Senior Manager, Government & Industry Affairs Operations

VGW is an interactive entertainment company, harnessing technology and creativity to deliver world-class, free-to-play online social games.

We have an exciting opportunity to join our Government & Industry Affairs team in the United States and are currently looking for a Senior Manager, Government & Industry Affairs Operations to join the team. 

This is a newly created role that will play an important part in helping VGW coordinate and execute its government affairs activity across the US. You will be responsible for bringing structure, discipline, and clear operating rhythm to a complex, multi state lobbying network, ensuring our external partners are well coordinated, accountable, and aligned to business priorities.

You will work closely with Government Affairs, Legal, Marketing, and external lobbying partners to ensure activity is well planned, compliant, and clearly tracked.

We’re open to candidates based anywhere in the US, and this role can be performed remotely. We do not currently have a US office, but occasional in person office attendance may be required if that changes in future.

The salary range  for this role is USD $200,000 - $230,000 per year.

Key responsibilities will include:

• Managing the day to day operations of VGW’s external lobbying contractors, ensuring activity is clearly understood, tracked, and delivered.
• Supporting compliance across VGW’s lobbying activity, including oversight of relevant registrations, disclosures, and state and federal requirements.
• Establishing a single source of truth for legislative tracking, reporting, and key activity across the lobbying network.
• Building dashboards, reporting frameworks, and quarterly operating reviews tied to clear KPIs for lobbying firms.
• Developing detailed execution plans and ensuring strong cross functional alignment across Government Affairs, Legal, Marketing, and other relevant teams.
• Driving accountability with external partners, including performance tracking, budget oversight, resource allocation, and renewal decisions.

What you will bring to the role:

• 8 plus years of experience in government affairs, public policy, lobbying operations, regulatory affairs, or a related field.
• Experience supporting lobbying or government affairs activity in fast moving, high growth, or highly regulated industries.
• Strong multi state coordination skills, with the ability to manage a complex network of external partners, priorities, and deadlines.
• A highly organised and operationally focused approach, with a track record of creating structure where it does not already exist.
• Strong vendor and contract management experience, including the ability to drive accountability and assess performance.
• The ability to read complex regulatory, legislative, or legal materials and translate the practical impact clearly for non technical audiences.
• Experience building tracking, documentation, reporting, or operating systems from scratch and ensuring they are adopted successfully.

About VGW

VGW is an interactive entertainment company, harnessing technology and creativity to deliver world-class, free-to-play online social games.

Our high-quality, acclaimed brands include Chumba Casino, Global Poker and LuckyLand Slots, which are enjoyed by millions of players in North America.

Our games are based on a freemium model, meaning they are available to play at no cost, but include optional in-game purchases to enhance gameplay. We also offer sweepstakes promotions where players can collect free entries for the chance to win real-world prizes.

At VGW, one of our core values is “our players come first”. This means always striving to deliver a safe, responsible and positive player experience.

Why VGW?

At VGW, we’re more than just a team. We’re a diverse and inclusive group of individuals, each playing a vital role in our success.

Our core values are clear and strong; we win together, do what’s right, put our players first and are powered by passion.

We believe in our people and are committed to creating an environment where everyone feels welcome, inspired, and supported. We recognise that life is more than just work - that’s why we’re all about flexibility so you can strike a healthy balance between your personal life and career. We’re also here to champion your growth in your current role and future aspirations, providing opportunities for learning and career advancement. And to top it off, we back this all up with competitive compensation, perks and benefits.  

But it’s not all business. We inject fun into the workplace, celebrate together and create lasting memories, from a mix of in-person and online events, to social gatherings and much more.

It’s our combined skills, ideas and visions that drive us forward. Join us on this exciting journey, and together, we’ll achieve remarkable things. 

If you want to join a team that does things differently, apply today - we look forward to seeing what you can bring to our team.

Find out more at www.vgw.co

 #LI-JG1

#LI-Remote

Senior Manager, Government & Industry Affairs Operations

VGW is an interactive entertainment company, harnessing technology and creativity to deliver world-class, free-to-play online social games.

We have an exciting opportunity to join our Government & Industry Affairs team in the United States and are currently looking for a Senior Manager, Government & Industry Affairs Operations to join the team. 

This is a newly created role that will play an important part in helping VGW coordinate and execute its government affairs activity across the US. You will be responsible for bringing structure, discipline, and clear operating rhythm to a complex, multi state lobbying network, ensuring our external partners are well coordinated, accountable, and aligned to business priorities.

You will work closely with Government Affairs, Legal, Marketing, and external lobbying partners to ensure activity is well planned, compliant, and clearly tracked.

We’re open to candidates based anywhere in the US, and this role can be performed remotely. We do not currently have a US office, but occasional in person office attendance may be required if that changes in future.

The salary range  for this role is USD $200,000 - $230,000 per year.

Key responsibilities will include:

• Managing the day to day operations of VGW’s external lobbying contractors, ensuring activity is clearly understood, tracked, and delivered.
• Supporting compliance across VGW’s lobbying activity, including oversight of relevant registrations, disclosures, and state and federal requirements.
• Establishing a single source of truth for legislative tracking, reporting, and key activity across the lobbying network.
• Building dashboards, reporting frameworks, and quarterly operating reviews tied to clear KPIs for lobbying firms.
• Developing detailed execution plans and ensuring strong cross functional alignment across Government Affairs, Legal, Marketing, and other relevant teams.
• Driving accountability with external partners, including performance tracking, budget oversight, resource allocation, and renewal decisions.

What you will bring to the role:

• 8 plus years of experience in government affairs, public policy, lobbying operations, regulatory affairs, or a related field.
• Experience supporting lobbying or government affairs activity in fast moving, high growth, or highly regulated industries.
• Strong multi state coordination skills, with the ability to manage a complex network of external partners, priorities, and deadlines.
• A highly organised and operationally focused approach, with a track record of creating structure where it does not already exist.
• Strong vendor and contract management experience, including the ability to drive accountability and assess performance.
• The ability to read complex regulatory, legislative, or legal materials and translate the practical impact clearly for non technical audiences.
• Experience building tracking, documentation, reporting, or operating systems from scratch and ensuring they are adopted successfully.

About VGW

VGW is an interactive entertainment company, harnessing technology and creativity to deliver world-class, free-to-play online social games.

Our high-quality, acclaimed brands include Chumba Casino, Global Poker and LuckyLand Slots, which are enjoyed by millions of players in North America.

Our games are based on a freemium model, meaning they are available to play at no cost, but include optional in-game purchases to enhance gameplay. We also offer sweepstakes promotions where players can collect free entries for the chance to win real-world prizes.

At VGW, one of our core values is “our players come first”. This means always striving to deliver a safe, responsible and positive player experience.

Why VGW?

At VGW, we’re more than just a team. We’re a diverse and inclusive group of individuals, each playing a vital role in our success.

Our core values are clear and strong; we win together, do what’s right, put our players first and are powered by passion.

We believe in our people and are committed to creating an environment where everyone feels welcome, inspired, and supported. We recognise that life is more than just work - that’s why we’re all about flexibility so you can strike a healthy balance between your personal life and career. We’re also here to champion your growth in your current role and future aspirations, providing opportunities for learning and career advancement. And to top it off, we back this all up with competitive compensation, perks and benefits.  

But it’s not all business. We inject fun into the workplace, celebrate together and create lasting memories, from a mix of in-person and online events, to social gatherings and much more.

It’s our combined skills, ideas and visions that drive us forward. Join us on this exciting journey, and together, we’ll achieve remarkable things. 

If you want to join a team that does things differently, apply today - we look forward to seeing what you can bring to our team.

Find out more at www.vgw.co

#LI-JG1

#LI-Remote

Senior Manager, Government & Industry Affairs Operations

VGW is an interactive entertainment company, harnessing technology and creativity to deliver world-class, free-to-play online social games.

We have an exciting opportunity to join our Government & Industry Affairs team in the United States and are currently looking for a Senior Manager, Government & Industry Affairs Operations to join the team. 

This is a newly created role that will play an important part in helping VGW coordinate and execute its government affairs activity across the US. You will be responsible for bringing structure, discipline, and clear operating rhythm to a complex, multi state lobbying network, ensuring our external partners are well coordinated, accountable, and aligned to business priorities.

You will work closely with Government Affairs, Legal, Marketing, and external lobbying partners to ensure activity is well planned, compliant, and clearly tracked.

We’re open to candidates based anywhere in the US, and this role can be performed remotely. We do not currently have a US office, but occasional in person office attendance may be required if that changes in future.

The salary range  for this role is USD $200,000 - $230,000 per year.

Key responsibilities will include:

• Managing the day to day operations of VGW’s external lobbying contractors, ensuring activity is clearly understood, tracked, and delivered.
• Supporting compliance across VGW’s lobbying activity, including oversight of relevant registrations, disclosures, and state and federal requirements.
• Establishing a single source of truth for legislative tracking, reporting, and key activity across the lobbying network.
• Building dashboards, reporting frameworks, and quarterly operating reviews tied to clear KPIs for lobbying firms.
• Developing detailed execution plans and ensuring strong cross functional alignment across Government Affairs, Legal, Marketing, and other relevant teams.
• Driving accountability with external partners, including performance tracking, budget oversight, resource allocation, and renewal decisions.

What you will bring to the role:

• 8 plus years of experience in government affairs, public policy, lobbying operations, regulatory affairs, or a related field.
• Experience supporting lobbying or government affairs activity in fast moving, high growth, or highly regulated industries.
• Strong multi state coordination skills, with the ability to manage a complex network of external partners, priorities, and deadlines.
• A highly organised and operationally focused approach, with a track record of creating structure where it does not already exist.
• Strong vendor and contract management experience, including the ability to drive accountability and assess performance.
• The ability to read complex regulatory, legislative, or legal materials and translate the practical impact clearly for non technical audiences.
• Experience building tracking, documentation, reporting, or operating systems from scratch and ensuring they are adopted successfully.

About VGW

VGW is an interactive entertainment company, harnessing technology and creativity to deliver world-class, free-to-play online social games.

Our high-quality, acclaimed brands include Chumba Casino, Global Poker and LuckyLand Slots, which are enjoyed by millions of players in North America.

Our games are based on a freemium model, meaning they are available to play at no cost, but include optional in-game purchases to enhance gameplay. We also offer sweepstakes promotions where players can collect free entries for the chance to win real-world prizes.

At VGW, one of our core values is “our players come first”. This means always striving to deliver a safe, responsible and positive player experience.

Why VGW?

At VGW, we’re more than just a team. We’re a diverse and inclusive group of individuals, each playing a vital role in our success.

Our core values are clear and strong; we win together, do what’s right, put our players first and are powered by passion.

We believe in our people and are committed to creating an environment where everyone feels welcome, inspired, and supported. We recognise that life is more than just work - that’s why we’re all about flexibility so you can strike a healthy balance between your personal life and career. We’re also here to champion your growth in your current role and future aspirations, providing opportunities for learning and career advancement. And to top it off, we back this all up with competitive compensation, perks and benefits.  

But it’s not all business. We inject fun into the workplace, celebrate together and create lasting memories, from a mix of in-person and online events, to social gatherings and much more.

It’s our combined skills, ideas and visions that drive us forward. Join us on this exciting journey, and together, we’ll achieve remarkable things. 

If you want to join a team that does things differently, apply today - we look forward to seeing what you can bring to our team.

Find out more at www.vgw.co

#LI-JG1

#LI-Remote

Senior Manager, Government & Industry Affairs Operations

VGW is an interactive entertainment company, harnessing technology and creativity to deliver world-class, free-to-play online social games.

We have an exciting opportunity to join our Government & Industry Affairs team in the United States and are currently looking for a Senior Manager, Government & Industry Affairs Operations to join the team. 

This is a newly created role that will play an important part in helping VGW coordinate and execute its government affairs activity across the US. You will be responsible for bringing structure, discipline, and clear operating rhythm to a complex, multi state lobbying network, ensuring our external partners are well coordinated, accountable, and aligned to business priorities.

You will work closely with Government Affairs, Legal, Marketing, and external lobbying partners to ensure activity is well planned, compliant, and clearly tracked.

We’re open to candidates based anywhere in the US, and this role can be performed remotely. We do not currently have a US office, but occasional in person office attendance may be required if that changes in future.

The salary range  for this role is USD $200,000 - $230,000 per year.

Key responsibilities will include:

• Managing the day to day operations of VGW’s external lobbying contractors, ensuring activity is clearly understood, tracked, and delivered.
• Supporting compliance across VGW’s lobbying activity, including oversight of relevant registrations, disclosures, and state and federal requirements.
• Establishing a single source of truth for legislative tracking, reporting, and key activity across the lobbying network.
• Building dashboards, reporting frameworks, and quarterly operating reviews tied to clear KPIs for lobbying firms.
• Developing detailed execution plans and ensuring strong cross functional alignment across Government Affairs, Legal, Marketing, and other relevant teams.
• Driving accountability with external partners, including performance tracking, budget oversight, resource allocation, and renewal decisions.

What you will bring to the role:

• 8 plus years of experience in government affairs, public policy, lobbying operations, regulatory affairs, or a related field.
• Experience supporting lobbying or government affairs activity in fast moving, high growth, or highly regulated industries.
• Strong multi state coordination skills, with the ability to manage a complex network of external partners, priorities, and deadlines.
• A highly organised and operationally focused approach, with a track record of creating structure where it does not already exist.
• Strong vendor and contract management experience, including the ability to drive accountability and assess performance.
• The ability to read complex regulatory, legislative, or legal materials and translate the practical impact clearly for non technical audiences.
• Experience building tracking, documentation, reporting, or operating systems from scratch and ensuring they are adopted successfully.

About VGW

VGW is an interactive entertainment company, harnessing technology and creativity to deliver world-class, free-to-play online social games.

Our high-quality, acclaimed brands include Chumba Casino, Global Poker and LuckyLand Slots, which are enjoyed by millions of players in North America.

Our games are based on a freemium model, meaning they are available to play at no cost, but include optional in-game purchases to enhance gameplay. We also offer sweepstakes promotions where players can collect free entries for the chance to win real-world prizes.

At VGW, one of our core values is “our players come first”. This means always striving to deliver a safe, responsible and positive player experience.

Why VGW?

At VGW, we’re more than just a team. We’re a diverse and inclusive group of individuals, each playing a vital role in our success.

Our core values are clear and strong; we win together, do what’s right, put our players first and are powered by passion.

We believe in our people and are committed to creating an environment where everyone feels welcome, inspired, and supported. We recognise that life is more than just work - that’s why we’re all about flexibility so you can strike a healthy balance between your personal life and career. We’re also here to champion your growth in your current role and future aspirations, providing opportunities for learning and career advancement. And to top it off, we back this all up with competitive compensation, perks and benefits.  

But it’s not all business. We inject fun into the workplace, celebrate together and create lasting memories, from a mix of in-person and online events, to social gatherings and much more.

It’s our combined skills, ideas and visions that drive us forward. Join us on this exciting journey, and together, we’ll achieve remarkable things. 

If you want to join a team that does things differently, apply today - we look forward to seeing what you can bring to our team.

Find out more at www.vgw.co

#LI-JG1

#LI-Remote

Senior Manager, Government & Industry Affairs Operations

VGW is an interactive entertainment company, harnessing technology and creativity to deliver world-class, free-to-play online social games.

We have an exciting opportunity to join our Government & Industry Affairs team in the United States and are currently looking for a Senior Manager, Government & Industry Affairs Operations to join the team. 

