familiar with deep learning concepts, agile development methodologies (e.g., Agile, Scrum), and the regulatory environment (FDA, HIPAA, and global guidelines)., • Comfortable working cross-functionally including ML/AI, clinical, engineering, sales, regulatory, and marketing teams., • 12+ years in product and portfolio management, with hands-on experience developing and launching SaMD, or AI-driven healthcare solutions., • Experience leading cross-functional project teams including ML/AI,imaging, clinical, engineering, sales, regulatory, and marketing teams., • Prior experience in the cardiovascular field with base knowledge of cardiovascular diseases and procedures, to be able to engage in thoughtful discussions with key stakeholders., • Comprehensive knowledge of one or more medical imaging modalities (CT, MRI, Ultrasound, Fluoroscopy, etc.) and their role in diagnostic decision making, procedure planning and guidance., • Prior experience in complex healthcare or medical imaging workflow applications and enterprise imaging IT solutions., • Track record of driving strategic ideas, building business cases, developing product roadmaps, and securing executive alignment to deliver high-impact solutions. *Total Target Compensation (TTC): Total Cash Compensation (including base pay, variable pay, commission, bonuses, etc.). Each role at Cleerly has a defined salary range based on market data and company stage. We typically hire at the lower to mid-point of the range, with the top end reserved for internal growth and exceptional performance. Actual pay depends on factors like experience, technical depth, geographic location, and alignment with internal peers. Working at Cleerly takes HEART. Discover our Core Values: • H: Humility- be a servant leader, • E: Excellence- deliver world-changing results, • A: Accountability- do what you say; expect the same from others, • R: Remarkable- inspire & innovate with impact OUR COMPANY IS AN EQUAL OPPORTUNITY EMPLOYER. We do not discriminate on the basis of race, color, national origin, ancestry, citizenship status, protected veteran status, religion, physical or mental disability, marital status, sex, sexual orientation, gender identity or expression, age, or any other basis protected by law, ordinance, or regulation. By submitting your application, you agree to receive SMS messages from Cleerly recruiters throughout the interview process. Message frequency may vary. Message and data rates may apply. You can STOP messaging by sending STOP and get more help by sending HELP. For more information see our Privacy Policy (). All official emails will come from @cleerlyhealth.com email accounts. #Cleerly

Job Description About Cleerly We're Cleerly – a healthcare company that's revolutionizing how heart disease is diagnosed, treated, and tracked. We were founded in 2017 by one of the world's leading cardiologists and are a growing team of world-class engineering, operations, medical affairs, marketing, and sales leaders. We raised $223M in Series C funding in 2022 which has enabled rapid growth and continued support of our mission. In December 2024 we received an additional $106M in a Series C extension funding. Most of our teams work remotely and have access to our offices in Denver, Colorado, New, York, New York, Dallas, Texas, and Lisbon, Portugal with some roles requiring you to be on-site in a location. Cleerly has created a new standard of care for heart disease through value-based, AI-driven precision diagnostic solutions with the goal of helping prevent heart attacks. Our technology goes beyond traditional measures of heart disease by enabling comprehensive quantification and characterization of atherosclerosis, or plaque buildup, in each of the heart arteries. Cleerly's solutions are supported by more than a decade of performing some of the world's largest clinical trials to identify important findings beyond symptoms that increase a person's risk of heart attacks. At Cleerly, we collaborate digitally and use a wide variety of systems. Our people use Google Workspace (GMail, Drive, Docs, Sheets, Slides), Slack, Confluence/Jira, and Zoom Video, prior experience in these areas is a plus. Role or department specific technology needs may vary and will be listed as requirements in the job description. While we are mostly a remote company, travel is required for some team meetings and cross function projects typically once per month or once per quarter, for some roles like sales or external facing roles travel could be up to 90% of the time. About the Opportunity We are seeking an accomplished Staff Product Manager to lead the release and launch of Cleerly's AI-powered products for cardiovascular health. The Product Manager will collaborate with cross-functional teams to define product requirements, prioritize features, and deliver innovative AI solutions that directly impact the diagnostic and prognostic care pathways for heart disease. This role requires a focus on understanding clinical needs, designing effective solutions, and making informed trade-offs to balance customer demands with technical feasibility. The Product Manager will be a primary contributor to product definition and will be responsible for prioritizing and articulating new opportunities in the marketplace and defining the product roadmap in alignment with the overall business objectives. Responsibilities • Lead the product roadmap for innovation products aligning with market demand, customer needs and company goals., • Engage with internal and external stakeholders, such as clinicians and AI scientists, to shape the product vision and direction; establish the voice of the customer funnel., • Write clear business and functional requirements that support development efforts while ensuring clinical relevance and regulatory alignment., • Understand the domain of diagnostic and prognostic care pathways for heart disease to guide product decisions., • Prioritize features and balance trade-offs between performance, feasibility, and business impact., • Collaborate with AI, regulatory, and engineering teams on implementation, from design and development reviews to launch, ensuring timely and high-quality delivery., • Work closely with product management and leadership teams to develop and support the go-to-market strategy., • Define, track, and interpret key product metrics to drive future product iteration, inform decisions and drive continuous improvement., • 10-12+ years in product and portfolio management, with hands-on experience developing and launching SaMD, or AI-driven healthcare solutions., • Bachelor's degree in Engineering, Biomedical Engineering, or a related technical field (MS or PhD a plus)., • Proven track record of leading the roadmap planning, end-to-end development, launch, and iteration of complex products in fast-paced or startup environments., • Deep understanding of clinical workflows and advanced imaging techniques, particularly in cardiology and radiology., • Track record of managing products through the full lifecycle, from concept to launch and beyond, while anticipating future needs and problems in the roadmap., • Strong research and analytical skills, a deep understanding of customer needs, and an ability to represent the customer as a stakeholder in detailed design team meetings., • Skilled at breaking down complex, ambiguous, or changing problems into clear product strategies and functional requirements., • Familiar with deep learning concepts, agile development methodologies (e.g., Agile, Scrum), and the regulatory environment (FDA, HIPAA, and global guidelines)., • Comfortable working cross-functionally including ML/AI, clinical, engineering, sales, regulatory, and marketing teams., • 12+ years in product and portfolio management, with hands-on experience developing and launching SaMD, or AI-driven healthcare solutions., • Experience leading cross-functional project teams including ML/AI, imaging, clinical, engineering, sales, regulatory, and marketing teams., • Prior experience in the cardiovascular field with base knowledge of cardiovascular diseases and procedures, to be able to engage in thoughtful discussions with key stakeholders., • Comprehensive knowledge of one or more medical imaging modalities (CT, MRI, Ultrasound, Fluoroscopy, etc.) and their role in diagnostic decision making, procedure planning and guidance., • Prior experience in complex healthcare or medical imaging workflow applications and enterprise imaging solutions, • Track record of driving strategic ideas, building business cases, developing product roadmaps, and securing executive alignment to deliver high-impact solutions. TTC $219,000 - $270,000 *Total Target Compensation (TTC): Total Cash Compensation (including base pay, variable pay, commission, bonuses, etc.). Each role at Cleerly has a defined salary range based on market data and company stage. We typically hire at the lower to mid-point of the range, with the top end reserved for internal growth and exceptional performance. Actual pay depends on factors like experience, technical depth, geographic location, and alignment with internal peers. Working at Cleerly takes HEART. Discover our Core Values: • H: Humility- be a servant leader, • E: Excellence- deliver world-changing results, • A: Accountability- do what you say; expect the same from others, • R: Remarkable- inspire & innovate with impact OUR COMPANY IS AN EQUAL OPPORTUNITY EMPLOYER. We do not discriminate on the basis of race, color, national origin, ancestry, citizenship status, protected veteran status, religion, physical or mental disability, marital status, sex, sexual orientation, gender identity or expression, age, or any other basis protected by law, ordinance, or regulation. By submitting your application, you agree to receive SMS messages from Cleerly recruiters throughout the interview process. Message frequency may vary. Message and data rates may apply. You can STOP messaging by sending STOP and get more help by sending HELP. For more information see our Privacy Policy (). All official emails will come from @cleerlyhealth.com email accounts. #Cleerly

