Position Overview

We are seeking a detail-oriented Director, Compliance to join Iterative Health's growing team in New York, NY or Cambridge, MA. This role will be instrumental in leading the strategic development of compliance programs to ensure our clinical trial optimization solutions meet all regulatory requirements across healthcare, clinical trials, and data privacy domains. The ideal candidate will have deep expertise in healthcare compliance frameworks and the ability to operationalize complex regulatory requirements in a fast-paced health tech environment.

Key Responsibilities

Regulatory Compliance & Risk Management

• Experienced with the compliance aspects of clinical trial & clinical research
• Maintain comprehensive compliance with GDPR, HIPAA, and other applicable data privacy regulations
• Lead SOC 2 Type II audit preparation and ongoing compliance, including controls documentation and evidence collection
• Develop and implement compliance policies and procedures specific to clinical trial technologies and healthcare AI solutions
• Ensure adherence to Anti-Kickback Statute, Stark Law, and PhRMA Code requirements in all business relationships
• Monitor evolving AI regulations and their impact on clinical trial optimization platforms

Quality Management & Documentation

• Oversee Quality Management System (QMS) in partnership with other team members, for maintenance and contractual compliance 
• Establish and maintain comprehensive record retention policies across clinical, regulatory, and business functions
• Manage document control processes for clinical protocols, compliance documentation, and regulatory correspondence
• Coordinate with clinical operations team to ensure GCP compliance in trial management and data collection

Contract & Vendor Compliance

• Review and negotiate compliance terms in customer agreements, vendor contracts, and clinical trial agreements
• Conduct vendor risk assessments and ongoing compliance monitoring for third-party service providers
• Ensure contract compliance with healthcare customer requirements, including BAAs and data processing agreements
• Support commercial team with compliance aspects of customer onboarding and due diligence processes

Training & Cross-Functional Support

• Develop and deliver compliance training programs for employees across all functions
• Serve as primary compliance liaison with external auditors, regulators, and certification bodies
• Collaborate with legal, clinical, and product teams on regulatory strategy and risk mitigation
• Maintain compliance calendar and ensure timely completion of regulatory filings and renewals

Required Qualifications

Education & Experience

• Bachelor’s degree in Life Sciences, Business, or a related field plus 8+ years of compliance experience in healthcare, biotech, or clinical research organizations; advanced degree preferred
• OR Juris Doctor (JD) or other advanced degree plus 5+ years of compliance experience in healthcare, biotech, or clinical research organizations
• Direct experience with clinical trial regulations and GCP requirements
• Proven track record managing compliance programs in regulated industries

Technical Expertise

• Employment law and HR compliance expertise, including workplace privacy, salary transparency, employee data protection, and regulatory training requirements
• Corporate governance and general business compliance including anti-corruption, export controls, and corporate record-keeping requirements
• Privacy program management across all business functions, including vendor privacy assessments and cross-border data transfer compliance
• Financial compliance awareness including regulatory reporting requirements
• Deep knowledge of GDPR and HIPAA requirements and implementation
• Hands-on experience with SOC 2 audits and information security compliance frameworks
• Familiarity with clinical research regulations (GCP, ICH guidelines, 21 CFR Part 11)
• Understanding of AI/ML regulatory landscape in healthcare and clinical trials

Core Competencies

• Strong analytical and problem-solving skills with ability to translate complex regulations into actionable policies
• Excellent written and verbal communication skills for regulatory correspondence and training delivery
• Project management experience with ability to manage multiple compliance initiatives simultaneously
• Detail-oriented approach with strong documentation and process improvement capabilities

Preferred Qualifications

• Professional certifications (CIPP, CISA, CCEP, CHRC, or similar compliance credentials)
• Experience with international regulations (EU Clinical Trials Regulation, other global markets)
• Background in clinical research or pharmaceutical compliance
• Familiarity with AI ethics and algorithmic bias considerations in healthcare
• Experience with healthcare technology or SaaS compliance programs

About the Role

The Regional Director is responsible for owning and optimizing site-level performance across a portfolio of GI-focused clinical research sites. This role ensures operational excellence by aligning teams around key performance goals, elevating site capabilities, and maintaining consistency in trial execution. As a strategic operations leader, the Regional Director plays a central role in connecting site level performance with broader business objectives.

Responsibilities

• Manages staff across multiple sites, ensuring execution is aligned with protocol, regulatory requirements, and IH standards.
• Owns overall performance of assigned sites, including enrollment, data quality, compliance, and team culture.
• Ensures sites are set up for success (i.e. staffed appropriately and equipped with the appropriate equipment and training) and makes recommendations to allocate resources based on business needs. 
• Builds strong relationships and collaborates with PIs to align their engagement with study goals and operational strategy.
• Influences study portfolio, optimizing for profitability and value to patients. 
• Identifies and manages issues, concerns and problems related to site performance.
• Leads and develops CRCs, and other site-based research staff through clear expectations, performance coaching, and team development.
• Serves as a visible, hands-on people manager who builds high-performing, accountable teams.
• Identifies levers to drive site level KPIs through monitoring KPIs and performance trends, escalating to appropriate parties. 
• Implements corrective actions or process improvements as needed.
• Serves as the primary operational liaison between site staff and central functions.
• Drives a culture of ownership, collaboration, and continuous improvement across all assigned sites.

What We’re Looking For

Required Qualifications

• Knowledgeable about the critical elements for success in clinical trials: Ability to review protocols, programs, and assess the success of a project.
• Ability to influence change management and model flexibility
• Problem-Solving Skills: Ability to identify problems, develop and implement solutions.
• Strategic Planning: Ability to plan for short, medium and long term success and make recommendations for growth
• Ability to use data as a tool, identify trends, and draw conclusions. 
• Project Management: Demonstrated ability to successfully manage people/projects.
• Proactive problem-solving abilities and follow-through.
• Practices professionalism and integrity in all actions. 
• Communication Skills: Excellent written and verbal communication skills. 
• Working knowledge of CTMS, eDC and other core research systems. 
• Ability to travel: Up to 30% travel to provide operational oversight, hold team meetings, and attend other professional meetings/conferences as needed.

Preferred Qualifications

• Experience in managing a large site network and demonstrated success in achieving targets and optimizing operations.
• Experience with gastroenterology and/or hepatology studies. 

What We Offer

• Medical, dental, and vision insurance
• Life and disability insurance
• Parental leave
• Stock options
• Flexible work hours
• Unlimited paid time off

We are seeking a strategic and data-driven People Business Partner role to partner closely with leaders across corporate functions and site-based operational teams in support of a high performing, highly distributed healthcare services organization. This role will act as a trusted advisor, aligning people strategies with business priorities to support growth, scalability, and performance across the organization. Operating in a high-growth, M&A driven environment, this role requires a strong balance of strategic thinking and hands-on execution. The People Business Partner will play a key role driving organizational effectiveness, enabling leadership and supporting change initiatives while fostering a high-performing, mission-driven culture. This individual must be comfortable pivoting between both a strategic and hands-on level of engagement, with a strong focus on change and performance management,
talent/leadership development, organizational design, employee relations and integration.

Key Responsibilities

Strategic Business Partnership
● Serve as a trusted advisor, coach and thought partner to department, team and operational leaders, providing guidance on organizational strategy, workforce planning, employee relations issues and talent implications of business decisions
● Translate business priorities into actionable HR strategies that drive growth, scalability, and operational excellence to enable a high performing and engaged workforce.
● Develop a deep understanding of IH business units, financial drivers, and market industry dynamics to proactively shape people initiatives that help transform the business as we grow and scale our infrastructure.
● Serve as a strategic liaison and advisor between the business and People Team Center of Excellence’s (COE) to align HR service delivery with business priorities
● Identify opportunities to implement data-informed people strategies that strengthen organizational health, culture and maturity while directly impacting leadership effectiveness and team performance
● Lead workforce planning with business partners, anticipating skills and capabilities needed to scale the organization beyond current state – develop plans in conjunction with TA to identify talent profiles and succession bench ready for promotion to increased level of scope and responsibility

Talent and Performance Management
● Drive talent and performance management processes that reinforce accountability, ownership and high standards of behaviors / values alignment to support our high-performance culture
● Partner with leaders on succession planning, leadership development, compensation strategies and retention initiatives across the enterprise
● Use data and insights to inform talent decisions and effectively balance business needs with employee advocacy
● Coach and develop leaders to engage, motivate and lead high performing teams, identifying least effective performance and partnering with team leaders to address performance issues early on.

Change Management and Culture
● Lead change management efforts across our growing and evolving teams/structures to support effective communication, accountability and alignment to our strategic priorities
● Champion a culture of innovation, collaboration, and continuous improvement aligned with Iterative Health’s mission
● Support leaders in navigating ambiguity and leading through transformational change as an organization, providing insights and serving as a “thought partner” on operational and people challenges that dynamic growth brings.

Employee Relations and Coaching
● Provide expert coaching on employee relations, leadership effectiveness, and team dynamics to enable a highly engaged, productive workforce while maintaining consistency and alignment to IH policies and procedures.
● Support positive culture building initiatives and drive employee engagement initiatives with team leaders to build highly engaged, motivated team members.
● Ensure compliance with employment laws and company policies – identify opportunities to improve, create and implement policies and procedures that balance business needs with operational realities M&A

HR Integration
● Partner with internal stakeholders including People COE’s on due diligence, integration planning, and execution as part of pre and post-acquisition integration process
● Support organizational design, talent assessment, and cultural integration efforts to ensure seamless onboarding of acquired entities and team members to IH
● Anticipate, identify and mitigate people-related risks associated with rapid growth and change, including supporting HR initiatives focused on harmonization of system, processes and policies across the growing enterprise.

HR Program Execution
● Partner with COE to deliver best-in-class HR transformational initiatives to support a growing and scaling workforce
● Own HR projects in support of strategic HR agenda focused on employee engagement, leadership development, performance management, and operationalizing best in class people initiatives and infrastructure that will attract, develop and retain talent.

Qualifications
● 7–10+ years of progressive HR experience, including working in a fast-scaling, high-growth, complex and ambiguous start-up environment
● Experience in healthcare, clinical research, medtech, life sciences, or related industries strongly preferred
● Experience supporting a highly distributed, growing multi-site location network both domestically and globally is strongly preferred
● Demonstrated experience across a wide range of HR functional domains
● Strong business acumen with the ability to link HR strategy to financial and operational outcomes
● Proven ability to communicate and influence senior leaders as well as operate as a strategic partner, understanding the operational and strategic priorities of the business and how people strategies can make an impact
● Experience in organizational design, change management, and talent strategy
● Data-driven, analytical mindset with comfort leveraging data and analytics to inform decisions
● Excellent communication, coaching, and stakeholder management skills
● Comfort navigating through ambiguity and managing multiple competing priorities
● A builder and inventor mindset – orientation towards thinking outside the box to pilot and test programs and initiatives to iterate before applying a one-size fits all approach.

About the Role

As the Director, Strategy & Operations - Growth, you will report to the VP, Growth and serve as the leader of Iterative Health's biological specimen collections business. This is a senior, highly autonomous role for an operator who is equally comfortable setting strategy and rolling up their sleeves to execute. You will own the go-to-market strategy, lead the full build-out of the business, and hold accountability for performance. You will also lead and develop the team that runs the day-to-day of collections operations. The ideal candidate brings a strong strategic and analytical foundation from management consulting or a high-growth startup environment, paired with the operational horsepower and ownership mindset to build something from the ground up.

Responsibilities

Go-to-Market Strategy

• Own the go-to-market strategy for Iterative Health's biological specimen collections business — defining the service offering, target customer segments, competitive positioning, and path to scale
• Define what we sell and how we sell it: Work with Business Development to scope the collections service model, establish pricing frameworks, and develop the materials and narrative needed to bring the offering to market
•  Identify and size the resourcing, infrastructure, and capability requirements needed to support the strategy and inform investment decisions

Business Build-Out

•  Lead the end-to-end build-out of the biological specimen collections business — standing up operational capabilities, and establishing the processes and infrastructure needed to execute at scale
• Own vendor contracting and relationships, including selection, negotiation, onboarding, and ongoing performance management for all collections-related vendors
• Partner with the Business Development team to develop and progress a pipeline of collections studies, supporting sponsor engagement and proposal development
• Work cross-functionally with site operations leaders to identify and onboard the right site network to support collections studies

Business Performance Ownership

• Own execution quality and sponsor satisfaction on active collections studies, serving as the senior point of escalation and ensuring trials are delivered to the highest standard
• Define and track KPIs across the business; use performance data to identify gaps, course-correct quickly, and communicate progress to senior leadership

Team Leadership

• Lead, develop, and hold accountable a team that includes pre-screeners, central Clinical Research Coordinators, and a Clinical Operations Manager — setting clear performance targets and maintaining a high-performance culture
• Train team members on workflows, protocols, and quality standards, and ensure the team has the tools, processes, and support needed to execute at pace
• Set the operational tempo for the team — running structured operations, maintaining visibility into study and team performance, and driving accountability at every level

Required Qualifications

• BS/BA or higher degree; advanced degree (MBA, MPH, or equivalent) strongly preferred
• 7+ years of experience in a strategic and operational role, with meaningful exposure to building or scaling a business — prior experience in management consulting, a high-growth startup, or a general management capacity is strongly preferred
• Experience leading cross-functional build-outs — standing up new capabilities, managing vendors, and driving commercial pipelines
• Proven people leadership experience with the ability to recruit, develop, and hold accountable a high-performing team
• Exceptional organizational and project management skills with the ability to manage multiple high-stakes workstreams simultaneously
• Strong executive presence and communication skills — able to represent the business credibly with sponsors, vendors, and senior internal stakeholders
• Comfortable operating with significant autonomy and building structure in ambiguous, fast-moving environments

Preferred Qualifications

• Experience in life sciences, clinical research, or healthcare services — particularly in biological specimen collections studies

About the Role

As the Manager, Growth, you will play a critical operational role at the center of Iterative Health's two core growth engines in Cardiology: expanding our sponsor portfolio and scaling our site network. This is a high-visibility, high-impact role for a sharp operator who thrives on process ownership, cross-functional coordination, and getting things done in a fast-moving environment. You will own the internal mechanics of business development — keeping the pipeline moving, deals progressing, and sponsors well-served — while simultaneously driving the operational build-out of new clinical research sites from contract execution through first study activation. The ideal candidate brings a strategic and operational mindset, is energized by variety, and is able to manage multiple workstreams with rigor and speed.