This is a newly created role that will play an important part in helping VGW coordinate and execute its government affairs activity across the US. You will be responsible for bringing structure, discipline, and clear operating rhythm to a complex, multi state lobbying network, ensuring our external partners are well coordinated, accountable, and aligned to business priorities.

You will work closely with Government Affairs, Legal, Marketing, and external lobbying partners to ensure activity is well planned, compliant, and clearly tracked.

We’re open to candidates based anywhere in the US, and this role can be performed remotely. We do not currently have a US office, but occasional in person office attendance may be required if that changes in future.

The salary range  for this role is USD $200,000 - $230,000 per year.

Key responsibilities will include:

• Managing the day to day operations of VGW’s external lobbying contractors, ensuring activity is clearly understood, tracked, and delivered.
• Supporting compliance across VGW’s lobbying activity, including oversight of relevant registrations, disclosures, and state and federal requirements.
• Establishing a single source of truth for legislative tracking, reporting, and key activity across the lobbying network.
• Building dashboards, reporting frameworks, and quarterly operating reviews tied to clear KPIs for lobbying firms.
• Developing detailed execution plans and ensuring strong cross functional alignment across Government Affairs, Legal, Marketing, and other relevant teams.
• Driving accountability with external partners, including performance tracking, budget oversight, resource allocation, and renewal decisions.

What you will bring to the role:

• 8 plus years of experience in government affairs, public policy, lobbying operations, regulatory affairs, or a related field.
• Experience supporting lobbying or government affairs activity in fast moving, high growth, or highly regulated industries.
• Strong multi state coordination skills, with the ability to manage a complex network of external partners, priorities, and deadlines.
• A highly organised and operationally focused approach, with a track record of creating structure where it does not already exist.
• Strong vendor and contract management experience, including the ability to drive accountability and assess performance.
• The ability to read complex regulatory, legislative, or legal materials and translate the practical impact clearly for non technical audiences.
• Experience building tracking, documentation, reporting, or operating systems from scratch and ensuring they are adopted successfully.

About VGW

VGW is an interactive entertainment company, harnessing technology and creativity to deliver world-class, free-to-play online social games.

Our high-quality, acclaimed brands include Chumba Casino, Global Poker and LuckyLand Slots, which are enjoyed by millions of players in North America.

Our games are based on a freemium model, meaning they are available to play at no cost, but include optional in-game purchases to enhance gameplay. We also offer sweepstakes promotions where players can collect free entries for the chance to win real-world prizes.

At VGW, one of our core values is “our players come first”. This means always striving to deliver a safe, responsible and positive player experience.

Why VGW?

At VGW, we’re more than just a team. We’re a diverse and inclusive group of individuals, each playing a vital role in our success.

Our core values are clear and strong; we win together, do what’s right, put our players first and are powered by passion.

We believe in our people and are committed to creating an environment where everyone feels welcome, inspired, and supported. We recognise that life is more than just work - that’s why we’re all about flexibility so you can strike a healthy balance between your personal life and career. We’re also here to champion your growth in your current role and future aspirations, providing opportunities for learning and career advancement. And to top it off, we back this all up with competitive compensation, perks and benefits.  

But it’s not all business. We inject fun into the workplace, celebrate together and create lasting memories, from a mix of in-person and online events, to social gatherings and much more.

It’s our combined skills, ideas and visions that drive us forward. Join us on this exciting journey, and together, we’ll achieve remarkable things. 

If you want to join a team that does things differently, apply today - we look forward to seeing what you can bring to our team.

Find out more at www.vgw.co

#LI-JG1

#LI-Remote

Senior Manager, Government & Industry Affairs Operations

VGW is an interactive entertainment company, harnessing technology and creativity to deliver world-class, free-to-play online social games.

We have an exciting opportunity to join our Government & Industry Affairs team in the United States and are currently looking for a Senior Manager, Government & Industry Affairs Operations to join the team. 

This is a newly created role that will play an important part in helping VGW coordinate and execute its government affairs activity across the US. You will be responsible for bringing structure, discipline, and clear operating rhythm to a complex, multi state lobbying network, ensuring our external partners are well coordinated, accountable, and aligned to business priorities.

You will work closely with Government Affairs, Legal, Marketing, and external lobbying partners to ensure activity is well planned, compliant, and clearly tracked.

We’re open to candidates based anywhere in the US, and this role can be performed remotely. We do not currently have a US office, but occasional in person office attendance may be required if that changes in future.

The salary range  for this role is USD $200,000 - $230,000 per year.

Key responsibilities will include:

• Managing the day to day operations of VGW’s external lobbying contractors, ensuring activity is clearly understood, tracked, and delivered.
• Supporting compliance across VGW’s lobbying activity, including oversight of relevant registrations, disclosures, and state and federal requirements.
• Establishing a single source of truth for legislative tracking, reporting, and key activity across the lobbying network.
• Building dashboards, reporting frameworks, and quarterly operating reviews tied to clear KPIs for lobbying firms.
• Developing detailed execution plans and ensuring strong cross functional alignment across Government Affairs, Legal, Marketing, and other relevant teams.
• Driving accountability with external partners, including performance tracking, budget oversight, resource allocation, and renewal decisions.

What you will bring to the role:

• 8 plus years of experience in government affairs, public policy, lobbying operations, regulatory affairs, or a related field.
• Experience supporting lobbying or government affairs activity in fast moving, high growth, or highly regulated industries.
• Strong multi state coordination skills, with the ability to manage a complex network of external partners, priorities, and deadlines.
• A highly organised and operationally focused approach, with a track record of creating structure where it does not already exist.
• Strong vendor and contract management experience, including the ability to drive accountability and assess performance.
• The ability to read complex regulatory, legislative, or legal materials and translate the practical impact clearly for non technical audiences.
• Experience building tracking, documentation, reporting, or operating systems from scratch and ensuring they are adopted successfully.

About VGW

VGW is an interactive entertainment company, harnessing technology and creativity to deliver world-class, free-to-play online social games.

Our high-quality, acclaimed brands include Chumba Casino, Global Poker and LuckyLand Slots, which are enjoyed by millions of players in North America.

Our games are based on a freemium model, meaning they are available to play at no cost, but include optional in-game purchases to enhance gameplay. We also offer sweepstakes promotions where players can collect free entries for the chance to win real-world prizes.

At VGW, one of our core values is “our players come first”. This means always striving to deliver a safe, responsible and positive player experience.

Why VGW?

At VGW, we’re more than just a team. We’re a diverse and inclusive group of individuals, each playing a vital role in our success.

Our core values are clear and strong; we win together, do what’s right, put our players first and are powered by passion.

We believe in our people and are committed to creating an environment where everyone feels welcome, inspired, and supported. We recognise that life is more than just work - that’s why we’re all about flexibility so you can strike a healthy balance between your personal life and career. We’re also here to champion your growth in your current role and future aspirations, providing opportunities for learning and career advancement. And to top it off, we back this all up with competitive compensation, perks and benefits.  

But it’s not all business. We inject fun into the workplace, celebrate together and create lasting memories, from a mix of in-person and online events, to social gatherings and much more.

It’s our combined skills, ideas and visions that drive us forward. Join us on this exciting journey, and together, we’ll achieve remarkable things. 

If you want to join a team that does things differently, apply today - we look forward to seeing what you can bring to our team.

Find out more at www.vgw.co

#LI-JG1

#LI-Remote

Senior Manager, Government & Industry Affairs Operations

VGW is an interactive entertainment company, harnessing technology and creativity to deliver world-class, free-to-play online social games.

We have an exciting opportunity to join our Government & Industry Affairs team in the United States and are currently looking for a Senior Manager, Government & Industry Affairs Operations to join the team. 

This is a newly created role that will play an important part in helping VGW coordinate and execute its government affairs activity across the US. You will be responsible for bringing structure, discipline, and clear operating rhythm to a complex, multi state lobbying network, ensuring our external partners are well coordinated, accountable, and aligned to business priorities.

You will work closely with Government Affairs, Legal, Marketing, and external lobbying partners to ensure activity is well planned, compliant, and clearly tracked.

We’re open to candidates based anywhere in the US, and this role can be performed remotely. We do not currently have a US office, but occasional in person office attendance may be required if that changes in future.

The salary range  for this role is USD $200,000 - $230,000 per year.

Key responsibilities will include:

• Managing the day to day operations of VGW’s external lobbying contractors, ensuring activity is clearly understood, tracked, and delivered.
• Supporting compliance across VGW’s lobbying activity, including oversight of relevant registrations, disclosures, and state and federal requirements.
• Establishing a single source of truth for legislative tracking, reporting, and key activity across the lobbying network.
• Building dashboards, reporting frameworks, and quarterly operating reviews tied to clear KPIs for lobbying firms.
• Developing detailed execution plans and ensuring strong cross functional alignment across Government Affairs, Legal, Marketing, and other relevant teams.
• Driving accountability with external partners, including performance tracking, budget oversight, resource allocation, and renewal decisions.

What you will bring to the role:

• 8 plus years of experience in government affairs, public policy, lobbying operations, regulatory affairs, or a related field.
• Experience supporting lobbying or government affairs activity in fast moving, high growth, or highly regulated industries.
• Strong multi state coordination skills, with the ability to manage a complex network of external partners, priorities, and deadlines.
• A highly organised and operationally focused approach, with a track record of creating structure where it does not already exist.
• Strong vendor and contract management experience, including the ability to drive accountability and assess performance.
• The ability to read complex regulatory, legislative, or legal materials and translate the practical impact clearly for non technical audiences.
• Experience building tracking, documentation, reporting, or operating systems from scratch and ensuring they are adopted successfully.

About VGW

VGW is an interactive entertainment company, harnessing technology and creativity to deliver world-class, free-to-play online social games.

Our high-quality, acclaimed brands include Chumba Casino, Global Poker and LuckyLand Slots, which are enjoyed by millions of players in North America.

Our games are based on a freemium model, meaning they are available to play at no cost, but include optional in-game purchases to enhance gameplay. We also offer sweepstakes promotions where players can collect free entries for the chance to win real-world prizes.

At VGW, one of our core values is “our players come first”. This means always striving to deliver a safe, responsible and positive player experience.

Why VGW?

At VGW, we’re more than just a team. We’re a diverse and inclusive group of individuals, each playing a vital role in our success.

Our core values are clear and strong; we win together, do what’s right, put our players first and are powered by passion.

We believe in our people and are committed to creating an environment where everyone feels welcome, inspired, and supported. We recognise that life is more than just work - that’s why we’re all about flexibility so you can strike a healthy balance between your personal life and career. We’re also here to champion your growth in your current role and future aspirations, providing opportunities for learning and career advancement. And to top it off, we back this all up with competitive compensation, perks and benefits.  

But it’s not all business. We inject fun into the workplace, celebrate together and create lasting memories, from a mix of in-person and online events, to social gatherings and much more.

It’s our combined skills, ideas and visions that drive us forward. Join us on this exciting journey, and together, we’ll achieve remarkable things. 

If you want to join a team that does things differently, apply today - we look forward to seeing what you can bring to our team.

Find out more at www.vgw.co

#LI-JG1

#LI-Remote

• Develop and drive a proactive, multi-state strategy across priority states, aligned with enterprise priorities, portfolio objectives, and commercial planning
• Identify, assess, and influence state legislation, regulations, and executive actions impacting pricing, reimbursement, Medicaid, PBM reform, 340B, newborn screening, rare disease access, and innovation policy
• Anticipate state political, legislative, and regulatory trends, translating complex developments into clear business risks, opportunities, and recommended actions for executive leadership 
• Lead coordinated advocacy campaigns in priority states, integrating direct lobbying, state trade association engagement, and coalition strategy to shape outcomes before they materially affect the business 
• Maintain disciplined oversight of all state lobbying and political compliance processes, ensuring all activity meets reporting requirements and that advocacy activities adhere to applicable state ethics and disclosure laws 

• Leverage established relationships and strategically build BridgeBio’s engagement with governors’ offices, state legislators and regulators, Medicaid and insurance leaders, and key staff to advance the company’s state policy priorities 
• Represent BridgeBio in state coalitions, and industry forums, serving as a credible and persuasive voice for the company’s positions 
• Lead engagement within state trade associations and coalitions, consultants, driving aligned action on priority issues while protecting BridgeBio’s independent strategy 

• This role is responsible for executing and advancing BridgeBio’s enterprise policy positions at the state level, in close coordination with the Head of Public Policy and Federal Government Affairs.
• Partner with key internal stakeholders including Commercial, Market Access and Patient Advocacy to integrate state policy strategy into coverage, reimbursement, and patient access planning, ensuring advocacy efforts directly support portfolio objectives and patient access across priority states 
• Advise executive leadership and cross-functional teams on state-level legislative and regulatory developments, translating state political dynamics into clear implications for pricing, reimbursement, Medicaid coverage, and patient access strategy 

• 10+ years of relevant experience in state government affairs, public policy, legislative advocacy, or state government 
• Strong knowledge of state health policy, reimbursement frameworks, Medicaid programs, and regulatory environments impacting the biopharmaceutical ecosystem 
• Established relationships with state legislators, governors’ offices, regulatory agencies, and other key state decision-makers 
• Demonstrated ability to interpret complex state legislative and regulatory proposals, assess commercial implications, and translate them into actionable recommendations for executive leadership 
• Proven ability to manage multiple priorities across diverse political environments while remaining highly organized, self-directed, and disciplined in execution 
• Demonstrated excellent written and verbal communication skills, with the ability to represent the company credibly with policymakers and clearly communicate complex policy issues to internal stakeholders 
• Ability and willingness to operate across multiple states, with regional travel as required 

Rewarding Those Who Make the Mission Possible

We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return. 

Financial Benefits:

• Market leading compensation 
• 401K with 100% employer match on first 3% & 50% on the next 2%
• Employee stock purchase program
• Pre-tax commuter benefits
• Referral program with $2,500 award for hired referrals

Health & Wellbeing:

• Comprehensive health care with 100% premiums covered - no cost to you and dependents
• Mental health support via Spring Health (6 therapy sessions & 6 coaching sessions)
• Hybrid work model - employees have the autonomy in where and how they do their work 
• Unlimited flexible paid time off - take the time that you need
• Paid parental leave - 4 months for birthing parents & 2 months for non-birthing parents
• Flex spending accounts & company-provided group term life & disability 
• Subsidized lunch via Forkable on days worked from our office

Skill Development & Career Paths:

• People are part of our growth and success story - from discovery to active drug trials and FDA pipelines, there are endless opportunities for skill development and internal mobility
• We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, Spring Health & BetterUp Coaching
• We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities

Position Description

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

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

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

Job Duties and Responsibilities

Core Responsibilities:

Labeling

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

Advertising and Promotion

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

Governance, Process and Compliance

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

Cross-Functional Leadership

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

Essential/Required Qualifications:

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

Preferred Qualifications:

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

Key Competencies:

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

Team Description:

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

Job Description and Responsibilities:

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

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

Required Qualifications:

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

Preferred Qualifications:

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

Expected Compensation:

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

Texas Hourly Range:

$21 – $35/Hr USD

Team Description:

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

Job Description and Responsibilities:

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

Strategic Oversight & Relationship Management

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

Operational Excellence & Scalability

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

Compliance & Regulatory Stewardship

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

Required Qualifications: 

Strategic Leadership & Clinical Expertise

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

Data Intelligence & Analytical Rigor

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

Communication & Interdisciplinary Integration

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

Mission-Critical Mindset

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

Preferred Qualifications: 

Advanced Academic & Technical Background

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

Strategic Clinical Leadership

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

Innovation & Process Design

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

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

Role Overview

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

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

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

Key Responsibilities

Direct end-to-end clinical trial management: 

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

Clinical Trial Operations Efficiency and optimization:

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

Resource Management and Direct High Performing team:

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

Direct and Support Vendor Partnership

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

Leadership Skills

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

Key Relationships

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

Requirements

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

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

Role Overview

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

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

Key Responsibilities

Scientific Engagement & External Partnerships

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

Clinical Research & Development Support

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

Medical Strategy Execution & Insights

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

Scientific Exchange & Medical Education

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

Cross‑Functional Collaboration & Leadership

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

Compliance & Operational Excellence

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

Requirements

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

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

Role Overview

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

Key Responsibilities

Strategic Intelligence & Insight Generation

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

Conference Coverage & Surveillance

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

Data & Analysis Leadership

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

Cross-Functional Partnership

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

Requirements

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

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

Role Overview

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

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

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

Key Responsibilities

Clinical Development Leadership

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

Regulatory & Compliance

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

Cross Functional & External Collaboration

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

People & Matrix Leadership

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

Requirements

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

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

Role Overview

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

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

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

Key Responsibilities

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

Clinical Trial Planning & Analytics:

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

Clinical Trial Operational Technologies:

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

Vendor Alliance Management:

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

Site contracts and Payments

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

Sample and Imaging Management Operations

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

Key Relationships

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

Requirements

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

#Li-AS1

#Li-Hybrid

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

Role Overview

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

Key Responsibilities

Strategic Leadership

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

Planning & Execution:

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

Cross-Functional Collaboration

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

Process Development & Transfer

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

Manufacturing Site & Operational Readiness

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

Quality and Compliance

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

Continuous Improvement & Lifecycle Management

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

Requirements

Education

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

Experience

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

Skills

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

#Li-BZ1

#Li-Hybrid

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

Role Overview

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

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

Key Responsibilities

Alliance Management:

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

Engagement & Communication:

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

Innovation & Strategy Acceleration:

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

Capability Building:

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

Requirements

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

#Li-JK1

#Li-Hybrid

Legend Biotech is seeking an Associate Director, Corporate Strategy & Competitive Intelligence as part of the Commercial team based in Somerset, NJ.