Job Description ByHeart is an infant nutrition company built from the ground up to deliver real innovation on behalf of babies and parents. Our mission is simple: make the best formula in the world. That's why we studied the latest breast milk science, worked directly with suppliers we know and trust, set uncompromising quality standards, developed our own small batch blending process, built our own manufacturing facilities, and conducted a groundbreaking clinical trial. Our goal is to create a future where all parents feel amazing about feeding their baby—no matter how they do it. When we launched our Whole Nutrition Infant Formula in 2023, we were the first new US infant formula manufacturer in 15 years. Since then, we've been leading the way in a lot of ways. We're… • The first and only US-made* infant formula made with organic, grass-fed whole milk, not skim., • The first and only U.S. infant formula company to add the two most abundant proteins found in breast milk—alpha-lac and lactoferrin—to our ingredients list., • The first infant formula company to receive Clean Label Project's Purity Award (and we test for 700 contaminants vs the required 400)., • We ran one of the largest clinical trials in the US in 25 years., • Our clinically proven benefits include:, • Less spit up**, • Softer poops**, • Easier digestion **Vs a leading infant formula As the only new entrant to establish three US manufacturing facilities (in Pennsylvania, Iowa, and Oregon), ByHeart has the capacity to meaningfully capture share of the US $6B infant formula market. With >$470M in funding, we're shifting the industry forward—and this is just the beginning. Help us build a future where all parents can feel amazing about feeding, by joining our growing team of >360 people that stretches across the country. We're proud to offer competitive, family-first benefits, including but not limited to: • Health insurance for the whole family: medical, dental, & vision insurance covered 100%, with 90% coverage for your family., • Flexible paid time off: plus 12+ company holidays, and your kid's birthday off!, • 16-weeks of fully-paid parental leave and new parent support: free 1-year supply of formula, cozy feeding suites, and paid pumping time., • Up to 6% 401(k) Match to help you plan for your future. ByHeart In the News • Entrepreneur: The Illusion of the Shelf – The Driving Force Behind Infant Formula Shortages, and What Needs to Change, • Forbes: A Startup Wanted To Make A Better Baby Formula. It Took Five Long Years., • Forbes: Entrepreneurs Breaking Barriers: Learn From Founders Who Took On The Impossible, • Business Insider: ByHeart Announces Published Data in a Scholarly Journal on Benefits of The Novel High Quality Protein Blend in Their Groundbreaking Next-Generation Easy to Digest Infant Formula, • Axios: Infant formula maker ByHeart raises $95 million, • Babylist 2025 Best formula for breastfed Babies, • Parents 2025 Closest to Breastmilk: The 7 Best Baby Formulas, • What to Expect: The 11 Best Baby Formulas of 2025, Vetted by Pediatricians and 300+ Moms, • New Modern Mom: The Clean Formula Moms Are Loving ROLE DESCRIPTION The Senior Principal Process Engineer is responsible for leading manufacturing process design, scale-up, and optimization. The role provides strategic technical direction, mentorship of process engineers, and leads cross-functional initiatives to enhance product quality, regulatory compliance, and operational efficiency. Reports To: VP, Supply Operations Location: Remote Key Responsibilities Process Design & Optimization • Lead process design for new and existing product lines, including spray drying, blending, CIP, and packaging operations., • Develop and validate process parameters to ensure consistent quality and compliance with FDA and GMP standards., • Serve as the SME (Subject Matter Expert) for critical process technologies (e.g., thermal processing, mixing, evaporation, drying)., • Drive continuous improvement projects focused on yield improvement, energy reduction, and waste minimization., • Author and approve process validation protocols and reports (IQ/OQ/PQ)., • Ensure process documentation aligns with FDA, FSMA, and internal Quality Management System (QMS) standards., • Partner with Manufacturing, Maintenance, and Quality leaders to troubleshoot and improve line performance., • Support capital project execution by defining process requirements and equipment specifications., • Use process modeling and data analytics (SPC, DOE, Six Sigma tools) to identify opportunities for process stability and optimization., • Education: Bachelor's or Master's in Chemical, Mechanical, or Process Engineering (PhD preferred)., • Experience: 10+ years of process engineering experience in FDA-regulated manufacturing, ideally with infant formula, dairy, or food ingredients., • Certifications: Six Sigma Black Belt or Lean certification preferred., • Advanced process modeling (Aspen, MATLAB, Minitab, etc.), • Strong understanding of cGMP, HACCP, and sanitary design principles, • Exceptional technical writing and documentation skills, • Decision Quality – Makes sound technical decisions that balance innovation with regulatory compliance., • Tech Savvy – Leverages process automation, sensors, and digital twin technologies to enhance efficiency., • Drives Results – Delivers measurable improvements in throughput, yield, and quality., • Collaborates – Works effectively across disciplines to solve complex operational challenges. We're excited about your interest in joining ByHeart! Our Talent Acquisition team reviews applications in the order they are received and will reach out directly to schedule interviews. We kindly ask that you refrain from contacting hiring managers or current employees directly. We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

Job Description About Immuneering: Immuneering is a clinical-stage oncology company outpacing cancer to help patients outlive their disease. Our lead product candidate, atebimetinib (IMM-1-104) is currently in a Phase 2a trial in patients with advanced solid tumors including pancreatic cancer. Immuneering’s R&D team is based in a ~38,000 square foot lab and office facility in San Diego. The company also has offices in New York City and Cambridge MA. Immuneering has grown to more than 50+ employees, all working to apply their expertise, passion and creativity to improve the lives of people with serious diseases. Immuneering’s team works collaboratively and relentlessly, thinking across traditional boundaries to help shape the frontiers of drug development. General Summary of Duties: The Director, Regulatory, CMC (Chemistry, Manufacturing, and Controls) is a pivotal regulatory role responsible for developing and executing regulatory strategies for CMC activities across the company’s clinical product portfolio. This position ensures compliance with all applicable regulatory requirements and works cross-functionally to support product development, registration, and lifecycle management. A successful candidate will be a highly collaborative individual with strong interpersonal skills and will be an exceptional team player. Specific Duties, may include but not be limited to the following: · Develop and lead global CMC regulatory strategies for investigational and commercial products to ensure timely submissions and approvals. · Prepare, review, and submit CMC sections of regulatory documents including INDs, IMPDs, NDAs, BLAs, ANDAs, and supplements to FDA, and other regulatory authorities including the EMA. · Provide regulatory guidance on CMC matters to project teams, including manufacturing changes, process development, and technology transfers. · Monitor and interpret current and emerging CMC regulatory requirements, guidelines, and trends to proactively address potential impacts. · Represent Regulatory CMC in cross-functional teams and meetings, providing expertise and input on regulatory implications of manufacturing and quality changes. · Lead interactions and communications with regulatory agencies regarding CMC topics, e.g. pre-IND, end-of-phase, and pre-submission meetings. · Work with a sense of purpose to get work done using influence and good project management skills, fostering alignment with organizational goals. · Collaborate with Quality, CMC, R&D, Finance, Legal, Clinical and other internal departments to ensure regulatory compliance and readiness. Partner effectively and smoothly with CRO’s and consultants. Desired Skills and Qualifications · Bachelor’s degree in Chemistry, Pharmacy, Life Sciences, or related field required; advanced degree (PhD, PharmD, MS) highly preferred. · Minimum of 8+ years of experience in CMC regulatory affairs within the biopharmaceutical or pharmaceutical industry, including experience with small molecule development in oncology. More experience is a plus. · Proven track record of successful CMC submissions and approvals in the US and internationally. · In-depth knowledge of FDA, EMA, and ICH guidelines, regulations, and processes related to CMC. · Strong leadership, communication, and project management skills. · Must be focused on working collaboratively and within our values of: Data rules, All-in, Own it (Accountable), Caring and Humble. · Ability to work effectively in a collaborative, fast-paced environment. Location: Remote or Hybrid, if you live near an Immuneering office, regular Meet Ups are available. Physical Demands/ Working Conditions The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Requires prolonged sitting, some bending, stooping, and stretching. Requires eye-hand coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment. Requires the ability to perform essential job functions with or without reasonable accommodation. No significant lifting is associated with the role. While extensive travel is not anticipated with this role, it is possible to perhaps up to [X]% at times. Requires prolonged sitting, some bending, stooping, and stretching. Requires eye-hand coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment. Requires normal range of hearing and eyesight to record, prepare and communicate appropriate reports. No significant lifting is associated with the role. Immuneering is an equal opportunity employer. We are committed to creating a diverse and inclusive workplace where all employees are treated with fairness and respect. We do not discriminate on the basis of race, ethnicity, color, religion, gender, sexual orientation, age, disability, or any other legally protected status. Our hiring decisions and employment practices are based solely on qualifications, merit, and business needs. We encourage individuals from all backgrounds to apply and join us in our mission. Job Offers: Immuneering uses the Immuneering.com domain and email addresses for all official communications. If you received communication from any other domain, please consider it spam. Note to Recruitment Agencies: We appreciate your interest in finding talent for Immuneering but please be advised that we do not accept unsolicited resumes from recruitment agencies. All resumes submitted to Immuneering without a prior written agreement in place will be considered property of Immuneering, and no fee will be paid in the event of a hire. Thank you for your understanding.