Responsibilities

Sponsor Growth: Business Development & Alliance Management Support

• Own the end-to-end internal business development process from initial sponsor engagement through contract execution, serving as the single internal touchpoint for new contracts
• Keep the business development pipeline organized and visible by maintaining up-to-date reporting on opportunity status, next steps, and deal progression
• Support the Director of Research Partnerships in preparing for key sponsor interactions — developing pitches and proposals, building conference materials, and ensuring the team shows up well-prepared for high-stakes meetings
• Support sponsor account meetings through internal data gathering, performance reporting, and post-meeting follow-through
• Continuously identify opportunities to streamline and improve the business development process to accelerate deal pull-through and reduce time to contract close

Site Network Growth: De Novo Site Builds 

• Partner with the Director of Clinical Research to support the end-to-end process of standing up de novo clinical research sites 
• Serve as the operational connective tissue during site stand-up, tracking progress, surfacing blockers, and ensuring all cross-functional inputs come together on schedule
• Work with the Director of Clinical Research to continuously evaluate and improve the site stand-up process — identifying inefficiencies, building out playbooks, and creating repeatable frameworks that scale as the network grows

Required Qualifications

•  BS/BA or higher degree
• 4+ years of experience in a strategic and operational role, such as management consulting, business operations, or growth/strategy at a high-growth startup
• Demonstrated ability to own and manage complex, cross-functional processes end-to-end with strong attention to detail
•  Excellent organizational skills with experience managing multiple projects and workstreams simultaneously in a fast-paced environment
• Strong communicator with the ability to synthesize information, build materials, and engage effectively with internal and external stakeholders
• Comfortable working with ambiguity and building structure where it doesn't yet exist

Preferred Qualifications

• Experience in life sciences, clinical research, or healthcare 
• Familiarity with clinical trial operations, site networks, or sponsor/CRO relationships

HubSpot welcomes individuals to join our Sales team as a Business Development Representative (BDR). As part of our commitment to building a hybrid company, BDRs can be flexible with their work location with the choice to either be based in Cambridge, Massachusetts, or remotely in the US. 

🚀 Join HubSpot as an Outbound Business Development Representative (BDR)
📍 Cambridge, MA or Remote (US)

We’ll be honest — sales isn’t easy, and it’s not for everyone. But for those who love a challenge, thrive on results, and want to launch a long-term path in sales, it’s incredibly rewarding.

If you’re looking to “try out” sales or just dip a toe in, this probably isn’t the role for you. But, if you’re the kind of person who wakes up hungry to compete, thrives on setting and smashing goals, and wants to build a career in tech sales from the ground up — we want to talk to you.

At HubSpot, our BDRs are not only the first point of contact for our prospects—they’re also developing the skills and mindset to become our next generation of Account Executives. This is not a placeholder job — it’s the first chapter of a high-growth sales career designed for those who want to build skills, embrace feedback, move fast, and grow even faster.

The Role:
As an Outbound BDR, you’ll play a key role in HubSpot’s growth engine. You'll be the first touchpoint for many of our future customers, sparking conversations through strategic outreach, uncovering pain points, and qualifying leads. You’ll partner closely with Account Executives to deliver high-quality meetings that drive pipeline, impact, and revenue. Along the way, you’ll sharpen your sales toolkit daily and gain exposure to a world-class sales organization.

What You’ll Do:

• Own and execute outbound prospecting through high-volume outreach (60–100+ activities/day) via phone, email, and LinkedIn.
• Collaborate with Account Executives to target strategic accounts and refine outreach strategy.
• Qualify leads based on fit, need, and urgency — and book quality discovery meetings.
• Hit (and exceed) KPIs for activity, meetings delivered, and pipeline impact.
• Grow fast. Learn fast. Get coached. Apply it. Repeat.
  
  

What You Won’t Do:

• Coast. We move fast, we test, we iterate, and we compete.
• Wait for someone to tell you what to do. We value self-starters who take ownership.
• Treat this as “just a job.” This is a foundational role, setting you up for a successful long term career in sales.
  
  

We’re Looking For People Who:
✅ Are eager to grow long-term within a sales path–if your focus is split between sales and other paths like customer success, marketing, operations, etc, this role likely won’t be the best fit.
✅ Are resilient, coachable, and crave feedback to improve.
✅ Are curious and ask why, not just how.
✅ Set high standards for themselves — and hit them.
✅ Are technologically fluent, adapting to new technologies and leveraging AI in your day-to-day.
✅ Communicate clearly, write thoughtfully, and can confidently conduct a cold call.
✅ Are energized by a fast-paced environment and a bit of friendly competition.
✅ Either have past sales success or have demonstrated excellence in goal-driven roles (think: fundraising, athletics, service industry, etc).

Tools We Use (and You’ll Learn):

• HubSpot (of course)!
• LinkedIn Sales Navigator
• AI Powered Tools across all aspects of the role for research & outreach
• Slack, Zoom, LeadIQ, Google Suite, Zoominfo, and more
  
  

To Apply:
📝 No cover letter required.
📄 Submit your resume.
👉 If you're new to sales, show us your grit: include examples of how you've hit ambitious goals in other roles.
📊 If you’ve been in sales before, highlight metrics like quota attainment.

Important information about the position.

Bottom Line:
We’re looking for future stars, not just seat-fillers. If you want to grow into an elite sales professional and are ready to work hard, get uncomfortable, and see what you're really capable of — this is your shot.

HubSpot welcomes individuals to join our Sales team as a Business Development Representative (BDR). As part of our commitment to building a hybrid company, BDRs can be flexible with their work location with the choice to either be based in Cambridge, Massachusetts, or remotely in the US. 

🚀 Join HubSpot as an Outbound Business Development Representative (BDR)
📍 Remote (US) or Cambridge, MA

We’ll be honest — sales isn’t easy, and it’s not for everyone. But for those who love a challenge, thrive on results, and want to launch a long-term path in sales, it’s incredibly rewarding.

If you’re looking to “try out” sales or just dip a toe in, this probably isn’t the role for you. But, if you’re the kind of person who wakes up hungry to compete, thrives on setting and smashing goals, and wants to build a career in tech sales from the ground up — we want to talk to you.

At HubSpot, our BDRs are not only the first point of contact for our prospects—they’re also developing the skills and mindset to become our next generation of Account Executives. This is not a placeholder job — it’s the first chapter of a high-growth sales career designed for those who want to build skills, embrace feedback, move fast, and grow even faster.

The Role:
As an Outbound BDR, you’ll play a key role in HubSpot’s growth engine. You'll be the first touchpoint for many of our future customers, sparking conversations through strategic outreach, uncovering pain points, and qualifying leads. You’ll partner closely with Account Executives to deliver high-quality meetings that drive pipeline, impact, and revenue. Along the way, you’ll sharpen your sales toolkit daily and gain exposure to a world-class sales organization.

What You’ll Do:

• Own and execute outbound prospecting through high-volume outreach (60–100+ activities/day) via phone, email, and LinkedIn.
• Collaborate with Account Executives to target strategic accounts and refine outreach strategy.
• Qualify leads based on fit, need, and urgency — and book quality discovery meetings.
• Hit (and exceed) KPIs for activity, meetings delivered, and pipeline impact.
• Grow fast. Learn fast. Get coached. Apply it. Repeat.
  
  

What You Won’t Do:

• Coast. We move fast, we test, we iterate, and we compete.
• Wait for someone to tell you what to do. We value self-starters who take ownership.
• Treat this as “just a job.” This is a foundational role, setting you up for a successful long term career in sales.
  
  

We’re Looking For People Who:
✅ Are eager to grow long-term within a sales path–if your focus is split between sales and other paths like customer success, marketing, operations, etc, this role likely won’t be the best fit.
✅ Are resilient, coachable, and crave feedback to improve.
✅ Are curious and ask why, not just how.
✅ Set high standards for themselves — and hit them.
✅ Are technologically fluent, adapting to new technologies and leveraging AI in your day-to-day.
✅ Communicate clearly, write thoughtfully, and can confidently conduct a cold call.
✅ Are energized by a fast-paced environment and a bit of friendly competition.
✅ Either have past sales success or have demonstrated excellence in goal-driven roles (think: fundraising, athletics, service industry, etc).

Tools We Use (and You’ll Learn):

• HubSpot (of course)!
• LinkedIn Sales Navigator
• AI Powered Tools across all aspects of the role for research & outreach
• Slack, Zoom, LeadIQ, Google Suite, Zoominfo, and more
  
  

To Apply:
📝 No cover letter required.
📄 Submit your resume.
👉 If you're new to sales, show us your grit: include examples of how you've hit ambitious goals in other roles.
📊 If you’ve been in sales before, highlight metrics like quota attainment.

Important information about the position.

Bottom Line:
We’re looking for future stars, not just seat-fillers. If you want to grow into an elite sales professional and are ready to work hard, get uncomfortable, and see what you're really capable of — this is your shot.

The Role:

Reporting to the Senior Director of Pharmacovigilance (PV) Operations, the Associate Director, PV Operations will provide vendor oversight and review of ICSR processing for assigned investigational products. They will ensure compliance and adherence to Safety processes and SOPs as well as manage and analyze data from the Global Safety Database. This SME will be responsible for PV operations’ role in Phase 1, 2, & 3 clinical studies, inclusive of inspection readiness, reconciliation, SMP maintenance, and site and regulatory authority reporting oversight. They will work in close collaboration with PV physicians and PV scientists on operational safety and case quality issues.

Responsibilities:

• Manage and support the relationship with safety vendor(s) to ensure effectiveness, quality and compliance of all outsourced activities.
• Provide Sponsor oversight of operational safety responsibilities, including the timely and accurate execution of the processes defined within the applicable Safety Management plans.
• Participate in daily management, operational oversight and execution of operational safety tasks for assigned Nuvalent clinical programs.
• Review incoming adverse event reports and communications from vendors to determine action required and ensure prompt review, follow-up, and timely submission of expedited safety reports.
• Oversee case workflow (case receipt through submission) between safety vendor and Nuvalent Pharmacovigilance team.
• Ensure safety case queries are resolved as per defined processes (interfacing with safety physicians, clinical operations team, other cross-functional teams within Nuvalent, and clinical vendors, as required) and facilitate case closure within required timelines.
• Serve as PV operations SME on safety reporting processes according to study protocol.
• Participate in the development and maintenance of SOPs, forms, plans, systems, and guidance documents to ensure compliance with all applicable regulatory requirements or guidelines, GVP and industry best practices.
• Serve as resource and contact for other functions within the company for pharmacovigilance
• operational activities.
• Serve as Pharmacovigilance representative for the operational aspects of the SAE reconciliation
•  
• Responsible for the development of safety management plans for assigned programs, and associated documents to ensure that study-specific and Regulatory Authority reporting requirements are met and that workflow responsibilities between CROs, and Nuvalent are clearly delineated and adhered to

Competencies Include:

• Excellent written and verbal communication skills.
• Demonstrated communications expertise with the ability to articulate, influence, and work successfully with internal/external stakeholders and within a matrixed environment.
• Ability to plan and handle multiple responsibilities simultaneously and still meet high quality and timeliness standards under pressure.
• Demonstrated contribution to strategy and innovation. Contributes to or leads actionable strategies.
• Demonstrated project management and prioritization capabilities.

Qualifications:

• Bachelor’s degree in Nursing, RN, Pharmacy, Pharm D., or other relevant health-care related fields.
• 8-10 years of progressive drug safety experience in a biotech/pharma company.
• Clinical Development experience.
• Strong knowledge of current and emerging regulatory requirements including EMA GVP Modules, FDA IND and NDA reporting requirements, ICH, CIOMS
• Ability to interpret and follow regulatory guidelines.
• Proven knowledge of Good Documentation Practices and cGXPs.
• Basic knowledge of MedDRA coding.
• Experience in ICSR case-processing and reporting.
• Experience working in and with safety databases.
• Direct experience managing relationships with service providers or external business partners

Additional Information:

Nuvalent is committed to fair and equitable compensation practices, aiming to provide employees with competitive total rewards packages.

The targeted salary range reflects what Nuvalent reasonably and in good faith expects to offer for this position at the time of posting, but the final salary determination may be within or outside this range based on various factors, including, but not limited to, experience, skills, education, and market factors.  The range will be reviewed regularly and is subject to change.

Nuvalent also offers a comprehensive benefit package to support our employees at each stage of their career, financial, health, and well-being journey, including medical, dental, and vision insurance, 401(k) retirement savings plan, generous paid time off (including a summer and winter company shutdown), and much more.