Role Overview

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

Key Responsibilities

• Conducting value stream mapping to identify inefficiencies and areas for improvement.
• Developing, implementing, and sustaining lean transformation strategies aligned with business objectives.
• Establishing and monitoring KPIs to track continuous improvement efforts.
• Collaborating with leadership to prioritize improvement opportunities and allocate resources.
• Lead competitive intelligence activities across assigned therapeutic areas, platforms, and/or programs, delivering high-quality, actionable insights to senior leadership and cross-functional stakeholders
• Monitor competitors’ pipelines, clinical data, regulatory actions, collaborations, and market events to identify emerging threats, opportunities, and early signals.
• Monitor new entrants and startup tracking: Monitoring early innovation signals, investments, and disruptive players
• Assist CI partners with end-to-end conference CI planning and execution, including surveillance plans, abstract triage, onsite (or virtual) monitoring, rapid-readouts, and post-conference summaries.
• Build and maintain CI frameworks, KPI dashboards, market landscapes, and tracking systems to support continuous monitoring.
• Assist in managing internally created CI dashboard and in some cases external CI vendors and ensure high-quality deliverables aligned with business needs.
• Serve as collaborator with R&D, commercial, BD, and strategy teams; participate in team meetings and strategic discussions as an insights partner.
• Partner with forecasting, medical affairs, and commercial strategy to ensure cohesive interpretation of external environment dynamics.
• Requires autonomy in making decisions related to day-to-day operations and their technical aspects mostly.

Requirements

• Advanced degree preferred (PhD, PharmD, MD, or Master’s in life sciences, business, or related field).
• 5+ years of experience in pharmaceutical/biotech competitive intelligence, strategy, consulting, market research.
• Strong scientific and clinical acumen in relevant therapeutic areas; hematology/oncology/IAI experience preferred (if applicable).
• Relevant certification in Six Sigma (Green Belt/Black Belt) or Lean Management.
• Experience with coding, use of R scripts, python and pivot tables is required.
• Strong analytical and strategic thinking abilities.
• Excellent written and verbal communication skills; ability to distill complex information into clear insights.
• Experience with coding, use of R scripts, python and pivot tables is required. Highly proficient in CI methodologies, secondary research, data interpretation, and triangulation.
• Skilled at working in fast-paced, cross-functional environments with tight timelines.
• High integrity and ability to manage sensitive/confidential information.
• Familiarity with CI tools, databases, and information platforms (e.g., Evaluate, Cortellis, Datamonitor, Alphasense, and clinical databases). 

#Li-LB1

#Li-Hybrid

Overview

The South Carolina Local Engagement Senior Specialist will drive Scout Motors’ local engagement in support of Scout Motors’ Production Center and the 4,000+ employees who will make it work. This entails serving as a visible and trusted representative to local government stakeholders and related civic organizations, including chambers, workforce partners, nonprofits, and neighborhood groups. At Scout Motors, we believe in going together and, as such, you’ll work in close partnership with our communications team, production leadership, and HR leadership to build and nurture relationships that strengthen Scout Motors’ regional impact, support workforce development efforts, and elevate our commitment to a positive employee experience. This role reports to the Vice President, Government & Regulatory Affairs. 

The ideal candidate is relationship driven, proactive, and highly skilled at building partnerships that benefit both the community and the company. 

What you’ll do

Become part of an iconic brand that is set to revolutionize the electric pick-up truck & rugged SUV marketplace by achieving the following:

Local Government Engagement & Community Partnerships 

• Serve as the primary liaison with South Carolina county and local governments as Scout Motors completes our Production Center and launches production of our Scout vehicles. 
• Build trusted relationships with local government, nonprofits, chambers, workforce and education partners, and community groups to strengthen the company’s presence in the region, and advance initiatives that reflect Scout Motors’ values, commitments, and long‑term community impact. 
• Partner with our Production Center-focused teams to develop and implement a comprehensive community engagement strategy for South Carolina, integrating Scout Motors executives and other team members into relevant business, nonprofit, and philanthropic networks of the broader Carolinas community. 
•  Cultivate strong relationships, and partner closely together with Scout Motors’ Strategy and Brand, HR, and Legal teams on local community engagements, plans and strategies. 
• Support Scout Motors’ Production HR team as they identify strategic opportunities for Scout Motors to support local priorities such as workforce development, STEM education, and economic mobility. 
• Partner with other functions and develop strategies to raise awareness of Scout Motors’ local contributions across the region. 

Corporate Citizenship & Programs 

• Support, as a member of the South Carolina community, Scout Motors’ Strategy and Brand team as they establish a strategy for philanthropic giving, sponsorships, and community investment programs. 
• Assist in facilitating volunteer programs partnering with the HR (Employee Experience team) and Public Affairs teams. 

 Stakeholder Relations & Communications 

• Work closely with Strategy and Brand, Communications, HR, and Government Affairs to align messaging and community initiatives. 
• Represent Scout Motors at public events, community forums, and civic engagements as needed. 

 Measurement & Reporting 

• Develop and track metrics to assess community impact and report outcomes to leadership. 
• Monitor community sentiment and identify opportunities or risks related to Scout Motors’ presence. 

Location & Travel Expectations:

• This role will be based out of the Scout Motors location in Columbia, South Carolina. 
• This role requires 4 days per week in the office, with regular in-person meetings and events. 
• Applicants should expect that the role will require the ability to convene with Scout colleagues in person and travel to participate in events on behalf of the company from time to time.

What you’ll bring 

We expect all Scout employees to have integrity, curiosity, resourcefulness, and strive to exhibit a positive attitude, as well as a growth mindset. You’ll be comfortable with change and flexible in a fast-paced, high-growth environment. You’ll take a collaborative approach to achieve ambitious goals. Here's what else you'll bring: 

• Bachelor’s degree in Government Affairs, Business, or related field; or equivalent experience. 
• 8+ years of experience in government affairs, external relations, or equivalent fields. 
• Deep connections within South Carolina and the greater Carolina community, including the local government, business, non-profit, educational, and philanthropic networks.  
• Strong written and verbal communication skills, with the ability to effectively interact with and build relationships with internal and external stakeholders. 
• Demonstrated leadership and people management abilities, with experience building, developing and executing a cross functional local government and community engagement strategy. 
• Excellent organizational skills ability to work in a fast-paced environment, prioritize and manage multiple projects/deadlines. 
• Ability to work well cross functionally and strengthen company culture through effective collaboration. 
• Strong relationship building, communication, and public speaking skills. 
• Experience working with local government, civic organizations, and community leaders. 
• Comfort representing the company in public settings. 
• Experience in manufacturing, automotive, energy, or economic development industries a plus. 

What you'll gain

The benefits of joining Scout include the chance to build products and a company from the ground up.  This is a chance to create something new and lasting – with an iconic brand at its foundation.  In addition, Scout provides competitive compensation and benefits to support your physical, mental, and financial wellbeing. Program specifics are detailed in company policies and employee benefit guides, select highlights:

• Competitive insurance including:
  • Medical, dental, vision and income protection plans
• 401(k) program with:
  • An employer match and immediate vesting
• Generous Paid Time Off including:
  • 20 days planned PTO, as accrued
  • 40 hours of unplanned PTO and 14 company or floating holidays, annually
  • Up to 16 weeks of paid parental leave for biological and adoptive parents of all genders
  • Paid leave for circumstances related to bereavement, jury duty, voting time, or military leave

Pay Transparency

This is a full-time, exempt position eligible to receive a base salary and to participate in an annual performance bonus program. Final salary offered will be determined based on factors including but not limited to the candidate's skills and experience. The annual performance bonus program is preset and not candidate dependent.

Initial base salary range = $110,000.00 - $135,000.00

Internal leveling code: IC8

Position Overview 

We are seeking a Technical Product Manager to drive technical requirements and RAN product specifications & solutions for gateway site installation, aligning engineering needs, regulatory constraints, and deployment workflows to enable compliant, commercially viable, and scalable satellite-gateway locations. This role serves as the critical bridge between technical engineering teams, regulatory affairs, commercial development, and site deployment operations to ensure gateway delivers production-ready infrastructure that meets both technical performance requirements and business objectives. 

This position requires deep understanding of satellite ground infrastructure, RAN solutions, RF propagation considerations, regulatory compliance frameworks, and site engineering requirements. The ideal candidate will bring proven experience in technical product management within satellite communications infrastructure, with specific expertise in gateway site development, regulatory coordination, and cross-functional technical program management.  

Key Responsibilities 

Technical Requirements & Product Specifications 

• Define comprehensive technical requirements for gateway site acquisition including RF performance criteria, RAN infrastructure specifications, and integration compatibility standards 

• Manage product and deployment requirements for RAN network related hardware 

• Own configuration standards, templates, and governance to ensure consistency across Gateway sites constraints and deployment workflow requirements 

• Coordinate and validate BOMs with Engineering, Supply Chain, and vendors for completeness and accuracy 

• Establish technical validation criteria and acceptance standards for RAN network at Gateway locationa  

• Ensure CIQs, configuration guides, port mappings, and as-built documentation are complete and deployment-ready 

• Coordinate technical requirements gathering sessions with engineering stakeholders, site development teams, and operations personnel 

• Ensure technical specifications support scalable satellite-gateway location development across diverse geographical environments 

• Enable smooth technical handover to Service Acceptance and Operations, ensuring documentation completeness and traceability 

• Support change control by ensuring updates reflected across HLDs, BOMs, configurations, and documentation 

Site Feasibility & Validation Management 

• Lead technical site feasibility assessments including RF propagation analysis, interference studies, and infrastructure capability evaluations for RAN network deployment 

• Validate site feasibility against established technical criteria,  and operational deployment standards 

• Coordinate multi-disciplinary feasibility studies involving RF engineering, utilities assessment, and regulatory compliance teams 

• Manage technical risk assessments and mitigation strategies for site acquisition projects 

• Establish standardized feasibility validation processes and documentation frameworks 

Cross-Functional Engineering Coordination 

• Coordinate engineering inputs from RF engineering, satellite systems, network operations, and infrastructure development teams 

• Facilitate technical collaboration between site acquisition teams and broader satellite network engineering organization 

• Ensure consistent engineering standards and technical approaches across multiple gateway site development projects for RAN network 

• Drive technical decision-making processes involving multiple engineering disciplines and stakeholder groups 

• Enable smooth technical handover to Service Acceptance and Operations, ensuring documentation completeness and traceability 

Documentation & Delivery Standards Management 

• Manage comprehensive technical documentation for gateway site including requirements specifications, RAN Rack layout design standards, and validation procedures 

• Ensure site acquisition outputs meet integration, build, and commercial-ready gateway delivery standards 

• Establish and maintain technical documentation standards and configuration management processes 

• Maintain technical traceability from requirements through final delivery and commissioning 

Technical Program Management & Process Optimization 

• Develop and optimize technical workflows for gateway site acquisition from RAN network prospects, including requirements definition, feasibility assessment, and delivery validation processes 

• Drive continuous improvement initiatives for technical processes, tools, and methodologies 

• Coordinate technical resource allocation and capacity planning for site acquisition programs  

Qualifications 

Education 

• Bachelor's degree in Electrical Engineering, Telecommunications Engineering, Systems Engineering, or related technical field 

• Master's degree in Engineering Management, Systems Engineering, or advanced technical discipline preferred 

Experience 

• Minimum 8+ years in satellite communications, telecommunications infrastructure, or wireless network engineering 

• Minimum 5 years’ relevant experience in RAN engineering, telecom site acquisition, or technical product management supporting ground facilities 

• Demonstrated experience producing or validating site engineering deliverables: site survey reports, RF/site feasibility and integration acceptance criteria 

• Strong written communication and technical documentation skills for creating ICDs, acceptance plans and status reports 

• Ability and willingness to travel domestically to candidate and active gateway sites as required for surveys, permitting meetings, and commissioning 

Required Technical Expertise 

• Deep understanding of satellite ground segment architecture, gateway systems, and RF infrastructure requirements 

• Hands on experience of eNB hardware and RAN architecture design 

• Strong knowledge of satellite communications link budgets, antenna systems, and RF propagation characteristics 

• Proven ability to translate complex technical requirements into actionable product specifications and delivery criteria 

• Experienced on CIQ handling and deployment documentation workflows 

Preferred Qualifications 

• Background in technical product management roles at satellite operators, ground infrastructure providers, or telecommunications companies 

• Experience with technical project management methodologies and cross-functional technical program coordination 

• Familiarity with 4G/ 5G NTN standards, satellite-cellular integration, and next-generation satellite communications architectures 

Leadership & Communication Skills 

• Strong technical leadership with ability to influence and coordinate across multiple engineering disciplines 

• Exceptional communication skills for presenting complex technical requirements to diverse stakeholder audiences 

• Proven ability to manage technical programs involving regulatory agencies, engineering teams, and commercial stakeholders 

• Experience building scalable technical processes and product management frameworks 

• Demonstrated success in technical decision-making and conflict resolution across cross-functional teams 

Technology Stack 

• Proficiency with technical documentation systems, requirements management tools, and project management platforms 

• Experience with RF simulation tools, link budget analysis software, and satellite communications modelling systems 

• Knowledge of geographic information systems (GIS) and site assessment tools commonly used in telecommunications infrastructure development  

Physical Requirements 

• Role will be based in the US with flexibility for remote work arrangements 

• Regular travel for site assessments, technical meetings, and stakeholder coordination (~25-30%) 

• Ability to participate in field site evaluations including outdoor assessments at potential gateway locations 

This job description may not be inclusive to the duties and responsibilities listed. Additional tasks may be assigned to the employee from time to time or the scope of the job may change as needed by business demands. 