Job Description Company introduction: Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. The Company is headquartered in London, UK, with offices in New York City in the US. We focus on developing novel treatments that have the potential to improve the lives of those who are suffering with mental health conditions and who are not helped by current treatments. We are pioneering a new paradigm for treating mental health conditions focused on rapid and durable responses through the development of our investigational COMP360 synthetic psilocybin treatment, potentially a first in class treatment. COMP360 has Breakthrough Therapy designation from the US Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD) due to the pressing unmet need in this area. We are currently in phase 3 for TRD, have completed phase 2 studies for both post-traumatic stress disorder (PTSD) and anorexia nervosa and are planning a further late-stage study in PTSD. We envision a world where mental health means not just the absence of illness but the ability to thrive. - Compass Pathways. Job overview: Compass is seeking a highly motivated and experienced Director, Regulatory Project Management to lead the end-to-end project management of a New Drug Application (NDA) submission. This individual will ensure that all activities are strategically planned, efficiently executed, and delivered on time, within scope, and to the highest quality standards. Location: Hybrid in our New York City office or remote on the East Coast, USA. Reports to: Senior Vice President, Regulatory Affairs. Duration: 12 months contract. Roles and responsibilities (Include but are not limited to): Submission Leadership • Develop, implement, and maintain a comprehensive NDA submission project plan, including detailed timelines, workstreams, milestones, and dependencies, • Drive the overall project plan for NDA preparation and submission, ensuring all components are planned, tracked, and delivered on schedule, • Define the critical path activities and proactively adjust plans in response to evolving requirements or risks, • Align submission activities with overall development program strategy and corporate objectives, • Partner with Regulatory Strategy and Operations leads to translate high-level regulatory strategy into detailed, executable submission plans Governance & Oversight • Establish appropriate submission governance forums (e.g., core team, functional sub-teams, steering committee, etc.), • Define decision-making process and escalation pathways to ensure effective risk and issue management, • Facilitate effective cross-functional working sessions to maintain alignment and momentum, • Provide regular status updates, metrics, and dashboards to cross-functional teams, management and executive leadership Execution & Deliverable Management • Drive collaboration across Clinical, CMC, Nonclinical, Clinical Pharmacology, Safety, Statistics, and Medical Writing, to ensure alignment of deliverables, • Track document authoring, review, and finalization cycles, providing clear visibility of status across teams, to ensure CTD content is delivered on schedule, • Partner with regulatory operations to oversee dossier compilation, QC, and submission readiness, • Serve as the central point of contact for submission progress and status inquiries Risk, Issue & Change Management • Proactively identify risks to submission timelines and establish mitigation and contingency plans, • Maintain a risk register and ensure issues are tracked, escalated, and resolved in a timely manner, • Manage changes in priorities or scope while preserving overall submission objectives Operational Excellence • Develop and maintain detailed timelines, trackers, and dashboards to drive execution against critical path activities, • Support Regulatory Operations efforts in publishing, document management, and inspection readiness with internal teams and external vendors, • Ensure adherence to SOPs while introducing pragmatic process improvements where gaps exist, • Develop, maintain, and monitor detailed submission project plans, including critical path analyses and contingency planning, • Ensure adherence to company standard operating procedures (SOPs), templates, and regulatory publishing requirements, • Support inspection readiness and documentation of submission-related activities Health Authority Engagement • Develop and oversee project plans and timelines for FDA interactions related to the NDA submission, including briefing packages, meeting logistics, and response management, • Ensure all submission components meet regulatory agency requirements and withstand internal/external audit scrutiny Post-Submission Transition • Establish mechanisms to track submission-related milestones, commitments, and queries from FDA (e.g., Labeling, REMS, IRs, etc.), • Develop and oversee response authoring timelines for FDA submission-related queries, • Transition governance from submission execution to lifecycle management and post-approval commitments Candidate profile: • Bachelor's degree in life sciences, pharmacy, or related discipline required; advanced degree (MS, PharmD, PhD, or MBA) preferred, • 10+ years of experience in the pharmaceutical/biotech industry, with significant experience in regulatory project management, • Demonstrated leadership in managing at least one NDA or BLA submission from initiation through completion; experience managing rolling and/or expedited reviews is a plus, • Deep knowledge of FDA regulations, ICH guidelines, and CTD/eCTD structure, • Proven ability to manage complex, multi-disciplinary projects under tight timelines, • Proficiency with project management methodologies and tools (e.g., MS Project, Smartsheet, Veeva Vault RIM, or equivalent), • Strong organizational, analytical, and facilitation skills, with an ability to influence across functions and levels 【For NYC】Compensation Description (annually): Please note that the base salary range is a guideline, and individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location. Base pay is one part of the Total Package that is provided to compensate and recognise employees for their work and any role at Compass, regardless of the location, is eligible for additional discretionary bonuses and equity. 【Base salary per annum】:$225,000—$275,000 USDBenefits & Compensation: For an overview of our benefits package and compensation information, please visit "Working at Compass". Equal opportunities: Reasonable accommodation We are committed to building a workplace where everyone's wellbeing matters. If you need reasonable accommodation during the interview process to be at your best, please let our recruiting team know. UK applicants We are proud of our commitment to diversity and equality (pursuant to the Equality Act 2010). We do not discriminate based upon race, religion or belief, colour, nationality, ethnic or national origin, gender, pregnancy or maternity, marital or civil partner status, sexual orientation, gender reassignment, age or disability. US applicants Compass Pathways is proud to be an equal opportunity employer. All employment decisions are based on business needs, job requirements, and individual qualifications, without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, and related medical conditions), ethnicity, age, disability, sexual orientation, gender identity, gender expression, military service, genetic information, familial or marital status, or any other status, category, or characteristic protected by applicable law. Sponsorship: Unfortunately, we cannot sponsor employment visas and can only accept applications if you have employment rights in the country to which you are applying. Data Privacy: All data is confidential and protected by all legal and data privacy requirements, please see our recruitment Privacy Notice to learn more about how we process personal data.

Job Description Corporate Counsel This role plays a vital part in enhancing collaboration with Hudson’s Sales team by leading the commercial contract process. Responsibilities include drafting, reviewing, revising, and negotiating contracts, as well as overseeing the work of Contract Specialists. Additionally, this position supports the [title] GLRG by coordinating with Operations to effectively manage Hudson’s compliance program, ensuring that we adhere to legal and regulatory standards. The role fosters teamwork with leadership and provides valuable insights on corporate, commercial, environmental, health, and safety (EHS), and regulatory matters. Moreover, it includes the management of outside counsel to further strengthen our legal framework. Essential Duties Include: • Contract Management: Draft, review, and negotiate a wide variety of commercial agreements, including sales contracts, vendor agreements, licensing agreements, and partnership agreements., • Commercial Transactions: Provide legal counsel and support for commercial transactions, ensuring compliance with applicable laws and regulations., • Review, negotiate, and advise on client and vendor contracts, non-disclosure agreements (NDAs), and other commercial agreements., • Legal Compliance: Ensure the organization's commercial practices comply with applicable legal and regulatory requirements., • Legal Advice and Support: Provide timely and accurate legal advice to internal stakeholders on commercial law matters and collaborate with business teams to support strategic initiatives., • Manages paralegal., • Works closely with Governance, Compliance, and Risk Assessment Manager, • Support and manage compliance processes and programs, ensuring adherence to laws, regulations, and Hudson policies., • Serve as a subject matter expert for compliance programs and guide business teams/consulting with outside counsel as needed., • Work closely with Government, Legal and Regulatory Affairs and Governance to manage outside counsel and consultants and serve as the initial point of contact for corporate, commercial, employment, and regulatory advice. Required education and experience • Juris Doctor (JD) degree from an accredited law school., • At least 3 years of relevant experience in a mix of a top law firm or an in-house legal group, • Excellent interpersonal, written, and oral communication skills, including the ability to work collaboratively, cross-functionally, and effectively with internal clients and customers., • Self-motivated, highly organized, articulate, detail-oriented, and hard-working with excellent analytical and negotiating skills., • Excellent organizational and interpersonal skills, with the ability to be flexible and adapt to frequently changing workloads and responsibilities with acute attention to detail and the ability to multi-task in a fast-paced environment., • Familiarity with regulatory frameworks and industry best practices, • Ability to communicate complex compliance topics clearly and effectively, • Must have initiative, be able to act decisively, work independently, and exercise good judgment., • Proven experience in program contract management leadership roles, overseeing the entire contract lifecycle process and being responsible for the overall management and coordination., • A firm grasp of legal terms and conditions to ensure that contracts, regulatory, and license programs meet all legal requirements., • Woodcliff Lake, NJ (or remote, depending upon candidate) Preferred experience • Licensed in New Jersey or willing to become a member of the bar in New Jersey, • Manufacturing or service industry experience., • Experience meeting sales support KPIs and compliance auditing., • Prior experience working cross-functionally within an organization., • Prior experience working in a multi-location org with remote workforce. Culture At Hudson Technologies, you’ll find a supportive community where each person helps each other to be their best self. Our future success is being built today by every one of our employees and their recommendations for improvement. Reclaiming the Future Together™. Mission Hudson Technologies is committed to providing products and services that reduce greenhouse refrigerant emissions, increase energy efficiency, and promote sustainability to encourage understanding and ensure future generations inherit a healthy planet. Vision Improving environmental quality and promoting a healthier planet through the sustainable recovery and reuse of natural resources. Benefits Overview We offer competitive market-based compensation. Benefits include medical/dental/vision/RX, 401(k) plan with company match and generous PTO plan. Hudson Technologies is proud to be an Equal Opportunity Employer.