The Role:

Reporting to the Senior Director of Pharmacovigilance (PV) Operations, the Associate Director of PV Operations will provide vendor oversight and review of ICSR processing. They will ensure compliance and adherence to Safety processes and SOPs as well as manage and analyze data from the Global Safety Database. This SME will be the primary point of contact for quality oversight of the case processing vendor. They will work in close collaboration with PV physicians, PV scientists, and PV Excellence on operational safety and case quality issues The role will expand and evolve in line with Nuvalent’s expansion as we approach potential market authorization.

Responsibilities:

• Manage and support the relationship with safety vendor(s) to ensure effectiveness, quality and compliance of all outsourced activities.
• Provide Sponsor oversight of operational safety responsibilities, including the timely and accurate execution of the processes defined within the applicable Safety Management plans.
• Monitor performance (metrics, other reports) of the safety vendor and the quality output of the ICSRs; provide appropriate feedback and training.
• Monitor key performance indicators of case processing and present findings to Head of PV and cross-functional stakeholders.
• Participate in daily management, operational oversight and execution of operational safety tasks for assigned Nuvalent clinical programs.
• As needed. review incoming adverse event reports and communications from vendors to determine action required and ensure prompt review, follow-up, and timely submission of expedited safety reports.
• Oversee case workflow (case receipt through submission) between safety vendor and Nuvalent Pharmacovigilance team.
• Ensure safety case queries are resolved as per defined processes (interfacing with safety physicians, clinical operations team, other cross-functional teams within Nuvalent, and clinical vendors, as required) and facilitate case closure within required timelines.
• Serve as PV operations SME on safety reporting processes according to study protocol.
• Participate in the development and maintenance of SOPs, forms, plans, systems, and guidance documents to ensure compliance with all applicable regulatory requirements or guidelines, GVP and industry best practices.
• Serve as resource and contact for other functions within the company for pharmacovigilance
• operational activities.
• Serve as Pharmacovigilance representative for the operational aspects of the SAE reconciliation.

Competencies Include:

• Excellent written and verbal communication skills.
• Demonstrated communications expertise with the ability to articulate, influence, and work successfully with internal/external stakeholders and within a matrixed environment.
• Ability to plan and handle multiple responsibilities simultaneously and still meet high quality and timeliness standards under pressure.
• Demonstrated contribution to strategy and innovation. Contributes to or leads actionable strategies.
• Demonstrated project management and prioritization capabilities.

Qualifications:

• Bachelor’s degree in nursing, RN, Pharmacy, Pharm D., or other relevant health-care related field.
• 8-10 years of experience in a biotech/pharma company.
• Direct experience managing relationships with service providers or external business partners
• Clinical Development experience.
• Strong knowledge of current and emerging regulatory requirements including EMA GVP Modules, FDA IND and NDA reporting requirements, ICH, CIOMS
• Ability to interpret and follow regulatory guidelines.
• Proven knowledge of Good Documentation Practices and cGXPs.
• Basic knowledge of MedDRA coding.
• Experience in ICSR case-processing and reporting.
• Experience working in and with safety databases.

Additional Information:

Nuvalent is committed to fair and equitable compensation practices, aiming to provide employees with competitive total rewards packages.

The targeted salary range reflects what Nuvalent reasonably and in good faith expects to offer for this position at the time of posting, but the final salary determination may be within or outside this range based on various factors, including, but not limited to, experience, skills, education, and market factors.  The range will be reviewed regularly and is subject to change.

Nuvalent also offers a comprehensive benefit package to support our employees at each stage of their career, financial, health, and well-being journey, including medical, dental, and vision insurance, 401(k) retirement savings plan, generous paid time off (including a summer and winter company shutdown), and much more.

Are you ready to make a significant impact in the world of casualty claims?

As a Claims Specialist, Casualty you will be at the helm of managing high-severity and complex casualty claims, including those in litigation. Your role will be pivotal in ensuring fair and efficient resolutions, conducting comprehensive file reviews, and mentoring junior claims handlers. Join our dynamic team and leverage your expertise to navigate intricate cases, collaborate with cross-functional teams, and stay ahead of industry trends. Your contributions will directly shape the future of our claims operations and drive our success.

What will you do? 

• Investigate, evaluate, negotiate, and settle moderate to severe bodily injury claims, as well as property damage liability claims
• Proactively manage your desk by adhering to deadlines, keeping clear notes, and maintaining timely and accurate reserves
• Mentor other more junior team members
• Support special projects as needed

Qualifications: 

• 5-10 years handling of moderate to severe casualty claims
• Prior experience in mentoring and technical evaluation
• Strong analytic and negotiation skills
• University or college degree
• CIP, FCIP or CRM designations an asset
• Proficient in investigation, evaluation, negotiation and settlement of claims
• Strong problem-solving skills
• Demonstrated willingness for continued development
• Travel may be required

Permanent, Full-Time 

Hybrid: This is a hybrid role. Please note, regular in-person workdays at our Cambridge Office or Toronto Office are expected minimum of two a week.

The expected base salary range for this position is $67,000 - $117,000. Depending on your relevant experience, skills, qualifications, market conditions and business needs, base compensation may vary. You have the potential to earn more through Gore Mutual’s discretionary bonus program which gives you an opportunity to increase your total compensation, provided the business meets its performance targets and you meet your individual goals.

Please note: This range reflects the expected base salary for this role but may not represent the full compensation range for all experience and skill levels. During the recruitment process, we will discuss and consider how your unique qualifications align with the broader range for this position.

Gore Mutual is proud to offer a comprehensive total rewards package which includes extended health and dental benefits, disability insurance, retirement plan matching, paid time off, recognition and perk programs.

About the role

Sana Biotechnology is growing, and we are hiring new team members who believe in the potential of engineered cells as medicines, who are passionate about delivering the possible to patients, and who lead with the desire to work on novel ideas. We are seeking an accomplished and strategic Senior Director, Regulatory Affairs to shape global clinical regulatory strategy across our pipeline, with a particular focus on programs in Type 1 diabetes, oncology, and autoimmune disease. This role is ideal for a seasoned regulatory leader who is excited by science‑driven development, cross‑functional collaboration, and advancing therapies for serious diseases.

You will develop and execute comprehensive regulatory strategies for clinical‑stage programs, guide teams on global regulatory requirements, and help shape the long‑term regulatory vision for the portfolio from Phase 1 to commercialization. Clinical-stage regulatory experience in our therapeutic areas of focus (Type 1 diabetes, oncology, autoimmune disease) and cell/gene therapies is preferred. Experience in regulatory operations and/or ex-US submission planning are also considered beneficial for the role. This position reports to the Vice President, Head of Regulatory Affairs and would work out of Sana’s offices in Cambridge (preferred), South San Francisco, or Seattle.

What you’ll do

• Direct clinical regulatory strategies for assigned programs, with emphasis on Type 1 diabetes, oncology, and autoimmune disease assets.
• Create regulatory development plans, including key milestones, registration strategies, health authority engagement plans, expedited pathways, pediatric development, and risk assessments.
• Partner closely with Clinical Development, CMC Regulatory Affairs, Clinical Operations, Safety, Technical Operations, and Program Leadership.
• Lead and/or oversee global regulatory submissions and health authority interactions/meetings.
• Provide strategic input into labeling, target product profiles, and benefit‑risk considerations.
• Serve as a senior regulatory representative on cross‑functional program teams.
• Lead regulatory operations improvement efforts to ensure submission quality, compliance, and efficiency.
• Proactively identify regulatory risks and mitigation strategies.
• Monitor evolving regulatory policy in Sana’s therapeutic areas of focus and for cell/gene therapy modalities.
• Support development of internal regulatory processes.
• Mentor junior regulatory staff.

What we’re looking for

• Bachelor’s degree required, advanced degree in relevant scientific field preferred.
• 10+ years of regulatory affairs experience in biopharmaceutical industry; experience with cell and/or gene therapy products highly desirable.
• Demonstrated success in preparing and leading IND/CTA submissions, pivotal-stage amendments, BLA/MAAs, and any associated regulatory interactions.
• Clinical-stage regulatory experience in Sana’s therapeutic areas of focus (Type 1 diabetes, oncology, autoimmune disease) and cell/gene therapies preferred.
• Demonstrated ability to lead regulatory strategy through complex decision points and influence cross-functional teams at the senior level.
• Demonstrated ability to collaborate productively across a broad array of functional areas, as well as raise and entertain different points of view and regulatory options.
• Experience in regulatory operations, and/or ex-US submission planning beneficial, though not required.
• Strong understanding of FDA, EMA, and international guidelines.
• Excellent oral and written communication skills.
• Ability to work from Sana offices in Cambridge, MA is preferred; will consider candidates who can work from our offices in South San Francisco, CA or Seattle, WA.

What will separate you from the crowd

• Deep motivation to advance therapies for people with serious unmet needs.
• Intellectual curiosity and scientific rigor.
• Strong skills in matrix leadership, influencing without direct authority

What you should know

• The base pay range for this position at commencement of employment is expected to be between $275,000 and $325,000/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience 

About the Role

We are seeking a detail-oriented and commercially driven Manager of Business Development Operations to own end-to-end BD execution across our IBD, broader GI, and hepatology portfolio. This is a highly cross-functional role that sits at the intersection of commercial strategy, site operations, and sponsor partnerships. Reporting to the Director of Business Development, you will serve as the primary internal point of contact for new contracts and play a critical role in ensuring seamless execution from lead to signed study. You will own the processes, metrics, and relationships that keep our BD pipeline moving — and ultimately help bring new therapies to patients faster.

Responsibilities

• Own the end-to-end, internal business development process from initial sponsor engagement through contract execution, serving as the single internal touchpoint for new contracts
• Lead the cross-functional scoping and pricing process for new study opportunities
• Keep the business development pipeline organized and visible by maintaining up-to-date reporting on where each opportunity stands
• Support the Director of Business Development in preparing for key sponsor interactions, including developing pitches and proposals, building conference materials, and ensuring the team shows up well-prepared for high-stakes meetings
• Continuously identify opportunities to streamline and improve the business development process to accelerate deal pull-through and reduce time to contract close

Required Qualifications

• 4–7+ years of experience in life sciences, clinical trials, business development, or enterprise partnerships
• Experience managing end-to-end commercial processes, from scoping and pricing through contract execution
• Strong cross-functional collaborator with a track record of working effectively across clinical, operations, and legal teams
• Highly organized with strong attention to detail and ability to manage multiple deals and workstreams simultaneously
• Excellent communication and relationship management skills
• Comfortable working in a fast-paced, high-growth environment with competing priorities

Preferred Qualifications

• Experience in gastroenterology, hepatology, or adjacent therapeutic areas
• Deep understanding of the clinical trials landscape
  • Advanced degree in healthcare or business (MBA, MPH, or equivalent)

About the Role

The Chief of Staff (CoS) will work closely with the CEO, serving as a trusted advisor, gatekeeper, problem solver and strategic partner to develop and implement strategies that advance our mission. It is a fast-track role to become an Executive in the company, and you will be a member of the Executive Team. In this role you will have both internal and external-facing responsibilities, and will provide strategic oversight to operational and communication needs across the company. 

As the CoS, you will have to handle complex situations and multiple responsibilities simultaneously, mixing long term projects with the urgency of immediate demands. This role is a front seat to all the action in getting a startup off the ground and a terrific opportunity to leverage your broad visibility into the organization to identify challenges, develop solutions, and be an integral part of executing critical workflows. This is an ideal role for a top-performer who thrives at the intersection of strategy and execution, enjoys solving ambiguous problems, and wants accelerated exposure to executive-level decision making. 

This role is part of the Office of the CEO and will directly manage the current Strategy and Operations team. You'll be onboarding with the current Chief of Staff, and reporting to our CEO once ramped.

Responsibilities

Strategic Partnership to the CEO

• Serve as a trusted advisor and strategic thought partner, helping the CEO prioritize, sequence, and drive the company’s most critical decisions
• Act as an extension of the CEO’s capacity - amplifying insight, synthesizing information, and ensuring the CEO’s time is leveraged for the highest-impact activities
• Prepare executive communications, board narratives, leadership offsites, and strategic briefings.

Organizational Alignment & Operating Rhythm

• Own the company’s operating cadence, including Executive Team meetings, quarterly planning, reviews, and cross-functional forums
• Ensure organizational alignment on priorities, metrics, and accountability frameworks
• Drive clarity across teams by translating strategic goals into executable plans

Decision Support & Insight Generation

• Structure analyses that distill complex data into actionable insights for the CEO and leadership team.
• Provide decision support for strategic opportunities, including market assessments, product expansion initiatives, partnership evaluation, or financial modelingIncrease the quality and speed of decision-making across the company through high-quality strategic research

Execution Leadership for Strategy and Operations function

• Lead and project manage multi-threaded, high-stakes company initiatives that span clinical operations, site network growth, product development, commercial strategy, and people operations.
• Build frameworks, workflows, and playbooks that improve organizational performance and scale
• Lead and manage the Strategy and Operations team (currently 1 direct report)

Internal and External Communications

• Support CEO communication with employees, the Board, investors, partners, and key customersEnsure information flows seamlessly across teams and that the CEO is prepared for all engagements
  
  

What We’re Looking For

Required Qualifications

• 6-8 years of experience in management consulting, strategy, business operations, or a comparable high-performance environment.
• Strong business acumen with familiarity in healthcare, life sciences, digital health, or tech-enabled services
• Proven ability to structure problems, build analytical frameworks, and generate concise, insight-rich recommendations
• Exceptional project management skills: ability to run multiple initiatives, align stakeholders, and drive outcomes independently
• Strong executive presence with the ability to earn trust quickly and communicate with clarity and influence
• Experience thriving in fast-paced, high-growth, ambiguous environments
• Willingness to be in our NYC or Cambridge office 2+ days per week
• Willingness to travel ~15% for customer, partner, or conference engagement

Preferred Qualifications

• Experience in health-tech, clinical research, or AI-driven healthcare solutions
• Exposure to C-suite advising, board engagement, or executive-level decision support
• Prior experience working inside a scaling startup or operator role

We are seeking an MBA Marketing Intern for a 3-month summer internship who thrives in a high-growth, fast-paced environment. This role will support the Marketing team while gaining exposure to a wide range of strategic and executional marketing initiatives. This is a highly cross-functional role, working closely with Operations, Product, Commercial, Medical Affairs, and Brand/Creative teams. Reporting to the Head of Marketing, you will contribute across multiple areas, including messaging and positioning, content development, campaign execution, customer insights, digital marketing, and brand strategy.