Your Opportunity

Scion is paving a path in student living, and we’re seeking an Insurance Claims Administrator to join our team. This position will provide essential support to corporate and property operations teams by assisting with insurance claims, legal documentation, and compliance efforts. 

This role is ideal for someone with a strong attention to detail, excellent communication skills, and an interest in legal and insurance administration.  

Your Responsibilities

• Coordinates all aspects of the making and collection of insurance claims on behalf of the Company and its managed properties.
• Responds promptly and professionally to requests for assistance from property staff.
• Drafts, revises, interprets and explains commercial contracts.
• Drafts and revises housing agreements and other relevant real estate documents.
• Identifies and responds promptly and professionally to resident complaints, vendor disputes and regulatory matters, and elevates to attorneys as required.
• Supports property operations staff with clear and consistent information regarding legal- and policy-related situations involving residents, staff and vendors.
• Supports outside counsel on litigation matters.
• Coordinates with inside and outside counsel on entity and asset acquisitions.
• Identifies and addresses various reporting and compliance issues with lenders, partners and governmental bodies.
• Monitors compliance with vendor insurance requirements.
• Monitors and assists in resolution of insurance claims.
• Other duties as assigned by Staff Attorneys, by the Vice President of Legal Affairs and/or the General Counsel.

The responsibilities listed above may not be all inclusive.

What We Require

• Associate’s degree or Paralegal certification preferred.
• 1+ years of experience in a legal, insurance, or administrative role is a plus.
• Strong organizational and communication skills.
• Ability to manage multiple tasks in a fast-paced environment.
• Proficiency in Microsoft Office and familiarity with property management systems is a plus. 

Operational Details

• Job location is based at Scion’s Chicago corporate headquarters.
• Working hours consist of standard daytime business hours.

Benefits

• FLSA Status Exempt
• Discretionary annual bonus
• Paid Time Off
• Health Insurance
• Dental Insurance
• Vision Insurance
• 401k Matching
• Paid Maternal Leave
• Parental Leave
• Learning reimbursement opportunities

The base salary range for this full-time position is $50,000-$65,000 + bonus + benefits. Our salary ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position across all US locations. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. Your recruiter can share more about the specific salary range for your preferred location during the hiring process.   

The Scion Group LLC provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, religion, creed, national origin, color, gender, sex, sexual orientation, gender identity or expression, age, physical or mental disability (as long as the employee/applicant is otherwise qualified for the job with or without a reasonable accommodation), genetic information, HIV/AIDS status, marital status, uniformed service, veteran status, pregnancy or other legally protected status or category under federal or state law. The Scion Group LLC complies with applicable state and local laws governing nondiscrimination in employment in all locations in which the Company has properties. This policy applies to all terms and conditions of employment, including hiring, placement, promotion, termination, layoff, recall, transfers, leaves of absence, compensation, training and other terms and conditions of employment. The Scion Group LLC is committed to the principles of equal employment opportunities.

IND-B  #wearehiring #werehiring

The Vision

At Okta, growth is our mandate, but a secure foundation is the prerequisite. In the Public Sector, this foundation is the bedrock of national security and citizen trust. As we scale, our focus is evolving beyond the "renewal transaction" toward a holistic strategy of Strategic Retention. We aren't just renewing contracts; we are securing the identity infrastructure of the US Federal Government and State & Local (SLED) agencies.

The Role

We are looking for a high-impact sales leader and strategic architect to lead our Public Sector Renewals team. As the Director, you are the steward of Okta’s largest and most complex public-interest partnerships.

In this role, you will lead a team of high-performing, individual contributor Renewals Managers. You will act as their coach, mentor, and lead strategist, navigating the unique procurement, regulatory, and budgetary landscapes of the Public Sector. You will be responsible for turning territory-level data into actionable retention playbooks, ensuring your team acts with precision, integrity, and long-term vision.

Core Responsibilities

1. Strategic Retention & Territory Architecture

• Segment Leadership: Own the retention strategy and execution for Okta’s Public Sector business, covering both US Federal and SLED markets.
• High-Value Deal Strategy: Act as the lead executive and strategic advisor for the segment’s most complex, high-stakes agreements, including those exceeding $5M+ in ARR.
• Predictive Intelligence: Move beyond basic forecasting to develop a deep, programmatic understanding of territory health, identifying risks early and designing "Path to Green" strategies that ensure long-term account stability.
• Retention Architect: Design and implement modern renewal playbooks that account for the unique cycles of public sector procurement, ensuring that our approach is proactive rather than reactive.

2. Leadership & Team Evolution

• The Leader as Coach: Manage and mentor a team of individual contributors, assisting them in navigating high-pressure negotiations and complex customer environments.
• Cultural Architect: Foster a culture of high accountability, integrity, and relentless customer focus. You will be responsible for recruiting, hiring, and developing the next generation of Public Sector renewal talent.
• Field Advocacy: Act as the voice of the Public Sector within the broader Renewals organization, ensuring that global processes are optimized for the nuances of government customers.

3. Diplomatic Power & Cross-Functional Partnership

• Sales Alignment: Partner as a peer to Public Sector Sales Leadership to ensure a unified strategy for account growth and retention.
• Government Affairs & Compliance: Collaborate closely with Government Affairs and Legal teams to stay ahead of regulatory shifts (e.g., FedRAMP) and procurement hurdles that impact our ability to retain and grow.
• Customer Success & Product Feedback: Drive a tight feedback loop with Customer Success and Product teams, ensuring that the "ground-level" reality of our government customers informs our long-term product and service roadmap.

Qualifications

• Experience: 10+ years in Renewals, Sales, or Account Management within the SaaS industry, with a minimum of 3-5 years in a high-performing leadership role.
• Public Sector Mastery: A proven track record of navigating US Federal and SLED procurement cycles, including experience with large-scale, $5M+ license agreements.
• Strategic Translator: The ability to take complex data sets and translate them into simple, winning tactics for the field.
• Negotiation Excellence: Expert-level negotiation skills with the ability to tactfully close high-value deals with a high degree of integrity and independence.
• Diplomatic Influence: Exceptional ability to partner cross-functionally with Sales, Customer Success, Product, and Government Affairs to drive collective outcomes.

Measures of Success

• Net Retention & ARR Growth: Achieve or exceed team goals for renewal rates and total ARR stabilization within the Public Sector.
• Operational Excellence: Maintain a highly accurate and predictable forecast for the segment.
• Talent Development: High engagement and performance scores from your team of Renewals Managers.

Cross-Functional Impact: Successful implementation of new retention playbooks that bridge the gap between Sales and Renewals.

#LI-Hybrd

#P25154_3426080

Position Summary:

ultrafocused – Work together to fearlessly uncover new possibilities

The Senior Director, Medical Writing-Publications will provide strategic direction within the department and lead the successful development and tactical execution of publication plans across multiple programs in alignment with integrated evidence generation plans and lifecycle strategies and in compliance with SOPs, publication guidelines, and company goals. In addition, the Senior Director will be responsible for writing and coordinating the writing of peer-reviewed scientific publications, including distribution of work to medical writers or agencies as needed. They will serve as the primary contact for publication activities in collaboration with a cross‐functional group, including Clinical Development, Medical Affairs, Biometrics, Pharm/Tox, Research, and other relevant functions.  

Work Model: 

Flex: This role will typically require onsite work 2-3 days each week, or more depending on business needs. In many locations, the business will set certain days each week that Flex employees are required to be onsite.

Remote: Officially documented as working full-time from home, with travel to Ultragenyx's offices or other locations on occasion as needed.

Responsibilities:

1. Lead key strategic initiatives within the department including publication strategy, planning, and execution of Ultragenyx products and pipeline publication plans, ensuring alignment with department and company goals. 
2. Provide leadership within the department by proposing and overseeing new initiatives and capabilities, such as establishing best practices for pubs strategy development and pull-through. 
3. Interact with external authors and key internal stakeholders to develop high-quality publications (manuscripts, abstracts, posters, slide presentations) for peer-reviewed journals and scientific congresses and provide publication support and ensure compliant development of company-sponsored publications. 
4. Ensure smooth and effective document management from start to finish (i.e., generation of a blank document to a final approved version), which may include, but is not limited to: first draft authoring, reference retrieval, generating bibliographies, editing (e.g., follow house style guide), and managing various processes (e.g., reviews, QC, QA, formatting, publishing, document archiving, journal and congress submissions).  
5. Liaise with relevant corporate functions and partner(s), as applicable, to ensure appropriate communication of publications‐related activities including manuscripts and congress abstracts/posters/presentations. 
6. Uses advanced communication and persuasion strategies to negotiate on behalf of their department or function on strategic matters. 
7. Contributes to strategic planning for the broader function and support high‐quality execution of Corporate‐wide initiatives. 
8. Acts as a trusted advisor and recognized technical expert. 
9. Manage and/or mentor junior medical writers and contractors. 
10. Support publication budget planning and management. 

Requirements:

1. BS, MS, or doctorate in a scientific or medical field. 
2. Solid experience (BS with >15 years or advanced degree with >10 years) in publication management and medical writing in the biotechnology/pharmaceutical industry preferred. 
3. Proven success with leading and managing medical writing agencies as well as track record for consistently meeting or exceeding quantitative targets. 
4. Demonstrated experience analyzing and communicating scientific data in peer-reviewed scientific publications; knowledge of applicable publications-related guidelines (i.e., ICMJE, GPP) and best practices, as well as legal, regulatory, compliance, and clinical/medical affairs. 
5. Experience writing and preparing manuscripts for publication in peer‐reviewed journals as well as abstracts, posters, and slide decks for presentation at scientific congresses. 
6. Successful and superior influencing skills across all levels of the organization and external collaborators. 
7. Exceptional oral and written communication skills. 
8. Experience in successfully engaging with cross‐functional product teams. 
9. Strong organizational abilities and experience in a multitasking environment. 
10. Motivated, self‐directed, and able to work autonomously and in team settings to meet aggressive organizational goals. 
11. Rare disease experience and a strong understanding of neurodevelopmental disorders are a plus. 

#LI-CS1 #LI-Hybrid, or #LI-Remote

About the role:

We are seeking a Government Affairs Associate to join our Government Affairs team. This role will help drive the company's executive and legislative strategies, shape external messaging, and support engagements in Congressional and Executive branches. Duties will include track legislation, policy and regulatory developments related to autonomy, defense technology, and physical AI; help develop the company’s positions and responses, support political and stakeholder engagement strategy; and represent the company in meetings with policymakers and other key external audiences. The role will have the opportunity to develop internal management processes, lead strategy discussions, and engage with Applied stakeholders. 

At Applied Intuition, you will:

• Build and maintain relationships with Members of Congress and congressional staff on relevant Appropriations and Authorization Committees/Subcommittees.
• Help shape the company’s federal legislative priorities, policy positions, and political engagement strategy by understanding business objectives, growth opportunities, and potential risks.
• Work closely with Applied’s external government affairs consultants, trade associations, and industry partners to advance shared priorities.
• Draft legislative language, policy memoranda, briefing materials,  presentations, hearing testimony, and position papers.
• Support and manage the company’s political action committee with strong attention to detail for compliance and execution. 
• Partner with cross-functional leaders across the company to drive special projects and ensure timely, high-quality execution.

We’re looking for someone who has:

• 2-5 years of experience on Capitol Hill or in the executive branch, in policy and legislative analysis, or issue advocacy.
• Strong familiarity with the federal legislative process, including Appropriations and Authorization.
• Knowledge of autonomy, emerging technologies, and defense technology policy.
• Strong organizational skills and close attention to detail to operate effectively in a fast-paced environment.
• A demonstrated track record of strong execution and follow-through and results-driven mentality.
• A practical, team-oriented, and customer-centric mindset and a willingness to take on tasks at any level.
• A sense of humor.
• “Can-do” attitude–no task is too small.

Nice to have:

• Experience in Congressional engagement, advocacy, or political strategy. 
• Experience with PAC management or political campaigns and fundraising.
• Graduate degree with a focus on legislative process, technology, or defense.
• Technical background, particularly related to autonomy or artificial intelligence.
• Experience with the Google suite of tools in addition to AI tools for increased productivity.
• Active Security Clearance

Compensation at Applied Intuition for eligible roles includes base salary, equity, and benefits. Base salary is a single component of the total compensation package, which may also include equity in the form of options and/or restricted stock units, comprehensive health, dental, vision, life and disability insurance coverage, 401k retirement benefits with employer match, learning and wellness stipends, and paid time off. Note that benefits are subject to change and may vary based on jurisdiction of employment.

Applied Intuition pay ranges reflect the minimum and maximum intended target base salary for new hire salaries for the position. The actual base salary offered to a successful candidate will additionally be influenced by a variety of factors including experience, credentials & certifications, educational attainment, skill level requirements, interview performance, and the level and scope of the position.

Please reference the job posting subtitle for where this position will be located. For pay transparency purposes, the base salary range for this full-time position in the location listed is: $80,000 to $140,000 USD annually.

Position Summary:

ultradedicated – Your biggest challenges yield rare possibilities

The Associate Director, GRA Global Labeling will be responsible for providing global labeling expertise and direction in support of the development, registration, and lifecycle management of innovative programs for rare diseases. This individual will liaise across key functional areas collecting critical regulatory milestones and developing detailed target label strategy plans during clinical development programs in order to align with company objectives and registration strategies. The responsibilities include managing labeling changes for lifecycle products, assisting in the development of labeling content for new products in pre-approval stages, and reviewing applicable regulatory documentation and artwork. The individual will also support implementation of approved labels which may include document control, QC/proofread, translations and verification of translations, and tracking project milestones and status. The individual must possess a thorough knowledge of global regulations and guidance governing drugs and biologics in all phases of clinical development. This position will report to Senior Director, GRA Global Labeling. 

Work Model: 

Remote: Officially documented as working full-time from home, with travel to Ultragenyx's offices or other locations on occasion as needed.

Responsibilities:

• Provides global labeling leadership in support of the development, registration, and life-cycle management of Ultragenyx products for rare diseases. 

• Prepare new and revised labeling content (Company Core Data Sheet, Prescribing Information, Summary of Product Characteristics, Major Market labels, Patient Information, and Instructions for Use) based on source reports, regulatory requirements, and other reference sources. 

• Demonstrate the ability to work in a matrix environment communicating label concepts and key messaging during label development consistent with program strategy and understanding and educating the impact to downstream activities (i.e., for commercial, and promotional educational purposes). 

• Build strong collaboration with key internal stakeholders, including Global Regulatory leadership team, Clinical Development, Safety, Quality, Commercial, Medical Affairs, Legal, Manufacturing, Supply Chain, and other functions to support development of draft label text.  

• Interact with the cross functional labeling team (Label Working Group and Label Review Committee) to ensure timely implementation of global labeling changes in local product information that are consistent with the company’s position defined in the CCDS and in compliance with local labeling regulations. 

• Prepare, deliver and/or manage all types of regulatory documents/submissions influencing and managing cross-functional team member input to provide high quality deliverables that meet regulatory standards, and corporate and program milestones. Facilitate LWG/LRC/SME meetings to develop content for label documents including resolution of complex label issues and ability to drive consensus utilizing current standard operating procedures, best practices and/or work instructions including work requests associated with partner companies and vendors. 

• Facilitate and lead target label strategies with cross functional labeling team incorporating key messaging aligned with target product profile and thorough understanding of competitive landscape environment. Provide necessary label output for HA interactions (i.e., FDA/EMA/PMDA/HC briefing book, scientific advice, and/or other key submission readiness milestones). 