Job DescriptionCompany Description Statistics show that women and underrepresented groups tend to apply to jobs only if they meet 100% of the qualifications. Sobi encourages you to change that statistic and apply. Rarely do candidates meet 100% of the qualifications. We look forward to your application! At Sobi, each person brings their unique talents to work as a team and make a difference. We are dedicated to developing and delivering innovative therapies to improve the lives of people who live with a rare disease. Our edge comes from our team of people and our commitment to patients. Our mission and culture at Sobi North America get us excited to come to work every day, but here are a few more reasons to join our team: • Competitive compensation for your work, • Generous time off policy, • Summer Fridays, • Opportunity to broaden your horizons by attending popular conferences, • Emphasis on work/life balance, • Collaborative and team-oriented environment, • Making a positive impact to help ultra-rare disease patients who are in need of life saving treatmentsJob Description The Medical Science Liaison functions as a highly trained, field-based, scientific expert who engages healthcare professionals to exchange clinical, scientific, and research knowledge. Following regulatory and corporate guidelines, they will facilitate and build scientific relationships and collaborations with the medical/scientific community. This position interacts with local, regional, and national HCPs, societies, and organizations. The MSL position is to provide educational, scientific, and research support for the Sobi rare disease portfolio of products in the rheumatology franchise. This is a remote position that requires up to 70% of travel. The candidate will have to reside within the territory: New York, New Jersey, Rhode Island, Vermont, Conntecticut, New Hampshore. Key Responsibilities • Appropriately interact with key thought leaders and healthcare professionals, • In an accurate, fair, and balanced manner, exchange scientific information with external parties, • Report field intelligence to Sobi including competitive information, perspectives about compounds, disease state, and the treatment landscape, • Provide support to the Sobi clinical development and operations teams through site recommendations, site initiation visits, facilitation of communication, and accrual support activities, • Participate in and/or lead advisory board meetings at the local, regional, and national level, • Provide internal and external training about preclinical science, clinical data, and outcomes, • Represent Sobi at medical conferences, engaging HCPs and providing scientific coverage, • Within guidelines, provide cross-functional support across the company by serving as a scientific resource, • Develop and maintain an advanced level of knowledge about pertinent studies, compounds, and diseases that would facilitate collegiate and scientific discussions with leading rheumatology & nephrology thought leaders, • Consistently demonstrate a high standard of excellence in the management of assigned territory while also supporting and contributing to the success of colleagues and the MSL organization as a whole, • Frequent travel by ground and/or air is required. Estimated ≥ 70% time away from remote office to support territory size and product support requirements, • Function as the primary point of contact in the field for Sobi Medical Affairs - RheumatoloyQualifications, • Accredited doctorate degree in a life-science or basic-science discipline (PharmD, PhD, MD/DO, DSc, DNP), • Ability to understand and effectively communicate scientific information; respond to inquiries and address needs of key stakeholders, • Demonstrated success managing internal/external stakeholders and leading or influencing cross-functional teams in a matrixed environment including strong teamwork and collaboration, • Proven track record of strategic thinking, problem-solving, and decision-making capabilities, • Strong written and oral communication skills to shape and articulate a clear strategy/story, • Proven ability to prioritize and manage multiple projects concurrently, • Ability to initiate and maintain relationships throughout the medical community, • Demonstrated ability to build positive constructive relationships with cross-functional team members, • Demonstrated high level of personal integrity, emotional intelligence, and flexibility, • Understanding of the highly regulated bio-pharm industry, including legal and regulatory environment, • A minimum of 2 year of MSL experience preferred, • Experience in relevant clinical practice, disease state knowledge, and rare disease preferred, • Passion for science and teaching and in addition, you must demonstrate behaviors in line with Sobi's core values: Care, Ambition, Urgency, Ownership and Partnership Additional Information Compensation and Total Rewards at Sobi At Sobi, we are dedicated to providing our employees with a comprehensive and industry-competitive total rewards package. Our compensation philosophy is designed to recognize and reward talent, ensuring that your contributions are valued and reflected in your overall rewards. Your total compensation at Sobi goes beyond just your base salary and annual bonus. It also includes a robust suite of benefits, such as: • A competitive 401(k) match to support your financial future., • Tuition and wellness reimbursements to invest in your personal and professional growth., • A comprehensive medical, dental, and vision package to prioritize your health and well-being. All Sobi employees need to demonstrate behaviors in line with Sobi's core values: Care, Ambition, Urgency, Ownership and Partnership. Are you ready to be on the Sobi team? Come join a culture that empowers every person to be the person that makes a difference for rare disease. Why Join Us? We are a global company with over 1,700 employees in more than 30 countries and are committed to the societies where we operate. With a deeply skilled management team directing our day-to-day wins, and a Board with a stellar track record, we’re ready to take on the world’s diseases, ailments and adversity. Our people believe they have the power to make a positive impact in others’ lives because that’s exactly what we do here. If you’re seeking a career that taps into your talents in a way that makes the world a better, healthier place, we just may have a job for you. We know our employees are our most valuable asset, and our culture conveys that. We offer a competitive benefits package, to support the health and happiness of our staff. Sobi Culture At Sobi, we refuse to accept the status quo. This is because we have witnessed first-hand the challenges facing those affected by rare diseases, and have used this knowledge to shape our business to find new ways of helping them. As a specialized biopharmaceutical company, we are dedicated to rare diseases. And we see this focus as a strength. By effectively turning our research into ground-breaking treatments, we help make medicine more accessible and open up more possibilities for patients and more opportunities for those caring for them. This has been our approach since day one, but we know we can’t change the world of rare diseases on our own. Accomplishing this requires strong partnerships with patients, partners and stakeholders across the entire value chain. Together, we define how our business can create solutions that serve the needs of those affected by rare diseases while facilitating sustainable growth. An Equal Opportunity Employer Sobi is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at Sobi are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity, protected veterans and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status or protected groups by the laws or regulations in the locations where we operate. Sobi is an affirmative action and equal opportunity employer. Disabled/Veterans. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation if you are unable or limited in your ability to use or access this website to apply for a vacancy as a result of your disability. You can request reasonable accommodations by sending an email to COVID-19 Policy For the safety of our employees and all individuals with whom we interact professionally, Sobi North America requires all new hires in the U.S. to be fully vaccinated for COVID-19 with proof of vaccination status. We will consider requests for reasonable medical or religious accommodations, as well as any state-specific exemptions, as required by applicable law.

Job DescriptionAre you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team? MMS is a award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research. Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit or follow MMS on LinkedIn. This person will participate in the development, writing, and management of highly technical nonclinical documents. This is a full-time, remote position. Roles and Responsibilities: • Strong experience with development and writing of nonclinical documents (eg, Module 2.4 and 2.6 eCTD submission documents, Investigator’s Brochure [IB], Nonclinical Study Reports, Meeting Requests, Briefing Documents, RTQs), • Lead projects independently with minimal oversight, lead the writing (structure, content and messaging) of nonclinical documents, ensure the nonclinical package aligns with current regulatory guidelines and meets scientific integrity, • Ability to author based on highly technical sources such as GLP and non-GLP nonclinical study reports, in vivo and in vitro nonclinical data, • Ability to develop a mapping plan for the placement of nonclinical studies within structure of Module 2.4 and 2.6 eCTD submission documents, • Interpret and analyze applicable pharmacokinetics, pharmacology, and toxicology data (eg, Prism files, bioanalytical reports, clinical pathology reports, PK/TK evaluation reports), • Collaborate with cross-functional teams such as project management, safety, efficacy, biostats, regulatory operations, and CMC, • Demonstrated ability to lead others to complete complex projects, • Ability to complete documents according to sponsor’s format, processes, and according to regulatory guidelines, • Ability to effectively operate in an environment that requires negotiation, persuasion, collaboration, and analytical judgment, • Organizational expert within the nonclinical subject area, • Excellent written/oral communication and strong time and project management skills, • Ability to attend regular team meetings, lead client meeting and CRMs, • Ability to work in various client systems (eg, SharePoint, Veeva RIM, PleaseReview, EndNote), templates and toolbars, • Strong understanding of regulatory guidances as it applies to nonclinical submission documents and drug development (eg, ICH, FDA and EMA regulations and guidelines, GLP, GCP, GMP and GDP)Requirements:, • BS + in pharmacology, toxicology, biology or chemistry, or related field, with industry experience within regulatory writing, regulatory affairs, laboratory sciences, quality assurance/control, • Knowledge of GLP, ICH guidelines, and applicable regulatory requirements, • 2+ years of pharmaceutical regulatory nonclinical writing experience, • Strong writing and analytical skills, • Proficiency with MS Office applications., • Hands-on experience with clinical trial and pharmaceutical development preferred uuQhjdtYkG