Specific Duties

• Own & Deliver a Marketing Capstone Project

• Lead a high-impact marketing project from scoping through execution and final presentation

• Partner with cross-functional stakeholders to define objectives, synthesize insights, pilot the program, track learnings, and deliver actionable recommendations

• Present findings to leadership at the conclusion of the internship

• Support Marketing Campaigns & Execution

• Assist in building and executing integrated marketing campaigns across channels

• Support white-glove in-person or digital event planning 

• Support content creation efforts, including thought leadership, sales enablement materials, and digital assets

• Support Customer & Market Insights

• Conduct market research, competitive intelligence, and customer analysis

• Synthesize secondary research to inform strategy and decision-making

• Support Marketing Operations & Performance

• Assist in tracking campaign performance and marketing KPIs

• Help maintain marketing systems, processes, and reporting frameworks to improve team efficiency

• Support Web, Digital & Social Media

• Contribute to website updates, SEO/SEM initiatives, and digital content optimization

• Support social media planning, content development, and performance tracking

We Value GRIT, So You’ll Fit In if:

• G — Growth: You are an avid learner and challenge yourself 

• R — Responsibility: You take immense pride in your work and follow through on your work, small or large 

• I — Impact: You are excited to roll up your sleeves and work on projects with true business meaning, and not just observe

• T — Team: You collaborate and communicate effectively with team members of different backgrounds and perspectives

Required Qualifications 

• Bachelor's degree in marketing, business, or a related field required

• Active MBA student pursuing Masters in Marketing, or related field 

Preferred Qualifications

• Familiarity with CRM and marketing automation tools, especially HubSpot

• Prior experience in healthcare

Travel: 

• Location: Hybrid role at Cambridge, MA headquarters 

• No other travel anticipated 

About the Role

We're looking for a driven, detail-oriented Clinical Contracts Specialist to join our small but mighty Legal team. In this role, you will manage and negotiate clinical trial agreements with sponsors and biotech partners, serving as a key point of contact throughout the contract lifecycle. Through your organization, communication skills, and daily dedication, you will have a meaningful impact on the success of our clinical partnerships and, ultimately, on the patients we serve.

Responsibilities

• Draft, review, and negotiate clinical trial agreements (CTAs), confidentiality agreements (CDAs), and related documents with sponsors and biotech partners
• Serve as the primary point of contact for external parties on contract status, redlines, and execution timelines
• Manage the contract lifecycle in Ironclad, including tracking pending agreements, maintaining version control, and ensuring timely follow-ups
• Route finalized agreements for signature and maintain organized records of executed contracts
• Collaborate with clinical, business development, and finance teams to align contract terms with operational and budgetary requirements
• Identify and escalate contractual issues or non-standard terms to the Director of Legal for resolution
• Drive excellence and efficiency by maintaining templates, playbooks, and standard operating procedures for clinical contracting
• Support audit and compliance requests by ensuring contract documentation is complete and accessible

What We're Looking For

• Bachelor's degree in Life Sciences, Legal Studies, Business, or a related field
• 3+ years of experience negotiating or administering clinical trial agreements, preferably within a sponsor, CRO, or healthcare technology company
• Proficiency with contract lifecycle management systems (Ironclad preferred; Agiloft, Concord, or similar acceptable)
• Strong understanding of clinical research processes and regulatory considerations (e.g., ICH-GCP, HIPAA)
• Excellent written and verbal communication skills with the ability to manage multiple external stakeholders
• You are highly organized and adept at managing time-sensitive work streams and competing priorities
• You are a team player who dives head first into accepting diverse and challenging assignments with rigor and tenacity
• You have high integrity and excellent judgment

What We Offer

• Medical, dental, and vision insurance
• Life and disability insurance
• Parental leave
• Stock options
• Flexible work hours
• Unlimited paid time off

Our Commitment to Diversity

At Iterative Health, we're building a team that reflects the diversity of the patients we serve. We are committed to fostering an inclusive and equitable workplace, including our hiring process. If you require accommodations during the application or interview process, please reach out to: CandidateAccommodations@iterative.health.

About the role

As the Manager of Facilities & Engineering and Site Operations Lead for the Cambridge site, you will serve as a site Facilities and Engineering leader responsible for driving strategic facility, asset, and site wide operational programs across two locations. You will provide clear direction, influence decisions, and ensure that all facilities, engineering, and teams work cohesively to support day-to-day operations and corporate objectives.

In partnership with the Facilities and Engineering leadership, you will translate organizational priorities into actionable plans, communicate expectations clearly to stakeholders, and cultivate a high trust, high performance environment. This role requires a leader who is proactive, systems minded, and able to align cross functional teams and external partners around shared goals.

What you’ll do

Operational Leadership

• Lead the development and execution of facility, equipment, and operational strategies that advance site readiness, reliability, safety, compliance, and efficiency.
• Drive short and long range planning for the site’s assets, capital improvements, the maintenance/calibration program, and operational continuity.
• Oversee implementation and continuous improvement of programs covering the management of facilities, equipment maintenance and calibration, building systems and utilities, and project management and execution.
• Lead the development and execution of Facilities and Engineering initiatives to support scientific objectives and corporate strategies.
• Participate with leadership in the development of site Facilities and Engineering budgets, and management of established budgets.

Communication and Execution

• Manage day to day operations for both facilities, ensuring that work is properly prioritized and performed in accordance with business, safety, and quality requirements.
• Establish and monitor operational metrics, customer service standards, and performance indicators to promote transparency and continuous improvement.
• Act as the primary point of contact for site Facilities and Engineering, ensuring clear, timely, and solution oriented and transparent communication.
• Collaborate on contract negotiations, vendor selection, and provide vendor oversight to ensure operational reliability and cost effective, compliant service delivery.
• Collaborate with other operations functions within Sana (Site Lead, IT, Procurement, Facilities & Engineering, People, Legal) to drive solutions for Cambridge site needs.
• Build strong relationships with internal partners, external vendors, and contractors to ensure business and quality requirements are fulfilled.
• Partner with Environmental Health and Safety and Business Leaders to support emergency response plans and events.
• Facilitate site wide messaging around operational changes, space planning, project impacts, and service disruptions.
• Oversee facility and equipment service contract administration, planning and scheduling, and procurement of parts, tools, and equipment.

What we’re looking for

• Bachelor’s degree in engineering or related field.
• 7+ years of experience leading facilities, engineering, or lab operations in biotechnology or related industries.
• Demonstrated ability to influence stakeholders, and lead through change in a fast-paced, dynamic environment.
• Exceptional communication skills—able to simplify complex operational problems to drive clarity and align diverse audiences around shared objectives.
• Proven ability to manage competing priorities while maintaining strong partnerships across scientific, operational, quality, and business teams.
• Deep understanding of facility and utility systems (HVAC, gases, DI water, electrical, etc.), and asset lifecycle management in GxP environments.
• Sound judgment and troubleshooting skills and the capacity to resolve diverse problems effectively and in alignment with business needs
• Experience managing preventive maintenance and calibration programs, capital projects, vendor relationships, and cross‑site operational systems.
• Strong analytical and problem‑solving capabilities, with the ability to provide fit for purpose solutions.
• Embodies Sana’s core values: Lead from every seat, Thrive as a team, Make it happen.
• Demonstrates sound judgment, proactive thinking, and a commitment to a safe, compliant, and collaborative workplace.

What you should know

• The base pay range for this position at commencement of employment is expected to be between $140,000 and $160,000/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience 

The Building Engineer I is responsible for maintaining, operating, and troubleshooting building systems, including HVAC, plumbing, and electrical systems, focusing on performing routine maintenance tasks, responding to tenant requests, and ensuring systems operate safely under the guidance of senior engineers.

Essential Duties and Responsibilities:

• Perform scheduled maintenance, repairs, and inspections of building systems; address service requests, including hot/cold calls, plumbing issues, and lighting repairs.
• Troubleshoot minor equipment malfunctions and escalate issues as needed.
• Replace light fixtures, filters, and other components as required.
• Maintain accurate records of inspections and equipment performance.
• Interact with tenants, contractors, and property managers and work closely with senior engineers and technicians to support smooth building operations and resolve tenant issues.
• Assist with preventive maintenance tasks and contractor oversight.
• Conduct property inspections to identify deficiencies.
• Record equipment readings and ensure assigned building systems are operating according to standards.
• Follow company safety protocols and wear appropriate PPE; ensure compliance with OSHA, NEC, NFC, NFPA regulations; report safety hazards; participate in safety inspections.
• Provide guidance to junior Technicians when needed.
• Communicate verbally and in writing with teammates, leadership team, vendors, tenants, and client employees in a professional manner, keeping the appropriate customer(s) informed/updated as needed.
• Work closely with senior engineers to develop technical skills and participate in professional development programs to grow into advanced roles.
• Perform other duties as assigned.

Qualifications:

• HS Diploma or GED required
• Two to three years of job related experience or commensurate certification/trade experience
• CFC Certification preferred or willingness to obtain as requested; possess engineering and trade licenses required according to local, state, or national requirements
• Basic working knowledge of laptop and phone applications for work order and facility operation systems as well as basic skills with Microsoft Outlook
• Familiar with fire/life safety equipment/procedures
• Proven track record for delivering excellent internal and external customer service; ability to successfully interact/communicate with tenants/vendors/contractors as well as teammates and leadership team
• Familiarity with blueprints and code requirements
• Ability to work after hours, weekends, holidays, and during emergency situations as necessary to meet the needs of the client
• Possess competent knowledge of use and care of tools
• Ability to read and write English in order to understand manuals and procedures, and to write reports.
• Exhibit a willingness to develop familiarity with HVAC, electrical, and plumbing systems and gain experience with BAS operation and troubleshooting.

Physical Requirements:

Ability to stand, walk, climb ladders, and lift up to 50 pounds; perform physically demanding tasks such as stooping, crouching, and kneeling.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 

This position is 100% in-office. The role requires working in office during standard business hours. Remote work or telecommuting is not an option for this position.

#IND123

About the role

Sana Biotechnology is growing, and we are hiring new team members who believe in the potential of engineered cells as medicines, who want to challenge status quo, and who lead with the desire to translate novel ideas into clinical and commercial product. As the Senior Director, Late-Stage Cell Therapy Process Development, you will report to the Head of Process and Analytical Development and provide strategic, technical leadership for late stage process development of a PSC-derived islet product for Type 1 diabetes. You will build and manage a high performing process development team to develop commercial ready manufacturing processes. You will play a critical role in advancing our pipeline through pivotal process development, technology transfer, process characterization, and commercial readiness, ensuring robust, scalable, and compliant manufacturing processes. Cool Stuff!  This role will require onsite leadership in Cambridge, MA.

What you’ll do

• Partner closely with Research to develop 3D stem cell seed train and differentiation processes, including integration of bioreactors and automated and closed technologies and drug product (DP) process-enabling studies including formulation, fill/finish, and cryopreservation.
• Lead late stage process development for PSC-derived products, ensuring scalability, robustness, quality and regulatory compliance.
• Lead process characterization and validation activities, leveraging design of experiments (DoE) and Quality by Design (QbD) approaches and support process performance qualification (PPQ).
• Establish and execute a comparability strategy for pivotal process changes.
• Enable technology transfer to CDMOs or internal manufacturing, providing technical input and ensuring successful implementation.
• Author and review CMC sections of regulatory submissions (e.g., IND, BLA) and support regulatory Q&A and inspections.
• Collaborate and influence partners across multidisciplinary teams (e.g. Research, Analytical Development, Quality, Regulatory, Manufacturing, Clinical and Supply Chain) to execute on CMC deliverables for pivotal and commercial.
• Hire, mentor and develop a team of engineers, fostering a culture of trust, curiosity, scientific rigor, collaboration, and continuous improvement across a fast-paced performance driven environment.
• Contribute to developing the organization strategy, cultivate opportunities for innovation and career development, champion the Sana culture and make it a great place to work.

What we’re looking for

• Ph.D. in Biochemical Engineering, Chemical Engineering, or related discipline with a minimum of 10 years experience in cell therapy process development (including >5 years late stage development), with at least 5 years in a leadership role.
• Hands-on experience with perfusion and single use bioreactor systems at various scales from benchtop to pilot/production scale and technologies that enable closed and automated cell therapy manufacturing.
• Knowledge of stem cell biology and 2D/3D stem cell expansion and differentiation, including raw material selection for GMP manufacturing.
• In depth knowledge and experience with application of engineering principles, DoE and QbD approaches to enable bioreactor scale up and scale down model development.
• Experience with risk and root cause analysis and tools (e.g. FMEA, Ishikawa).
• Knowledge of cGMP, and quality and regulatory expectations for commercial cell therapy and/or biologics products.
• Experience supporting regulatory submissions, Q&A and audits/inspections.
• Experience supporting tech transfer of a cell therapy process to manufacturing.
• Strong influencing skills and ability to work in a matrixed, fast paced environment with evolving roles and responsibilities.
• Excellent written and verbal communication skills with ability to effectively communicate and partner with all levels of the organization.