• Manage approved labels in a document label management system to ensure accurate and up-to-date labeling is always available and accessible for global submissions and inspection readiness. 

• Contribute to the review and approval of artwork supporting global submissions. 

• Implement and maintain a quality control measure during all stages of label development. 

• Maintain knowledgebase of current global rules, regulations, and relevant guidance (draft or final) governing drugs and biologics in all phases of development, as well as knowledge of therapeutic area(s).   

• Initiate or contribute to local and/or global process and/or system improvements which have a significant impact on business. 

Requirements:

• Minimum BA/BS degree in life sciences. Advanced degree preferred. 

• Strong scientific background with 8 years’ experience in the biotechnology and/or pharmaceutical industry including at least 4+ years in a global regulatory/labeling position. 

• Excellent attention to detail with solid coordinating, task planning and time management skills. 

• Excellent verbal, written and interpersonal communication skills. 

• Ability to work independently and in a team environment, with strong leadership, negotiation and influencing ability. 

• Strategic thinker and problem-solver capable of providing advice, identifying risks, decision making in a collaborative way, and implementing plans and risk mitigation strategies. 

• Thorough understanding of global drug development regulations and guidelines. 
• Willingness to work in a dynamic, fast paced and changing corporate environment where roles and responsibilities are not well defined. 

#LI-CS1 #LI-Remote

About The Team:

At Archer, we are designing the future of flight. From unveiling our production aircraft, Midnight, to launching a defense-focused division in late 2024, our mission is to revolutionize urban air mobility and defense applications globally. We are a lean, fast-paced team that thrives on technical innovation, a "safety-first" culture, and a commitment to commercializing electric vertical take-off and landing (eVTOL) technology in the world’s busiest cities.

Our Government Affairs team is the bridge between Archer’s cutting-edge engineering and the federal policy landscape. We manage critical agency relationships across the DOT, FAA, and the White House. Our team ensures Archer remains at the forefront of the regulatory conversations that will define the next century of aviation.

What You’ll Do:

Archer is seeking a Federal Affairs Lead to serve as a key liaison on Capitol Hill. Based in Washington, D.C., you will be the "boots on the ground" responsible for navigating the complexities of the federal legislative environment. This is a junior to mid-level role designed for a self-starter who thrives in a high-autonomy environment—specifically our D.C. hub—and can navigate fast-paced environments.

You will report to Archer's Head of Government Affairs to ensure Archer’s mission is understood and supported by key policymakers.

• Shape the Future of Flight: Execute a high-impact federal strategy to architect the policy frameworks that will define the next century of Advanced Air Mobility.
• Champion Archer’s Mission: Build and cultivate influential partnerships across Capitol Hill, federal agencies, and industry associations to champion Archer’s vision and strategic priorities.
• Drive Strategic Intelligence: Act as the internal pulse on Washington, translating complex regulatory and policy shifts into actionable insights that steer our global business strategy.
• Be the Voice of Innovation: Represent Archer as a thought leader at premier D.C. events and member organizations, ensuring our voice is at the center of the conversation shaping the AAM industry.
• Craft Compelling Narratives: Develop high-stakes briefings and advocacy materials that simplify complex technologies into powerful, persuasive narratives for the nation’s top policymakers.
• Collaborate for Impact: Partner with internal innovators to bridge the gap between policy and technology, fostering a nimble, results-driven environment that moves at the speed of flight.

What You Need:

• Proven Track Record: 3+ years of impact within policy, regulatory, or government affairs—ideally forged on Capitol Hill—paired with a degree in Public Policy, Political Science, or a related field.
• Sector Sophistication: Familiarity with the federal landscape, specifically within transportation, aerospace, or emerging technology policy.
• Master Communicator: An exceptional ability to translate complex, cutting-edge technical concepts into clear, persuasive narratives for diverse, non-technical audiences.
• Relationship Architect: A natural at building and sustaining high-trust partnerships with Congressional staff, agency stakeholders, and key advocacy organizations.
• Analytical Rigor: A sharp eye for detail, with the ability to dissect complex policy documents and distill them into high-level, actionable business intelligence.
• Industry Edge: Prior exposure to Advanced Air Mobility (AAM) or aviation concepts is a significant advantage, but a passion for disrupting the status quo is a must.

Bonus Qualifications:

• Strategic thinker with a bias for action and results
• Comfortable balancing multiple priorities in a fast-paced environment
• Collaborative team player who thrives across time zones with diverse stakeholders

Please note that this job description is intended to provide a general overview of the position and does not include an exhaustive list of responsibilities and qualifications.

At Archer we aim to attract, retain, and motivate talent that possess the skills and leadership necessary to grow our business. We drive a pay-for-performance culture and reward performance that supports the Company’s business strategy. For this position we are targeting a base pay between $115,000 - $154,000. Actual compensation offered will be determined by factors such as job-related knowledge, skills, and experience.

Archer is committed to working with and providing reasonable accommodations to job applicants with physical or mental disabilities, and those with sincerely held religious beliefs. Applicants who may require reasonable accommodation for any part of the application or hiring process should provide their name and contact information to Archer’s People Team at people@archer.com. Reasonable accommodations will be determined on a case-by-case basis.

Who we are

Neros is a defense technology company rebuilding America’s drone industrial base. We design and manufacture high-performance unmanned systems that are tested in combat, iterated at startup speed, and built at massive scale. Our team culture is fast, hands-on, and obsessed with closing the gap between design and deployment.

As drones transform the character of warfare, Neros is delivering the systems the West needs to compete on the modern battlefield and deter the adversaries of democracy. We’re hiring engineers, operators, and builders who want to move fast, take on extreme ownership, and get capability into the hands of warfighters in months, not years.

What you will be doing

As the Government Affairs Associate, you would be responsible for assisting the Government team in navigating the complex budgetary, regulatory, and policy landscape that affects the company's operations and vision. This position will support identifying and providing analysis to leadership on the federal budget process. Additionally, the Government Affairs Associate should leverage existing relationships within the different branches of government. This position will have ownership of compliance related operations of the Neros PAC.

You should have the following

• 3+ years experience in monitoring federal strategy, or related fields
• Experience working in high-intensity environments
• Ability to work closely with leadership in rapid iteration cycles
• Exceptional communication skills with military and civilian stakeholders
• Knowledge of the U.S. defense ecosystem, including DoD procurement, Congressional appropriations, and national security policy
• Ability to translate complex technical issues into compelling policy narratives
• Understanding of Political Action Committees

Nice to have

• Prior government or military experience
• Proven track record monitoring DoD contracts
• Active TS/SCI clearance, or ability to obtain one
• Experience engaging with the government or military stakeholders

US Salary Range

$80,000 - $130,000 USD

The salary range for this role is an estimate based on a wide range of compensation factors, inclusive of base salary only. Actual salary may vary based on (but not limited to) work experience, education and/or training, critical skills, and/or business considerations. Highly competitive equity grants are considered part of Neros' total compensation package.

We’re an equal opportunity employer. We welcome all applicants without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

Position Summary:

ultradedicated – Your biggest challenges yield rare possibilities

Ultragenyx is seeking a dynamic and experienced physician to join the Gene Therapy Treatment Team. The physician will play a key medical affairs leadership role within the gene therapy portfolio, initially focused on GSDIa and MPS IIIA, where the company is in position to launch two gene therapies this year. This position will be instrumental in providing clinical and scientific education to gene therapy treating centers to ensure that patients receive their one-time therapy in the most effective manner and achieve their optimal therapeutic outcome.  

Reporting to the VP Global Medical Expert – Gene Therapies, the Executive Director is a senior medical affairs leader responsible for ensuring scientifically rigorous, compliant, and effective implementation of one-time gene therapies. The Executive Director will work closely with Medical Science Liaisons in the high-profile and innovative Gene Therapy Treatment Team through a largely externally facing role. The Executive Director also partners closely with Medical Affairs, Clinical Development, Regulatory, and Commercial leadership to enable successful launch and post launch adoption, while shaping external scientific dialogue around safety, durability, immunomodulation, and patient outcomes.   

The role requires extensive peer-to-peer interactions with external physicians providing gene therapy treatment in the commercial setting. The successful candidate will be comfortable working in a fast-paced intellectual environment, understand patient care including immunomodulation, and is able to work at the interface between clinical development and medical affairs leveraging their expertise to advance our mission to change the future of rare disease medicine. 

Work Model: 

Remote: Officially documented as working full-time from home, with travel to Ultragenyx's offices or other locations on occasion as needed.

Responsibilities:

• Serve as a senior external medical leader for Ultragenyx gene therapies, leading compliant complex, scientific discussions with treating physicians  

• Enable successful implementation of gene therapies globally both within Ultragenyx and with external medical experts 

• Respond to inquiries and questions from treating sites with appropriate level of urgency 

• Lead the strategic and scientific requirements for educational materials and lead the delivery of training for the gene therapy treatment centers to ensure those centers are well prepared to manage patients throughout their gene therapy treatment journey 

• Provide expertise and contribute as needed to protocol development, steering committee meetings, data generation initiatives of Disease Monitoring Programs, and life-cycle management for label/indication expansion 

• Advise on strategic development of publications and medical materials that enable external medical engagement and address evidence gaps to inform clinical decision making 

• Work in partnership with VP, GME – Gene Therapies to develop and implement the global Gene Therapies Treatment Team Framework  

• Mentor and develop Global Medical Expert physicians and MSLs, helping build a scalable, high‑performing medical organization to support current and future gene therapy launches 

• Provide expertise and contribute as needed to key regulatory agency communications, including filings and information request responses 

• Represent Ultragenyx at key scientific and external stakeholder meetings to advance awareness and deep understanding of our science and therapies 

• As an expert, lead the education and training of Ultragenyx internal teams  

• Stay abreast of internal and external developments, trends and dynamics and provide direction for strategic implications to the development and commercialization of gene therapy  

Requirements:

• Medical Doctor (MD required, MD plus PhD preferred) with Board Certification (or equivalent) in Clinical Immunology, Clinical/Biochemical Genetics, Rheumatology or Neurology (required) 

• Academic/Faculty experience (+7 years) with a track record of high-quality publications   

• Pharmaceutical experience in drug development and clinical trials or Medical Affairs (+7 years) 

• Experience in the management of patients receiving systemic AAV gene therapy in the clinical trial and/or post FDA approval setting  

• Demonstrated ability to prioritize and lead complex post‑approval gene therapy activities, applying sound scientific judgment while enabling cross‑functional decision‑making 

• Demonstrated ability to lead through ambiguity and make strategic medical decisions in first‑ or best‑in‑class therapeutic settings 

• Availability for some out-of-hours work is an expectation 

• Demonstrated success working in a cross functional or multidisciplinary setting is essential 

• An established broad network of key experts and leaders within the rare disease community  
• Travel: 25-50% but may reduce with time as launches progress and team grows   

#LI-CS1 #LI-Remote

Join The Simtra Talent Community

Are you passionate about making an impact in the Contract Development and Manufacturing Organization (CDMO) industry? Even if you don’t see a current role that matches your skills and interests, we’d love to stay connected with you!

By joining our Talent Community, you'll be the first to know about exciting new opportunities across a wide range of roles within the CDMO industry, including areas like:

• Research and Development: Contribute to innovative solutions that drive progress.
• Manufacturing and Operations: Ensure high-quality production and efficiency.
• Quality Assurance and Regulatory Affairs: Maintain excellence and compliance.
• Project Management: Lead transformative projects from concept to completion.
• Business Development: Drive growth and foster meaningful partnerships.

As a valued member of our Talent Community, you'll receive:

• Early notifications of new job openings in the CDMO sector.
• Updates on company news and advancements.
• Exclusive insights into what it’s like to work with us.

We’re always looking for talented individuals who are eager to make a difference. Take the first step—join our Talent Community today—and let’s shape the future of the CDMO industry together!

Job Title: Associate Director, CMC Lead, Late-Stage Biologics      

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

Role Overview: The Associate Director of CMC Leadership will provide technical and strategic leadership for late-stage CMC activities supporting the development, characterization, validation, licensure application, commercial readiness, and lifecycle management of biologics manufacturing process, with a focus on monoclonal antibodies. This role is a critical addition to our growing organization and is highly visible within the CMC team and across other functions. Serving as a matrix leader, this role will work closely with the CMC function leads in drug substance, drug product, analytical, and clinical supply chain. This role will also partner closely with Program Management, Quality, Regulatory Affairs, CDMOs, and consultants.

The ideal candidate is an established technical and matrix leader with hands-on technical experience in biologics process development and manufacturing support, and proven track record in leading cross-functional teams to achieve complex technical and regulatory milestones and bring late-stage biologics therapeutics to commercialization.

Key Responsibilities: 

• Oversee technical operations and lead strategy discussions for late-stage CMC activities including process characterization, PPQ, licensure application, regulatory inspection, and lifecycle management of monoclonal antibody therapeutics.
• Work with internal and CDMO CMC teams to ensure timely delivery of PC & PPQ protocols and reports, in-process-control documents, process validation master plan, and BLA Module 3 sections.
• Lead CMC meetings and ensure drug substance, drug product, analytical, clinical supply chain, quality, program management, and regulatory affairs teams are aligned with overall CMC and program strategy.
• Maintain an effective action tracker for internal and external CMC deliverables. Adapt to changing priorities to ensure corporate CMC objectives are at the forefront.
• Facilitate problem solving, action planning, and decision making within the CMC team while keeping program level stakeholders informed at regular intervals.
• Foster a strong relationship with CDMOs and consultants. Ensure the external partners are fully aligned on Oruka strategy and goals.
• Liaise with internal and external stakeholders to support timely completion of technical. documents, batch records, campaign readiness, lot release, campaign reports, change controls, deviation investigations, and CAPAs.
• Partner with CDMO counterparts to oversee all CMC service, ensuring high quality work, timely delivery, and efficient meetings.
• Collaborate with manufacturing and clinical supply chain stakeholders to ensure robust clinical supply and distribution plans.
• Drive preparation and presentation of CMC content for internal and external meetings, facilitate cross-functional offsite workshops, and help organize business review meetings with CDMOs
• Support the diligence process and contract negotiation with new CDMOs and consultants.
• Work with program managers and Finance to track budgets, contracts, and change orders.
• 20-25% travel in support of diligence process, strategy discussion meetings, and activity supervision at CDMOs.

Qualifications:

• Master’s or PhD in relevant disciplines with 10+ (MS) or 7+ (PhD) years of experience in biologics CMC functions including upstream, downstream, analytical, and drug product.
• Must have experience leading late- and commercial-stage CMC activities including process characterization, PPQ, BLA, regulatory inspections, life cycle management, and post approval submissions.
• Prior matrix leadership experience is highly preferrable. Have led cross-functional CMC teams to drive strategy alignment on risk mitigation, resource planning, process validation, regulatory filing, and post approval changes.
• Experience with pre-filled syringe and/or auto-injector is a plus.
• Strong program management skills with operational experience in tracking multiple activities, deliverables, timelines, contracts and budgets.
• In-depth knowledge of CMC quality and regulatory requirements in support of global regulatory filings
• Experience with managing CDMOs. Demonstrated track record of successful tech transfers to commercial CDMOs
• Excellent writing, organization, communication and people management skills with the ability to work effectively with a diverse group of internal and external stakeholders
• Strong sense of urgency and ability to direct the CMC team towards their deliverables in a highly fast paced environment

Compensation:

• An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.
• The anticipated salary range for candidates, who will work in Waltham, MA -OR-remotely, is $182,000 to $208,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Oruka is a multi-state employer and this salary range may not reflect positions that work in other states.