Job Description Position Summary: Oncology Avyxa Pharma, a leading manufacturer of 505(b)(2) oncology products, is seeking an experienced and driven Director of Sales to lead our sales efforts in the eastern and western United States. These individuals will be responsible for managing a team of sales professionals, driving business growth, and developing strategic relationships with key stakeholders in the oncology space while maintaining a competitive and positive work culture. The ideal candidate will have pharmaceutical sales experience, with a strong background in oncology and 505(b)(2) drug commercialization. This role requires up to 70% travel and reports to the Vice President of Sales & Corporate Accounts. Key Responsibilities: · Following company strategic goals and philosophy, the Director of Sales will provide sales leadership and guide strategic direction for direct reports in assigned territory. · Lead and mentor a team of sales professionals, setting performance objectives and ensuring successful execution as evidenced by quarterly goal attainment for all qualified Avyxa products. · Will work independently and with direct reports to identify and develop new business opportunities to drive market penetration and revenue growth endeavoring to maintain strong customer relationships over an extended period. • Team Management & Development:, • Recruit, train, and develop a high-performing sales team that will have responsibility for selling Avyxa’s products including but not limited to Docivyx®, Frindovyx™, Posfrea™ and Axtle™., • Conduct regular performance reviews, provide coaching, and support career development., • Foster a collaborative, results-driven culture within the sales organization., • Customer Engagement & Relationship Management:, • Build and maintain strong relationships with customers, including but not limited to oncologists, pharmacists, nurses, key business personnel, aggregator and group purchasing organizations (GPOs) sales representatives., • Work closely with direct reports to ensure customer needs are met and growth opportunities are maximized by maintaining close relationships with customers, providing Avyxa product contract updates, Avyxa support materials, and ensuring productive collaboration between customers and other internal Avyxa resources (market access, field reimbursement, payer team, operations) • Represent Avyxa Pharma at industry conferences, advisory boards, and networking events. Data-Driven Decision Making: • Utilize Tableau, Excel, and other analytics tools to track sales performance and market trends., • Prepare and present sales reports, forecasts, and business reviews for senior leadership., • Communicate and leverage market intelligence to adjust strategies and optimize sales efforts., • Cross-Functional Collaboration:, • Partner with Avyxa Strategic Account Directors, Data and Analytics, Field Reimbursement Team, Operations Team, and Medical Affairs to ensure effective product positioning and messaging., • Provide customer insights to support product development and commercialization efforts., • Ensure compliance with pharmaceutical regulations and corporate policies. Qualifications & Experience: • 8+years of pharmaceutical sales experience, with at least 3 years in oncology. Managerial experience preferred. Candidates with similar experience and exceptional track record of success will be considered., • Strong understanding of the 505(b)(2) regulatory pathway and drug commercialization in community oncology and hospital/IDN setting preferred., • Proven leadership experience with a track record of managing and developing sales teams., • Excellent verbal and written communication skills., • High proficiency in PowerPoint, Excel, Tableau, and other sales analytics tools., • Ability to travel up to 70% across the designated region. Preferred Qualifications: • Experience working with community oncology practices, hospitals, and integrated delivery networks (IDNs)., • Sales management · Understanding of the buy-and-bill oncology reimbursement methodology, GPO and aggregator relationships. • Prior experience launching 505(b)(2) oncology drugs. Location: Remote (Must reside within the designated region) Compensation & Benefits: Competitive salary, performance-based bonus, comprehensive benefits package, and travel reimbursement. Company DescriptionAvyxa Pharma is a specialty pharmaceutical company that is focused on the development and marketing of complex therapies that make a difference for cancer patients, providers and the healthcare system. Our core values are grounded in providing access to meaningful products that improve patient care.Avyxa Pharma is a specialty pharmaceutical company that is focused on the development and marketing of complex therapies that make a difference for cancer patients, providers and the healthcare system.\r\n\r\nOur core values are grounded in providing access to meaningful products that improve patient care.

Job Description Job Title : Regulatory Support Location: Basking Ridge NJ Remote Option: Yes. But the candidate should be available to attend customer meetings twice in a month Requirements Mandatory skills: -experience in pharmaceutical environment. -Experience in regulatory environment is required. -High level exposure or knowledge about FDA inspection and internal audit process. -Knowledge or exposure on Veeva RIM Submission/Archive, Publishing etc. Job Title: Consultant JD details : -Ensure compliance with company Standard Operating Procedures and regulatory agency regulations/guidance. -Represents Regulatory Affairs on cross-functional project teams. -Provide technical expertise to cross-functional teams on managing the lifecycle of submission-related documents. -Work with subject matter experts, and cross functional departments to support business needs. -Effectively communicate and work collaboratively with cross-functional teams, including regulatory affairs, clinical operations, and quality assurance & validation. -Gather and assemble information necessary for submissions in accordance with regulations/guidance. -Capable of reviewing documentation with a high degree of attention to detail. Proactive to identify issues and propose solutions, as necessary. -Conduct review of published submissions to ensure consistency and compliance with regulatory requirements. -Maintain knowledge of local and global regulatory submission requirements. -Maintain compliance with GxP, government regulations, industry standards, approved specifications, and Company procedures &directives. -Provide Regulatory Affairs support during internal and external audits and inspections. -Exposure in Change management process, requirement gathering, qualifying the changes etc., -Actively participate in the development of Regulatory Operations processes like SOPs/GOPs, Work instructions, Checklist, templates etc. -Consistently support for regulatory systems access and change management. -Responsible for communicating business process improvements, business related issues, status updates or opportunities. Qualifications: -Bachelors’ degree, preferably in a life science or a related field -5 to 10 years of experience in pharmaceutical environment. -Experience in regulatory environment is required. -Excellent written, verbal communication and presentation skills. -High level exposure or knowledge about FDA inspection and internal audit process.