What will separate you from the crowd

• > 10 years direct experience developing cell therapy processes from pre pivotal to commercial.
• Experience with optimizing protocols to generate stem cell derived islets
• Experience with PSC differentiation at >10 L in bioreactors
• Knowledge of media development including analytical tools to evaluate spent media and regulatory expectations for raw materials.
• Knowledge of process analytical technology (PAT) and analytical methods for deep characterization of stem cell derived products
• Strong track record of identifying and implementing novel cell therapy manufacturing technologies into GMP.

What you should know

• The base pay range for this position at commencement of employment is expected to be between $250,000 and $300,000/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.

Environmental Health & Safety Consultant

Triumvirate Environmental, one of the largest environmental services firms in North America, is seeking an Environmental Health & Safety Consultant to join our Somerville team.

As an Environmental Health & Safety Consultant, you will have a strong understanding of EH&S concepts, issues, challenges, and will be able to identify unmet issues and opportunities with resolutions, for current and new clients while ensuring the highest level of satisfaction. This service-oriented individual will be responsible for short- and long-term consulting and staff augmentation engagements. 

Triumvirate provides leading institutions in the higher education, life sciences, healthcare, and industrial sectors with diverse services and advice to assist them with compliance management. At Triumvirate, we strive to WOW both our employees and our customers. Our unique culture fosters growth, development, education, and creativity.

This position reports to a Regional EHS Director.  The position is onsite and will be supporting our clients in the greater Boston area.  

Essential responsibilities:

• Measure occupational and environmental hazards, such as noise and ergonomics, using calibrated scientific equipment and/or collecting samples of dust, vapors, or gases according to a defined operating procedure.
• Measure the effectiveness of engineered control systems such as fume hoods.
• Participate in the inspection and examination of machinery and equipment, such as lifting devices, machine guards, or scaffolding.
• Conduct workplace safety inspections according to a defined procedure, evaluating the use of personal protective equipment, such as respirators, respirators, protective eyewear, or hardhats, according to applicable regulations. These inspections of the workplace will involve talking with workers and observing their work.
• Identify potential accident and health hazards, such as toxic vapors, mold, mildew, and explosive gas-air mixtures and help implement appropriate control measures, such as adjustments to ventilation systems.
• Help investigate accidents and injuries, identifying causes and recommending remedial action.
• Communicate with client personnel regarding workplace safety issues, recommending corrective actions.
• Conduct routine EH&S safety trainings such as new employee orientation, hazard communication, fork truck training, without supervision.
• Write reports, including accident reports, and enter information on required Occupational Safety and Health Administration recordkeeping forms.
• Assist in the development of specific areas of occupational health and safety systems, including drafting or updating policies, procedures, and manuals.

Requirements:

• 2+ years' experience in an EH&S capacity.
• Bachelor’s degree in Occupational Health, Safety, or a related scientific field.
• Excellent communication & customer service skills.
• Detail orientation.
• Problem solver with the ability to remain calm in stressful situations.
• Possess valid driver's license and personal vehicle.
• Applicants must be authorized to work in the US without sponsorship.

Preferred requirements:

• Prior experience as a professional advisor or consultant to third party clients.
• Completed two or more industry-recognized trainings (OSHA 10 or 30, ABSA, HAZWOPER, DOT/IATA HAZMAT Transportation).
• Active member in at least one national professional safety organization including local chapters.
• Working towards meeting the requirements of and obtaining one professional designation/certification (CSP, CHMM, CIH, etc.).

 #LI-Onsite

#LI-JB1

Besides Health, Dental and Vision Insurance, we contribute to a 401k, offer a generous tuition reimbursement program, TONS of safety training for some positions with opportunities for external trainings and certifications, Mentorship & Career Succession Planning, Relocation Opportunities, Auto/Home insurance discounts, pet assistance discount plans, discounted movie passes & more!  

To learn more about our business, culture, and the exciting work that we are doing in the industry, find us on LinkedIn, Instagram (@triumvirateenvironmental), or our website! 

Triumvirate Environmental is committed to a diverse and inclusive workplace. As an Equal Opportunity Employer (EOE), Triumvirate does not discriminate on the basis of race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Individuals with Disabilities and Protected Veterans are encouraged to apply.

If you have a disability and need an accommodation during the application and hiring process, please contact us at https://www.triumvirate.com/contact or call us at 888-834-9697.  The requirements listed above are representative of the knowledge, skill, and/or ability required. To view our California Privacy Notice and Policy, click here.

About the role  

Sana Biotechnology is growing, and we are hiring new team members who believe in the potential of engineered cells as medicines, who want to challenge status quo, and who lead with the desire to work on novel ideas. As an Associate Director, Project Management, you will report to the program team lead (PTL) and work directly with our functional leaders to coordinate research, development, and manufacturing activities for Sana’s in vivo CAR T cell engineering program. You’ll help us target those small details that unlock big successes. This is a hybrid role that requires onsite presence at least 3 days a week in Cambridge.

What you’ll do  

• Partner with the PTL to manage a complex, cross-functional in vivo CAR T cell engineering program from preclinical through clinical development.
• Owner of project plan templates, tools, and project management best practices to organize and facilitate program team activities.
• Create and maintain a comprehensive project timeline and dashboard to monitor program performance, identify risks, and implement mitigation strategies in real time.
• Maintain close collaboration and great communication with internal and external key stakeholders to track program milestones where critical path risks at CDMO, CTL, and CRO are identified, escalated, and resolved promptly.
• Manage development and program budget.

What we’re looking for

• Batchelor’s degree in life sciences, biotechnology, or engineering field
• 6+ years of experience in pharmaceutical or life sciences industry, including 3+ years direct project management experience
• Proficiency in project management methodologies and tools such as Smartsheet and MS Timeline
• Excellence in stakeholder management with track record of working in matrix organization and influencing across multi-site, multi-function project teams
• Flexibility to work with external vendors in various time zones
• Strong understanding of drug development lifecycle and compliance in biotechnology
• Ability to operate effectively in a dynamic start-up environment that requires learning agility and the ability to plan and execute through ambiguity

What will separate you from the crowd  

• PM Experience in Cell and Gene Therapy development
• PMP certification
• Global experience

What you should know      

• The base pay range for this position at commencement of employment is expected to be between $160,000 and $200,000/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience

Are you driven by data, inspired by innovation, and eager to shape the future of insurance?

Join a fast-growing Canadian P&C insurer where you'll play a pivotal role in advancing our Actuarial Services function. We're building on a solid foundation—powered by cutting-edge technology, a robust enterprise data analytics team, and bold investments in AI. With this groundwork in place our talented team is now focused on scaling and refining our capabilities.

We're looking for bright, analytical minds to help bring our strategy to life. If you're passionate about solving complex problems and want to explore Pricing, Underwriting, and Claims, we want to hear from you.

Senior Data Scientist

We're looking for a Senior Data Scientist to join our growing team and build the next generation of predictive analytics solutions. In this role, you won’t just be crunching numbers, you’ll be using machine learning (ML) and artificial intelligence (AI) models to transform raw data into powerful insights that drive our business forward.

This is an opportunity to directly contribute to our core operations, working alongside a supportive team who are invested in your growth. If you have a passion for data and a desire to see your work make a tangible impact, this role is for you.

What you'll do:

• Deliver value through data-driven algorithms and models: You will apply the right mix of ML and AI to solve high-impact business problems. You’ll partner with stakeholders to select and defend the best model architecture and explainability approaches to balance performance, interpretability, and trade-offs.
• Embed ML/AI into core business capabilities: You will build deep expertise in P&C insurance workflows and translate that knowledge into practical ML/AI-powered analyses, decision tools, and visualizations that improve how work gets done.
• Partner with stakeholders to ensure adoption, value, and model integrity: You’ll align with stakeholders on goals and success metrics, then pressure-test solutions against real constraints to ensure they’re feasible and valuable. You will communicate your insights and recommendations with clarity and confidence to both technical and non-technical audiences.
• Invest in Your Future: We're committed to your professional development. You'll engage in project-specific research to continually grow your skills and have the unique opportunity to collaborate with our Claims and Finance departments.

 What You’ll Need to Succeed

• Education: You have a master’s degree in a quantitative or technical discipline
• Experience: You have 3–5 years of experience in an ML/AI development role, with experience deploying ML / AI models into production and associated governance procedures.
• Technical Skills: You have a broad understanding of modern ML architectures, familiarity with cloud and ML platforms. You have strong Python programming skills and experience with various ML libraries.
• Core Competencies: You have excellent analytical, quantitative, and critical thinking skills. You are highly analytical and use your communication and collaboration skills to engage with stakeholders to solve problems.

If you're ready to be a core part of our mission and make a tangible impact from day one, we want to hear from you.

#LI-Hybrid

The expected base salary range for this position is $79,500 - $129,500. Depending on your relevant experience, skills, qualifications, market conditions and business needs, base compensation may vary. You have the potential to earn more through Gore Mutual’s discretionary bonus program which gives you an opportunity to increase your total compensation, provided the business meets its performance targets and you meet your individual goals.

Please note: This range reflects the expected base salary for this role but may not represent the full compensation range for all experience and skill levels. During the recruitment process, we will discuss and consider how your unique qualifications align with the broader range for this position.

Gore Mutual is proud to offer a comprehensive total rewards package which includes extended health and dental benefits, disability insurance, retirement plan matching, paid time off, recognition and perk programs.

The Manager, IT Service Management (ITSM) is accountable for the end‑to‑end leadership, governance, and continuous improvement of core ITSM processes, including Incident, Problem, Change, Request, Knowledge, and Event Management. This role reports into Director, ITSM & Service Management.

This role serves as both an operational leader and strategic partner, ensuring IT services are reliable, resilient, and aligned with business objectives. The Manager, ITSM leads teams responsible for restoring service during disruptions, preventing recurrence through root cause analysis, enabling controlled change, and driving proactive service improvement through data‑driven insights. The role works extensively across Technology and Business teams, providing enterprise‑level coordination, governance, and executive reporting, and acts as a trusted advisor to senior leadership on service performance, risk, and operational maturity. 

What will you do in this role:

Manage a Team of Incident and Problem Management Specialists

• ​​Provide coaching, mentoring and performance management to direct reports.
• Maintain equitable afterhours and weekend work schedules (Incident response and support coverage).
• Assign work activities, project deliverables, product training, troubleshooting and research assignments etc.   
• ​Facilitate 1:1s, team ceremonies, and skills development aligned to ITSM best practices. 
• ​Ensure appropriate on call, after hours, and weekend coverage for major incidents and critical services. 
• ​Build cross training and succession capability to support service continuity. 

 Responsible for the Development, Implementation and Governance of the core ITSM processes

• Define, implement, and govern ITSM processes in alignment with ITIL and organizational standards. 
• Lead P1/P2 incident response, escalation, communications, and post incident reviews. 
• Oversee Problem Management, including root cause analysis, corrective actions, and trend analysis. 
• Govern Change Management practices, including change lifecycle controls, CAB participation, and risk assessment. 
• Ensure Knowledge Management practices support effective resolution, reuse, and organizational learning. 
• Oversee Event Management practices to enable proactive detection and prevention of service disruptions. 
• Drive continuous improvement to reduce service impact, improve stability, and meet availability targets. 

TSM Strategy, Roadmap, and Governance

• ​​Contribute to and shape the ITSM strategy and multi year roadmap, aligning process maturity improvements with business and technology priorities. 
• ​Participate in IT governance forums, risk reviews, and operational committees. 
• ​Ensure ITSM processes align with enterprise standards for risk management, compliance, audit readiness, and operational resilience. 
• ​Identify improvement opportunities based on performance data, lessons learned, and emerging best practices. 

Cross‑Functional Leadership and Enterprise Coordination

• Act as the primary ITSM liaison with DevOps, Architecture, Infrastructure, Security, Business Continuity, Risk Management, Compliance, PMO, and Process Governance teams. 
• Coordinate cross functional responses during major incidents, changes, and service disruptions. 
• Ensure ITSM processes are integrated with delivery, security, continuity, and risk management practices. 
• Support enterprise initiatives requiring ITSM input, readiness assessments, or operational transition. 

Performance Management, Metrics, and Executive Reporting

• Define, monitor, and report ITSM KPIs and KRIs across all ITSM capabilities. 
• Produce enterprise‑level dashboards and executive reporting covering service performance, risk indicators, trends, and improvement initiatives. 
• Present insights, findings, and recommendations to senior and executive leadership. 
• Use data to drive fact‑based decisions, risk mitigation, and service improvement outcomes. 

What will you need to succeed in this role:

• Community College/Undergraduate degree in Computer Science, Programming
• Certifications: ITIL (required), CMMI DevOps (preferred) 
• 10-15 years' experience in ITSM leadership across multiple process domains 
• 5-7 + years of experience in People Leadership/Management( Team size of 3+)
• 5-7 years' experience in Process Governance (developed, written and implemented process) 
• Strategic planning and roadmap development 
• Executive communication and presentation 
• KPI/KRI definition and dashboard reporting 
• Cross functional and matrix leadership 
• Risk and compliance awareness 
• Data analysis and trend identification 
• ITSM tooling literacy (e.g., ServiceNow) and testing collaboration 

#LI-Hybrid 

The expected base salary range for this position is $118,500 - $168,500. Depending on your relevant experience, skills, qualifications, market conditions and business needs, base compensation may vary. You have the potential to earn more through Gore Mutual’s discretionary bonus program which gives you an opportunity to increase your total compensation, provided the business meets its performance targets and you meet your individual goals.