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

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

Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation medicines, the next frontier in innovative drug design aimed at improving treatment options for patients with cancer and inflammatory diseases. Powered by a fully AI-integrated discovery engine capable of tackling any protein class, and coupled with unparalleled ligase expertise, Nurix’s dedicated team has built a formidable advantage in translating the science of targeted protein degradation into clinical advancements. Nurix aims to establish degrader-based treatments at the forefront of patient care, writing medicine’s next chapter with a new script to outmatch disease.

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

Responsibilities:

• Develop and implement competitive and effective global clinical & nonclinical regulatory strategies for various immunology and inflammation indications and identify potential risks and mitigation strategies associated with proposed strategies
• Work in close collaboration with the SVP, Head of Regulatory Affairs and the development team leader and other cross-functional colleagues, including CROs to deliver sound, efficient development strategies and operational plans
• Represent Regulatory Affairs on assigned cross-functional development teams.
• Lead and manage the development and preparation of high-quality global submissions (including IND, CTAs, NDAs, and MAAs) for early and late-stage programs in collaboration with the regulatory and project teams to support and accelerate clinical development and regulatory approval, as applicable
• Lead communication with global Health Authorities (HA), such as FDA and EMA, including, planning and preparing for formal meetings with regulatory agencies and interpreting HA feedback from these interactions.
• Develops and executes, or oversees global regulatory strategy for long-term planning, including the potential to accommodate expedited development needs
• Anticipate issues and guide cross-functional teams on risk mitigation strategies for any development challenges Provides insight and guidance on the implementation of current regulations and assesses regulatory risk based on precedence
• Ensure adherence to current regulations associated with regulatory activities
• Works strategically with all regulatory functions to develop detailed, actionable submission plans, tracks major submission deliverables, and ensures consistent management submission documents, health authority communications, and all other regulatory information supporting Nurix’s investigational and marketing applications
• Plays an essential part in defining requirements for, implementing, and supporting future systems and tools to be employed by Nurix in the areas of document management, submission content planning, and regulatory information management
• Tracks the status of major deliverables for regulatory submissions (e.g., study reports, summary documents, labeling) along with their dependencies
• Develops and maintains submission plan templates to ensure Nurix regulatory submissions are consistently planned and executed across programs
• Participates in cross-functional process initiatives impacting regulatory submission processes and systems
• Manages consultants and contractors as needed

Requirements

• Bachelor's degree in life-sciences or related scientific discipline; advanced degree preferred Manager:
• Must have minimum of 12 years in Regulatory affairs strategy with significant experience in the immunology and inflammation therapeutic area
• Strong demonstration of knowledge of drug development, FDA, EMA and ICH guidelines and regulations
• Experience providing hands-on support for planning clinical trial and marketing applications to health authorities including but not limited to FDA, EMA
• Proven track record of supporting Regulatory affairs in the planning and execution of major filings and ongoing maintenance of clinical trial and marketing applications
• Strong project management and critical thinking skills
• Experience applying project management techniques and tools (e.g., MS Project, Smartsheet, Excel trackers) to the planning and execution of regulatory submissions
• Excellent organizational and communication skills, both written and verbal
• Ability to work independently as well as part of a team environment
• Positive attitude, energetic and proactive
• Proven ability to manage multiple projects, identify and resolve regulatory issues
• Strong interpersonal skills and the ability to effectively work with others

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

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

What you’ll own:

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

What success looks like:

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

What you bring:

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

Where you’ll live:

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

Job Title: QA/RA Consultant
Employment Status: Full-time
Office Hours: Monday - Friday; hybrid schedule
Location: Boston, Massachusetts
Compensation: $130,000 - $150,000, plus equity options. (Compensation dependent on experience level)

As a Ketryx QA/RA Consultant, you will lead quality management system implementations and regulatory compliance strategies for cutting-edge medical device clients as we scale our AI-powered compliance platform. This is a rare opportunity to shape the future of regulatory affairs. You'll have the autonomy and expertise to drive repeatable QMS deployment processes while helping shape the future of regulatory affairs through innovative technology and enabling the success of the world’s most innovative companies. We offer the opportunity to work with high-growth clients, establishing best-in-class quality systems from the ground up using our revolutionary AI platform.

Our ideal candidate will have demonstrated success in quality systems management with 5-8 years of experience in the medical device industry. Someone who is strategic yet hands-on, passionate about regulatory excellence, and eager to leverage cutting-edge AI technology will thrive in this position. In this role, you'll have the opportunity to directly impact our mission to improve 100 million patient lives by 2030 by ensuring the highest quality standards for life-saving medical devices.

This position will be based in our Boston, Massachusetts office with a hybrid schedule (Monday, Tuesday, Thursday, Friday in office, Wednesday WFH option). Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of employment Visas (including H-1B), F-1 visas, or Optional Practical Training (OPT) status at this time.

About You:

You're a proven QMS expert who's successfully navigated complex medical device regulatory landscapes and is ready to scale your impact through innovative technology. You've built or significantly improved quality systems at medical device companies, consulting firms, or high-growth startups, and you're excited to combine your regulatory expertise with AI-powered tools to create something category-defining.

Responsibilities:

• Lead Quality Management System (QMS) setup and deployment for medical device clients.
• Own and manage QMS templates and regulatory compliance frameworks.
• Provide expert consulting on ISO 13485, MDSAP, GxP, and other quality systems standards.
• Scale operations to support high-growth clients.
• Develop repeatable QMS deployment processes leveraging AI platform capabilities and automatic compliance.
• Shape the future of regulatory affairs through innovative product development.
• Work independently on complex quality assurance projects requiring minimal oversight.
• Ensure customer success across the entire customer engagement lifecycle.

Required Skills:

• 4-8 years of experience in quality systems management, management representative or senior specialist role.
• Familiar with eQMS implementation, validation and implementation.
• Deep expertise in Quality Management System setup, sub-systems, and implementation.
• Strong knowledge of ISO 13485 and Global QMS requirements.
• Expertise in AI, Digital, and Cyber Compliance.
• Deep understanding of medical device cybersecurity.
• Experience as quality management representative in regulated environments.
• Experience with regulatory and Notified Body submission requirements.
• Background in medical device industry quality systems.
• Ability to work independently and own complex regulatory projects.
• Proven track record in consulting or client-facing roles.

Preferred Skills:

• Experience at large medical device companies (Stryker, Medtronic, Boston Scientific).
• Background with consulting firms specializing in QMS setup.
• Startup experience (Series A/B) with QMS implementation.
• Specializations in cybersecurity, usability, or computer software validation.
• Experience scaling quality operations in high-growth environments.
• Knowledge of AI applications in regulatory affairs.
• Submission experience.
• Experience working in an early stage, product-based start up.

Keywords: ISO 13485, MDSAP, Quality Management System (QMS), Management representative, Medical device quality, Stryker, Medtronic, Boston Scientific, QMS setup, Regulatory consulting, Quality systems manager, Computer software validation, Cybersecurity, Usability, Startup experience, Series A/B, Boston/Massachusetts, Consulting firms, Quality assurance, Medical device industry

Job Title: Delivery and Success Manager 
Employment Status: Full-time
Office Hours: Monday - Friday; 4:1 hybrid schedule
Location: Boston, Massachusetts
Compensation: $90,000 - $115,000 base + variable + equity options
*compensation may be negotiated based on experience level

About Ketryx:

Ketryx is an AI software platform that enables healthcare life sciences companies to ship life-saving regulated products in weeks instead of years.

Exploding product complexity is burying companies in compliance paperwork and blocking innovation. Our AI software removes this friction, dissolving the historical tradeoff between innovation and compliance, and enables regulated industries to innovate at the pace of modern software.

Just two years since launch, Ketryx already touches the lives of 25M patients and powers 3 of the world’s top 5 MedTech companies and 25% of the Fortune 500 MedTech market. Backed by Lightspeed Ventures, our founders are the former Head of AI at Amgen and CTO of Wolfram Cloud.

Healthcare and life sciences is just the beginning for us. Automotive, aerospace, energy — if it’s regulated, it’s because society decided it matters. These products move humanity, shape our future, and are safety-critical. Come join us and help build the AI platform to power safe innovation.

The Role

As a Delivery and Success Manager at Ketryx, you will lead strategic client engagements, guiding enterprise MedTech companies through onboarding and implementation. You’ll act as a trusted advisor, collaborating with regulatory and solutions experts to solve complex technical challenges and drive measurable business value.

This role is ideal for a self-starter who thrives in a fast-paced, high-growth environment and wants to make a direct impact on both clients and patient safety. You’ll have the autonomy to shape outcomes and grow your career as Ketryx continues to scale.

Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of employment Visas (including H-1B), F-1 visas, or Optional Practical Training (OPT) status at this time.

Responsibilities

Client Leadership

• Lead key client relationships from onboarding to long-term partnership and success.
• Work as part of a team of SMEs, account managers, and consultative experts to deliver value across technical and regulatory domains.
• Act as a trusted advisor using strong consultative skills to identify challenges and drive measurable outcomes.
• Partner directly with customer stakeholders to facilitate strategic discussions, drive decision-making, and ensure alignment.
• Conduct onsite sessions to understand client workflows, process bottlenecks, and critical questions, mapping opportunities to optimize operations through Ketryx.

Implementation Excellence

• Manage multiple client portfolios, balancing priorities and deadlines.
• Partner with Engineering, Product, and Quality to align client needs with product evolution.
• Lead process improvements that enhance scalability, efficiency, and team performance.
• Facilitate workshops and training sessions to ensure the product meets user needs and drives tangible operational results.

Technical & Quality Expertise

• Collaborate closely with Quality SMEs and Solution Architects to implement tailored configurations and ensure clients meet both technical and regulatory requirements.
• Develop deep expertise in the Ketryx platform and regulated development workflows.
• Guide clients on platform configuration, documentation, and compliance practices.

Team Leadership & Culture

• Build and mentor high-performing teams.
• Foster a high-trust, accountable, and collaborative culture.

Required Skills

• 5–10 years in client-facing or operational leadership roles in SaaS, MedTech, or regulated industries.
• Experience leading cross-functional teams and managing complex portfolios.
• Familiarity with safety-critical or compliance-driven environments.
• Experience managing full implementation lifecycle: project planning, requirements gathering, migration, configuration, validation, go-live.
• Understanding of quality systems and regulatory frameworks (ISO 13485, ISO 14971, IEC 62304, 21 CFR Part 820).
• Technical fluency with software and quality processes.
• Outstanding communication and presentation skills with a demonstrated track record of influencing effectively at all levels of the organization.
• Ability to drive effective and influencing conversations at the program level; facilitate difficult discussions and be adept at handling objections.
• Ability to facilitate complex discussions, handle objections, and drive consensus.
• Bachelor’s degree in engineering, life sciences, or related field, or equivalent experience.

Preferred Skills

• Experience in customer success, professional services, or product operations in B2B SaaS.
• Background in quality, regulatory affairs, or systems engineering.
• Familiarity with Software as a Medical Device (SaMD).
• Experience working in an early stage, product-based start up.

Keywords: customer success, professional services, systems engineer, Solutions Architect, Software as a Medical Device, SaMD, product management, technology, client management, quality, regulatory, system engineer, B2B

Job Title: Delivery and Success Associate - Enterprise
Employment Status: Full-time
Office Hours: Monday - Friday; hybrid schedule
Location: Boston, Massachusetts
Compensation: $62,000 - $75,000 base + variable + equity options
*compensation may be negotiated based on experience level

About Ketryx:

Ketryx is an AI software platform that enables healthcare life sciences companies to ship life-saving regulated products in weeks instead of years.

Exploding product complexity is burying companies in compliance paperwork and blocking innovation. Our AI software removes this friction, dissolving the historical tradeoff between innovation and compliance, and enables regulated industries to innovate at the pace of modern software.

Just two years since launch, Ketryx already touches the lives of 25M patients and powers 3 of the world’s top 5 MedTech companies and 25% of the Fortune 500 MedTech market. Backed by Lightspeed Ventures, our founders are the former Head of AI at Amgen and CTO of Wolfram Cloud.

Healthcare and life sciences is just the beginning for us. Automotive, aerospace, energy — if it’s regulated, it’s because society decided it matters. These products move humanity, shape our future, and are safety-critical. Come join us and help build the AI platform to power safe innovation.

The role

As a Delivery and Success Associate - Enterprise, you’ll work closely with customers who rely on Ketryx to manage safety‑critical and regulated development processes. This is a technical, engineering‑adjacent role.

You’ll support customers from onboarding through long‑term partnership, helping configure the Ketryx platform, supporting requirements and quality workflows, and applying structured problem solving to real challenges. You’ll develop a deep understanding of how regulated teams build, verify, and validate software.

This is an excellent opportunity for early‑career engineers or technically trained professionals who want exposure to regulated industries, verification & validation practices, and customer‑facing technical work, while growing alongside a mission‑driven team.

About you

You bring an engineering mindset to your work. You like understanding how systems fit together, why processes exist, and how to improve them. You’re comfortable learning complex concepts and applying structure and logic to ambiguous problems.

You’re excited by the opportunity to work close to engineering, quality, and regulated product development, while also collaborating directly with customers.

You’re curious, detail‑oriented, and motivated by meaningful work that has real‑world impact.

Responsibilities 

• Support Customer Success: Partner with clients during onboarding and ongoing use of the Ketryx platform, helping them apply best practices for requirements, verification, and quality workflows.
• Configure and Support the Platform: Assist with configuring Ketryx to align with customer development processes, including requirements traceability, documentation workflows, and validation artifacts.
• Apply Engineering & Quality Thinking: Help customers reason through leaving evidence, verification activities, and structured development processes commonly used in regulated and safety‑critical environments.
• Troubleshoot and Problem‑Solve: Investigate technical and workflow challenges, escalate thoughtfully when needed, and follow through to resolution.
• Collaborate Cross‑Functionally: Share customer insights with Product, Engineering, and Quality teams to help improve the platform and internal processes.
• Support Quality & Compliance Efforts: Contribute to accurate, well‑structured documentation within the Quality Management System (QMS) and reinforce strong process discipline.
• Grow Your Technical Skill Set: Build fluency in regulated software development concepts such as requirements management, verification & validation (V&V), and the V‑model.

Required Skills

• Technical or Engineering Background: Bachelor’s degree in engineering, computer science, or a related technical field (or equivalent hands‑on technical experience).
• Exposure to Structured Development: Familiarity with concepts such as requirements, verification & validation, testing, systems engineering, or the V‑model (academic or professional exposure is sufficient).
• Interest in Regulated Industries: Curiosity about or comfort working in regulated, safety‑critical environments (medical devices, biotech, pharma, aerospace, automotive, etc.). Prior regulated experience is a plus, not a requirement.
• Technical Communication Skills: Ability to understand and explain technical concepts clearly, both verbally and in writing.
• Analytical Problem‑Solving: Comfort troubleshooting issues, asking good questions, and reasoning through complex workflows.
• Collaborative Mindset: Enjoys working across teams and building trusted relationships with customers and teammates.

Preferred Skills

• Experience in customer success, professional services, or product operations in B2B SaaS.
• Background in quality, regulatory affairs, or systems engineering.
• Familiarity with Software as a Medical Device (SaMD).
• Experience working in an early stage, product-based start up.

Keywords: customer success, client operations, delivery and success, professional services, systems engineer, Solutions Architect, Software as a Medical Device, SaMD, product management, technology, client management, quality, regulatory, system engineer, B2B, regulation, task management, project management, Greater Boston, MA, SQL, KQL, python, java

Job Summary: The Government Affairs Associate will support the Chief of Staff and Head of Government Affairs in managing domestic and international external relations with government entities, tracking policy developments, and coordinating advocacy efforts. This role focuses on maintaining trade associations, regulatory monitoring across global jurisdictions, reporting dashboards, and interfacing with key stakeholders to advance the organization's interests in legislative and regulatory matters worldwide.