Job DescriptionCoreWeave is The Essential Cloud for AI™. Built for pioneers by pioneers, CoreWeave delivers a platform of technology, tools, and teams that enables innovators to build and scale AI with confidence. Trusted by leading AI labs, startups, and global enterprises, CoreWeave combines superior infrastructure performance with deep technical expertise to accelerate breakthroughs and turn compute into capability. Founded in 2017, CoreWeave became a publicly traded company (Nasdaq: CRWV) in March 2025. Learn more at . What You'll Do: CoreWeave is the Essential Cloud for AI™, delivering a cloud platform of cutting-edge services powering the next wave of AI. Our Legal and Government Affairs team plays a crucial role in shaping and safeguarding the company's growth as we expand globally. We are collaborative, forward-thinking, and deeply integrated into every part of the business — helping to balance innovation, compliance, and risk with speed and precision. About the Role: As the Head of Credits and Tax Incentives, you will be responsible for identifying, securing, and managing government incentive programs that support CoreWeave's rapid growth in the AI infrastructure and data center industry. You'll drive strategies to capture state, local, and international financial incentives, while assisting in building and maintaining a world-class compliance program. This role is highly cross-functional and impactful, working closely with leadership teams to unlock value and efficiency in every region where CoreWeave operates. Your day-to-day will include: • Overseeing the sourcing, application, and execution of incentive programs, such as state sales tax exemptions, and personal and real property tax abatements at the local level., • Partnering across Finance, Data Center Operations, and People teams to gather required documentation and ensure timely submission of applications., • Representing the company in discussions with State and local Government officials to advocate for and advance incentive initiatives., • Advising leadership and operational teams on incentive utilization and compliance., • Managing outside counsel and subject matter experts to support incentive strategy and reporting., • 10+ years of relevant tax experience, with a focus on state and local data center incentive programs, including sales and use tax exemptions, and real estate and property tax abatements., • Proven record of success in identifying, securing, and managing government incentives., • Strong understanding of statutory and regulatory frameworks governing state and local incentive programs., • Experience managing teams and complex multi-stakeholder projects., • Demonstrated ability to negotiate effectively with government entities., • Experience with commercial and financial deal structures., • Proficiency in maintaining compliance programs and reporting frameworks., • Experience with non-U.S. tax systems and incentive programs in Canada, the United Kingdom (UK), or European Union member states., • Prior experience supporting large-scale infrastructure or data center operations., • You love finding creative ways to align government programs with business goals., • You're curious about how incentives can accelerate technological and regional growth., • You're an expert in balancing compliance and innovation under tight timelines. Why CoreWeave? At CoreWeave, we work hard, have fun, and move fast! We're in an exciting stage of hyper-growth that you will not want to miss out on. We're not afraid of a little chaos, and we're constantly learning. Our team cares deeply about how we build our product and how we work together, which is represented through our core values: • Be Curious at Your Core, • Act Like an Owner, • Empower Employees, • Deliver Best-in-Class Client Experiences The base salary range for this role is $240,000 to $285,000. The starting salary will be determined based on job-related knowledge, skills, experience, and market location. We strive for both market alignment and internal equity when determining compensation. In addition to base salary, our total rewards package includes a discretionary bonus, equity awards, and a comprehensive benefits program (all based on eligibility). What We Offer The range we've posted represents the typical compensation range for this role. To determine actual compensation, we review the market rate for each candidate which can include a variety of factors. These include qualifications, experience, interview performance, and location. In addition to a competitive salary, we offer a variety of benefits to support your needs, including: • Medical, dental, and vision insurance - 100% paid for by CoreWeave, • Company-paid Life Insurance, • Voluntary supplemental life insurance, • Short and long-term disability insurance, • Flexible Spending Account, • Health Savings Account, • Tuition Reimbursement, • Ability to Participate in Employee Stock Purchase Program (ESPP), • Mental Wellness Benefits through Spring Health, • Family-Forming support provided by Carrot, • Paid Parental Leave, • Flexible, full-service childcare support with Kinside, • 401(k) with a generous employer match, • Flexible PTO, • Catered lunch each day in our office and data center locations, • A casual work environment While we prioritize a hybrid work environment, remote work may be considered for candidates located more than 30 miles from an office, based on role requirements for specialized skill sets. New hires will be invited to attend onboarding at one of our hubs within their first month. Teams also gather quarterly to support collaboration California Consumer Privacy Act - California applicants only CoreWeave is an equal opportunity employer, committed to fostering an inclusive and supportive workplace. All qualified applicants and candidates will receive consideration for employment without regard to race, color, religion, sex, disability, age, sexual orientation, gender identity, national origin, veteran status, or genetic information. As part of this commitment and consistent with the Americans with Disabilities Act (ADA), CoreWeave will ensure that qualified applicants and candidates with disabilities are provided reasonable accommodations for the hiring process, unless such accommodation would cause an undue hardship. If reasonable accommodation is needed, please contact: . Export Control Compliance This position requires access to export controlled information. To conform to U.S. Government export regulations applicable to that information, applicant must either be (A) a U.S. person, defined as a (i) U.S. citizen or national, (ii) U.S. lawful permanent resident (green card holder), (iii) refugee under 8 U.S.C. § 1157, or (iv) asylee under 8 U.S.C. § 1158, (B) eligible to access the export controlled information without a required export authorization, or (C) eligible and reasonably likely to obtain the required export authorization from the applicable U.S. government agency. CoreWeave may, for legitimate business reasons, decline to pursue any export licensing process.

Job Description About Cleerly We're Cleerly – a healthcare company that's revolutionizing how heart disease is diagnosed, treated, and tracked. We were founded in 2017 by one of the world's leading cardiologists and are a growing team of world-class engineering, operations, medical affairs, marketing, and sales leaders. We raised $223M in Series C funding in 2022 which has enabled rapid growth and continued support of our mission. In December 2024 we received an additional $106M in a Series C extension funding. Most of our teams work remotely and have access to our offices in Denver, Colorado, New, York, New York, Dallas, Texas, and Lisbon, Portugal with some roles requiring you to be on-site in a location. Cleerly has created a new standard of care for heart disease through value-based, AI-driven precision diagnostic solutions with the goal of helping prevent heart attacks. Our technology goes beyond traditional measures of heart disease by enabling comprehensive quantification and characterization of atherosclerosis, or plaque buildup, in each of the heart arteries. Cleerly's solutions are supported by more than a decade of performing some of the world's largest clinical trials to identify important findings beyond symptoms that increase a person's risk of heart attacks. At Cleerly, we collaborate digitally and use a wide variety of systems. Our people use Google Workspace (GMail, Drive, Docs, Sheets, Slides), Slack, Confluence/Jira, and Zoom Video, prior experience in these areas is a plus. Role or department specific technology needs may vary and will be listed as requirements in the job description. While we are mostly a remote company, travel is required for some team meetings and cross function projects typically once per month or once per quarter, for some roles like sales or external facing roles travel could be up to 90% of the time. About the Opportunity We are seeking a highly skilled Staff Scientist to lead the design, development, validation of innovative clinical workflow that can directly impact the diagnosis and treatment for heart disease. In this senior-level role, you are responsible for architecting a cutting-edge product that integrates our existing technologies while pushing the boundary of innovation in cardiac vascular imaging. You will also represent the company in strategic research collaborations with leading academic and clinical institutions, driving innovation at the intersection of AI and cardiovascular health. About the Team You will join our expert Computational Imaging team, where we develop sophisticated algorithms to enhance and improve medical imaging. We are focused on improving the quality and clinical value of medical images, creating powerful, extra software components that correct artifacts, standardize data, and ensure the utmost precision before the final analysis. Our work is essential for elevating the reliability and accuracy of Cleerly's regulated products. Responsibilities • Research and develop state-of-the-art AI and non-AI algorithms for coronary CT/fluoroscopy imaging applications., • Implement an efficient and robust image processing pipeline to solve challenging problems in low latency environments., • Translate product and clinical requirements into algorithmic specifications in collaboration with Product and Clinical teams., • Partner with Regulatory Affairs to support regulatory submissions (e.g., 510(k), De Novo,PCCP), including generating evidence and documentation., • Collaborate with engineering teams to deploy AI and non-AI based solutions in clinical practice., • Communicate findings and strategy to internal stakeholders and leadership through clear technical documentation, presentations, and demos., • Contribute to intellectual property development through patents and scientific publications., • Mentor junior scientists and foster a culture of technical excellence and scientific rigor. Requirements • Ph.D. in Computer Science, Data Science, Biomedical Engineering, Biomedical Imaging, or a related technical field, with 5+ years combined postdoc and/or industry experience; OR an M.S. with 8+ years of relevant experience., • R&D experience in medical image processing, demonstrating subject matter expertise in image quality enhancement, optical flow analysis and 2D&3D rigid/deformable image registration., • Proven track record of publications in top-tier medical imaging or computer vision conferences and journals (e.g., MICCAI, IEEE TMI, CVPR, Medical Image Analysis)., • Strong experience in C++ and Python., • Prior experience with ITK, OpenCV, VTK, CMake, Slicer is a plus, • Prior experience with cardiac motion modelling or tracking is a plus, • Excellent interpersonal, cross-functional, and cross-cultural collaboration skills. Preferred qualifications • 5+ years of industry experience in AI-based medical device development or clinical deployment., • Experience supporting FDA regulatory submissions for ML-based software, including familiarity with De Novo, 510(k), and PCCP pathways., • Deep domain knowledge in cardiovascular imaging and CT interpretation workflows. TTC*: $265k - $305k *Total Target Compensation (TTC): Total Cash Compensation (including base pay, variable pay, commission, bonuses, etc.). Each role at Cleerly has a defined salary range based on market data and company stage. We typically hire at the lower to mid-point of the range, with the top end reserved for internal growth and exceptional performance. Actual pay depends on factors like experience, technical depth, geographic location, and alignment with internal peers. Working at Cleerly takes HEART. Discover our Core Values: • H: Humility- be a servant leader, • E: Excellence- deliver world-changing results, • A: Accountability- do what you say; expect the same from others, • R: Remarkable- inspire & innovate with impact OUR COMPANY IS AN EQUAL OPPORTUNITY EMPLOYER. We do not discriminate on the basis of race, color, national origin, ancestry, citizenship status, protected veteran status, religion, physical or mental disability, marital status, sex, sexual orientation, gender identity or expression, age, or any other basis protected by law, ordinance, or regulation. By submitting your application, you agree to receive SMS messages from Cleerly recruiters throughout the interview process. Message frequency may vary. Message and data rates may apply. You can STOP messaging by sending STOP and get more help by sending HELP. For more information see our Privacy Policy (). All official emails will come from @cleerlyhealth.com email accounts. #Cleerly