Please note: This range reflects the expected base salary for this role but may not represent the full compensation range for all experience and skill levels. During the recruitment process, we will discuss and consider how your unique qualifications align with the broader range for this position.

Gore Mutual is proud to offer a comprehensive total rewards package which includes extended health and dental benefits, disability insurance, retirement plan matching, paid time off, recognition and perk programs.

About Dimagi

Dimagi is an award-winning social enterprise and a certified B-corp and Benefit Corporation. We build software solutions and provide technology consulting services to improve the quality of essential services for underserved populations. Our open-source technology platform, CommCare, is the world’s most widely-used and researched mobile data collection platform for frontline workers. Our choice to be a certified B-Corp and to legally incorporate as a Benefit Corporation sends a clear signal to our partners, our team members, and our communities that we not only believe but also take action in using business as a force for good. This approach combines our passion and commitment to tackle complex health and social inequities and work towards a brighter future for all.

About the Position

Dimagi is looking for a Project Manager to support our Data & Analytics work within the US Solutions Division. This position will be affiliated with our Cambridge, MA office but is open to remote employment within the United States. This is a 12-month fixed-term position with the possibility of renewal based on business requirements and mutual interest. 

The Project Manager will play a critical role in coordinating the delivery, evolution, and adoption of Dimagi’s Data Platform across multiple projects. In this role, you will work closely with Data Engineers, Project Directors, and project teams to manage timelines, priorities, and cross-functional dependencies related to data pipelines, reporting, and analytics deliverables.

You will coordinate data-related workstreams across projects, ensuring work is well-scoped, appropriately sequenced, and aligned with both project needs and broader platform considerations. This includes managing sprint execution, facilitating requirements definition for data use cases, and supporting consistent approaches to data modeling, reporting, and system integration across projects.

This role assumes comfort using AI-assisted tools to support planning, documentation, analysis, and learning in a complex technical environment.

Responsibilities

The specific responsibilities of this role can vary per project but are likely to include:

• Coordinate delivery of data and analytics workstreams, including data pipeline development, reporting, and dashboarding efforts, ensuring alignment with project timelines and priorities.
• Serve as a key external-facing representative for a project team. Project Managers are responsible for leading conversations around project planning, roadmapping and ensuring adherence to standard project management practices.
• Facilitate requirements gathering and refinement for data use cases, including reporting needs, data integrations, and analytics workflows, in collaboration with clients and internal technical teams.
• Manage sprint planning and execution for data-focused work, working closely with Data Engineers and a Project Director to ensure clear prioritization, sequencing, and delivery of tasks.
• Support cross-project consistency in data platform usage, helping teams align on approaches to data modeling, reporting structures, and integration patterns where appropriate.
• Track and manage dependencies across data systems and external integrations, ensuring risks are identified early and communicated clearly to stakeholders.
• Use AI-assisted tools thoughtfully to improve efficiency in requirements synthesis, project documentation, risk tracking, and stakeholder communications, while ensuring accuracy and alignment with project standards.

At Dimagi, Project Managers may fulfill a variety of functional roles, which will likely change over time as Dimagi partners with new clients and takes on new challenges and will vary depending upon the size and complexity of a project. 

Relevant Skills

• 5+ years of experience managing software or technical projects, including coordination across cross-functional teams
• Demonstrated ability to manage delivery of complex technical workstreams, including coordinating timelines, dependencies, and stakeholders across multiple teams
• Experience gathering and translating requirements from diverse stakeholders into clear, actionable plans for technical teams
• Experience running agile delivery processes, including sprint planning, backlog management, and cross-team coordination
• Strong organizational and project management skills, with the ability to manage multiple concurrent workstreams, dependencies, and timelines
• Comfort working with technical concepts and systems, with the ability to engage effectively with engineers and understand system constraints, integrations, and data flows
• Demonstrated ability to operate in ambiguous environments, prioritize effectively, and make tradeoffs across competing priorities
• Excellent written and verbal communication skills, including the ability to synthesize complex information for different audiences
• Strong analytical and problem-solving mindset, with comfort investigating issues, identifying root causes, and driving resolution
• Comfort using AI-assisted tools to support project management tasks such as documentation, requirements synthesis, risk analysis, and onboarding to new systems or domains
• Self-motivated, detail-oriented, and able to operate independently while coordinating across teams
• Eligible to work in the United States

Bonus Experience

• Experience working in the US public health or healthcare space (including with EMRs)
• Experience delivering technology to support healthcare or health service delivery.
• Experience in delivering enterprise software implementations

Benefits and Compensation

We aim to make a difference, not just as a company but also as an employer! We are transparent about salaries at all levels of the organization and have a standard, global pay scale for all positions. Our salaries are cost of living adjusted and non-negotiable. The estimated salary range for this position is 58,680 USD - 96,166 USD annually. Your final salary within the range will be dependent on where you are geographically based and might fall outside of this estimated range.

However, the benefits we offer are geared towards having a strong impact on our staff’s well-being. A few of our key benefits are outlined below:

• 100% employer-sponsored medical insurance paired with a generous Health Reimbursement Account (HRA) fund
• Access to voluntary dental and vision insurance plans
• A 401K plan with up to a 4% employer match
• Employee stock option plan
• 30 days paid time off inclusive of holidays
• Unlimited sick time and excellent parental leave policy
• Access to a flex-time policy that allows employees to work based on a flexible work schedule
• Access to an Employee Assistance Program (EAP) through ComPsych

Please Note: Dimagi is unable to consider candidates who require sponsorship for employment visa status now or in the future for this role.

Dimagi is an Equal Opportunity Employer. We celebrate and support diversity and are committed to providing a work environment that is inclusive and free of discrimination and harassment. All employment decisions are based on individual qualifications without regard to race, color, religion, age, sex, sexual orientation, ethnicity, gender identity and expression, national origin, family or parental status, veteran or disability status.

About Dimagi

Dimagi is an award-winning social enterprise and a certified B-corp and Benefit Corporation. We build software solutions and provide technology consulting services to improve the quality of essential services for underserved populations. Our open-source technology platform, CommCare, is the world’s most widely-used and researched mobile data collection platform for frontline workers. Our choice to be a certified B-Corp and to legally incorporate as a Benefit Corporation sends a clear signal to our partners, our team members, and our communities that we not only believe but also take action in using business as a force for good. This approach combines our passion and commitment to tackle complex health and social inequities and work towards a brighter future for all.

About the Position

Dimagi is looking for a Project Manager to support our Data & Analytics work within the US Solutions Division. This position will be affiliated with our Cambridge, MA office but is open to remote employment within the United States. This is a 12-month fixed-term position with the possibility of renewal based on business requirements and mutual interest. 

The Project Manager will play a critical role in coordinating the delivery, evolution, and adoption of Dimagi’s Data Platform across multiple projects. In this role, you will work closely with Data Engineers, Project Directors, and project teams to manage timelines, priorities, and cross-functional dependencies related to data pipelines, reporting, and analytics deliverables.

You will coordinate data-related workstreams across projects, ensuring work is well-scoped, appropriately sequenced, and aligned with both project needs and broader platform considerations. This includes managing sprint execution, facilitating requirements definition for data use cases, and supporting consistent approaches to data modeling, reporting, and system integration across projects.

This role assumes comfort using AI-assisted tools to support planning, documentation, analysis, and learning in a complex technical environment.

Responsibilities

The specific responsibilities of this role can vary per project but are likely to include:

• Coordinate delivery of data and analytics workstreams, including data pipeline development, reporting, and dashboarding efforts, ensuring alignment with project timelines and priorities.
• Serve as a key external-facing representative for a project team. Project Managers are responsible for leading conversations around project planning, roadmapping and ensuring adherence to standard project management practices.
• Facilitate requirements gathering and refinement for data use cases, including reporting needs, data integrations, and analytics workflows, in collaboration with clients and internal technical teams.
• Manage sprint planning and execution for data-focused work, working closely with Data Engineers and a Project Director to ensure clear prioritization, sequencing, and delivery of tasks.
• Support cross-project consistency in data platform usage, helping teams align on approaches to data modeling, reporting structures, and integration patterns where appropriate.
• Track and manage dependencies across data systems and external integrations, ensuring risks are identified early and communicated clearly to stakeholders.
• Use AI-assisted tools thoughtfully to improve efficiency in requirements synthesis, project documentation, risk tracking, and stakeholder communications, while ensuring accuracy and alignment with project standards.

At Dimagi, Project Managers may fulfill a variety of functional roles, which will likely change over time as Dimagi partners with new clients and takes on new challenges and will vary depending upon the size and complexity of a project. 

Relevant Skills

• 5+ years of experience managing software or technical projects, including coordination across cross-functional teams
• Demonstrated ability to manage delivery of complex technical workstreams, including coordinating timelines, dependencies, and stakeholders across multiple teams
• Experience gathering and translating requirements from diverse stakeholders into clear, actionable plans for technical teams
• Experience running agile delivery processes, including sprint planning, backlog management, and cross-team coordination
• Strong organizational and project management skills, with the ability to manage multiple concurrent workstreams, dependencies, and timelines
• Comfort working with technical concepts and systems, with the ability to engage effectively with engineers and understand system constraints, integrations, and data flows
• Demonstrated ability to operate in ambiguous environments, prioritize effectively, and make tradeoffs across competing priorities
• Excellent written and verbal communication skills, including the ability to synthesize complex information for different audiences
• Strong analytical and problem-solving mindset, with comfort investigating issues, identifying root causes, and driving resolution
• Comfort using AI-assisted tools to support project management tasks such as documentation, requirements synthesis, risk analysis, and onboarding to new systems or domains
• Self-motivated, detail-oriented, and able to operate independently while coordinating across teams
• Eligible to work in the United States

Bonus Experience

• Experience working in the US public health or healthcare space (including with EMRs)
• Experience delivering technology to support healthcare or health service delivery.
• Experience in delivering enterprise software implementations

Benefits and Compensation

We aim to make a difference, not just as a company but also as an employer! We are transparent about salaries at all levels of the organization and have a standard, global pay scale for all positions. Our salaries are cost of living adjusted and non-negotiable. The estimated salary range for this position is 58,680 USD - 96,166 USD annually. Your final salary within the range will be dependent on where you are geographically based and might fall outside of this estimated range.

However, the benefits we offer are geared towards having a strong impact on our staff’s well-being. A few of our key benefits are outlined below:

• 100% employer-sponsored medical insurance paired with a generous Health Reimbursement Account (HRA) fund
• Access to voluntary dental and vision insurance plans
• A 401K plan with up to a 4% employer match
• Employee stock option plan
• 30 days paid time off inclusive of holidays
• Unlimited sick time and excellent parental leave policy
• Access to a flex-time policy that allows employees to work based on a flexible work schedule
• Access to an Employee Assistance Program (EAP) through ComPsych

Please Note: Dimagi is unable to consider candidates who require sponsorship for employment visa status now or in the future for this role.

Dimagi is an Equal Opportunity Employer. We celebrate and support diversity and are committed to providing a work environment that is inclusive and free of discrimination and harassment. All employment decisions are based on individual qualifications without regard to race, color, religion, age, sex, sexual orientation, ethnicity, gender identity and expression, national origin, family or parental status, veteran or disability status.

About Dimagi

Dimagi is an award-winning social enterprise and a certified B-corp and Benefit Corporation. We build software solutions and provide technology consulting services to improve the quality of essential services for underserved populations. Our open-source technology platform, CommCare, is the world’s most widely-used and researched mobile data collection platform for frontline workers. Our choice to be a certified B-Corp and to legally incorporate as a Benefit Corporation sends a clear signal to our partners, our team members, and our communities that we not only believe but also take action in using business as a force for good. This approach combines our passion and commitment to tackle complex health and social inequities and work towards a brighter future for all.

About the Position

Dimagi is looking for a Project Manager to support our Data & Analytics work within the US Solutions Division. This position will be affiliated with our Cambridge, MA office but is open to remote employment within the United States. This is a 12-month fixed-term position with the possibility of renewal based on business requirements and mutual interest. 

The Project Manager will play a critical role in coordinating the delivery, evolution, and adoption of Dimagi’s Data Platform across multiple projects. In this role, you will work closely with Data Engineers, Project Directors, and project teams to manage timelines, priorities, and cross-functional dependencies related to data pipelines, reporting, and analytics deliverables.

You will coordinate data-related workstreams across projects, ensuring work is well-scoped, appropriately sequenced, and aligned with both project needs and broader platform considerations. This includes managing sprint execution, facilitating requirements definition for data use cases, and supporting consistent approaches to data modeling, reporting, and system integration across projects.

This role assumes comfort using AI-assisted tools to support planning, documentation, analysis, and learning in a complex technical environment.