Key Responsibilities:

• Manage trade association memberships and participation, including renewals, event coordination, and representation on behalf of the organization at both domestic and international levels.
• Track regulatory and legislative developments at federal, state, local, and international levels, providing timely summaries and impact assessments to leadership.
• Coordinate lobbyist activities and deliverables, ensuring alignment with organizational goals and monitoring progress on domestic and international advocacy initiatives.
• Interface with legal and compliance teams to align government affairs strategies with internal policies and risk management, including global regulatory compliance.
• Support congressional, agency, and international engagements (e.g., with foreign governments or multilateral organizations), including preparing briefing materials, scheduling meetings, and following up on action items.
• Collaborate with cross-functional teams to gather inputs on policy positions, report global policy risks to executive leadership, and contribute to enterprise-wide risk monitoring.
• Assist in ad-hoc tasks such as policy research, stakeholder mapping, or supporting global policy strategies, as needed.

Qualifications:

• Bachelor's degree in Political Science, Public Policy, International Relations, or a related field.
• 3–5 years of experience in government affairs, public policy, advocacy, or related roles, preferably in a corporate or association setting with international exposure.
• Strong knowledge of domestic and international regulatory and legislative processes, with experience tracking global developments and building relationships with stakeholders.
• Excellent research, analytical, and organizational skills with attention to detail.
• Superior communication abilities for interfacing with internal teams, lobbyists, and external officials across cultures and time zones.
• Preferred: Experience in trade associations, lobbying coordination, international policy, or certifications in public policy (e.g., relevant professional associations).

Summary:

Vaxcyte is seeking a Director, Health Economics & Outcomes Research (HEOR) to establish and lead the company’s health economic strategy across the vaccine lifecycle, with initial focus on adult pneumococcal programs. This strategic leadership role will be responsible for developing and executing global health economic models to support payer value propositions, immunization policy engagement, reimbursement strategy, and external stakeholder communications.

This role will focus specifically on health economic modeling and payer value strategy. Observational real-world evidence and epidemiology studies will be led by the Epidemiology & Real-World Evidence function. The Director, HEOR will work in close collaboration with RWE and Epidemiology colleagues to ensure economic models are grounded in robust disease burden, vaccine effectiveness, and coverage assumptions.

As Vaxcyte advances toward commercialization, this role will partner closely with Market Access colleagues, who will lead pricing and contracting strategy. The Director, HEOR will provide the analytic foundation and economic evidence required to inform pricing strategy, payer engagement, and health technology assessment discussions.

Essential Functions:

Health Economic Strategy & Leadership

• Develop and lead Vaxcyte’s HEOR strategy across early development, launch planning, and lifecycle management.
• Define the economic evidence generation plan required to support payer access and policy recommendations.
• Ensure health economic considerations are incorporated early into development planning.

Health Economic Modeling

• Lead development of cost-effectiveness, budget impact, and population health models for adult and pediatric vaccine programs.
• Design and oversee decision-analytic models (e.g., Markov models, microsimulation models, dynamic transmission models as appropriate).
• Establish modeling assumptions grounded in epidemiologic, clinical, and real-world data.
• Ensure all models are scientifically rigorous, transparent, and defensible in policy and payer environments.

Value Communication & Policy Support

• Translate health economic findings into clear, compelling value narratives for internal leadership and external stakeholders.
• Support development of global value dossiers, AMCP dossiers, and materials for payer engagement.
• Contribute to peer-reviewed publications and scientific congress presentations.

Cross-Functional Partnership

• Partner closely with Epidemiology & RWE to integrate disease burden and vaccine effectiveness assumptions into economic models.
• Collaborate with Clinical Development, Regulatory, Medical Affairs, and Market Access teams to align value strategy.
• Support consistent, aligned value messaging across stakeholders.

Capability Building

• Establish best practices and governance processes for health economic modeling.
• Build and manage external modeling partnerships.
• Mentor future HEOR team members as the function expands.

Requirements: 

PhD in Health Economics, Health Services Research, Public Health, Epidemiology, or related quantitative field with 8+ years of relevant industry experience required OR Master’s degree (e.g., MPH, MSc, MBA) with 12+ years of relevant industry experience in health economic modeling.

• Demonstrated experience leading cost-effectiveness and budget impact models.
• Deep expertise in decision-analytic modeling methodologies.
• Experience supporting payer submissions or health technology assessments.
• Strong cross-functional leadership and communication skills.

Summary:

The Quality Control Operations function is an executive role within a matrixed global vaccine organization, responsible for the implementation of Vaxcyte analytical strategies at our CDMO’s and CRO’s. This role is the single point of contact for our CDMO’s and CRO’s to ensure they deliver the quality, accuracy, and compliance of testing and analytical services.  Working closely with the analytical technical lead and other functions within Analytics, Process Development, Analytical and Manufacturing Science and Technology, Quality Assurance, Manufacturing, and Regulatory Affairs, this role provides leadership and oversight for implementation of analytical strategies at the CDMO / external lab supporting analytical readiness and deliverables. The role is accountable that testing and release at our CDMO & CRO is performed in a timely and compliant manner to ensure secure and uninterrupted supply of Vaxcyte’s innovative therapies.

Essential Functions:

• Implement and maintain analytical strategies for process-related, release and stability testing for our programs at our CDMO/contract labs and ensure they are aligned with the CDMO's goals and objectives as well as comply with relevant regulations and industry standards.
• Implement, and maintain robust quality control systems that encompass sampling, testing, documentation, and release procedures.
• Ensure on-time performance for QC testing at our CDMO’s or contract laboratories related to raw materials, intermediates, and drug substance.
• Ensure that contracted QC laboratories are equipped with appropriate instrumentation and equipment, maintained according to regulatory requirements, and calibrated regularly to ensure accuracy and reliability of test results.
• In partnership with analytical technical lead and analytical science and technology as well as the contract laboratories, oversee method validation and transfer activities between contract laboratories.
• Assure that appropriate systems for data management, including secure storage, retrieval, and retention of QC data and documentation are in place. Ensure that all testing activities are well-documented and comply with Good Documentation Practices (GDP).
• Review and approval of analytical data, test reports, and certificates of analysis (CoAs) generated by contract laboratories to verify accuracy, completeness, and compliance with specifications for both release and stability testing.
• Lead and support investigations and deviations, out-of-specification (OOS), out-of-trend (OOT), out-of-expectation (OOE) results, laboratory incidents, and customer complaints related to contract laboratory testing, collaborating with contract laboratories and internal stakeholders to implement corrective and preventive actions (CAPAs).
• Provide technical support for product related regulatory documents and inspections by Health Authorities.
• Writing, review and approval of documents related to Quality Control to ensure compliance with applicable regulatory and industry standards.

Requirements: 

Bachelor of Science with 10+ years of relevant experience in the biotechnology/pharmaceutical industry specifically in Quality Control. Other combinations of education and/or experience may be considered.

• Experience in Pneumococcal vaccines is a plus.
• Excellent experience in managing CDMOs and/or contract laboratories.
• Comprehensive knowledge in cGMP and experience in multi-national regulations.
• Excellent communication, negotiation, and relationship-building skills, with the ability to collaborate effectively with internal and external stakeholders.
• Strong analytical and problem-solving abilities, with a focus on data-driven decision-making and continuous improvement.
• Strong teamwork and interpersonal skills.
• Relentless focus and passion around process improvements (efficiency and automation).
• Experience with digital tools for data management, document review workflows.
• Level of Supervision: General Supervision
• The role will perform a variety of routine work within established policies and procedures. It is expected that the role receives rather high-level project information instead of detailed instructions on a weekly basis and general instructions on new projects and assignments.

Summary:

We are seeking a Vice President of Marketing to lead our marketing strategy as we prepare to become a U.S. commercial vaccine company within the next 18 months. This role is critical to shaping our U.S. launch, building the marketing foundation for a first commercial product, and positioning the company for future global expansion.

The ideal candidate brings deep vaccine marketing experience, a strong understanding of the U.S. immunization landscape, and a proven track record of leading pre-launch and launch activities in a highly regulated environment. This leader will balance strategic vision with hands-on execution, building capabilities, teams, and processes appropriate for a first commercial launch. This individual should have demonstrated experience driving commercial demand across target audiences—including healthcare providers, consumers/patients, payers, and public health stakeholders—with a particular emphasis on consumer engagement strategies that build disease awareness and motivate vaccination behavior.

Essential Functions:

U.S. Launch & Commercial Strategy

• Lead the development and execution of the U.S. marketing strategy for our initial vaccine launch, including disease awareness, brand positioning, and go-to-market planning.
• Develop differentiated value propositions grounded in clinical data, public health impact, and real-world evidence.
• Partner closely with the Chief Commercial Officer to align marketing strategy with overall commercial, sales, and market access plans.

Vaccine & Immunization Expertise

• Apply deep understanding of the U.S. vaccine ecosystem, including immunization schedules, CDC/ACIP considerations, public health stakeholders, and provider types.
• Design marketing strategies that address the unique dynamics of vaccine adoption, including site-of-care complexity, and public trust.
• Collaborate with Medical Affairs and Regulatory to ensure compliant, scientifically sound communications.
• Partner with Government Affairs and Policy teams to ensure marketing strategies account for evolving immunization policy, public funding mechanisms, and advocacy stakeholder dynamics.
• Collaborate with HEOR and Market Access to develop evidence-based value narratives and payer-facing materials that support formulary positioning and access.

Brand & Portfolio Marketing

• Establish the company’s commercial brand and narrative as we transition from a development-stage biotech to a commercial organization.
• Lead brand development, messaging, and omnichannel promotional strategy across HCP, payer, and patient audiences.
• Design and execute integrated omnichannel engagement strategies spanning personal promotion, digital channels, and non-personal promotion to optimize customer reach, frequency, and impact across the vaccine adoption journey.
• Develop digital-first engagement models for hard-to-reach HCP segments, including pharmacists and public health practitioners critical in vaccine delivery.
• Develop and execute consumer/patient engagement strategies—including disease awareness campaigns, direct-to-consumer (DTC) advertising, and health literacy initiatives—that drive vaccination demand at the population level.
• Build multi-audience demand generation strategies that create a pull-through effect across HCPs, consumers, payers, employers, and public health decision-makers to maximize vaccine adoption.
• Partner with Patient Advocacy organizations and community health stakeholders to inform patient-centric messaging and overcome barriers to vaccination, including vaccine hesitancy and health equity gaps.
• Develop lifecycle and indication expansion strategies to support future growth and pipeline advancement.

Market Insights & Analytics

• Lead market research, customer insights, and competitive intelligence to inform launch readiness and ongoing optimization.
• Define KPIs and performance metrics to measure marketing effectiveness and launch success.
• Leverage data analytics and AI-powered tools to enhance competitive intelligence, identify prescriber behavior patterns, and inform real-time marketing optimization decisions.

Team, Infrastructure & Capability Building

• Build and lead a high-performing marketing organization, scaling the team and capabilities over time.
• Establish agency partnerships and external vendors to support launch execution. Build and manage a high-performing agency roster with clear scopes of work, performance metrics, and governance structures that drive accountability and cost efficiency.
• Implement marketing processes, governance, and operating models consistent with U.S. commercial and regulatory requirements.
• Implement marketing operations infrastructure including project management systems, digital asset management (DAM), and content supply chain processes designed for scale and speed-to-market.
• Own the marketing budget, ensuring disciplined resource allocation across brand, digital, and promotional investments with clear ROI measurement and launch investment frameworks.

Future Global Expansion

• Design U.S. marketing strategies with future global scalability in mind.
• Partner cross-functionally to support early planning for potential international expansion, including global brand frameworks and knowledge transfer.

Digital Innovation & AI-Enabled Marketing

• Champion the integration of AI and emerging technologies into marketing workflows to improve quality, speed, cost efficiency, and decision-making across the marketing organization.
• Evaluate and deploy AI-powered tools for content creation, personalization, competitive intelligence, and customer engagement—ensuring all applications comply with regulatory and MLR requirements.
• Leverage generative AI to accelerate content development cycles, enable omnichannel personalization at scale, and streamline the Medical-Legal-Regulatory (MLR) review process.
• Establish an AI-informed marketing operations model that uses predictive analytics to optimize targeting, message sequencing, and media mix allocation.
• Identify opportunities to use AI and automation to reduce agency costs, accelerate time-to-market for promotional materials, and improve ROI across marketing investments.
• Partner with IT, Data Science, and Commercial Operations to build a connected, data-driven marketing ecosystem from the ground up.

Requirements: 

• Bachelor’s degree required; advanced degree (MBA, MS, PhD) preferred with 15+ years of progressive marketing experience in biotech or pharmaceuticals.
• Other combinations of education and/or experience may be considered
• Significant experience in vaccine marketing, including U.S. launch experience.
• Demonstrated success leading pre-launch and first-launch marketing efforts.

Preferred Qualifications:

• Experience building a marketing organization in a pre-commercial or first-launch biotech environment.
• Track record of leading omnichannel marketing strategies integrating digital, non-personal, and field-based promotion.
• Experience managing complex agency rosters and marketing vendor ecosystems across creative, media, digital, and analytics functions.
• Familiarity with AI/ML applications in marketing, including content generation, customer segmentation, predictive analytics, and campaign optimization.
• Demonstrated fluency in marketing analytics, including KPI frameworks, attribution modeling, and data-driven optimization.
• Experience with MLR processes and demonstrated ability to partner effectively with Medical and Legal/Regulatory in a compliant promotional environment.
• Strong executive presence with the ability to influence C-suite stakeholders and represent the marketing function on cross-functional leadership teams.
• Proven experience driving commercial demand generation across both HCP and consumer/patient audiences in a regulated healthcare environment, including DTC, disease education, or unbranded awareness campaigns.
• Public health marketing or disease awareness campaign experience preferred

Job Summary

The QA Compliance Intern will provide foundational administrative and operational support to the Quality Department. This role is designed to offer a student or recent graduate hands-on experience in oversight of external manufacturing operations and Contract Manufacturing Organization (CMO) partnerships. As an intern, you will assist in ensuring compliance with international regulatory requirements and industry standards and support the internal quality team with various tasks and projects.

Core Responsibilities

• Assist in the initiation and administrative tracking of incoming inquiries, including Product Quality Complaints (PQCs), Adverse Events (AEs), and Medical Inquiries (MIs).
• Support the Quality Team in maintaining seamless communication between internal departments (Supply Chain, Pharmacovigilance, Regulatory Affairs) and external manufacturing partners.
• Learn to support the initiation of investigations, CAPAs (Corrective and Preventive Actions), change controls, and validation documentation within a Good Manufacturing Practice (GMP) environment.
•  Monitor the general QA mailbox, ensuring inquiries are routed to the appropriate stakeholders in a timely manner.
• Assist in the maintenance and implementation of internal policies, procedures, and training programs.
• Contribute to the organization of files and documentation required for internal and external audits.
•  Provide general project management support for the Quality Department, including data entry into Excel and drafting correspondence.

Qualifications & Requirements

• Currently enrolled in or a recent graduate of a BA/BS program in Life Sciences, Chemistry, Pharmacy, or a related field.
• Previous internship or coursework related to Quality Assurance, Quality Control, or Regulatory Compliance is a plus but not required.
• Excellent verbal and written communication skills with a focus on professional email etiquette.
• Proficiency in Microsoft Office Suite (Word, Excel, Outlook) is required.
• High attention to detail and the ability to manage multiple assignments simultaneously while meeting deadlines.
• Ability to ask compelling questions and a desire to understand
• Ability to work both autonomously and collaboratively in a fast-paced environment.
• Basic knowledge of CAPAs, Deviation investigations, Change Controls, and Supplier Qualification Program.