Job DescriptionCorporate Counsel Employment Type: Full-Time Minimum Experience: 5-7 years of experience in a similar role Location: Hybrid in the New York City Metropolitan Area or McLean, VA About the Role As a fast-growing multinational enterprise, Pixalate is seeking an experienced corporate governance professional to help accelerate growth in a cost-effective and legally-compliant manner. Experience analysing legislative and regulatory obligations for applicability, under U.S. and international laws and regulations, and a proven track record of unwavering adherence to governmental filing cadences are essential elements of this role. Candidates should possess excellent written and verbal communication skills, a deep understanding of contract law, and a general working knowledge of corporate formalities, including board and shareholder resolutions, shareholder agreements, and share option awards. The role will require extensive collaboration across multiple functions. Responsibilities • Experience coordinating preparation and filing of annual financial returns, corporation tax returns, VAT returns, R&D tax credit applications, and service provider utilisation disclosures;, • Thorough understanding of the material terms and conditions of subscription and data licensing agreements for software-as-a-service (SAAS) businesses, and significant experience drafting, negotiating, and amending such agreements;, • Demonstrable instances where the candidate generated business ROI by identifying and leveraging governmental incentives (e.g., R&D tax credits targeting emerging growth companies) to improve corporate financial performance;, • Project management for the incorporation of international affiliates and subsidiaries., • Drafting intercompany agreements and written board resolutions for international entities (e.g., Ireland, Delaware);, • Familiarity with Organisation for Economic Co-operation and Development (OECD) Guidelines for Multinational Enterprises;, • Excellent interpersonal and written/verbal communication skills., • Experience with fundraising activities, including but not limited to, Series A raises, Venture Debt raises, and Convertible Notes.Requirements, • Subscription Agreements: Deep familiarity with the complexities of SaaS agreements, including understanding user rights, service level agreements (SLAs), and compliance with applicable laws., • Intercompany Agreements: Skilled in negotiating and structuring intercompany agreements to align with corporate strategy while ensuring legal compliance., • Data Privacy: Knowledgeable in data protection laws and regulations, equipped to address data privacy matters, conduct risk assessments, and implement compliance measures., • Board Resolutions: Experienced in drafting and presenting board resolutions, supporting governance and compliance initiatives at the executive level., • Cross-Functional Collaboration: Effective communicator with the ability to collaborate with product teams to align legal terms with product development and market strategy., • Ad-Hoc Legal Tasks: Versatile in managing various legal tasks as required, demonstrating adaptability and a proactive approach to legal support.Qualifications, • Bachelor’s degree required (e.g., Law, Finance, Economics, Business Administration, International Affairs, or Management), • Legal education (e.g., LLB, GLD, JD) required, • Startup and SAAS experience preferred, • Excellent benefits package, including medical, dental, and vision insurance, • Premiums are 100% covered for employees and 50% covered for dependents, • Unlimited PTO, • 401(k) Plan, • Monthly internet reimbursement, • Casual, remote work environment, • Hybrid, flexible hours, • Opportunity for advancement Our platform has been used to unearth multiple high-profile criminal and illegal surveillance cases, including: • Gizmodo: An iCloud Feature Is Enabling a $65 Million Scam, New Research Says, • Adweek: A 7-Figure Ad Fraud Scheme Running on Roku Underlines Murkiness of CTV, • Washington Post: Your kids’ apps are spying on them, • Pro Publica: Porn, Piracy, Fraud: What Lurks Inside Google’s Black Box Ad Empire, • ABC7 News: The State of Children's Privacy Online Powered by JazzHR VclanZShka

Job Description About Cleerly We're Cleerly – a healthcare company that's revolutionizing how heart disease is diagnosed, treated, and tracked. We were founded in 2017 by one of the world's leading cardiologists and are a growing team of world-class engineering, operations, medical affairs, marketing, and sales leaders. We raised $223M in Series C funding in 2022 which has enabled rapid growth and continued support of our mission. In December 2024 we received an additional $106M in a Series C extension funding. Most of our teams work remotely and have access to our offices in Denver, Colorado, New, York, New York, Dallas, Texas, and Lisbon, Portugal with some roles requiring you to be on-site in a location. Cleerly has created a new standard of care for heart disease through value-based, AI-driven precision diagnostic solutions with the goal of helping prevent heart attacks. Our technology goes beyond traditional measures of heart disease by enabling comprehensive quantification and characterization of atherosclerosis, or plaque buildup, in each of the heart arteries. Cleerly's solutions are supported by more than a decade of performing some of the world's largest clinical trials to identify important findings beyond symptoms that increase a person's risk of heart attacks. At Cleerly, we collaborate digitally and use a wide variety of systems. Our people use Google Workspace (GMail, Drive, Docs, Sheets, Slides), Slack, Confluence/Jira, and Zoom Video, prior experience in these areas is a plus. Role or department specific technology needs may vary and will be listed as requirements in the job description. While we are mostly a remote company, travel is required for some team meetings and cross function projects typically once per month or once per quarter, for some roles like sales or external facing roles travel could be up to 90% of the time. About the Opportunity We are seeking a highly skilled Machine Learning Scientist to drive the development and translation of cutting-edge ML models that have a direct impact on the care pathway for heart disease diagnosis and prognosis. In this role, you will collaborate with ML scientists, data engineers, biostatisticians, regulatory experts, and senior leadership to understand clinical requirements, develop innovative solutions, and support product development and regulatory approvals. You will also engage in high-impact research collaborations with world-renowned academic and medical institutions. Responsibilities • Research and develop state-of-the-art machine learning models for coronary CT angiography imaging applications., • Conduct rigorous analysis and validation of machine learning algorithms and prototypes., • Explore novel methods for processing and analyzing large, complex medical imaging datasets., • Collaborate with engineering teams to deploy ML algorithms in clinical practice., • Present research findings, insights, and recommendations to internal stakeholders and external collaborators., • Author scientific publications and contribute to patent development., • Ph.D. in Computer Science, Data Science, Biomedical Engineering, Biomedical Imaging, or a related technical field; OR an M.S. with 5+ years of relevant experience., • Strong theoretical and practical expertise in image science, applied mathematics, machine learning, and deep learning., • Research experience in applying ML and deep learning techniques to medical image processing, including segmentation, registration, classification, reconstruction, and detection., • Proven track record of publications in top-tier medical imaging or computer vision conferences and journals (e.g., MICCAI, IEEE TMI, CVPR, Medical Image Analysis)., • Proficiency in Python, with experience handling large datasets, implementing ML pipelines, and visualizing analysis results., • Ability to translate complex clinical requirements into machine learning solutions., • Strong critical thinking, problem-solving, and project management skills., • 2+ years of postdoctoral research or industry experience., • Hands-on experience in developing and applying advanced deep learning models, including vision transformers, semi-supervised/self-supervised/unsupervised learning, incremental learning, and continuous learning techniques. *Total Target Compensation (TTC): Total Cash Compensation (including base pay, variable pay, commission, bonuses, etc.). Each role at Cleerly has a defined salary range based on market data and company stage. We typically hire at the lower to mid-point of the range, with the top end reserved for internal growth and exceptional performance. Actual pay depends on factors like experience, technical depth, geographic location, and alignment with internal peers. Working at Cleerly takes HEART. Discover our Core Values: • H: Humility- be a servant leader, • E: Excellence- deliver world-changing results, • A: Accountability- do what you say; expect the same from others, • R: Remarkable- inspire & innovate with impact OUR COMPANY IS AN EQUAL OPPORTUNITY EMPLOYER. We do not discriminate on the basis of race, color, national origin, ancestry, citizenship status, protected veteran status, religion, physical or mental disability, marital status, sex, sexual orientation, gender identity or expression, age, or any other basis protected by law, ordinance, or regulation. By submitting your application, you agree to receive SMS messages from Cleerly recruiters throughout the interview process. Message frequency may vary. Message and data rates may apply. You can STOP messaging by sending STOP and get more help by sending HELP. For more information see our Privacy Policy (). All official emails will come from @cleerlyhealth.com email accounts. #Cleerly