Responsibilities

The specific responsibilities of this role can vary per project but are likely to include:

• Coordinate delivery of data and analytics workstreams, including data pipeline development, reporting, and dashboarding efforts, ensuring alignment with project timelines and priorities.
• Serve as a key external-facing representative for a project team. Project Managers are responsible for leading conversations around project planning, roadmapping and ensuring adherence to standard project management practices.
• Facilitate requirements gathering and refinement for data use cases, including reporting needs, data integrations, and analytics workflows, in collaboration with clients and internal technical teams.
• Manage sprint planning and execution for data-focused work, working closely with Data Engineers and a Project Director to ensure clear prioritization, sequencing, and delivery of tasks.
• Support cross-project consistency in data platform usage, helping teams align on approaches to data modeling, reporting structures, and integration patterns where appropriate.
• Track and manage dependencies across data systems and external integrations, ensuring risks are identified early and communicated clearly to stakeholders.
• Use AI-assisted tools thoughtfully to improve efficiency in requirements synthesis, project documentation, risk tracking, and stakeholder communications, while ensuring accuracy and alignment with project standards.

At Dimagi, Project Managers may fulfill a variety of functional roles, which will likely change over time as Dimagi partners with new clients and takes on new challenges and will vary depending upon the size and complexity of a project. 

Relevant Skills

• 5+ years of experience managing software or technical projects, including coordination across cross-functional teams
• Demonstrated ability to manage delivery of complex technical workstreams, including coordinating timelines, dependencies, and stakeholders across multiple teams
• Experience gathering and translating requirements from diverse stakeholders into clear, actionable plans for technical teams
• Experience running agile delivery processes, including sprint planning, backlog management, and cross-team coordination
• Strong organizational and project management skills, with the ability to manage multiple concurrent workstreams, dependencies, and timelines
• Comfort working with technical concepts and systems, with the ability to engage effectively with engineers and understand system constraints, integrations, and data flows
• Demonstrated ability to operate in ambiguous environments, prioritize effectively, and make tradeoffs across competing priorities
• Excellent written and verbal communication skills, including the ability to synthesize complex information for different audiences
• Strong analytical and problem-solving mindset, with comfort investigating issues, identifying root causes, and driving resolution
• Comfort using AI-assisted tools to support project management tasks such as documentation, requirements synthesis, risk analysis, and onboarding to new systems or domains
• Self-motivated, detail-oriented, and able to operate independently while coordinating across teams
• Eligible to work in the United States

Bonus Experience

• Experience working in the US public health or healthcare space (including with EMRs)
• Experience delivering technology to support healthcare or health service delivery.
• Experience in delivering enterprise software implementations

Benefits and Compensation

We aim to make a difference, not just as a company but also as an employer! We are transparent about salaries at all levels of the organization and have a standard, global pay scale for all positions. Our salaries are cost of living adjusted and non-negotiable. The estimated salary range for this position is 58,680 USD - 96,166 USD annually. Your final salary within the range will be dependent on where you are geographically based and might fall outside of this estimated range.

However, the benefits we offer are geared towards having a strong impact on our staff’s well-being. A few of our key benefits are outlined below:

• 100% employer-sponsored medical insurance paired with a generous Health Reimbursement Account (HRA) fund
• Access to voluntary dental and vision insurance plans
• A 401K plan with up to a 4% employer match
• Employee stock option plan
• 30 days paid time off inclusive of holidays
• Unlimited sick time and excellent parental leave policy
• Access to a flex-time policy that allows employees to work based on a flexible work schedule
• Access to an Employee Assistance Program (EAP) through ComPsych

Please Note: Dimagi is unable to consider candidates who require sponsorship for employment visa status now or in the future for this role.

Dimagi is an Equal Opportunity Employer. We celebrate and support diversity and are committed to providing a work environment that is inclusive and free of discrimination and harassment. All employment decisions are based on individual qualifications without regard to race, color, religion, age, sex, sexual orientation, ethnicity, gender identity and expression, national origin, family or parental status, veteran or disability status.

About the role

Sana Biotechnology is growing, and we are hiring new team members who believe in the potential of engineered cells as medicines, who want to challenge status quo, and who lead with the desire to work on novel ideas.  As an Associate Director, External Manufacturing you will report to the Executive Director, External Manufacturing to oversee day-to-day operational performance of key Sana contract development and manufacturing organizations (CDMOs). This will include coordinating and driving activities for pre-clinical and clinical phase drug substance (DS) and/or drug product (DP) manufacturing for Sana’s cell and gene therapy programs at 3rd party CDMOs. You will be an essential business partner within Technical Operations and will support Sana's manufacturing strategy to bring Sana's pipeline to patients across the world.

What you’ll do

• Acts as primary liaison and relationship manager between Sana Technical Operations and the CDMO to ensure timely delivery of high quality pre-clinical and clinical CGT product(s)
• Responsible for adherence to project schedule(s)
• Implement and execute governance structure with CDMO(s)
• Develops and oversees budget(s) for project(s) under their purview, including contributing to internal Sana budgeting activities and ensuring CDMO performance to financial plan in collaboration with Sana accounting.
• Partner with our technical departments to help ensure success of tech transfer activities from Sana to the CDMO partner.
• Monitors technical transfer and production campaign activities and reports on CDMOs performance against plans
• Identifies, notifies, and/or escalates risks and issues that may affect project timelines, resource requirements, finances, or business relationships
• Executes strategies that drive effective operational performance and service levels at contract organizations
• Negotiates and facilitates approval of contracts including proposals, master supply agreements, work orders, and changes of scope.
• Effectively communicates project, performance, and resource issues to management and within project teams
• Ensure CDMOs deliver to support Sana’s business needs including ensuring flexibility to accommodate changing program timelines and compliance with GMP practices as well as Sana's quality expectations

What we’re looking for

• Bachelors degree with 5+ years plus of outsourced clinical and/or commercial manufacturing experience in the biotech/pharmaceutical industry
• Knowledge and understanding of the regulatory guidelines and working experience in the GLP and GMP environment, including knowledge of cGMP quality systems
• Experience operating in early-stage clinical to commercial environments
• Ability to communicate across all levels of an organization and efficiently coordinate activities with both internal and external customers.
• Proven ability to problem solve, build strong relationships, and to organize effectively
• Business acumen with an ability to anticipate operational issues and proactively recommend mitigations/solutions
• Results-oriented and demonstrated focus on achieving business results. Experience with project team meetings, cross-functional communication, supporting decision making, influencing outcomes, and ensuring alignment among internal and external stakeholders
• Successful track record of developing cooperative, productive relationships across all functions with people at all levels within and external to the organization
• High degree of self-motivation
• Ability to quickly adapt to changing business conditions

What will separate you from the crowd

• Prior experience working with cell and gene therapy CDMOs

What you should know

• The base pay range for this position at commencement of employment is expected to be between $170,000 and $210,000/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience 
• Up to 25% travel (domestic and/or international)

The Opportunity

Amylyx is seeking a Senior Medical Director, Clinical Development to provide strategic and scientific leadership for one or more late-stage, pivotal programs with the potential to expand into additional indications and/or programs within the same molecule or across the portfolio. This individual will play a critical role in shaping the overall clinical development strategy and may lead multiple programs or key components of a broader development portfolio.

Reporting to the Senior VP of Clinical Development, you will be responsible for leading the design, execution, and interpretation of clinical studies and overseeing the development and implementation of Clinical Development Plans across assigned assets. You will provide strategic input into study design, endpoints, and regulatory strategy, ensuring alignment with the overall program and corporate objectives.

The successful candidate will collaborate with cross-functional teams in a matrix environment, influencing stakeholders across Research, Regulatory Affairs, Clinical Operations, and Commercial to ensure that clinical and scientific considerations are fully integrated into development plans. You will proactively identify and mitigate risks, guide decision-making through data-driven insights, and ensure the highest standards of scientific rigor and data integrity.

In this role, you will also serve as a key external representative, engaging with global medical experts, investigators, regulatory authorities, and alliance partners. You may lead or mentor a team of clinical scientists and physicians and contribute to broader organizational and portfolio-level initiatives.

Responsibilities

• Provides strategic medical leadership and oversight for assigned clinical programs, including late-stage and pivotal trials.
• Leads development and execution of Clinical Development Plans (CDPs), integrating clinical, scientific, regulatory, and commercial considerations.
• Drives study design, protocol development, and interpretation of complex clinical data to inform key program decisions.
• Serves as a core member of cross-functional program teams, influencing strategy and ensuring alignment across disciplines.
• Provides senior-level medical monitoring and guidance, ensuring patient safety, data integrity, and high-quality trial execution.
• Leads interactions with external stakeholders including key opinion leaders, investigators, regulatory agencies, and alliance partners.
• Oversees preparation of key program documents including protocols, investigator brochures, clinical study reports, regulatory submissions, and publications.
• Mentors and provides scientific guidance to junior team members, including Medical Directors and Clinical Scientists.
• Identifies and implements process improvements and best practices within Clinical Development.

Required Qualifications

• MD required
• Significant experience in late-stage clinical development and drug development in biotech/pharmaceutical industry; rare disease experience strongly preferred
• Typically 5+ years of experience leading clinical development programs with demonstrated impact on program strategy and execution
• Demonstrated ability to collaborate with cross-functional teams and influence without authority in a matrix environment
• Strong strategic thinking, problem-solving, and decision-making skills
• Proven ability to interpret complex clinical data and translate insights into actionable strategies
• Excellent communication and leadership skills, with experience interacting with senior stakeholders and external experts
• Experience mentoring or leading team members preferred
• Ability to travel internationally and domestically

Work Location and Conditions

• At Amylyx, we proudly support remote work opportunities within the United States. However, due to business considerations related to health insurance coverage and state tax regulations, we are unable to hire employees who reside and/or work in certain states. Currently, we are not considering applicants from Alaska, Arizona, Hawaii, Michigan and Tennessee.
• You will be expected to travel to our corporate location in Cambridge, MA several times a year and attend other company-related events as necessary and requested.
• You must have access to work in setting which enables meeting all requirements of the role (including privacy, reliable internet access, phone, ability to video conference, etc.) at your remote location.

About the role

Sana Biotechnology is growing and we are hiring new team members who believe in the potential of engineered cells as medicines, who want to challenge status quo, and who lead with the desire to work on novel ideas. As a CMC Project Manager, you will report to Sr. Director, Supply Strategy. You will work directly with our CMC team leads to develop and deliver CMC project plans and with our functional leaders to improve our efforts to deliver a complex, innovative CMC portfolio. You will help us target those small details that unlock big successes and replicate them across programs.

What you’ll do

• Develop a master project plan using MS Project or Smartsheet. Based on task interdependencies, define CMC project critical path and establish monitoring mechanisms to align and correct any schedule modifications that impact the critical path.
• Publish regular dashboards to align team on project progress and any modifications to the critical path. Support the CMC team on enabling decisions and risk management.
• Partner with CMC Team Leaders to set and monitor CMC strategy and team goals. You will create and maintain the cross-functional CMC project plan and keep team activities and timelines on track.
• Support assembling and maintaining key CMC information to guide CMC execution (e.g. QTPP, risk assessment, decision and action item logs, etc.)
• Identify potential CMC risks, resource constraints, and conflicts that could impact program timelines; work with CMC lead and team members to develop and execute functional mitigation strategies, and to identify and develop options for CMC risks that rise to program level impact.
• Deliver consistent and high-quality CMC program management services to enable CMC team, overall program and project success by being strategic in project planning, team management, and process management.
• Ensure close collaboration and great communication with core program team PM to ensure that CMC plans deliver Sana program priorities and that critical path risks are identified, escalated, and resolved fast
• Help improve communication and help CMC teams learn from one another so that CMC teams and functions work together effectively to deliver Sana’s new medicines to patients

What we’re looking for

• Bachelor’s degree in relevant science or engineering field
• At least 6+ years’ experience in pharmaceutical or life sciences industry including 4+ years of CMC development or CMC project management experience
• Experience taking programs to INDs and pivotal INDa submission.
• Expert knowledge of Project Management methodologies, concepts, and tools
• Track record of working in matrix organization and influencing across multi-site, multi-function program teams
• Ability to operate effectively in a dynamic start-up environment that requires learning agility and the ability to plan and execute through ambiguity
• Ability to communicate strategic and technical concepts, plans, and tradeoffs effectively to stakeholders at many levels of the organization and from different technical functions or backgrounds

What will separate you from the crowd

• Experience with Cell and Gene Therapy CMC development
• Portfolio or multi-program PM experience
• PMP certification
• Lean Six Sigma or other certification in Operational Excellence

What you should know 

• The base pay range for this position at commencement of employment is expected to be between $165,000 and $205,000/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience 

About the role

Sana Biotechnology is growing, and we are hiring new team members who believe in the potential of engineered cells as medicines, who are passionate about delivering the possible to patients, and who lead with the desire to work on novel ideas. As an MSAT Associate Director, you will report to the Executive Director of MSAT to support manufacturing of Sana’s stem cell-derived pancreatic islet cell program for persons with type 1 diabetes (SC451). You will lead an MSAT team responsible for the pancreatic cell maturation and aggregation process to generate DP at an external manufacturing partner. You will define and execute the technology transfer strategy in alignment with program timelines. Your team will provide technical coverage at the external manufacturing partner throughout the phase I manufacturing campaign including people-in-plant, executed batch record review, investigations, and batch summaries. You will collaborate with internal partners across Quality, External Manufacturing, and Supply Chain to complete batch disposition. You will draft applicable CMC sections of regulatory documents (IND module 3).  You will provide your team members with technical guidance and mentorship.   