Position Type 

• Remote

Travel

• (5% travel)

Job Summary

The Pharmacovigilance Intern will support the Pharmacovigilance team with day-to-day activities in drug safety surveillance, adverse event (AE) processing, and regulatory compliance. This role provides hands-on exposure to pharmacovigilance processes, including intake and triage of incoming inquiries in compliance with regulatory requirements, management of Individual Case Safety Reports (ICSRs), safety database entry, and literature surveillance.

The intern will collaborate with cross-functional teams, including Quality Assurance, Regulatory, Clinical, and Medical Affairs, to gain a well-rounded understanding of pharmacovigilance within the pharmaceutical industry.

Core Responsibilities

• Assist in the intake, documentation, and triage of incoming inquiries, including adverse events (AEs), product quality complaints (PQCs), and medical inquiries, in accordance with internal procedures and regulatory requirements
• Perform data entry, coding (e.g., MedDRA), and narrative writing within the safety database
• Support follow-up activities to obtain missing or additional information from reporters or internal stakeholders
• Aid in literature surveillance activities, including screening scientific publications for potential adverse events
• Provide support in the preparation of safety reports for submission to regulatory authorities
• Collaborate with cross-functional teams (e.g., Medical Affairs, Regulatory, Quality, Clinical) to support pharmacovigilance activities
• Perform other duties and projects as assigned to support the Pharmacovigilance department

Qualifications & Requirements

• Currently pursuing or recently completed a Bachelor’s or Master’s degree in a scientific discipline (e.g., Biology, Pharmacy, Life Sciences, Public Health or related field)
• Strong interest in pharmacovigilance, drug safety, and pharmaceutical development
• Basic understanding of pharmacovigilance concepts (e.g., adverse events, product quality complaints, case intake/processing) is a plus
• Familiarity with medical terminology is preferred
• Familiarity with FDA regulations and ICH guidelines is a plus
• Excellent written and oral communication skills
• Strong organizational skills and attention to detail
• Ability to manage multiple tasks and meet deadlines in a fast-paced environment
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook)
• Self-motivated with a proactive approach to learning and problem-solving
• Ability to work both independently and collaboratively within a team setting
• Prior internship or coursework experience in pharmacovigilance, quality assurance, clinical research, or healthcare is preferred but not required

Position Type

• Remote/Hybrid

Travel

• Minimal; up to 10%

About the role

Reporting to the General Counsel, the Senior Counsel, Privacy & AI Governance will lead Applied Intuition’s global privacy and AI governance efforts and serve as a key legal partner to Product, Engineering, Data Science, Security, and Go-to-Market. You will own the company’s privacy program end-to-end, advise on GDPR, CCPA/CPRA, cross-border data transfers, and privacy impact assessments, and help build the policies, frameworks, and processes needed to support responsible AI development and deployment, including compliance with the EU AI Act and other emerging requirements. You will also partner closely with Regulatory Affairs, outside counsel, regulators, and standards bodies, while building the data governance infrastructure needed to scale the business.

At Applied Intuition, you will:

• Own and operationalize the global privacy program across the company

• Lead AI governance strategy, policy development, and implementation

• Advise Product, Engineering, Data Science, Security, and Go-to-Market teams on privacy, data protection, and responsible AI issues

• Conduct privacy and AI impact assessments and support regulatory compliance efforts worldwide

• Advise on cross-border data transfers, SCCs, adequacy frameworks, and other transfer mechanisms

• Manage engagement with data protection authorities, outside counsel, regulators, and standards bodies

• Build and maintain data mapping, records of processing activities, consent frameworks, and vendor privacy diligence processes

• Support commercial transactions and product launches requiring privacy review

We’re looking for someone who has:

• 8+ years of law firm and/or in-house experience, with substantial privacy and data protection focus

• Deep experience advising on GDPR and CCPA/CPRA compliance programs

• Experience with data processing agreements and cross-border data transfer mechanisms, including SCCs and adequacy frameworks

• Experience with AI regulatory requirements, including the EU AI Act or similar emerging frameworks

• Experience advising on machine learning data use, training data governance, algorithmic bias and fairness, and transparency obligations

• Experience in a technology company in-house role, or in a dedicated privacy and data security practice at a law firm

• J.D. from an accredited law school and active membership in at least one state bar

Nice to have:

• CIPP/E, CIPP/US, or equivalent privacy certification

• Experience with autonomous systems, sensor data, and the privacy implications of physical AI

• Experience spanning both law firm and in-house practice

Compensation at Applied Intuition for eligible roles includes base salary, equity, and benefits. Base salary is a single component of the total compensation package, which may also include equity in the form of options and/or restricted stock units, comprehensive health, dental, vision, life and disability insurance coverage, 401k retirement benefits with employer match, learning and wellness stipends, and paid time off. Note that benefits are subject to change and may vary based on jurisdiction of employment.

Applied Intuition pay ranges reflect the minimum and maximum intended target base salary for new hire salaries for the position. The actual base salary offered to a successful candidate will additionally be influenced by a variety of factors including experience, credentials & certifications, educational attainment, skill level requirements, interview performance, and the level and scope of the position.

Please reference the job posting’s subtitle for where this position will be located. For pay transparency purposes, the base salary range for this full-time position in the location listed is: $180,000 - $325,000 USD annually.

Vast is looking for a Director, Government Affairs and National Security Programs, reporting to the Vice President of Government Affairs, to support the development of the systems that will be required for the design and build of artificial-gravity human-rated space stations. 

They will lead and expand the company’s engagement with the U.S. Department of Defense and associated national security stakeholders. This role will drive policy, partnership, and advocacy strategies to advance Vast’s initiatives to launch and operate the world’s leading commercial space stations in support of both civil and national security space objectives.

This will be a full-time, exempt position located in our Washington D.C. location.

Responsibilities:

• Strategic Leadership
  
  • Develop and execute a comprehensive DoD and national security engagement strategy aligned with Vast’s government affairs and policy objectives.
    Collaborate across internal teams including Legal, Programs, Engineering, and Business Development to align advocacy efforts with mission and programmatic priorities.
• DoD and Interagency Engagement
  
  • Build and maintain strong relationships with key offices within the Department of Defense, U.S. Space Force, Air Force, Space Development Agency (SDA), Defense Innovation Unit (DIU), and other defense-related organizations.
    Engage with relevant Congressional committees and staff, particularly those overseeing defense, space, and appropriations matters.
    Coordinate with the National SecurityCouncil (NSC), Office of Management and Budget (OMB), and others in the Executive Office of the President (EOP) when cross-agency alignment is required.
• Policy and Advocacy
  
  • Monitor, analyze, and interpret U.S. defense and national security policy, legislation, and appropriations developments impacting commercial space capabilities.
  • Prepare policy briefs, talking points, and legislative summaries to inform internal leadership and support strategic decision-making.
  • Develop recommendations and written submissions for defense-related requests for information (RFIs), trade reports, and industry-government engagements.
• Program and Partnership Support
  
  • Collaborate with Vast’s business development team to support DoD-related contracting opportunities, cooperative agreements, and partnerships.
  • Identify emerging defense needs where Vast’s commercial capabilities can contribute to resilience, mission assurance, and space domain awareness objectives.
  • Provide policy support for defense-related technology initiatives, security reviews, and regulatory engagement.

Minimum Qualifications:

• 6+ years of professional experience in government affairs and/or relevant experience.

Preferred Skills & Experience:

• Experience working on DOD space programs and policies.
• Experience with government contracting and government procurement.
• Experience with Congressional appropriations and the National Defense Authorization Act (NDAA) process.
• Proven ability to adapt to rapidly changing priorities and schedules with ease and grace.
• Ability to simplify complex concepts into straightforward and concise explanations.
• Comfortable operating outside of areas of expertise and in new territory.
• Excellent communication, analytical, collaboration, and interpersonal skills.
• Self-starter with excellent time-management and prioritization skills.

Additional Requirements:

• Ability to travel up to 25% of the time.
• Ability to obtain appropriate security clearance to support DOD space programs.

GENERAL SUMMARY: 

The Principal Medical Writer will support 4D‑150, a gene therapy in late-stage development for retinal vascular diseases, including nAMD and DME, and associated BLA‑enabling activities as well as clinical stage work within the lung program. This role is responsible for the planning, development, and delivery of high‑quality clinical and regulatory documents across late‑stage development, working closely with Clinical Science, Clinical Operations, Data Science, Regulatory Affairs, Quality, and external partners. This role is expected to play a central role in BLA readiness, including oversight of the development, coordination, and execution of key BLA modules, and management of internal and external medical writing resources to ensure timely, high‑quality regulatory deliverables.

The ideal candidate brings strong late clinical‑stage medical writing experience, demonstrated ability to manage complex timelines, and a deep understanding of regulatory expectations for global Phase 3 programs and BLA readiness.

MAJOR DUTIES & RESPONSIBILITIES: 

• Provide oversight for the planning, development, and execution of BLA modules, working closely with Clinical Science, Regulatory Affairs, Data Science, and Quality to ensure alignment with submission strategy and timelines.
• Lead and coordinate external medical writers and vendors, including selection, scope definition, timeline management, content review, and quality oversight.
• Ensure consistency, scientific accuracy, and regulatory alignment across BLA components and supporting clinical documents.
• Serve as a key point of integration between internal subject matter experts and external writing resources to support efficient document development and review cycles.
• Author, review, and coordinate key clinical and regulatory documents for the 4D‑150 Phase 3 program as well as for the early-phase lung program, including but not limited to protocols, protocol amendments, CSRs, IBs, DMC materials, briefing documents, and BLA‑enabling content.
• Lead document planning and timeline management in collaboration with cross‑functional teams to support aggressive development milestones.
• Ensure consistency, clarity, and scientific accuracy across clinical documents, aligning with regulatory standards and internal expectations for quality.
• Partner closely with Clinical Science, Biostatistics, and Clinical Operations to integrate data interpretations, safety narratives, and efficacy analyses.
• Manage document review cycles, address comments, and ensure timely resolution of feedback from internal stakeholders and external vendors.
• Maintain document version control and adherence to internal SOPs, templates, and quality standards.
• Contribute to continuous improvement of writing processes, tools, and templates to support scale‑up of late‑stage development activities.
• Other duties as assigned

QUALIFICATIONS: 

Education

• Advanced degree in life sciences (MS, PhD, PharmD, MD) preferred; Bachelor’s degree required.

Experience

• 5+ years of medical or clinical writing experience in biotech, pharmaceutical, or CRO settings.
• Direct experience supporting Phase 3 clinical trials required; direct experience supporting early clinical trials (Phase 1/2) preferred.
• Prior experience authoring or contributing to BLA‑enabling documents strongly preferred.

Other Qualifications / Skills

• Strong understanding of ICH guidelines, FDA regulatory expectations, and clinical development processes.
• Demonstrated ability to manage multiple complex deliverables under tight timelines.
• Excellent written communication skills with attention to scientific detail and clarity.
• Proven ability to work effectively in a fast‑paced, cross‑functional environment.
• Experience in gene therapy is a plus.
• Experience with leveraging AI-enabled tools to aid in document authoring is a plus.

Travel

• Minimal; occasional travel (<10%) as needed.

Physical Requirements and Working Conditions:

Sedentary work involving extended periods of sitting, typing, and screen use. Repetitive hand and finger movements required. Virtual meetings may occur across time zones.

Base salary compensation range: $180,000 - 202,000

Please note, the base salary compensation range and actual salary offered to the final candidate depends on various factors: candidate’s geographical location, relevant work experience, skills, and years of experience.

Job Title: Executive Medical Director, Clinical Development         

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

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

Key Responsibilities:

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

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

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

Qualifications:

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

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

Compensation:

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

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

This role will serve as a strategic and operational partner to the Vice President of Medical Affairs and Medical leadership team, and is responsible for ensuring that medical capabilities, processes, systems, and execution models are efficient, compliant, scalable, and aligned with Alumis’ growth strategy. The Senior Director, Medical Strategy and Operations, will be responsible for advancing key initiatives aimed at optimizing and showcasing the impact of the Medical Affairs team. This is a hands-on position that includes driving medical strategic initiatives, enhancing the Medical Affairs systems, supporting critical medical insights processes, and developing innovative solutions to measure and report on medical affairs performance and impact. The role demands an individual who combines scientific knowledge with strong operational leadership to thrive in a fast-paced, agile environment to elevate our medical affairs capabilities.

Key Responsibilities:

· Strategic Leadership: Lead and drive the development and execution of initiatives that elevate the strategic and operational effectiveness of the Medical Affairs team in a consistent and scalable manner.

· Medical Affairs Systems Optimization:

o Oversee the design, implementation, and optimization of our Medical Affairs systems to improve internal efficiencies, engagement and communications with key opinion leaders (KOLs), healthcare providers, and other relevant stakeholders.

o Lead continuous improvement initiatives to enhance efficiency, quality, and compliance across the Medical function.

o Implement best practices for operational metrics, KPIs, dashboards, and reporting to support data-driven decision-making.

· Medical Insights: Collaborate with Medical Affairs Leadership to collect, analyze, and integrate valuable medical insights that inform strategic decisions and optimize the impact of our medical programs.

· Content Management: Serve as Medical Affairs content owner through review and approval process for external-facing materials.

· Cross-functional Collaboration: Collaborate with other functional areas such as Clinical Development, Marketing, Market Access, Commercial, Analytics, Compliance, and Regulatory to ensure alignment and integration of medical excellence within the broader organizational strategy.

· Guidance and SOP Development: Leverage expertise to develop guidance documents and SOPs to foster consistency, clarity, and accountability across Medical Affairs.

· Planning, Budgeting & Resource Management

o Lead medical annual planning, forecasting, and budget management.

o Optimize headcount planning, vendor strategy, and external spend to maximize impact and efficiency.

o Provide transparency and insights into medical investments and their impact.

Qualifications:

· Experience: Minimum of 10 years in Medical Affairs leadership. Proven experience in managing and optimizing medical operations, systems, content, and medical insights. Experience in a fast-paced, small biotech environment a plus

  Education: Advanced degree (PhD, MD, MBA, PharmD or similar)

· Leadership Skills: Exceptional leadership abilities with a demonstrated ability to manage cross-functional teams and drive change across complex medical operations. Must have track record of effectively leading without authority

· Operational Expertise: Strong experience in developing and managing Medical Affairs dashboards and other qualitative outcomes to measure impact and performance.

· Strategic Thinking: Ability to develop and implement strategic initiatives aligned cross-functionally that drive organizational goals and enhance the impact of Medical Affairs functions.

· Strong Communication: Excellent communication and interpersonal skills, with the ability to engage and influence stakeholders at all levels, both internally and externally.

The salary range for this position is $265,00 to 310,000 USD annually. This salary range is an estimate, and the actual salary may vary based on the Company’s compensation practices degree and background.

Alumis Inc. is an equal opportunity employer.

Alumis compensation packages include generous stock option grants for all employees as well as an annual bonus program.  

Other benefits include:

• Health insurance premiums paid at 90% for employee, 80% for dependents
• Free access to Genentech Bus & Ferry Share program
• $100 monthly cell phone stipend
• Unlimited PTO for Exempt employees
• Free onsite gym and a kitchen stocked with yummy snacks and drinks!

We are a hard-working, collaborative team on a mission to transform patient’s lives-- and we aspire to elevate, challenge and nurture one another along the way.