Job Description About Cleerly We're Cleerly – a healthcare company that's revolutionizing how heart disease is diagnosed, treated, and tracked. We were founded in 2017 by one of the world's leading cardiologists and are a growing team of world-class engineering, operations, medical affairs, marketing, and sales leaders. We raised $223M in Series C funding in 2022 which has enabled rapid growth and continued support of our mission. In December 2024 we received an additional $106M in a Series C extension funding. Most of our teams work remotely and have access to our offices in Denver, Colorado, New, York, New York, Dallas, Texas, and Lisbon, Portugal with some roles requiring you to be on-site in a location. Cleerly has created a new standard of care for heart disease through value-based, AI-driven precision diagnostic solutions with the goal of helping prevent heart attacks. Our technology goes beyond traditional measures of heart disease by enabling comprehensive quantification and characterization of atherosclerosis, or plaque buildup, in each of the heart arteries. Cleerly's solutions are supported by more than a decade of performing some of the world's largest clinical trials to identify important findings beyond symptoms that increase a person's risk of heart attacks. At Cleerly, we collaborate digitally and use a wide variety of systems. Our people use Google Workspace (GMail, Drive, Docs, Sheets, Slides), Slack, Confluence/Jira, and Zoom Video, prior experience in these areas is a plus. Role or department specific technology needs may vary and will be listed as requirements in the job description. While we are mostly a remote company, travel is required for some team meetings and cross function projects typically once per month or once per quarter, for some roles like sales or external facing roles travel could be up to 90% of the time. About the Opportunity We're looking for our next Staff Technical Program Manager, an experienced scrum master who knows how to shepherd a product portfolio through the full product realization cycle while navigating competing priorities for a regulated product. About the Team You will join our expert Computational Imaging team, where we develop sophisticated algorithms to enhance and improve medical imaging. We are focused on improving the quality and clinical value of medical images, creating powerful, extra software components that correct artifacts, standardize data, and ensure the utmost precision before the final analysis. Our work is essential for elevating the reliability and accuracy of Cleerly's regulated products. Responsibilities You'll help to lead the development team from planning through verification and validation to produce the best possible solution in a compliant, high-quality, and timely manner. You'll have strong experience in risk management and delivering products in a regulated environment, such as software as a medical device (SaMD). On any given day you could be doing any of the following: • Communicating and coordinating activities across the product, engineering, AI, regulatory, quality, and external partnership teams., • Developing and maintaining SOPs, work instructions, and other process documentation for the team and ensuring team alignment and compliance, • Leading risk analysis activities in accordance with ISO 14971 and IEC 62304, • Tracing requirements to product architecture, system design and verification/validation test cases for compliance and regulatory needs, • Coordinating with AI scientists, engineers, and product managers to develop documentation to support regulatory submissions, • Running agile ceremonies and orchestrating sprint and project milestones in coordination with Product Management, • Ensuring that engineers have all of the information, requirements, acceptance criteria, and designs they need to implement and deliver new features and functionality effectively and efficiently, • Coordinating with engineering managers and product managers on release planning activities, timelines, and documentation., • Providing executive-level reporting on program status, risks, and critical path items to leadership and external partners., • Leading bug triage and prioritization with the team Requirements • 8+ years of technical program manager experience, or an equal combination of relevant experience in related disciplines, • BS in Engineering preferred or other relevant field with prior experience, • Certified scrum master with demonstrated experience facilitating agile processes, • Excellent verbal and written communication skills, • Demonstrated work history maintaining product documentation & versioning within a Quality Management System, • Ability to engage technical and non-technical audiences via strong written, verbal, and visual communication skills, • Proven ability to build relationships, collaborate, and influence internal teams and partners, • Strong analytical and problem solving skills, • Capability to succeed in a fast-paced environment with shifting priorities, and manage projects with competing priorities and timelines, • Previous experience working daily with data scientists, engineers, product managers, regulatory and quality team, and clinicians in a digital health environment, • Previous experience working in a start-up environment with a highly collaborative culture, wearing multiple hats as needed and "pitching in" as necessary TTC*: $224,250.00 - $258,750.00 *Total Target Compensation (TTC): Total Cash Compensation (including base pay, variable pay, commission, bonuses, etc.). Each role at Cleerly has a defined salary range based on market data and company stage. We typically hire at the lower to mid-point of the range, with the top end reserved for internal growth and exceptional performance. Actual pay depends on factors like experience, technical depth, geographic location, and alignment with internal peers. Working at Cleerly takes HEART. Discover our Core Values: • H: Humility- be a servant leader, • E: Excellence- deliver world-changing results, • A: Accountability- do what you say; expect the same from others, • R: Remarkable- inspire & innovate with impact OUR COMPANY IS AN EQUAL OPPORTUNITY EMPLOYER. We do not discriminate on the basis of race, color, national origin, ancestry, citizenship status, protected veteran status, religion, physical or mental disability, marital status, sex, sexual orientation, gender identity or expression, age, or any other basis protected by law, ordinance, or regulation. By submitting your application, you agree to receive SMS messages from Cleerly recruiters throughout the interview process. Message frequency may vary. Message and data rates may apply. You can STOP messaging by sending STOP and get more help by sending HELP. For more information see our Privacy Policy (). All official emails will come from @cleerlyhealth.com email accounts. #Cleerly

Job Description Position Summary: Avyxa Pharma, a leading manufacturer of 505(b)(2) oncology products, is seeking an experienced and driven Director of Sales to lead our sales efforts in the eastern and western United States. These individuals will be responsible for managing a team of sales professionals, driving business growth, and developing strategic relationships with key stakeholders in the oncology space while maintaining a competitive and positive work culture. The ideal candidate will have pharmaceutical sales experience, with a strong background in oncology and 505(b)(2) drug commercialization. This role requires up to 70% travel and reports to the Vice President of Sales & Corporate Accounts. Key Responsibilities: · Following company strategic goals and philosophy, the Director of Sales will provide sales leadership and guide strategic direction for direct reports in assigned territory. · Lead and mentor a team of sales professionals, setting performance objectives and ensuring successful execution as evidenced by quarterly goal attainment for all qualified Avyxa products. · Will work independently and with direct reports to identify and develop new business opportunities to drive market penetration and revenue growth, endeavoring to maintain strong customer relationships over an extended period. • Team Management & Development:, • Recruit, train, and develop a high-performing sales team that will have responsibility for selling Avyxa’s products, including but not limited to Docivyx®, Frindovyx™, Posfrea™, and Axtle™., • Conduct regular performance reviews, provide coaching, and support career development., • Foster a collaborative, results-driven culture within the sales organization., • Customer Engagement & Relationship Management:, • Build and maintain strong relationships with customers including but not limited to oncologists, pharmacists, nurses, key business personnel, aggregator and group purchasing organizations (GPOs) sales representatives., • Work closely with direct reports to ensure customer needs are met and growth opportunities are maximized by maintaining close relationships with customers, providing Avyxa product contract updates, Avyxa support materials, and ensuring productive collaboration between customers and other internal Avyxa resources, (market access, field reimbursement, payer team, operations) • Represent Avyxa Pharma at industry conferences, advisory boards, and networking events. Data-Driven Decision Making: • Utilize Tableau, Excel, and other analytics tools to track sales performance and market trends., • Prepare and present sales reports, forecasts, and business reviews for senior leadership., • Communicate and leverage market intelligence to adjust strategies and optimize sales efforts., • Cross-Functional Collaboration:, • Partner with Avyxa Strategic Account Directors, Data and Analytics, Field Reimbursement Team, Operations Team and Medical Affairs to ensure effective product positioning and messaging., • Provide customer insights to support product development and commercialization efforts., • Ensure compliance with pharmaceutical regulations and corporate policies. Qualifications & Experience: • 8+years of pharmaceutical sales experience, with at least 3 years in oncology. Managerial experience preferred. Candidates with similar experience and exceptional track record of success will be considered., • Strong understanding of the 505(b)(2) regulatory pathway and drug commercialization in community oncology and hospital/IDN setting preferred., • Proven leadership experience, with a track record of managing and developing sales teams., • Excellent verbal and written communication skills., • High proficiency in PowerPoint, Excel, Tableau, and other sales analytics tools., • Ability to travel up to 70% across the designated region. Preferred Qualifications: • Experience working with community oncology practices, hospitals, and integrated delivery networks (IDNs)., • Sales management · Understanding of the buy-and-bill oncology reimbursement methodology, GPO and aggregator relationships. • Prior experience launching 505(b)(2) oncology drugs. Location: Remote (Must reside within the designated region) Compensation & Benefits: Competitive salary, performance-based bonus, comprehensive benefits package, and travel reimbursement. Company DescriptionAvyxa Pharma is a specialty pharmaceutical company that is focused on the development and marketing of complex therapies that make a difference for cancer patients, providers and the healthcare system. Our core values are grounded in providing access to meaningful products that improve patient care.Avyxa Pharma is a specialty pharmaceutical company that is focused on the development and marketing of complex therapies that make a difference for cancer patients, providers and the healthcare system.\r\n\r\nOur core values are grounded in providing access to meaningful products that improve patient care.