What you’ll do

• Lead a team of 1-2 individuals supporting phase I manufacturing of a PSC-derived pancreatic islet cell therapy product
• Partner with CDMO technical team to achieve phase I manufacturing readiness and address manufacturing challenges
• Oversee people-in-plant, manufacturing operator training, technical documentation, and process execution
• Draft CMC sections for regulatory filings (IND module 3) and other technical documents
• Collaborate with Quality to close deviations, analyze manufacturing trends, and recommend process improvements
• Lead investigations and troubleshoot process execution challenges by applying root cause analysis
• Perform comparability studies in collaboration with Research and PD teams to assess technology transfer success
• Engage in crucial conversations by providing and receiving feedback supporting the growth and development of team members
• Demonstrate ability to engage and effectively influence team members across multidisciplinary teams while prioritizing multiple projects and meeting deadlines
• Drive curiosity, scientific rigor and excellent problem-solving skills across a fast-paced performance driven environment
• Innate ability to assess talent that will help grow the organization and add to Sana’s culture

What we’re looking for

• BSc. in Chemical, Biological, or Biomedical Engineering plus 8 yrs or equivalent combination of education and work experience
• >3 year experience supporting early phase cell therapy manufacturing including technology transfers
• Well versed with cGMP requirements and experience working in a regulated environment, including as person-in-plan and/or GMP operator/supervisor
• Experience operating perfusion bioreactors and with fill/finish unit operations
• Knowledge of PSC culture and differentiation biology to pancreatic islets
• Experience managing a team of >2 direct reports
• Detail-oriented with good problem-solving, technical writing and verbal communication skills
• Ability to effectively work in multidisciplinary teams, meet deadlines, and prioritize multiple projects
• Aptitude for working in a self-driven, performance/results-oriented, fast-paced matrix environment

What will separate you from the crowd

• Experience with key cell therapy equipment and unit operations to support phase 1 clinical trials including PBS bioreactor
• Familiarity with cell therapy drug product development, including stability studies
• Working knowledge of statistical design of experiments (DoE) and RCA
• Experience working in grade B / ISO 7 cleanroom
• Knowledge of single-use technologies applicable to cell therapies
• Experience with process closure and automation
• Understanding of analytical methods such as flow cytometry
• Familiar with data analysis tools such as R, Python, JMP and FlowJo software

What you should know

• Travel to the manufacturing site ~25% of the time (Texas)
• Some weekend work required
• Lift up to 25 lbs
• Work within a cleanroom environment
• The base pay range for this position at commencement of employment is expected to be between $170,000 and $210,000/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience

Sana Biotechnology is growing, and we are hiring new team members who believe in the potential of engineered cells as medicines, who are passionate about delivering the possible to patients, and who lead with the desire to work on novel ideas. As a Director, Contract Counsel, you will report to the SVP, Head of Intellectual Property to manage all aspects of contract operations, negotiation, review, and execution while advising the business on legal matters related to contracts. You will form close partnerships within our legal team and with internal clients to provide service-oriented support that helps get cutting-edge cell and gene therapies to patients.

What you’ll do

• Draft, review, and negotiate a broad range of contracts touching all areas of our business in research, development, and G&A, including sponsored and contract research, manufacturing, confidentiality, material transfer, consulting, advisory board, vendor, master services, purchasing, outsourcing, software, licensing, data-related agreements, and clinical trial agreements
• Coordinate contract management by overseeing our software-based contract lifecycle management system (CLM) and in the development and implementation of contract-related policies/procedures, template libraries, and standard language
• Work closely and collaboratively with all legal team members as part of an engaged and efficient team
• Advise internal business owners on the range of issues involved in contracting to provide practical problem-solving guidance and communicate potential business and legal risks
• Promote compliance with internal approval and financial controls regarding contract initiation and requisition
• Partner with IT and Legal stakeholders to maintain the CLM and train end-users effectively
• Provide internal training across the company regarding legal concepts, privacy matters, and contract-related policies
• Provide support on various compliance and privacy matters
• Provide support on all other matters requested by other members of the legal department, as needed

What we’re looking for

• A JD degree from an accredited law school and a license to practice in good standing in Massachusetts (or eligibility to practice as Registered In-House Counsel)
• 4+ years of experience as an attorney drafting and negotiating a wide variety of contracts within a high-growth biotech/pharmaceutical company or law firm equivalent
• Proven ability to analyze legal contractual terms and assess risks in complex business arrangements
• Strong verbal and analytical skills with a track record of making risk-appropriate decisions in line with company standards
• Demonstrated organizational skills necessary to manage multiple, parallel contract negotiations simultaneously while meeting shifting deadlines.
• A customer-service orientation and a positive attitude, balanced with honesty and integrity

What will separate you from the crowd

• Prior experience managing a CLM transition or significant optimization project
• Specific expertise in data privacy regulations as they relate to clinical and research contracts

What you should know

• The base pay range for this position at commencement of employment is expected to be between $225,000.00 and $275,000/year, however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience
• This role requires a high volume of written and verbal communication with internal stakeholders and external partners

How we work together for patients

• Lead from every seat – we seek to understand, act with honesty, and engage in the crucial conversations
• Thrive as a team – we hire amazing people, are intensely curious, and cultivate inclusion and personal connectivity
• Make it happen – we value vigorous debate, alignment around our decisions, and resilient execution

The Lead Building Engineer leads and oversees the day-to-day operations and maintenance of building systems, ensuring efficient and safe building performance while supervising engineering staff and contractors.

Essential Duties and Responsibilities:

• Monitor the operating condition of all HVAC, plumbing, and electrical equipment.
• Coordinate preventive maintenance and emergency repairs for the building.
• Oversee service contractors while ensuring compliance with building standards.
• Supervise and mentor junior Engineers and Technicians; assist in setting staff performance goals and evaluating progress.
• Collaborate with tenants, contractors, and property managers to ensure reliable building operations and resolve tenant issues.
• As assigned, work with vendors to identify scopes of work and oversee compliance with contract terms and quality control.
• Conduct regular building inspections and proactively address deficiencies
• Manage preventive maintenance schedules and ensure they are executed effectively.
• Record equipment readings and ensure assigned building systems are operating according to standards.
• Follow company safety protocols and wear appropriate PPE; ensure compliance with OSHA, NEC, NFC, NFPA regulations; report safety hazards; participate in safety inspections; ensure all staff follow safety protocols and comply with building codes and regulations; oversee safety training and maintain compliance logs.
• Communicate verbally and in writing with teammates, leadership team, vendors, tenants, and client employees in a professional manner, keeping the appropriate customer(s) informed/updated as needed.
• Perform other duties as assigned.

Qualifications:

• HS Diploma or GED required
• Five to seven years of industry-related experience or commensurate certification/trade experience
• At least one year of formal or informal supervisory, training, and/or mentoring experience
• CFC Certification preferred or willingness to obtain as requested; possess engineering and trade licenses required according to local, state, or national requirements
• In-depth knowledge of Microsoft Office products, energy management software systems, CMMS, and other building operational platforms
• Familiar with fire/life safety equipment/procedures
• Proven track record of delivering excellent internal and external customer service; ability to successfully interact/communicate with tenants/vendors/contractors as well as teammates and leadership team
• Familiarity with blueprints and code requirements
• Ability to work after hours, weekends, holidays, and during emergency situations as necessary to meet the needs of the client
• Possess competent knowledge of use and care of tools
• Ability to read and write English in order to understand manuals and procedures, and to write reports.
• Ability to demonstrate in-depth knowledge of building automation systems (BAS), HVAC, and electrical controls with skills in troubleshooting complex mechanical and electrical systems

Physical Requirements:

Ability to stand, walk, climb ladders, and lift up to 50 pounds; perform physically demanding tasks such as stooping, crouching, and kneeling.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 

This position is 100% in-office. The role requires working in office during standard business hours. Remote work or telecommuting is not an option for this position.

#IND123

About the role  

Sana Biotechnology is growing, and we are hiring new team members who believe in the potential of engineered cells as medicines, who want to challenge the status quo, and who lead with the desire to work on novel ideas. You will join the Beta Islet Team at the Cambridge location to optimize 3D expansion and differentiation in stem cell (SC)-islet differentiation. As a Senior Scientist, you will execute optimization experiments critical to scaling up our differentiation process. The ideal candidate should have ample experience handling bioreactors and performing directed PSC differentiation in 3D. The ability to work in a highly collaborative environment and learn from each other will be essential to your success.

What you’ll do

• Execute routine 2D and 3D PSC expansion, passaging and directed SC-islet differentiation
• Design optimization experiments with the goal to achieve a highly scalable and robust 3D SC-islet differentiation process that is compliant to manufacturing standards
• Optimize the differentiation protocol to achieve highly pure on-target populations
• Hands-on experience with closed systems (tube welder, sealer, single-use assemblies)
• Expertise in controlled bioreactor setup, operation, automation, and process control (DO, pH, perfusion, agitation)
• Collaborate and communicate findings with other team members
• Maintain excellent scientific documentation and contribute to SOP development
• Assure compliance with all relevant lab safety and biosafety regulations
• Demonstrate Sana’s core values and the attributes that support these core values (Lead from every seat, Thrive as a team, Make it happen)
• Engage in crucial conversations by providing and receiving feedback supporting the growth and development of team member
• Demonstrate ability to engage and effectively influence team members across multidisciplinary teams while prioritizing multiple projects and meeting deadlines
• Drive curiosity, scientific rigor, and excellent problem-solving skills across a fast-paced performance-driven environment
• Innate ability to assess talent that will help grow the organization and add to Sana’s culture

What we’re looking for

• PhD in Stem cell biology, biochemical/biomedical Engineering or related fields with 3-5 years of direct cell therapy industry experience
• Significantly experienced and knowledgeable in operating various types of bioreactors for suspension culture.
• Experienced with bioreactor control software, process development tools, or DOE-base optimization is preferred
• Significantly experienced in operating a closed system for cell culture
• Significantly experienced in Flow cytometry, Immunofluorescent staining,
• Proficient with standard flow cytometry and imaging software (e.g. FACSDiva, FlowJo, ImageJ, Halo, etc.) 

What will separate you from the crowd   

• Knowledge or direct experience in directed stem cell differentiation toward pancreatic islet lineage
• Proven ability to optimize differentiation yield and reproducibility across platforms
• Passion for GMP transition, automation, and continuous process improvement
• Strong cross-functional collaboration skills and enthusiasm for advancing cell therapies to the clinic
• Significant experience in operating large bioreactors (15L+) for cell therapy purposes
• Expertise in controlled bioreactor setup, operation, automation, and process control (DO, pH, perfusion, agitation)
• Proven ability to optimize differentiation yield and reproducibility across platforms

What you should know

• The base pay range for this position at commencement of employment is expected to be between $160,000 and $190,000/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience

About the role

Sana Biotechnology is growing, and we are hiring new team members who believe in the potential of engineered cells as medicines, who are passionate about delivering the possible to patients, and who lead with the desire to work on novel ideas. As an MSAT Director, you will report to the Executive Director of MSAT and support manufacturing of Sana’s stem cell-derived pancreatic islet cell program for persons with type 1 diabetes (SC451). You will lead an MSAT team responsible for the PSC seed train and differentiation to beta cells at an external partner. You will define and execute the technology transfer strategy in alignment with program timelines and provide your team with technical mentorship. Your team will provide technical coverage at an external manufacturing partner throughout the phase I manufacturing campaign including people-in-plant, executed batch record review, investigations, and batch summaries. You will collaborate with internal partners across Quality, External Manufacturing, and Supply Chain to complete batch disposition. You will draft applicable CMC sections of regulatory documents (IND module 3). 

What you’ll do

• Lead a team of 2-4 individuals supporting Phase I manufacturing of a PSC-derived pancreatic islet cell therapy product
• Partner with CDMO technical team to achieve manufacturing readiness and address technical challenges
• Oversee people-in-plant, manufacturing operator training, technical documentation, and process execution
• Author CMC sections for regulatory filings (IND module 3) and other technical documents
• Collaborate with Quality to close deviations, analyze manufacturing trends, and recommend process improvements
• Lead investigations and troubleshoot process execution challenges including root cause analysis
• Perform comparability studies in collaboration with Research and PD teams to assess technology transfer success
• Engage in crucial conversations by providing and receiving feedback supporting the growth and development of team members
• Demonstrate ability to engage and effectively influence team members across multidisciplinary teams while prioritizing multiple projects and meeting deadlines
• Drive curiosity, scientific rigor and excellent problem-solving skills across a fast-paced performance driven environment
• Innate ability to assess talent that will help grow the organization and add to Sana’s culture

What we’re looking for

• BSc. in Chemical, Biological, or Biomedical Engineering plus 10 yrs or equivalent combination of education and work experience
• >5 year experience supporting early phase cell therapy manufacturing including technology transfers
• Well versed with cGMP requirements and working in a regulated environment, including experience as person-in-plan and/or GMP operator
• Knowledge of PSC culture and differentiation biology to pancreatic islets
• Experience managing a team of >3 direct reports
• Detail-oriented with good problem-solving, technical writing and verbal communication skills
• Ability to effectively work in multidisciplinary teams, meet deadlines, and prioritize multiple projects
• Aptitude for working in a self-driven, performance/results-oriented, fast-paced matrix environment

What will separate you from the crowd

• Experience with key cell therapy equipment and unit operations to support phase 1 clinical trials including cryopreservation
• Working knowledge of statistical design of experiments (DoE) and RCA
• Experience working in grade B / ISO 7 cleanroom
• Understanding of analytical methods such as flow cytometry
• Experience with cell therapy process closure and automation
• Knowledge of single-use technologies as applicable to cell therapies
• Familiar with data analysis tools such as R, Python, JMP and FlowJo software

What you should know

• Travel to the manufacturing site ~25% of the time (Canada)
• Some weekend work required
• Lift up to 25 lbs
• Work within a cleanroom environment
• The base pay range for this position at commencement of employment is expected to be between $200,000 and $250,000/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience