About the Role

Roku is seeking a Senior Contracts Negotiator with a passion for technology and innovation to be part of a high-performing and collaborative legal team.  Reporting to the Assistant General Counsel, Business & Legal Affairs, you will negotiate complex technology agreements that support Roku’s business and technical operations, often addressing topics such as data privacy, information security, intellectual property, and emerging technologies, including AI.

This position is a hybrid role, Monday – Thursday in office with the option to work from home on Friday. This position based in either Boston, MA, San Jose, CA or Austin, TX.

The estimated annual salary for this position is between $144,500 – $170,000 base salary. Compensation packages are based on factors unique to each candidate, including but not limited to skill set, certifications, and specific geographical location. This role is eligible for health insurance, equity awards, life insurance, disability benefits, parental leave, wellness benefits, and paid time off.

This role is ideal for someone with expertise in negotiating and closing commercial transactions, who excels at navigating complex contract issues, takes pride in partnering with business stakeholders to close strategic, high-impact deals and thrives in a fast-paced, collaborative environment.

What You Will Be Doing

• Negotiate, draft and close commercial agreements, including cloud services agreements, SaaS, artificial intelligence solutions, professional services, non-disclosure agreements and data privacy agreements, with a solution-driven mindset.
• Identify and implement improvements to existing templates, playbooks, and CLM tools to develop scalable processes for the contracting process, including the use of AI tools and other technologies
• Collaborate with your Roku legal colleagues to provide guidance to internal business partners on a wide variety of contract-related issues, including data privacy, security, confidentiality and artificial intelligence
• Be proactive, organized, and dependable — you take initiative, communicate early and clearly, and keep internal business partners informed as deals progress.
• Have fun while doing it: work with best-in-class colleagues on some of the most interesting and novel issues arising in the TV streaming industry.  Lead with a mindset that embraces innovation, empathy, humor and kindness.

We Are Excited if You Have

• At least 7 years of experience structuring and negotiating commercial technology agreements
• A bachelor’s degree from an accredited college or university
• A proven ability to draft and negotiate agreements using existing templates and playbooks or from scratch
• Strong written and verbal communication skills with proven ability to persuade
• Ability to work both independently and collaboratively in a cross-department and cross-functional role
• Strong Microsoft Office Skills including Word, Outlook, Excel, and PowerPoint
• Experience drafting and negotiating SaaS and cloud services contracts, including data privacy and security terms
• Experience with Ironclad, SharePoint, DocuSign, and Confluence.
• Experience using AI to streamline the contract lifecycle
• A great sense of humor and a customer-service mindset

#LI-FA1

Senior Associate Consultant

Position Summary 

As one of Putnam’s Senior Associate Consultants, you will be an integral part of a cohesive engagement team and will be instrumental in driving and developing the core components of each engagement. In this role you will:

• Work throughout each engagement to help identify critical issues
• Lead key analytical components of the project
• Help drive the ultimate strategic conclusions and client recommendations

At Putnam, Senior Associate Consultants are relied upon to both execute the analytical underpinnings of our engagements, help drive the growth of our junior staff, as well as actively participate in the development of the strategic recommendations we provide our clients.

At Putnam, we pride ourselves on a team-based approach that is client focused and impact oriented.  We serve many of the industry leaders, including all of the top 10 global biopharmaceutical companies. Almost all of our studies combine sophisticated quantitative analytics with significant qualitative fact-finding and synthesis to inform strategic decision-making. Our diverse casework spans portfolio prioritization, development pathway and resource optimization, market assessment, product pricing and launch strategies, market segment growth strategies, sales and marketing strategies, franchise development and patent expiration strategies. While the client-service core of our work can be demanding, we pride ourselves on the collegial, friendly and balanced environment at Putnam where consulting can be a long-term career option.

Our offices are located in the vibrant neighborhoods of Boston’s Back Bay, San Francisco, New York City, and globally in London. However - these openings are for placements in either BOSTON or NEW YORK CITY. Please select preference during application process. 

Desired Skills and Experience

The ideal candidate for the Senior Associate position is:

• A highly intelligent and self-motivated individual with a strong work ethic and excellent team skills.
• Proven analytic abilities, a strong academic track record and problem-solving skills,
• Minimum of 3 year of relevant consulting experience are required.
• Life sciences and healthcare industry experience required. 
• Our Senior Associate Consultants take on management level opportunities on their cases, introductory management experience of both teams and projects is preferred.
• Opportunities for continued professional growth abound at Putnam where we have a long track record of promoting from within as our primary source of management level talent.

Compensation & Benefits

• Competitive compensation packages
• Exceptional professional growth and promotion opportunities
• Additional benefits include a 401(k) plan, health, dental & disability insurance, 3 weeks paid vacation
• Comprehensive training program and potential for graduate education tuition reimbursement

Company Description -- Inizio Ignite, Putnam

Inizio Ignite is the global advisory partner for health and life sciences, encompassing connected expertise across Research Partnership, Putnam, Vynamic, and STEM. Guided by purpose, passion, and precision, we collaborate with clients to ignite impact, accelerate performance, and deliver lasting change for patients. By uniting strategy, insights, and innovation with a unique depth and breadth of expertise, we drive transformation and shape the future of health. Our Putnam strategy consulting team bridges science and strategy to enable confident decision-making and build value for pharma. We partner with leading health and life science companies serving brand & commercial leaders, Medical Affairs, access & pricing, and R&D.  

Our expertise spans offerings including therapeutic area strategy, data & AI strategy, go-to-market strategy, commercialization & growth, value, pricing & access (VPA) strategy, and evidence generation. Proudly part of Inizio – the market-leading commercialization partner for health and life sciences. From early-stage development to loss of exclusivity, we simplify complexity, unlock value, and make collaboration seamless at every pivotal moment – supporting confident, insight-driven decisions that move innovation forward.

We believe that to create real, lasting change on human health, we must bring out the best in our people, in every way and at every level. We offer a boutique-firm feel inside a global enterprise, opening the door to limitless opportunities to kickstart your career or hone your expertise. Built on the pillars of empowerment, collaboration, and meaning, we’re proud to offer a fulfilling environment where world-class advisors can come together to shape the future of healthcare for the better.

Serving the life sciences industry, including the top 20 global biopharmaceutical companies, consistently ranked as one of the top consulting firms by Vault, and maintaining a true global team of experts sitting across 3 continents, we offer a unique opportunity to play a central role in supporting our clients.

Diversity, equity, and inclusion are tenets of our core values. We strive to create a culture and environment that fosters belonging and authenticity across all levels and values individuals for their skills, experience, diverse backgrounds, and unique perspectives. Collectively, DEI serves as a foundational element of who we are and how we work with our clients and with each other.

Our core values:

• Team
• Excellence
• Strategic
• Passion
• Diversity

This is an Equal Employment Opportunity

Please note that Putnam Associates is in no way affiliated with Putnam Investments and that this is not a finance opportunity.

As a Senior Manager at Vynamic, you will leverage your life science consulting expertise to drive transformative outcomes for clients, fostering innovation and strategic growth within the life sciences industry. You will play a pivotal role in shaping strategies, managing complex projects, and cultivating meaningful relationships that align with Vynamic’s mission and values. 

What you'll be doing:

• Deliver High-Impact Solutions: Lead the design and delivery of high-quality, strategic solutions that align with client objectives and drive measurable business and scientific outcomes. Apply advanced life sciences consulting expertise to solve complex challenges and elevate client performance.
• Program & Risk Leadership: Oversee entire programs or multiple workstreams, proactively identifying and mitigating risks, resolving issues, and ensuring successful delivery. Serve as a trusted escalation point and advisor for clients and internal teams.
• Strategic Analysis & Executive Recommendations: Lead the synthesis of scientific, operational, and market data to generate actionable insights. Deliver confident, data-driven recommendations with urgency, tailored to executive-level stakeholders and aligned with broader business strategy.
• Firm Growth & Thought Leadership: Actively contribute to Vynamic’s growth by shaping intellectual capital, developing new service offerings, and sharing life sciences consulting expertise. Represent the firm in external forums and contribute to brand-building initiatives.
• Brand Representation: Serve as a senior ambassador of the Vynamic brand, consistently modeling company values and influencing culture both internally and externally. Champion the firm’s mission and vision in client engagements and industry interactions.
• Strategic Stakeholder Engagement: Cultivate and manage high-value relationships with senior stakeholders, ensuring alignment, trust, and long-term partnership. Consistently deliver outcomes that exceed expectations and reinforce Vynamic’s reputation for excellence.
• Team Development & Talent Cultivation: Lead and mentor teams by identifying growth opportunities, fostering a culture of continuous learning, and integrating life sciences consulting best practices into daily operations. Support career development through coaching and performance feedback.
• Collaborative Leadership Across the Firm: Partner with Navigators, Go-Tos, Account Managers, and Counselors to guide professional development journeys. Influence firm-wide initiatives and contribute to strategic decision-making processes.
• Continuous Feedback & Organizational Improvement: Model a commitment to personal and organizational growth by actively seeking feedback, implementing development plans, and driving a culture of excellence and accountability.
• Inclusive Leadership & Culture Building: Champion impact and inclusion by recognizing and celebrating diverse perspectives. Ensure inclusive decision-making and foster environments where all voices are heard and valued.
• Business Development & Network Expansion: Proactively identify opportunities where Vynamic’s services can add value to current or prospective clients, and escalate to Account Managers or Business Development leads as appropriate. Build and maintain strategic professional networks to support long-term business development and market visibility.

 What you'll need:

• Bachelor’s degree in life sciences, healthcare, or a related field with 6+ years of progressive experience in life science consulting. An advanced degree (MS, MBA, PhD) is preferred
• Demonstrated success in leading cross-functional teams and managing large-scale, complex projects in dynamic, fast-paced environments. Proven ability to mentor and develop talent, foster collaboration, and drive high-performance cultures.
• Deep understanding of relationship management principles, with a focus on building strategic partnerships and influencing key stakeholders across the life sciences ecosystem.
• Extensive experience applying project and program management methodologies to oversee multiple workstreams, ensuring alignment with organizational goals and delivering measurable outcomes.
• Industry Insight: Familiarity with Vynamic’s sectors, services, and unique value proposition is preferred. Ability to translate industry trends into actionable strategies that drive client value and business growth.
• Exceptional presentation and communication skills, with the ability to engage and influence diverse audiences, including scientific, operational, and executive stakeholders.
• A proactive, growth-oriented mindset that embraces challenges as opportunities for innovation, learning, and continuous improvement. Demonstrated ability to drive strategic initiatives and contribute to organizational thought leadership.

Why Join Vynamic?

At Vynamic, we believe in leading with authenticity, purpose, and passion. As a Senior Manager with a life science consulting background, you’ll not only help organizations achieve strategic goals but also inspire scientific and operational excellence—contributing to meaningful change that drives industry innovation.

Ready to make an impact? Join us at Vynamic and be part of a team where your expertise in life science consulting will thrive and grow.

Inizio Ignite, Vynamic 

Inizio Ignite is the global advisory partner for health and life sciences, encompassing connected expertise across Research Partnership, Putnam, Vynamic, and STEM. Guided by purpose, passion, and precision, we collaborate with clients to ignite impact, accelerate performance, and deliver lasting change for patients. By uniting strategy, insights, and innovation with a unique depth and breadth of expertise, we drive transformation and shape the future of health. Our Vynamic management consulting team connects strategy to action, driving healthcare transformation. We partner with leading health and life science companies serving brand & commercial, Medical Affairs, R&D, and Health Services. Our expertise spans offerings including strategic planning & mobilization (SP&M), operating model & organization design (OMOD), deal activation & partnership enablement (DAPE), product launch strategy & planning, customer experience transformation, tech & digital transformation, strategic project management office, and change management. Proudly part of Inizio – the market-leading commercialization partner for health and life sciences. From early-stage development to loss of exclusivity, we simplify complexity, unlock value, and make collaboration seamless at every pivotal moment – supporting confident, insight-driven decisions that move innovation forward

Further Information

This is a full-time role and will follow a hybrid work environment in either Boston, Philadelphia, or New York City.

As a Senior Associate at Vynamic, you will apply your life science consulting experience to support project execution, foster strategic insights, and contribute to transformative outcomes for clients within the life sciences industry. You will collaborate with cross-functional teams, manage key deliverables, and build meaningful relationships aligned with Vynamic’s mission and values.

Key Responsibilities:

• Support High-Impact Solutions: Execute high-quality project deliverables under the guidance of project leads, applying life science consulting knowledge to achieve client objectives.
• Project & Risk Support: Assist in managing project plans or workstreams, identifying potential risks and issues, and escalating them appropriately to ensure project success.
• Data Analysis & Insights: Gather, analyze, and interpret scientific and business data to support strategic recommendations with clarity and confidence.
• Contribute to Vynamic's Growth: Share life science consulting insights, contribute to Vynamic’s knowledge base, and actively participate in firm development initiatives.
• Brand Representation: Uphold Vynamic’s values and act as a brand ambassador both internally and externally, demonstrating professionalism and integrity.
• Stakeholder Engagement: Develop genuine relationships with stakeholders through effective communication, collaboration, and high-quality project delivery.
• Team Collaboration: Engage with Navigators, Go-Tos, Account Managers, and self-selected Counselors to support personal and professional development journeys within Vynamic.
• Feedback & Growth: Proactively seek feedback, apply learnings to personal growth, and contribute to a culture of continuous improvement.
• Inclusive Collaboration: Value diverse perspectives, experiences, and cultures, ensuring all voices are heard to enhance project outcomes.

Qualifications:

• Bachelor’s degree in life sciences, healthcare, or a related field with a minimum of 1+ years of experience in life science consulting, advanced degree (MS, MBA, PhD) preferred.
• Experience supporting project teams and contributing to project deliverables within dynamic, fast-paced environments.
• Understanding of project management methodologies and consulting processes.
• Strong interpersonal skills with the ability to build authentic stakeholder relationships.
• Effective communication skills, both written and verbal, tailored to diverse audiences.
• Growth-oriented mindset, embracing challenges as opportunities for learning and personal development.

Why Join Vynamic?
At Vynamic, we believe in leading with authenticity, purpose, and passion. As a Senior Associate with a life science consulting background, you’ll contribute to projects that drive scientific and operational excellence while growing your consulting skills in a collaborative and supportive environment.

Ready to grow your career? Join us at Vynamic and be part of a team where your life science consulting expertise will thrive and make an impact.

Inizio Ignite, Vynamic 

Inizio Ignite is the global advisory partner for health and life sciences, encompassing connected expertise across Research Partnership, Putnam, Vynamic, and STEM. Guided by purpose, passion, and precision, we collaborate with clients to ignite impact, accelerate performance, and deliver lasting change for patients. By uniting strategy, insights, and innovation with a unique depth and breadth of expertise, we drive transformation and shape the future of health. Our Vynamic management consulting team connects strategy to action, driving healthcare transformation. We partner with leading health and life science companies serving brand & commercial, Medical Affairs, R&D, and Health Services. Our expertise spans offerings including strategic planning & mobilization (SP&M), operating model & organization design (OMOD), deal activation & partnership enablement (DAPE), product launch strategy & planning, customer experience transformation, tech & digital transformation, strategic project management office, and change management. Proudly part of Inizio – the market-leading commercialization partner for health and life sciences. From early-stage development to loss of exclusivity, we simplify complexity, unlock value, and make collaboration seamless at every pivotal moment – supporting confident, insight-driven decisions that move innovation forward

Further Information

This is a full-time role and will follow a hybrid work environment in either Boston, Philadelphia, or New York City.

#LI-ND1

#LI-Hybrid

As a Manager at Vynamic, you will leverage your life science consulting expertise to drive transformative outcomes for clients, fostering innovation and strategic growth within the life sciences industry. You will play a pivotal role in shaping strategies, managing complex projects, and cultivating meaningful relationships that align with Vynamic’s mission and values.

Key Responsibilities:

• Deliver High-Impact Solutions: Create and deliver high-quality project outcomes that align with client objectives, incorporating life science consulting principles to promote business excellence and scientific advancement.
• Project & Risk Management: Lead project plans or workstreams, proactively resolving issues, mitigating risks, and escalating concerns when necessary to ensure project success.
• Strategic Analysis & Recommendations: Systematically gather, analyze, and interpret scientific and business information, using a life science consulting lens to make confident, data-driven recommendations with urgency.
• Contribute to Vynamic's Growth: Dedicate time to enhancing Vynamic’s competencies by sharing life science consulting insights and contributing to the firm’s knowledge base and brand.
• Brand Representation: Act as a Vynamic brand ambassador, demonstrating a strong commitment to company values both internally and externally.
• Stakeholder Engagement: Build authentic, trust-based relationships with stakeholders through partnership, effective communication, and delivering outcomes that exceed expectations.
• Team Development: Support team growth by identifying learning opportunities, mentoring colleagues, and integrating life science consulting practices into daily operations to achieve collective goals.
• Collaborative Leadership: Work closely with Navigators, Go-Tos, Account Managers, and self-selected Counselors to support personal and professional development journeys within Vynamic.
• Continuous Feedback & Growth: Proactively seek feedback, develop actionable personal growth plans, and contribute to a culture of continuous improvement.
• Inclusive Leadership: Recognize and celebrate diverse perspectives, experiences, and cultures, ensuring all voices are heard and valued in decision-making processes.

Qualifications:

• Bachelor’s degree in life sciences, healthcare, or a related field with a minimum of 4+ years of experience in life science consulting, advanced degree (MS, MBA, PhD) preferred.
• Proven track record of managing collaborative teams or projects within dynamic, fast-paced environments.
• Strong understanding of relationship management principles, with a focus on fostering genuine connections within the life sciences ecosystem.
• Experience applying project management methodologies to oversee workstreams and complex initiatives.
• Familiarity with Vynamic’s sectors, services, and unique value proposition (preferred but not required).
• Strong presentation skills, with the ability to communicate effectively through written and verbal channels to diverse audiences, including scientific and executive stakeholders.
• Growth-oriented mindset, embracing challenges as opportunities for learning and personal development.

Why Join Vynamic?

At Vynamic, we believe in leading with authenticity, purpose, and passion. As a Manager with a life science consulting background, you’ll not only help organizations achieve strategic goals but also inspire scientific and operational excellence—contributing to meaningful change that drives industry innovation.

Ready to make an impact? Join us at Vynamic and be part of a team where your expertise in life science consulting will thrive and grow.

Inizio Ignite, Vynamic 

Inizio Ignite is the global advisory partner for health and life sciences, encompassing connected expertise across Research Partnership, Putnam, Vynamic, and STEM. Guided by purpose, passion, and precision, we collaborate with clients to ignite impact, accelerate performance, and deliver lasting change for patients. By uniting strategy, insights, and innovation with a unique depth and breadth of expertise, we drive transformation and shape the future of health. Our Vynamic management consulting team connects strategy to action, driving healthcare transformation. We partner with leading health and life science companies serving brand & commercial, Medical Affairs, R&D, and Health Services. Our expertise spans offerings including strategic planning & mobilization (SP&M), operating model & organization design (OMOD), deal activation & partnership enablement (DAPE), product launch strategy & planning, customer experience transformation, tech & digital transformation, strategic project management office, and change management. Proudly part of Inizio – the market-leading commercialization partner for health and life sciences. From early-stage development to loss of exclusivity, we simplify complexity, unlock value, and make collaboration seamless at every pivotal moment – supporting confident, insight-driven decisions that move innovation forward

Further Information

This is a full-time role and will follow a hybrid work environment in either Boston, Philadelphia, or New York City.

#LI-Hybrid

#LI-ND1

At Vynamic, we partner with leading pharmaceutical and life sciences companies to address critical strategic, operational, and organizational challenges—from early-stage planning through commercialization and beyond. Our Directors serve as trusted advisors to senior client stakeholders, shaping strategy, leading high-impact engagements, and driving measurable outcomes.

We are looking for individuals who bring deep industry knowledge, strong business acumen, and the ability to translate evolving market dynamics into actionable solutions. Our work spans key service areas including Strategic Planning, Vendor Selection & Management, Process Design, Systems Implementation, and Organizational Change.

What you'll be doing:

• Serve as a strategic advisor to pharmaceutical and life sciences clients, aligning engagement objectives with business priorities across the product lifecycle
• Lead complex engagements spanning areas such as commercialization strategy, launch planning, operating model design, and transformation initiatives
• Build and maintain strong relationships with senior stakeholders across functions (e.g., Commercial, Medical Affairs, Market Access, R&D, and Operations)
• Drive execution of client initiatives, ensuring high-quality deliverables and measurable business impact
• Identify emerging client needs and industry trends (e.g., market access pressures, digital transformation, evolving regulatory landscape) and translate them into new opportunities
• Contribute to business development efforts by expanding existing accounts and supporting new client acquisition
• Lead, mentor, and develop high-performing teams, fostering ownership, growth, and a collaborative culture
• Ensure clarity, rigor, and quality in all client deliverables, including executive-level presentations and strategic recommendations
• Proactively manage risks, timelines, and competing priorities across multiple engagements
• Build Vynamic’s presence in the pharma sector through thought leadership, industry insights, and participation in relevant forums
• Support recruiting efforts by engaging with and attracting top talent to the firm
• Foster a culture aligned with Vynamic’s values, emphasizing collaboration, excellence, and impact

What you'll need:

• Bachelor’s degree with 6–8+ years of experience at a leading consulting firm (life sciences-focused consulting experience preferred)
• Demonstrated experience leading engagements within the pharmaceutical or life sciences industry
• Deep understanding of the pharmaceutical value chain, including drug development, commercialization, market access, and lifecycle management
• Experience in one or more of Vynamic’s core service areas, with application in pharma contexts:
  • Strategic Planning (e.g., portfolio strategy, launch readiness)
  • Vendor Selection & Management (e.g., outsourcing models, partner ecosystems)
  • Process Design (e.g., commercial operations, medical affairs processes)
  • Systems Implementation (e.g., CRM, data & analytics platforms)
  • Organizational Change (e.g., transformations, operating model shifts)
• Strong executive presence with the ability to influence and advise senior client stakeholders
• Proven ability to identify, shape, and convert business development opportunities
• Excellent communication and presentation skills, with experience engaging executive audiences
• Demonstrated ability to lead teams, develop talent, and drive high performance
• Strong problem-solving skills, intellectual curiosity, and comfort with ambiguity
• Resilience and adaptability in fast-paced, evolving environments
• Alignment with and embodiment of Vynamic’s brand and values

Inizio Ignite, Vynamic 

Inizio Ignite is the global advisory partner for health and life sciences, encompassing connected expertise across Research Partnership, Putnam, Vynamic, and STEM. Guided by purpose, passion, and precision, we collaborate with clients to ignite impact, accelerate performance, and deliver lasting change for patients. By uniting strategy, insights, and innovation with a unique depth and breadth of expertise, we drive transformation and shape the future of health. Our Vynamic management consulting team connects strategy to action, driving healthcare transformation. We partner with leading health and life science companies serving brand & commercial, Medical Affairs, R&D, and Health Services. Our expertise spans offerings including strategic planning & mobilization (SP&M), operating model & organization design (OMOD), deal activation & partnership enablement (DAPE), product launch strategy & planning, customer experience transformation, tech & digital transformation, strategic project management office, and change management. Proudly part of Inizio – the market-leading commercialization partner for health and life sciences. From early-stage development to loss of exclusivity, we simplify complexity, unlock value, and make collaboration seamless at every pivotal moment – supporting confident, insight-driven decisions that move innovation forward

Further Information

This is a full-time role and will follow a hybrid work environment in either Boston, Philadelphia, or New York City.

#LI-ND1

#LI-Hybrid

Consultant, Value Pricing and Market Access

Position Summary

As a Consultant within the Value Pricing & Market Access practice, you will help lead and manage teams of Associates & Life Sciences Consultants – working with Partners and Principals you will:

• Interact with clients to understand problems, and develop and refine hypotheses to test
• Structure complex strategic and analytical problems that constitute the core of the team’s work
• Lead the daily operations of the team in executing and synthesizing analyses into key findings and actionable recommendation and participate in delivering these recommendations to our clients

At Putnam, we pride ourselves on a team-based approach that is client focused and impact oriented.  We serve many of the industry leaders, including all of the top 10 global biopharmaceutical companies. Almost all of our studies combine sophisticated quantitative analytics with significant qualitative fact-finding and synthesis to inform strategic decision-making. Our diverse casework spans portfolio prioritization, development pathway and resource optimization, market assessment, product pricing and launch strategies, market segment growth strategies, sales and marketing strategies, franchise development and patent expiration strategies. While the client-service core of our work can be demanding, we pride ourselves on the collegial, friendly and balanced environment at Putnam where consulting can be a long-term career option.

Desired Skills and Experience 

The ideal candidate for the Consultant position will:

• Have demonstrated excellence during their academic career (MBA or post-graduate degree is preferred but not required).
• Previous employment experiences (minimum 4-5 years’ work experience) with other top-tier consulting firms or within the Pharmaceutical or Biotechnology industries.
• Strong competitive analysis and scenario planning skills; participation in the development of innovative strategies and plans based on a deep understanding of long-term trends, industry/category value drivers, payer, physician and patient needs, technological advances, competitive behavior, etc.
• Proven analytic abilities and presentation skills
• Demonstrated subject matter expertise in US pharmaceuticals pricing and/or market access for HCP-administered and/or patient self-administered small molecule and/or biologic medicines, for instance:
  • Drivers of payer access control design and implementation
  • Role and implications of channel intermediaries (retail pharmacies, specialty pharmacies, buy-and-bill distributors)
  • Impact of payer controls on physician ability and willingness to prescribe
  • Gross-to-net management e.g. payer rebating, provider contracting, and/or patient support services
  • Average Sales Price (ASP) modeling and contract strategy development
• Team management and project management experience
• Team-oriented attitude is essential.
• A working knowledge of the pharmaceutical or biotechnology industry is also a prerequisite.

Compensation & Benefits

• Competitive compensation and total rewards packages
• Exceptional professional growth and promotion opportunities
• Leadership training program
• Additional benefits include a [list depending on country]

Inizio Ignite, Putnam 

Inizio Ignite is the global advisory partner for health and life sciences, encompassing connected expertise across Research Partnership, Putnam, Vynamic, and STEM. Guided by purpose, passion, and precision, we collaborate with clients to ignite impact, accelerate performance, and deliver lasting change for patients. By uniting strategy, insights, and innovation with a unique depth and breadth of expertise, we drive transformation and shape the future of health. 

Our Putnam strategy consulting team bridges science and strategy to enable confident decision-making and build value for pharma. We partner with leading health and life science companies serving brand & commercial leaders, Medical Affairs, access & pricing, and R&D.  Our expertise spans offerings including therapeutic area strategy, data & AI strategy, go-to-market strategy, commercialization & growth, value, pricing & access (VPA) strategy, and evidence generation. Proudly part of Inizio – the market-leading commercialization partner for health and life sciences. From early-stage development to loss of exclusivity, we simplify complexity, unlock value, and make collaboration seamless at every pivotal moment – supporting confident, insight-driven decisions that move innovation forward.

We believe that to create real, lasting change on human health, we must bring out the best in our people, in every way and at every level. We offer a boutique-firm feel inside a global enterprise, opening the door to limitless opportunities to kickstart your career or hone your expertise. Built on the pillars of empowerment, collaboration, and meaning, we’re proud to offer a fulfilling environment where world-class advisors can come together to shape the future of healthcare for the better.

Serving the life sciences industry, including the top 20 global biopharmaceutical companies, consistently ranked as one of the top consulting firms by Vault, and maintaining a true global team of experts sitting across 3 continents, we offer a unique opportunity to play a central role in supporting our clients.

Diversity, equity, and inclusion are tenets of our core values. We strive to create a culture and environment that fosters belonging and authenticity across all levels and values individuals for their skills, experience, diverse backgrounds, and unique perspectives. Collectively, DEI serves as a foundational element of who we are and how we work with our clients and with each other.

Our core values:

• Team
• Excellence
• Strategic
• Passion
• Diversity

Position Summary 

Come join a growth engine as a leader in our Data & AI Practice! Inizio Advisory & Putnam Associates continue to advance our Commercial Life Sciences Data, Analytics and AI Team and Solutions.  We are looking for an experienced innovator and senior leader to join Data Strategy, Analytics and AI Practice.   

The Advanced Data Analytics Lead role within the Data Strategy, Analytics and AI team will be responsible for advising clients on business strategy through data-driven decision-making, leading project teams, and developing innovative solutions to complex business challenges through data and AI. The ideal candidate should have a deep understanding of Pharmaceutical commercial business strategies, project management, and a proven problem-solving capability through data strategies, technology, and emerging AI/GenAI solutions.  

This leadership role is responsible for independently driving client and business development at the company.  They must effectively identify potential client engagements, qualify leads and drive the business development process.  They will write and submit project proposals, develop and deliver capability presentations, and respond to prospective client needs.  They are responsible for developing intellectual thought leadership for the company and for developing and enhancing practice areas within the firm.    

They are also responsible for building and enhancing existing Pharma client relationships and for overseeing the delivery of Data Strategy/Analytics/AI projects, managing a global team of data scientists and business analysts to support and deliver client projects.  

In addition to Putnam growth, this is a broader opportunity to support growth within the Inizio Advisory companies to collaborate and work with other teams, as the Data Analytics & Strategy practice evolves to support the industry and our clients’ needs.  

Holistic view of responsibilities and measurements of success:  

• Extensive project work planning and client interaction and management.   

• Leadership effectiveness through team management effectiveness, coaching and mentoring, participation in positive firm culture building, practice area development contributions, and general firm development contributions   

• Development of key insights from all workstreams and translation of those insights into a compelling storyline and presentation   

• Proposal development and revenue generation   

• Participation in industry thought leadership  

• Establish clearer resourcing method and process for the team for scale  

• Support the evolution of our hiring strategy for team based on expected future client work (e.g. growth of claims analytics offerings, commercial analytics, AI/GenAI solutions, and other growth areas accordingly.  

Desired Skills & Experience   

• Experience in Life Sciences data analytics (minimum of 10 years) and consulting  

• Working knowledge of pharmaceutical data sets such as: claims data, prescription data, lab data, change/content data, engagement and experience data  

• Experience in data visualization tools (e.g., Tableau, PowerBI, Qlik Sense)  

• Experience in healthcare datasets (e.g., Komodo, IQVIA, Symphony, Truven, Optum, Flatiron, Charge Master, Lab, Provider and Payer data)  

• Practical application of AI/ML/NLP use cases in the Life Sciences business (e.g, NBE, patient-finding, content generation, or other relevant cases)  

• A GenAI pioneer, with experience of LLMs in Pharma (e.g. generative writing, content, predictive models OR other) and ability to apply to daily work to promote adoption across Putnam  

• Extensive experience in project work planning and client management. (insert min years needed)  

• A successful history of people and team management through mentorship, knowledge sharing, and leadership.   

• Development of key insights from all workstreams and translation of those insights into a compelling storyline and presentation   

• Proposal development  

• Participation in industry thought leadership  

Compensation & Benefits  

• Industry competitive total rewards programs [salary and bonus packages]  

• Exceptional senior partner mentorship, leadership training and career development support  

• Industry competitive benefits [paid time off, 401k, health insurance]  

• Hybrid working model - this role can be based out of our NYC office or Boston office 

Company Description

Inizio Ignite, Putnam 

Inizio Ignite is the global advisory partner for health and life sciences, encompassing connected expertise across Research Partnership, Putnam, Vynamic, and STEM. Guided by purpose, passion, and precision, we collaborate with clients to ignite impact, accelerate performance, and deliver lasting change for patients. By uniting strategy, insights, and innovation with a unique depth and breadth of expertise, we drive transformation and shape the future of health. Our Putnam strategy consulting team bridges science and strategy to enable confident decision-making and build value for pharma. We partner with leading health and life science companies serving brand & commercial leaders, Medical Affairs, access & pricing, and R&D.  Our expertise spans offerings including therapeutic area strategy, data & AI strategy, go-to-market strategy, commercialization & growth, value, pricing & access (VPA) strategy, and evidence generation. Proudly part of Inizio – the market-leading commercialization partner for health and life sciences. From early-stage development to loss of exclusivity, we simplify complexity, unlock value, and make collaboration seamless at every pivotal moment – supporting confident, insight-driven decisions that move innovation forward.

We believe that to create real, lasting change on human health, we must bring out the best in our people, in every way and at every level. We offer a boutique-firm feel inside a global enterprise, opening the door to limitless opportunities to kickstart your career or hone your expertise. Built on the pillars of empowerment, collaboration, and meaning, we’re proud to offer a fulfilling environment where world-class advisors can come together to shape the future of healthcare for the better.

Serving the life sciences industry, including the top 20 global biopharmaceutical companies, consistently ranked as one of the top consulting firms by Vault, and maintaining a true global team of experts sitting across 3 continents, we offer a unique opportunity to play a central role in supporting our clients.

Diversity, equity, and inclusion are tenets of our core values. We strive to create a culture and environment that fosters belonging and authenticity across all levels and values individuals for their skills, experience, diverse backgrounds, and unique perspectives. Collectively, DEI serves as a foundational element of who we are and how we work with our clients and with each other.

Our core values:

• Team
• Excellence
• Strategic
• Passion
• Diversity

This is an Equal Employment Opportunity

Please note that Putnam Associates is in no way affiliated with Putnam Investments and that this is not a finance opportunity.

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.

About Every Cure:   

Every Cure is an AI-driven nonprofit, biotech organization on a mission to save and improve lives by repurposing existing medicines for diseases with significant unmet need. We are working to create a world where every drug is used to treat every disease it possibly can, so that no patient suffers when an existing treatment could help them. We are filling a gap left by the current biomedical system, which doesn’t systematically pursue new uses for old drugs. Through artificial intelligence technologies, collaboration with healthcare professionals, and patient advocacy, Every Cure is dedicated to unlocking the full potential of existing medicines to treat every disease and every patient we possibly can. Inspired by Every Cure’s co-founders' work repurposing drugs for Castleman disease and other rare diseases, Every Cure is advancing repurposed treatments for neglected diseases and has been featured in The New Yorker,  New York Times, USA Today, Good Morning America and other news media. Led by a talented leadership team and an outstanding Board of Directors, Every Cure is supported through funding from leading philanthropic organizations like Chan Zuckerberg Initiative, TED’s Audacious Project, and ARPA-H. 

 Our approach:  

• AI-Powered Identification: We use advanced artificial intelligence to analyze the world’s biomedical knowledge and identify FDA-approved drugs that can be repurposed for untreated conditions. This cutting-edge technology enables us to explore new therapeutic possibilities efficiently.  
• Open-Source Commitment: We are dedicated to making our predictive pipeline open-source, fostering collaboration and transparency within the scientific community and unlocking the potential for discovering new treatments.  
• High-Impact Focus: We prioritize drug repurposing opportunities that will relieve the most suffering and have the greatest impact possible.  
• Rigorous Validation: Promising opportunities are thoroughly validated through laboratory and clinical studies to confirm their efficacy and safety before advancing to broader application.  
• Strategic Marketing and Access: We disseminate information about effective repurposed treatments through multiple channels and are committed to ensuring that new cures are accessible to all patients.

Applicants must reside in the state specified at the top of this job posting. Residency in that state is a requirement for consideration and must be maintained for the duration of employment.

The Head of Clinical Development leads Every Cure’s clinical research and development function, serving as both strategic architect and working clinical lead on priority programs. They manage a diverse portfolio of drug repurposing initiatives including Every Cure-sponsored interventional trials (with full sponsor IND accountability and REMS complexity where applicable), collaborative investigator-sponsored trials, and Every Cure-led patient registries, natural history studies, and other real-world studies. They collaborate directly with computational and data science teams to translate AI-driven repurposing hypotheses into clinically testable programs and represent the organization to external partners and stakeholders. This role owns sponsor compliance under ICH E6(R3) including maintenance of the clinical QMS and SOP infrastructure regardless of CRO engagement  and oversees regulatory strategy and dissemination. The HCD supports Every Cure’s CSO and engages directly with external stakeholders including CROs, clinical trial technology vendors, academic investigators, patient advocacy organizations, the IRB of record, and FDA. The HCD helps build and lead a lean internal clinical development team, modeling the working-leader norm expected in a small, mission-driven organization.

How you will make an impact: 

Strategic Leadership of Clinical Development and Medical Affairs

• Set the direction for Every Cure’s clinical research and development, ensuring alignment with the organization’s mission to repurpose FDA-approved drugs for high-impact unmet needs, while personally leading or co-leading priority programs.
• Lead the execution of organizational goals through operational planning and cross-functional integration, personally owning project timelines, quality standards, and accountability metrics for priority programs rather than delegating all execution.
• Provide expert counsel to the CSO, President and Scientific Advisory Council on medical strategy, program development, and organizational growth.

Research and Clinical Development Oversight

• Design, author, and review key study documents (protocols, statistical analysis plans, informed consent documents, clinical study reports, investigator brochures) for Every Cure-sponsored clinical trials, patient registries, natural history studies, and real-world evidence assessments. Own study design decisions end-to-end, from scientific rationale through data integrity and analysis.
• Serve as sponsor medical lead and/or medical monitor on Every Cure-sponsored IND-holding studies (delegating per-study where appropriate), ensuring all research activities are ethically sound, methodologically rigorous, and regulatory compliant under FDA 21 CFR Part 312, ICH E6(R3), and ICH E9 principles.
• Translate complex medical findings into strategic decisions regarding program continuation, optimization, or sunsetting, based on efficacy, feasibility, and patient impact.
• Responsible for compliance and oversight of the Human Subjects Research program at Every Cure, including IRB (Advarra) submissions and amendments, sponsor safety reporting (IND safety reports, DSURs), SAE adjudication, signal detection, and REMS program participation where applicable (e.g., lenalidomide).

Portfolio Strategy and Program Management

• Partner on strategic prioritization and dynamic management of Every Cure’s diverse portfolio of drug repurposing opportunities, applying a risk-adjusted, impact-oriented lens to maximize outcomes.
• Direct the progression of programs through clinical and dissemination stages, using insights from AI models and external scientific inputs. Personally lead CRO and clinical technology vendor selection, contracting input, and ongoing governance (joint steering committees, KPIs, oversight plans) for highest-priority programs.
• Develop and manage resource allocation frameworks across disease areas and therapeutic modalities, ensuring optimal investment of time, talent, and funding toward the most promising interventions.

Leadership and Team Development

• Build, mentor, and lead a lean, high-performing team of clinical research and medical professionals united around a shared vision of maximizing patient impact through drug repurposing, modeling a working-leader norm in which senior leaders contribute directly alongside their teams.
• Define roles, responsibilities, and performance standards for the clinical team while fostering a culture of excellence, integrity, psychological safety, and cross-functional collaboration.
• Promote continuous learning and growth through coaching, training programs, and development opportunities that build both individual capability and team effectiveness.

Stakeholder Engagement, Compliance, and Dissemination

• Act as medical spokesperson and lead regulatory interface for Every Cure in public, scientific, and regulatory forums (including FDA pre-IND and Type B/C meetings), promoting the organization’s mission and sharing results from preclinical and clinical programs.
• Cultivate and manage partnerships with CROs, patient advocacy groups, academic institutions, and regulatory agencies to ensure successful execution and wide-scale impact of therapeutic programs.
• Guide the regulatory approval and post-study dissemination strategies to ensure timely and effective translation of research into therapies accessible to patients, including peer-reviewed publications, policy briefs, and healthcare provider outreach.
• Partner with the Impact lead to provide input and perspective on dissemination and to engage with key stakeholders to ensure medicines reach patients.

What you bring to the team:

Education 

• MD or MD/PhD preferred; PhD DO, or PharmD acceptable

Work Experience (Two-Tier: Head of / VP)

• Minimum for Head of Clinical Development: 8+ years of clinical development experience post-MD (or equivalent), including service as clinical lead on at least one sponsor-held Phase 2 trial from protocol through database lock.
• Demonstrated leadership experience recruiting, mentoring, and managing cross-functional clinical teams, with explicit willingness and proven ability to work hands-on alongside direct reports in a small-organization setting.
• Expertise in drug development, clinical trial design (including interventional trials in rare or ultra-rare populations), and clinical decision-making.
• Sponsor-side experience running Phase 2 trials (distinct from CRO or academic investigator experience).
• Experience working across more than one therapeutic research area.
• Experience with small-sample trial designs and natural history or registry data.
• Proven leadership in driving strategic initiatives and cross-functional collaboration to advance scientific and organizational goals.

Preferred for Vice President designation:

• 12+ years of clinical development experience, including prior functional leadership at a sponsor (Executive Director, Head of, or VP level); multiple sponsor-held INDs led through Phase 2 or beyond; direct experience with REMS programs, risk-based monitoring, or similarly complex regulatory programs; and prior responsibility for building or scaling a clinical QMS under ICH E6(R3) or predecessor standards.

Skills 

• Proficiency in clinical research, real-world evidence assessments, evidence generation, patient registry design, clinical trial execution, and sponsor-side pharmacovigilance.
• Working knowledge of FDA IND regulations (21 CFR Part 312), ICH E6(R3) Good Clinical Practice, ICH E9 statistical principles, 21 CFR Part 11 for electronic records, and REMS program requirements; familiarity with EU CTR a plus.
• Exceptional communication and presentation abilities.
• Demonstrated ability to foster and sustain a collaborative, cross-functional culture grounded in shared organizational mission and values.
• Able to partner effectively with computational and data science teams and critically evaluate AI/ML-driven repurposing hypotheses for clinical translatability.
• Strategic thinker with a focus on urgency, efficiency, and impact.
• Passionate about Every Cure’s mission and values.
• Highly adaptable, thriving in a fast-paced, start-up environment.
• Explicit willingness to be hands-on: comfort authoring and reviewing key clinical documents (protocols, SOPs, CSRs), directly managing vendor/CRO relationships, and working alongside junior staff rather than exclusively through delegation. Candidates seeking a purely oversight or figurehead role are not a fit for this position.

Compensations & Benefits: 

• Your paycheck: Competitive salary based on experience, ranging from $250,000 - $275,000 annually. 
• Health and wellness: Comprehensive plans with medical, dental, and vision coverage, plus a Flexible Spending Account (FSA) for eligible healthcare expenses. 
• Future nest egg: A 403(b)-retirement plan with an employer match of 3.5% helps you save for your future. 
• Relax and recharge: Generous time off, including paid time off and paid holidays. 
• We have you covered: Comprehensive paid leave for family and medical needs, ensuring you have the support you need during important times. 

This role is based in Cambridge, MA, with an expectation of minimum 3 days per week in office.  

Every Cure is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We provide equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, genetics, or any other characteristic protected by federal, state, or local laws.

Real Chemistry is looking for an Account Director to join our growing Medical Communications team! We are open to Account Director, Senior Account Director, and Group Account Director level candidates!

The Account Director for the Scientific and Medical Affairs team serves as the primary client contact, leading client relationships of ~$2M, providing strategic counsel, and overseeing the successful execution of projects for emerging and mid-stage biotech companies as part of our Biotech Center of Excellence (COE). You will ensure high-quality deliverables, proactively identify opportunities for account growth, and manage internal teams effectively. 

This is a hybrid role based in our Boston office. 

What You’ll Do: 

• Serve as the day-to-day client lead and trusted advisor for emerging and mid-stage biotech partners across medical affairs and publication workstreams, leveraging our Biotech COE
• Provide senior-level strategic counsel on key programs, tailoring recommendations to the realities of emerging and mid-stage biotech (e.g., evolving evidence, rapid timelines, and lean teams).
• Oversee account operations to ensure seamless execution of high-quality deliverables - driving proactive issue resolution, clear stakeholder communication, and consistent delivery standards across the Biotech COE
• Drive strategic planning and account growth by identifying opportunities to evolve and expand programs for existing and identified emerging and mid-stage biotech clients. 
• Ensure financial stewardship across the account, including budget oversight, forecasting, resourcing, and profitability management.
• Mentor and develop team members, fostering a collaborative, high-performing environment and contributing to capability-building within the Biotech COE.
• Stay current on industry trends, competitor activity, and relevant regulatory updates - translating insights into practical guidance for biotech clients.
• Support new business efforts for emerging and mid-stage biotech, contributing to pitches and proposals and partnering with the Biotech COE to showcase differentiated expertise. 

What You Should Have: 

• 6+ years of experience in medical affairs and ideally publications, in an agency setting.
• Minimum of 3 years of experience servicing biotech clients.
• Proven leadership skills, with experience managing client relationships and internal teams.
• Strong strategic thinking and problem-solving abilities, with a track record of driving account growth.
• Exceptional communication and presentation skills, with the ability to influence and engage stakeholders at all levels.
• Highly organized, detail-oriented, and able to manage multiple priorities in a fast-paced environment.
• Proficiency in financial management, including budget tracking and forecasting.
• Experience with Advisory boards, investigator meetings, and meeting management.
• Veeva management expertise (preferred but not required).
• Bachelor’s degree or equivalent work experience required. 

This position is a perfect fit for you if:  

• ​Our Company values – Best Together, Impact-Obsessed, Excellence Expected, Evolve Always and Accountability with an “I” – really speak to you. 
• You are adaptable, resilient, and OK with adjusting your scope, responsibilities, and focus as we grow. When things change, so do we. We’re always evolving. 
• You are proactive, driven, and resourceful with strong prioritization skills and a desire to dive into the data. 
• You are a highly organized self-starter, able to work independently and under tight deadlines.  

About the role: We are hiring frontline sales professionals to be part of a diverse and elite biopharma sales team dedicated to helping patients in need. With a laser focus on the eye care customer, the Territory Leader will be responsible for territory disease state education along with the launch and ongoing growth of XDEMVY. They will deliver high standards for the ongoing launch and beyond and will champion a culture of outstanding performance, compliance and full ownership of all activity and results. The Territory Leader will be experts in account management, business ownership, sales execution, resource utilization, and they will build and foster relationships with key eye care customers. The Territory Leader will relentlessly pursue excellence to maximize sales in their territory while learning to adapt to changes and needs of the business. In doing so, they will have the unique opportunity to meaningfully contribute to the growth and performance of Tarsus. This critical sales role will be ideal for someone who thinks strategically, operates with tactical precision and strives for excellence.

Geography: Candidates must live in Worcester, Framingham, Wellesley, Waltham 

Let’s talk about some of the key responsibilities of the role:

Account Management & Eye Care Experts

• Experts in eye care clinical information: anatomy, disease state, products, XDEMVY and office treatment patterns
• Experts in selling skills and account development including building relationships with all key stakeholders
• Experts in pull through tactics with a full understanding of managed care hurdles
• Understand all functions within an ophthalmology/optometry practice and how their roles impact product prescribing and pull through
• Maximize managed care opportunities within the territory and have an understanding of how it impacts the District, Region and Nation and share important feedback
• Understand key opinion leaders within respective geographies and foster engagement with Tarsus leadership
• As eye care experts, champion compliant promotion in alignment with our corporate values

Business Acumen & Sales Execution

• Drive top tier execution by exceeding sales performance goals and key productivity metrics across the territory
• Use expert analytical skills to guide highly productive activity – prioritize key customer engagements, drive reach and frequency to extend depth and breadth of product trial and utilization
• Drive a successful launch and ongoing performance by monitoring all key performance metrics weekly, monthly, quarterly, and annually – ability to adjust approach as needed based on data
• Ensure actionable business plans are set - align all selling activities to drive impact
• Share ongoing insights with leadership and internal stakeholders to ensure feedback is captured
• Personal accountability for driving the highest standards of ethics and compliance

Business Owners & Culture Champions

• Drive our culture of commitment, empowerment and teamwork which includes extreme ownership, high accountability, continuous improvement and relentless pursuit of excellence
• Achieve success and be prepared to adapt in a complex selling environment partnering with many stakeholders: district leaders, marketing, market access, medical affairs, sales ops, inside sales, training, and other important stakeholders
• Provide frontline feedback and intel to sales leadership and the broader organization
• Ensure PDMA compliance and adhere to all company & industry compliance guidelines
• Share ongoing best practices among peers and leadership to elevate national performance
• Maximize all key resources that lead to territory success

Factors for Success:

• Bachelor’s degree in business, science, or related field or commensurate experience
• 2+ years pharmaceutical sales / relevant healthcare sales experience or a proven track record of business to business sales - required
  • Proven track record of pharmaceutical launch experience - strongly preferred
  • Eye Care experience- preferred
• Established track record with evidence of excellent problem solving and collaboration
• Highly adaptable to change, able to quickly pivot and respond given new market information in a fast-paced environment
• Strong communication and change management skills
• Proven ability to escalate difficult issues and make tough decisions
• Established track record in the following job competencies:
  • Selling skills
  • High performance
  • Impact & influence
  • Customer focus & account management
  • Maximizing resources
  • Analytical skills
  • Relationship building
  • Decision making & judgment
  • Teamwork & collaboration
  • Adaptability & GRIT

A Few Other Details Worth Mentioning:

• This is a field-based position reporting to the District Sales Leader
• Geography: Candidates must live in Worcester, Framingham, Springfield, Pittsfield
• Travel will be required within the selling geography and beyond to sales meetings, possibly across various customer conventions and occasional travel to HQ in Irvine CA
• 40% - 50% travel required in some larger geographies
• Territory Leader Salary Range;
• • Associate Territory Leader – 2+ years proven B2B selling - $110,000
  • Territory Leader – 1-2 years pharma selling - $123,000
  • Territory Leader – 2-5 years pharma selling - $139,000    
  • Sr. Territory Leader – 5-8 years pharma selling - $145,000            
  • Sr. Territory Leader – 8+ years pharma selling - $161,000

At Tarsus, we understand the importance of attracting and retaining top talent. In addition to a competitive base pay, we offer an incentive bonus, stock equity, and comprehensive benefits. The base pay range reflects the target range for this position, but individual pay will be determined by additional factors such as job-related skills, experience and relevant education or training. Our benefits include health, dental and vision insurance benefits to ensure your well-being. We believe in work-life balance and offer generous paid time off, including vacation, holidays, and personal days. For more details regarding Tarsus benefits, please visit: https://eb.alliant.com/26tarsusbenefitssnapshot.

#LI-Remote

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

Client Program Coordinator 

• Location: Newton, Massachusetts (Hybrid, 2-3 days per week in office)
• Reporting to: Client Program Manager
• Employment Type: Full-Time
• Salary: $55,000

Position Summary

The Client Program Coordinator (CPC) serves as a key member of our operations team, which supports the account management and business development teams. The CPC plays a central role in helping to guide clients through our onboarding, product delivery, and renewal process to help drive revenue growth. Primary responsibilities include executing operations and logistics for our training programs, developing relationships with client accounts, which could be across corporate, public, and university verticals, and contributing to key account retention and expansion. The CPC must thrive in novel, high-stakes situations that require creativity, intuition, and big-picture thinking, and will have an opportunity to work closely with senior leaders at Wall Street Prep as well as with decision-makers at top investment banks, private equity firms, and Fortune 500 Companies

Key Responsibilities

Client Program Management

• Support Client Program Managers by coordinating all logistics for live seminars (in person and/or virtual) including scheduling, being proactive with internal communications with trainers, reviewing travel bookings, and having professional client communications.
• Take the lead in executing additional tasks related to key client accounts and the integration of users into our LMS system.
• Coordinate planning/debrief calls with existing clients. 
• Assist with client quarterly business review sessions or other periodic check-ins
• Work with our business development teams to provide best-in-class service to our potential future and existing key corporate client accounts.
• Oversee and execute on logistics for our University, Public Seminars and/or virtual or live team or marketing events. This includes scheduling, coordinating calendar invites, reviewing travel booking, creating logistics docs, setting up online accounts

General Operations

• Assist in fulfilling client requests within Wall Street Prep’s customer support desk.
• Assist various members of the senior leadership team with ad hoc projects, such as documentation of internal processes, creation of marketing materials, and the upload and management of website content in WordPress.
• Work in partnership with the Head of Learning to coordinate staffing assignments for training sessions. 
• Serve as a liaison to the Finance department to ensure invoicing information is processed correctly. 

Required Skills

• Demonstrable customer service experience
• Excellent follow-through and ability to build trust and credibility with clients by consistently delivering best-in-class client service experience
• Ability to think and plan ahead without prompting
• High degree of organizational skills and attention to detail
• Superb ability to communicate effectively (verbally and in writing) with a team and client base that has diverse and varying communication styles. 
• Excellent listening, negotiation and presentation skills
• Experience working with Excel and PowerPoint
• Ability to prioritize tasks in a dynamic and ever-changing environment
• A collaborative team player who is excited to have a dynamic role in a growing organization
• Proven ability to work cross-functionally with operations, business development and account management teams
• Passion and commitment to bringing the best financial services training resources to improve training outcomes for all our clients.

Required Education and Experience

• Bachelor’s degree from an accredited college or university.
• 0-2 years of experience in account management, client services, operations, media relations or public affairs. (Internships count as experience!)
• Experience in financial services (investment banking, asset management or private wealth management) is a plus.

Work Environment

• Hybrid (2-3 days in office)
• Office Located in Newton, MA
• Free parking 
• Light travel required (primarily to New York City)

Salary

$55,000 per year

CORE COMPETENCIES

• TEAMWORK – As a Client Program Coordinator, you will work with a diverse set of individuals and you must have the ability to empathize and collaborate with individuals from a range of background and experiences.
• INTEGRITY – Much of our work is dependent on trust and respect, so consistency of actions and taking responsibility for one’s own actions is very important. We value team members that strive to do what is right.
• ACCOUNTABILITY – We value the ability of our team and organization to honor our commitment to clients and to other team members.
• HUMILITY – Value openness and curiosity to learn from team members and all that we serve. Be open to personal change and continuous improvement.
• RESULTS-DRIVEN – Have an excellent track record of outcomes. Our clients depend on us to deliver top quality trainings and content. Every task (small or great) should be geared at delivering excellent work and results.
• TRANSPARENCY – At WSP, we pride ourselves on being transparent about our work and methods. Every team member should embody honest and open communication.

WHAT WE OFFER

• A fun, lively, startup culture
• Unlimited PTO
• Full benefits package including medical, dental, and vision
• 401(k)
• Parental leave
• Stipend to setup home office
• Core values-based leadership
• Ample opportunities to learn and take on new responsibilities in a fast-paced, growth-mode company

ABOUT WALL STREET PREP

Wall Street Prep (WSP) is the leading provider of financial services training solutions to the world's preeminent investment banks and private equity firms. Founded in 2004, WSP seeks to bridge the gap between academia and the real world by providing our clients with the practical skills and knowledge needed to succeed in the finance sector. We provide clients with this hands-on, competitive edge through classroom training led by experienced industry practitioners as well as through online self-study programs designed by subject matter experts. WSP's clients include global investment banks, private equity and investment management firms, Fortune 500 companies, and top undergraduate business and MBA programs.

Wall Street Prep is proud to be an equal opportunity employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status or any other legally protected status. We celebrate diversity and are committed to building an inclusive work environment where all team members are encouraged to be their authentic and whole selves.

What You’ll Do:

Reporting to the Senior Medical Director, Global Patient Safety and Pharmacovigilance (DSPV), the Medical Director will provide strategic, scientific, and tactical leadership for global medical safety evaluation and benefit-risk management for assigned Kailera products throughout their lifecycle with focus on patient well-being and compliance with applicable regulatory requirements.

This role is instrumental in ensuring patient safety, regulatory compliance, and robust characterization of benefit-risk in both clinical development and real-world use, including shaping risk-management strategies, integrated evidence generation planning, and real-world evidence approaches. 

The medical director will collaborate extensively across and within their own function to advance Kailera’s pharmacovigilance strategy to support the company’s evolving pipeline, innovation, and mission. 

Required location: Waltham, MA (hub-based, onsite 3-4 days per week)

Responsibilities:

• Provide expert medical interpretation of safety data from all sources (clinical, post-marketing, literature, and RWE) and perform medical review of Individual Case Safety Reports (ICSR) within the ARGUS database
• Oversee and execute safety signal detection and evaluation activities, ensuring timely, scientifically sound assessments and the optimization of signaling systems through data visualization and analysis tools
• Incorporate insights from real-world data (EHRs, claims, registries) into surveillance and benefit-risk assessments to support evidence-generation strategies
• Lead the development and oversight of global benefit-risk assessments and safety surveillance for clinical development programs and post-marketing phases
• Drive the lifecycle management of Risk Management Plans (RMPs) and other risk minimization strategies, ensuring proactive identification and mitigation of safety risks
• Lead the authoring and medical review of safety sections for regulatory documents (IBs, Protocols, DSURs, PSUR/PBRERs, and RMPs) and safety modules for marketing applications
• Support labeling decisions and contribute medical expertise to safety communications, risk materials, and scientific publications
• Collaborate with cross-functional stakeholders to integrate safety considerations into clinical development, post-marketing activities, and evidence-generation strategies
• Lead and inspire a team of PSPV MDs, scientists, and operational colleagues, fostering a culture of accountability, scientific excellence, and collaboration
• Partner with senior leadership (SVP/Medical Director) on departmental goals, organizational design, budgeting, and long-term pharmacovigilance planning
• Act as a Subject Matter Expert (SME) for safety technology strategies, identifying innovative technical or resourcing solutions to improve DSPV surveillance capabilities
• Contribute to the design, implementation, and enhancement of drug safety processes and systems to ensure high-performance PV operations
• Maintain the medical safety governance framework, ensuring the timely identification, assessment, and escalation of significant safety issues
• Represent the PSPV function during audits and inspections, leading the preparation of responses and managing deviations or CAPAs related to medical safety science.
• Drive the development of SOPs, work instructions, and "fit-to-purpose" pharmacovigilance training for internal and external partners

Required Qualifications:

• 8+ years of experience in global pharmacovigilance
• 2+ years of experience in clinical practice or academic medicine
• Proven experience in safety data analysis, signal management, and benefit-risk evaluation
• Working knowledge of safety databases (Argus, ArisG/LifeSphere Safety, or similar)
• Demonstrated ability to develop and implement drug safety strategies, risk management plans, and safety governance models
• Proven experience with authoring or contributing to clinical study and regulatory submission documents
• Thorough knowledge of relevant FDA and International Conference on Harmonization (ICH) guidelines, including Good Clinical Practices (GCP) guidelines
• Strong knowledge of global safety and pharmacovigilance regulations, guidelines, and industry standards (FDA, EMA, ICH, GVP)
• Experience in creating or managing working documents such as SOPs or Work Instructions
• Strong ability to proactively identify risks and initiate/manage risk minimization activities
• Strong ability to lead in a cross functional setting and work collaboratively with internal and external partners in a fast-paced environment
• Strong ability to prioritize, multitask, and deliver quality results that meet tight timelines
• Ability to influence and keep teams focused and motivated
• Strong ability to communicate complex issues clearly

Preferred Qualifications:

• Experience in pharmacoepidemiology, data science, or medical affairs is a plus

Education:

• MD, DO or equivalent medical degree required. Ph.D. degree is a plus

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.

Your Impact

You will design and lead the strategy that unlocks scalable procurement and partner-driven growth across our US Public Sector business. By building and optimizing our state and cooperative contract portfolio, activating high-impact commercial partnerships, and proactively clearing procurement hurdles for new products, you will remove friction from the buying process, expand market access and accelerate revenue growth. This role sits at the intersection of Sales, Legal, Product, Finance, and Government Affairs — translating go-to-market priorities into executable contracting and commercialization frameworks that drive measurable growth.

What You’ll Do

Location: This role is based out of our Boston, MA office and follows a hybrid schedule. We rely on in-person collaboration and ask that team members work onsite Tuesdays through Fridays, with the flexibility to work remotely on Mondays, unless there is an approved workplace accommodation. We believe that connection fuels innovation, and our in-office culture is designed to foster meaningful teamwork, mentorship, and shared success.
Reports to: Senior Director, Strategy & Enablement
Direct Reports: None

State & Cooperative Contract Strategy

• Develop and execute a forward-looking state and cooperative contract strategy aligned to go-to-market priorities; anticipate procurement needs 12–18 months in advance and establish required vehicles ahead of revenue timelines.
• Establish, expand, and renew statewide and cooperative contracts to include new products, services, and pricing models that support growth objectives.
• Lead negotiations for new and expanded contracts, aligning Legal, Sales, Finance, and external stakeholders to secure favorable commercial and operational terms.
• Own strategic relationships with cooperative purchasing organizations and evaluate new vehicles based on revenue potential and market coverage.
• Track contract utilization and performance, identifying opportunities to optimize scope, usability, and adoption across priority markets.

Commercial Partner Strategy & Activation

• Operationalize new commercial partnerships identified by Corporate Development by designing the revenue activation plan and establishing repeatable pathways to secure the first deals on Axon paper.
• Identify priority accounts and use cases where partner products strengthen Axon’s solution; align Sales, Product, Marketing, and the partner on positioning, pricing, and enablement readiness.
• Build scalable procurement and contracting frameworks that allow Axon to compliantly resell partner products within public sector constraints, tracking early performance and refining activation strategy based on results.

New Product Growth Enablement

• Proactively identify and remove procurement, contracting, and regulatory barriers that could delay adoption of new products in state and local markets.
• Ensure state-specific requirements and contract inclusion strategies are understood early and addressed in alignment with launch revenue timelines.
• Translate complex procurement considerations into actionable guidance for Sales and Enablement teams.

What You Bring

• 7+ years of experience in public sector strategy, government contracting, channel/partner strategy, business development, or sales operations within a complex, multi-stakeholder environment.
• Demonstrated success designing and executing strategies that expanded market access and accelerated revenue growth.
• Experience operationalizing commercial partnerships or resell models, translating partnership agreements into executable revenue plans.
• Comfortable balancing legal, financial, and commercial considerations in negotiations.
• Proven ability to influence senior stakeholders and drive cross-functional alignment without direct authority.
• Experience supporting new product launches or commercialization strategies within regulated or procurement-constrained markets.
• Analytical mindset with ability to assess performance metrics, identify friction points, and refine strategy based on data.
• Strategic thinker with a bias for action and a track record of delivering complex, long-horizon initiatives to completion.
• Deep understanding of public sector procurement, including statewide master contracts and cooperative purchasing organizations is a plus.
• Experience in Government Technology, SaaS, or Public Safety Technology preferred.

Benefits that Benefit You

• Competitive salary and 401k with employer match
• Discretionary paid time off
• Paid parental leave for all
• Medical, Dental, Vision plans
• Fitness Programs
• Emotional & Mental Wellness support
• Learning & Development programs
• And yes, we have snacks in our offices

Benefits listed herein may vary depending on the nature of your employment and the location where you work

About the Role

We are seeking a highly motivated, proactive, strategic, and solution-focused Head of Clinical Operations. This hands-on position will lead and support all aspects of clinical trial operations including planning, implementation, execution, and management of clinical studies by overseeing day-to-day operations, including direct management of outside Clinical Research Organizations (CROs) for several clinical stage oncology assets. In this role, the Clinical Operations leader will manage multiple priorities in a fast-paced environment and enact quick problem solving to ensure the successful conduct of clinical trials and the timely delivery of high-quality data. This role will oversee early and late phase trials with an emphasis on proactivity and creative solutions to overcome regulatory and operational hurdles. The successful candidate will have experience, and interest in, working in a small, dynamic environment with broad responsibilities.

Responsibilities

• Develop and lead a team of clinical operations professionals to ensure high-quality execution of early and late phase clinical trials and the professional development of team members.
• Serve as subject matter expert in clinical operations, providing guidance and expertise to cross-functional teams, including clinical development, regulatory affairs, and data management.
• Provide operational expertise and strategic input to Clinical Development Plans and support the overall clinical strategy for clinical programs. 
• Proactively communicate study plans, progress, risks and mitigations with senior leaders.
• Develop, implement, and modify when needed a successful resource and outsourcing model to meet the evolving demands of an expanding clinical portfolio.
• Manage study site selection, qualification, initiation, and monitoring activities to ensure that clinical trials are conducted according to the study protocol and in compliance with regulatory requirements.
• Evaluate and negotiate budgets, oversee selection and provide oversight and management of CROs, consultants and vendors to ensure the effective and timely execution of clinical trials, with high quality (including inspection ready) and within agreed budget.
• Monitor progress of clinical activity and report on the progress of clinical trials including budget, timelines, enrollment, and data collection / review. 
• Participate in the creation, review, and finalization of clinical study-related documents such as protocols, protocol amendments, clinical study reports (CSRs), regulatory submissions and other publications as required.
• Coordinate the delivery of clinical trial supplies in collaboration with CRO and other company team members.
• Develop and maintain strong relationships with clinical investigators and study site staff to ensure site performance, patient enrollment, and data quality; perform periodic visits to sites and/or vendors to assess progress and compliance.
• Ensure clinical trials maintain an inspection readiness state throughout the lifecycle of the trial and provide subject matter expertise for regulatory inspections.
• Maintain knowledge across the clinical operations team of program specific therapeutic areas, current medical practice, and pharmaceutical regulations in order to ensure best practice across all activities and appropriate communication to study sites.
• Proactively implement process improvements and innovative approaches. Support the creation of clinical operations Standard Operating Procedures (SOPs), systems, and processes across the trials; ensures compliance with regulatory and other applicable standards and guidelines.

Qualifications:

• Bachelor’s degree (BA/BS) in a relevant scientific field (e.g. nursing, biology, biochemistry, or related areas); advanced degree preferred.
• At least 15 years of experience of successfully leading studies within clinical research operations. Experience with both small and large biotechnology companies is favorable.
• Experience in Phase I-III oncology clinical studies. Global experience preferred.
• Demonstrated expertise building and managing clinical operations teams.
• Excellent verbal and written skills, allowing for an open and effective dialogue throughout the company.
• Highly accountable for the results and outcomes of their responsibilities and understands the impact of their efforts, results, and attitudes on others.
• Experience with agency submissions and inspections, understands adherence to SOPs, ICH/GCP, and FDA and other health authorities’ regulations.
• Forward thinking mindset with ability to manage multiple projects, identify and resolve issues.
• Strong analytical, organizational, and time management skills with a track record of identifying and implementing novel solutions and problem-solving.
• Demonstrated agility and ability to navigate and be successful in a fast-paced, dynamic work environment.
• Proven hands-on leadership and communication skills (written and verbal).
• Team player who collaborates effectively with internal stakeholders as well as external contract organizations.
• Be a champion of a highly collaborative, transparent, data driven, “make it happen” culture.

This position is classified as exempt. The anticipated annual base salary range for candidates who will work in Watertown, MA is $319,333 - $375,665. The final base salary offered to the successful candidate will be dependent upon 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 job, education, and other factors. Treeline Biosciences is a multi-state employer, and this salary range may not reflect positions that work in other cities or states.

Recruitment fraud statement

Please be aware of recruitment fraud and related job scams, where scammers present themselves as recruiters but are seeking to steal money or personal information. Keep the following in mind to protect yourself:

• Treeline Biosciences will never ask for money from you as part of our recruitment process. Do not provide bank details or pay somebody for the promise of a job at Treeline.
• We do not conduct interviews through Skype or Telegram.
• Our job openings are first posted to treeline.bio/careers. If you locate a listing for a Treeline job on another site, please ensure it is also posted on our careers website.
• You can find more information about job scams at consumer.ftc.gov/articles/job-scams.
• To report job scams, head to ReportFraud.ftc.gov.

Real Chemistry is looking for a Account Manager/Senior Account Manager join our growing team!   

The Account Manager/Senior Account Manager for the Scientific and Medical Affairs is the client’s key day-to-day contact, managing relationships and helping to set their expectations of the agency. You make sure that your colleagues know what is going on and are delivering effectively. You are thinking about future opportunities as well as today’s work.   

This is a hybrid role, based in any of our US offices—including New York City, Boston, Chicago, Carmel, or San Francisco—or remotely within the US, depending on team and business needs.

What you’ll do:  

• Day-to-day client contact: provide regular status updates to your client; respond to client queries and share recommendations (following discussion with your account lead); manage client expectations on timelines, scope of project, etc.; take client briefs and clearly communicate to team members, implementing realistic project plans  
• Take responsibility for the day-to-day management of your account, including managing the processes of the account (including running regular internal team meetings), flow of work, delegation of tasks (oversee status reports to ensure all team actions are complete) and the status of jobs across the account (not just your own)  
• Ownership of and accountability for medium/large client projects, ensuring that projects are delivered to highest possible standards within budget and agreed timeframes  
• Ongoing communication with your account lead on the progress of projects; alerting them to any barriers to project completion and being proactive in making recommendations and proposing solutions on how to proceed  
• Awareness of the client’s business priorities and a sound understanding of the program strategy; have a good understanding of competitor activity  
• Keep abreast of trends and developments in the medical communications and pharma industries  
• Start to identify areas for growth (evolving existing programs and/or additional tactics), proactively sharing new ideas with your team and client  
• Keep abreast of market changes  
• Be proactive when new business opportunities arise, flagging relevant experience and areas of interest, contributing thoughts and ideas, assisting in the production of credentials and pitch presentations  
• Maintains general understanding of account finances; supports account lead with financial management  
• Support new business research and ideation, participate in pitch presentations as required 
• Continued professional development engagement; work with manager to identify training opportunities based on areas of interest and need  

This position is a perfect fit for you if:  

• ​Our Company values – Best Together, Impact-Obsessed, Excellence Expected, Evolve Always and Accountability with an “I” – really speak to you.  
• You are adaptable, resilient, and OK with adjusting your scope, responsibilities, and focus as we grow. When things change, so do we. We’re always evolving.  
• You are proactive, driven, and resourceful with strong prioritization skills and a desire to dive into the data.  
• You are a highly organized self-starter, able to work independently and under tight deadlines.  

What you should have:   

• A minimum of 3 years of prior experience in healthcare agency client services roles with medical affairs, publications, and/or medical information experience required 
• Highly organized with a mindfulness of deadlines, the ability to manage multiple tasks based on priorities and a strong attention to detail  
• Independent thinker confident in taking ownership of assets and material development, but a team player who enjoys collaboration  
• Professional presence, performs with a sense of urgency and with a client service orientation  
• Has confidence to manage upward when required; able to communicate with managers when deadlines will not be met or when issues are foreseeable  
• High energy, able to effectively operate in fast-paced, growing and evolving environment  
• Demonstrated strong work ethic, with a track record of following through on client requests and with high-quality deliverables on schedule and on budget  
• Able to work independently and as part of a team 
• Competent in using Microsoft Word, PowerPoint, Excel, and Outlook 
• Experienced in developing client relationships and networking 
• Strong financial acumen 
• Comprehension of project and account objectives, contributing to strategic planning 
• Able to devise and articulate solutions to problems on an ongoing basis  
• Able to clearly communicate project updates, scopes and recommendations to clients  
• Veeva management and/or iEnvision experience recommended but not required  
• BA or equivalent work experience required  

Pay Range: $70,000.00-$100,000.00

This is the pay range the Company believes it will pay for this position at the time of this posting.  Consistent with applicable law, compensation will be determined based on job-related, non-discriminatory factors including but not limited to work experience, skills, certifications, and geographical location. The Company reserves the right to modify this pay range at any time.  

Position Summary:

The Director of Scientific Communications & Evidence Generation will be responsible for developing a plan for disseminating the company’s scientific data (manuscripts, abstracts, posters, presentations); as well as identifying clinical evidence gaps, overseeing non-registrational research, and collaborating with cross-functional teams to generate real-world evidence (RWE), health economics and outcomes research (HEOR), and investigator-sponsored research (ISR) to support product value and safety profiles. This role requires strong scientific writing skills, advance understanding of industry best practices related to publication-related and research-related compliance, as well as cross-functional leadership savvy.

Key Responsibilities:

Scientific Communications & Publication Planning

• Develop and maintain and 18-month publication plan and lead the publication review process (abstracts, posters, oral presentations, manuscripts, review articles, etc) in compliance with GPP (Good Publication Practice) and ICMJE authorship criteria, as well as data transparency, and fair balance.
• Utilize innovative formats (micro‑learning, interactive pathways, patient‑friendly visuals) and ensure accessibility for diverse audiences
• Maximize the scientific impact of company data via the strategic selection of journals and congresses
• Collaborate with internal/external expertsand vendors to draft content and ensure the scientific accuracy of all data to be presented.
• Maintain the enterprise scientific lexicon and core claims matrix; ensure consistency across materials and channels.

Data Generation: 

• Lead the development of an integrated evidence generation plan (IEGP) aligned with overall medical affairs goals to address unmet needs in collaboration with Clinical Development, Regulatory, HEOR, and Commercial teams to avoid duplicative efforts. 
• Evaluate and acquire new data sources (clinical trials, RWD, registries) to support evidence plans.
• Create processes for synthesizing feedback from various sources, including field insights and advisory boards and analyze the data to uncover trends and actionable insights to guide scientific communication and strategic decision-making designed to effect change.
• Conceptualize and execute non‑promotional education for multidisciplinary audiences (hematology, BMT/transplant, apheresis, transfusion medicine, genetic counseling, nursing), including webinars, symposia, workshops, and digital learning modules.
• Establish content measurement frameworks (reach, engagement, knowledge lift, practice intent) and continuous improvement loops.
• Provide operational management for Medical Affairs-led research, including RWE, HEOR, and ISR, including monitoring the contractual commitments of vendors and collaborators to ensure quality and timeline adherence.
• Ensure all evidence generation activities follow ICH-GCP guidelines, SOPs, and compliance requirements for post-marketing research.

Cross‑Functional Partnership

• Collaborate within Medical Affairs and with Clinical Development, Regulatory, Pharmacovigilance, Commercial, Market Access, and Patient Advocacy to ensure accuracy and balance across communications.
• Develop and deliver scientific training programs for internal teams (e.g., onboarding for MSLs/field medical; refresher modules on gene therapy mechanisms, safety monitoring, LTFU requirements)..

Associated Responsibilities:

• Own Med Affairs content as well as related SOPs and work processes.
• Ensure adherence to policies and procedures via audits.
• Develop and deliver monthly and quarterly updates to track progress and align on key priorities.
• Develop and manage department budget
• Lead or co‑lead medical review for scientific materials; partner with Legal/Compliance/Regulatory on clear SOPs and guardrails.

Qualifications:

• MD, PharmD, PhD in a biomedical field; experience in hematology or Oncology or cell and gene therapy strongly preferred.
• 8+ years in Medical Affairs/Scientific Communications within biopharma, including publication planning and medical education leadership.
• Understanding of hemoglobinopathies (SCD, β‑thalassemia), cell‑based gene therapy modalities, safety monitoring (including long‑term follow‑up), and registry/RWE experience is preferred
• Experience building omnichannel education programs.
• Fluency with compliance frameworks (GPP, ICMJE, ACCME, OIG, PhRMA Code) and medical review processes.
• Exceptional scientific writing, editorial judgment, and stakeholder management; comfortable engaging with KOLs, investigators, and advocacy leaders.

Your Impact:

• Northeast: As a Government Affairs Senior Manager, you will report directly to Axon’s Sr. Director of Government Affairs and work closely with internal and external stakeholders to support the team’s state and local legislative and regulatory, sales procurement, and grassroots advocacy efforts in the Northeast region (KY, WV, VA, MD, DE, PA, NJ, NY, CT, MA, VT, RI, NH, ME) . You will help drive Axon’s presence and position with state, city and county governments related to issues impacting the company, the sales team, and the industry. You will be a representative of Axon and lead meetings with state, city and county government officials to advance Axon’s position with relevant government and law enforcement stakeholders, as well as to drive broader awareness and support for Axon’s mission. In addition to the specific requirements listed below, the Senior Manager should be highly motivated, enjoy working in a fast-paced and often changing environment, have the ability to learn quickly, and be adept at setting priorities and anticipating needs.

What You’ll Do

Location: Northeast. Must be willing to travel 50%+ of time

• Assist in the development of strategic government affairs planning with a focus on supporting business development
• Monitor and assess state legislative and regulatory actions and initiatives
• Prepare position papers and project messaging points
• Lead meetings with elected officials, appointed officials, and government staffers
• Develop and maintain contacts with industry, elected officials and associations/third party groups
• Work closely with the sales team on assigned procurement opportunities
• Conduct research on local purchasing by-laws, council legislative process, and create purchasing process maps for city and county governments to support sales team efforts
• Assist in management of external government affairs consultants

What You Bring

• Minimum of 8 years combined full-time employment in city/county/state government and/or government relations firm
• Experience driving legislation
• Strong policy and analytical skills
• Experience multi-tasking and prioritizing work assignments under deadlines
• Excellent written and verbal communications skills, including the ability to synthesize complex information
• Recognized ability to work independently to drive assigned goals but also a team player to support the holistic needs of the department and the company
• A strong desire to continually improve and undertake new challenges
• A strong sense of accountability with high ethical standards
• Experience working with city, county, or state governments is a plus

Benefits that Benefit You

• Competitive salary and 401k with employer match
• Discretionary paid time off
• Paid parental leave for all
• Medical, Dental, Vision plans
• Fitness Programs
• Emotional & Mental Wellness support
• Learning & Development programs

Benefits listed herein may vary depending on the nature of your employment and the location where you work

What You’ll Do:

The Associate Director, Scientific Communications is responsible for leading the strategic planning, development, and execution of high‑quality scientific communications that advance Kailera’s Medical Affairs objectives. As a key member of a highly collaborative and fast-moving team, this individual will shape scientific narratives, drive publication strategy, and ensure the delivery of clear, accurate, and impactful scientific communication materials.

Required location: Waltham, MA (hub-based, onsite 3-4 days per week)

Responsibilities:

• Provide strategic leadership for scientific communications across our portfolio of assets, including publications, field medical resources, medical symposia content, and internal/external training materials
• Lead cross‑functional planning discussions and oversee timely development of scientific communications deliverables in a dynamic, fast‑paced environment
• Manage external agencies, writers, and vendors to ensure high‑quality, cost‑effective execution aligned with program strategy
• Ensure all materials are scientifically rigorous, accurate, balanced, compliant, and consistent with Kailera policies and industry standards (e.g. GPP, ICMJE)
• Contribute to the evolution of scientific platforms, lexicons, and communication frameworks that support Kailera’s growing pipeline
• Represent Scientific Communications in internal governance discussions and support preparation for scientific congresses and external engagements

Required Qualifications:

• At least 5+ years of relevant experience in Scientific Communications within Medical Affairs or a medical communications agency with an advanced degree
• Demonstrated experience in scientific publications and/or medical communications is required
• Excellent interpersonal, analytical, and communication skills, with the ability to incorporate feedback from diverse stakeholders
• Strong planning and organizational capabilities; able to manage multiple priorities and thrive in a fast-paced environment
• Ability to travel to scientific meetings as needed (up to ~10%)

Preferred Qualifications:

• Experience in the obesity therapeutic area or adjacent metabolic/endocrine fields is preferred, but not required
• CMPP certification is not required, but is a plus

Education:

Advanced degree (PharmD, MD, PhD preferred) in the life/health sciences

Job Summary:

Real Chemistry is looking for a Managing Director to join our growing team!

The Managing Director will be a senior leader tasked to drive the agency strategy, positioning, and offerings for our clients.  They will support a distinctive employee experience for our multi-disciplinary and multi-cultural team.

The majority of clients come from the healthcare sector with aspirations to expand into non-healthcare markets over time while continuing growth in healthcare. The current scopes are diverse and include multiple fields: PR, CTR, digital and social marketing, internal communications, branding, analytics and tech dev. Our clients know us as an integrated consultancy to whom they can trust – regardless of project scope or scale.

Our Managing Directors are agile, responsive, and have strong conceptual thinking capabilities. As Real Chemistry has continuously achieved significant growth over the past several years, this person should also be comfortable with ambiguity and the uncertainty which comes with rapid innovation and growth. We are a senior-led team and our clients expect to have access and regular counsel from our leadership. This person will also need to be comfortable being tactically involved in the day-to-day workings of client work.

In addition, there is a need for strong internal communications to help lead change within the organization, support controlled growth, and maintain strong retention rates.

This is a hybrid role, based in any of our US offices—including New York City, Boston, Chicago, Carmel, or San Francisco—or remotely within the US, depending on team and business needs.

What you’ll do:

• Position yourself as an industry leader, networking to develop brand awareness.
• Build on current Medical Communication and Marketing offering to establish an operationalized, multi-disciplinary team including analytics, digital and creative.

• Previous experience of working in an agency environment in a similar position
• Proven track record of growing complex and multi discipline and integrated clients
• Proven success in new business and business development
• An entrepreneurial and innovative approach to growing clients and revenue for the business
• Must demonstrate strong commercial and financial acumen; having led a profitable business or business vertical

• Develop programs targeted specifically at Medical Affairs and Clinical Trials teams to access a new target audience for our consultancy.
• Grow the opportunities with clients into a broader portfolio of offerings including digital media, marketing, advertising, and social media.
• Lead all aspects of current portfolio and growth through current client base, net new business, and manage to profitability.
• Provide counsel across several existing accounts and lead multi-disciplinary team to deliver against client critical metrics.
• Client lead on a number of accounts providing senior strategic counsel, building multi- disciplinary teams by working in collaboration with shared services (analytics and creative) teams, as well as SMEs.
• Immerse quickly in Real Chemistry offerings and methodologies to take a coordinated approach to clients and new business.
• Develop 30-60-90 day plan to outline key needs and contributions; set expectations internally.
• Partner with current leadership team to drive and deliver a robust strategy for the consultancy.
• Facilitate training and mentoring of team to support the growth of the business. Infuse team with energy and passion through internal communication and respected partnership.
• Identify new hires to accelerate business growth through broader network or new skill set.

This position is a perfect fit for you if:

• ​Our Company values – Best Together, Impact-Obsessed, Excellence Expected, Evolve Alwaysand Accountability with an “I” – really speak to you.
• You are adaptable, resilient, and OK with adjusting your scope, responsibilities, and focus as we grow. When things change, so do we. We’re always evolving.
• You are proactive, driven, and resourceful with strong prioritization skills and a desire to dive into the data.
• You are highly organized self-starter, able to work independently and under tight deadlines.

What you should have:

• Bachelor’s degree or equivalent experience is required.
• 15+ years in a professional environment within the public relations, communications, or advertising industry.
• Management experience required; an approach to staff management that brings out the best in team members yielding operational excellence, pride, ownership, and a deep dedication to Real Chemistry.
• A successful track record of winning new business and growing current business.
• Outstanding communication skills to connect with a variety of audiences.
• The experience, ability and inclination to be an effective, inspiring leader for Real Chemistry.
• Exemplary interpersonal and listening skills; cultural sensitivity, particularly with respect to collaborating with global audiences via multiple media.
• Exceptional client management skills.
• A keen eye for operational efficiency and optimal use of resources; an aptitude for use of data and metrics in decision-making; the ability to plan, monitor, and tightly manage a budget.
• An awareness, appreciation, and knowledge of analytics and multi-channel marketing.
• A genuine passion for contributing to the transformation of a consultancy that is operating in a constantly evolving environment and a desire to work with a high-energy leadership team who sets the highest standards of performance.
• Strong team-based orientation; a personality that thrives in matrixed environments and enjoys partnering with all levels of team members to achieve results.

Pay Range: $200,000-$230,000
This is the pay range the Company believes it will pay for this position at the time of this posting.  Consistent with applicable law, compensation will be determined based on job-related, non-discriminatory factors including but not limited to work experience, skills, certifications, and geographical location. The Company reserves the right to modify this pay range at any time.  

Job Title: Medical/Senior Medical Director, Clinical Development (Multiple openings)        

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 Medical/Senior Medical Director of Clinical Development plays a key role in the execution and operational oversight of clinical trials, ensuring high-quality data generation to support the safety and efficacy of our pipeline products. This role involves supporting clinical study design, implementation, and data interpretation while working cross-functionally to align clinical activities with overall development plans. The Medical Director collaborates closely with internal and external stakeholders to ensure trial execution meets regulatory, scientific, and business objectives.

Key Responsibilities:

• Clinical Trial Design and Oversight:
  • Supports the development of clinical trial protocols, including patient selection criteria, study endpoints, and data collection methods
  • Oversees the conduct of clinical trials at study sites, ensuring adherence to protocols and good clinical practice (GCP) guidelines
  • Reviews and interprets clinical data to assess the safety and efficacy of the investigational drug
  • Authors and contributes to clinical and non-clinical documents required during the clinical development process (including but not limited to: Clinical Study Protocols, Investigator Brochures, Clinical Study Reports)
• Medical Expertise:
  • Provides medical expertise of the therapeutic area, disease state, and potential drug effects 
  • Reviews clinical data to identify and analyze safety concerns and adverse events, and makes appropriate recommendations to the team 
  • Stays current with relevant medical literature and clinical trial methodologies
  • Contributes medical expertise to external interactions with collaborators throughout the clinical development cycle  
• Cross-Functional Collaboration:
  • Works closely with other functions including clinical operations, regulatory affairs, medical affairs, biometrics, pre-clinical and project management teams to help ensure optimization of the clinical development process 
  • Presents clinical data to internal and external stakeholders
• Strategic Leadership:
• Contributes to the overall clinical development strategy
• Helps to identify critical clinical development milestones and helps the team to drive toward meeting or exceeding timelines
  • Leads the clinical contribution for clinical study reports, clinical documents and regulatory submissions
  • May oversee the work of Clinical Scientists working on the same or other programs

Qualifications:

• Medical degree (MD) with board certification in a relevant specialty
• Extensive experience in clinical research and development, ideally within the pharmaceutical industry
• Strong understanding of clinical trial design, GCP guidelines, and regulatory requirements
• Excellent communication, leadership, and analytical skills 

 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 the Medical Director is $255,00-288,000 and for the Senior Medical Director $306,000 to $343,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Oruka is a multi-state employer and this salary range may not reflect positions that work in other states.

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

About the Opportunity

We are seeking a highly skilled Machine Learning Scientist to drive the development and translation of cutting-edge ML models that have a direct impact on the care pathway for heart disease diagnosis and prognosis. In this role, you will collaborate with ML scientists, data engineers, biostatisticians, regulatory experts, and senior leadership to understand clinical requirements, develop innovative solutions, and support product development and regulatory approvals. You will also engage in high-impact research collaborations with world-renowned academic and medical institutions.

Responsibilities

• Research and develop state-of-the-art machine learning models for coronary CT angiography imaging applications.
• Conduct rigorous analysis and validation of machine learning algorithms and prototypes.
• Explore novel methods for processing and analyzing large, complex medical imaging datasets.
• Collaborate with engineering teams to deploy ML algorithms in clinical practice.
• Present research findings, insights, and recommendations to internal stakeholders and external collaborators.
• Author scientific publications and contribute to patent development.
• Manage collaborative research projects with leading academic partners.

Requirements

• Ph.D. in Computer Science, Data Science, Biomedical Engineering, Biomedical Imaging, or a related technical field; OR an M.S. with 5+ years of relevant experience.
• Strong theoretical and practical expertise in image science, applied mathematics, machine learning, and deep learning.
• Research experience in applying ML and deep learning techniques to medical image processing, including segmentation, registration, classification, reconstruction, and detection.
• Proven track record of publications in top-tier medical imaging or computer vision conferences and journals (e.g., MICCAI, IEEE TMI, CVPR, Medical Image Analysis).
• Proficiency in Python, with experience handling large datasets, implementing ML pipelines, and visualizing analysis results.
• Ability to translate complex clinical requirements into machine learning solutions.
• Strong critical thinking, problem-solving, and project management skills.
• Excellent interpersonal, cross-functional, and cross-cultural collaboration skills.

Preferred Qualifications: 

• 2+ years of postdoctoral research or industry experience.
• Hands-on experience in developing and applying advanced deep learning models, including vision transformers, semi-supervised/self-supervised/unsupervised learning, incremental learning, and continuous learning techniques.
• Strong domain knowledge in CT imaging and its clinical applications.

The base salary range for this role varies by location and is aligned to market benchmarks.

• Candidates located in higher-cost labor markets, including California, Washington, New York, New Jersey, Connecticut, Massachusetts, and Washington, DC represent the middle to high end of the range, while candidates located in all other U.S. locations represent the low to middle end of the range.
• Final compensation is determined based on location, experience, skills, and internal equity.

This role is eligible for a 15% target annual bonus, resulting in the following base salary and Total Target Compensation (TTC) ranges:

• Base Salary: $186,000 - $212,000
• TTC: $214,000 - $245,000

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

RC Resolve is a strategic communications advisory firm working at the intersection of finance, corporate reputation, public affairs, and brand for healthcare companies, backed by the capabilities and expertise of Real Chemistry.  

We partner with boards and management teams during normal course and transformative periods to design communications strategies that help companies advance business goals, build trust, and seize timely market opportunities. We counsel executives and boards through highstakes moments including M&A, IPOs, restructurings, shareholder activism, crises, and major corporate transformations. 

We are seeking a senior leader to build and lead our Financial and Transaction Communications offering, working with clients across sectors and geographies. 

This is a hybrid role, based in any of our US offices—including New York City, Boston, Chicago, Carmel, or San Francisco—or remotely within the US, depending on team and business needs.

Role Overview 

The Head of Financial and Transaction Communications will be a senior leader responsible for: 

• Building and leading our financial communications practice 

• Serving as a primary advisor to CEOs, CFOs, General Counsel, Heads of IR, and Boards working in concert with their key advisors 

• Driving new business and deepening relationships with existing clients to support issues and opportunities  

• Leading teams through complex, high-stakes, timesensitive, and confidential situations 

This role suits an experienced financial communications professional from a top-tier advisory firm, inhouse IR/corporate comms team, or similar environment, who thrives in fastpaced, transaction driven work and business- and relationship-building opportunities. 

Key Responsibilities 

Client Advisory & Strategy 

• Serve as trusted counselor to senior executives on all aspects of financial and capital markets communications. 

• Develop and oversee integrated communications strategies around:

• IR Advisory
• M&A
• IPOs and SPACs
• Activist Defense & Preparedness
• Restructuring
• Bankruptcy
• Executive Transitions
• Divestitures & Spins
• Investor and R&D Days
• Financial Media Relations & Storytelling

• Craft clear, compelling narratives that translate complex financial and strategic issues for investors, media, employees, regulators, and other stakeholders. 

• Provide real-time strategic counsel in high pressure, confidential situations, often in partnership with legal and banking advisors. 

Transaction/Event-driven Communications 

• Lead communications workstreams for event-driven situations (to include but not limited to: M&A, IPOs/Spins/SPACs, activism, bankruptcies/restructurings, crisis (cyber, litigation and beyond), Board/management transitions.), including: 

• Prospecting, relationship building with key advisors (bankers, lawyers, etc.) focused on HC sector. 

• Leading transaction / event-driven work. 

• Development of comms strategy, materials, media and social considerations. Support of the lead up to announcement, announcement day as well as integration support. 

• Deal playbook and scenario planning to protect and preserve reputation and valuation throughout the deal process 

• Development of strategy, scenario planning, communications playbook, etc. for lead up to, day of and post-announcement situation  

• Drafting key materials (press releases, Q&As, investor decks, fact sheets, talking points, etc.) 

• Coordinating with key advisors (lawyers, bankers, etc.) and ensure alignment with regulatory and disclosure requirements 

IR Advisory & Related Services 

• Develop and refine clients’ equity story/investor narrative 

• Oversee creation and quality of investor facing collateral, including: 

• Investor presentations 

• Investor day/R&D day materials  

• Infographics 

• IR website alignment with collateral 

• Earnings Advisory: Advise and support the development of earnings materials: to include press release, deck, scripts, Q&A prep  

• Advise on engagement with sellside and buyside analysts in coordination with IR and legal teams. 

• Annual reports as well as sustainability reports (in partnership with design/ESG teams as needed). 

• Advise on integration of financial communications with broader corporate reputation, ESG, and public affairs strategies. 

Financial Media & Stakeholder Engagement 

• Lead financial and business media strategy, cultivating relationships with key journalists and outlets. 

• Prepare executives for highstakes media interviews, investor meetings, earnings calls, and roadshows. 

Practice & People Leadership 

• Build and lead a high-performing financial communications team within the agency, including integration of legacy IR team, recruitment, training, and mentorship. 

• Set practice standards, playbooks, and bestinclass approaches for transaction and capital markets mandates. 

• Foster collaboration across practices (corporate, crisis, public affairs, digital, ESG, brand) to deliver integrated solutions. 

• Contribute to firm leadership, culture, and DEI objectives. 

Business Development 

• Drive growth of the financial communications practice through: 

• Identifying and pursuing new business opportunities 

• Leading and contributing to pitch development and presentations across significant client base 

• Build rapport and become a trusted, go-to referral partner for network among corporates, private equity, banks, law firms, and other advisors. 

• Help shape the agency’s market profile via thought leadership (reports, opeds, conferences, webinars) on capital markets, M&A, activism, and related themes. 

Qualifications 

• 15+ years of experience in financial communications, investor relations, investment banking, equity research, or related fields, with a strong advisory component. 

• Proven track record working on complex, highstakes situations such as: 

• M&A (including crossborder, contested, and private equitybacked deals) 
• IPOs and significant capital markets transactions 
• Shareholder activism and governance/ESG-related campaigns 
• Restructurings, turnarounds, and crisis situations with market impact. 
• Experience in a leading strategic communications/PR firm (e.g., financial/transaction communications practice) or top-tier in-house corporate role strongly preferred.  

• Experience working with healthcare clients a plus      

Skills & Capabilities 

• Deep understanding of capital markets and the needs of institutional investors and analysts. 

• Exceptional writing skills: capable of producing clear, concise, and persuasive materials under tight deadlines. 

• Strong judgment and discretion, with demonstrated ability to advise senior executives and boards in sensitive situations. 

• Comfortable operating in fast-paced, ambiguous, and time pressured environments; calm and solutions-oriented under stress. 

• Strong project and team management skills; able to run multiple complex engagements simultaneously. 

• Collaborative and low ego; able to integrate with cross-functional teams including legal, banking, IR, public affairs, digital, and creative. 

Education & Other 

• Bachelor’s degree required; advanced degree (MBA, JD, or related) a plus but not required. 

• Understanding of US regulatory and disclosure frameworks; global regulatory expertise not required but helpful 

• Willingness to work extended hours during live situations and to travel as required. 

  Pay Range: $300,000 - $360,000

  This is the pay range the Company believes it will pay for this position at the time of this posting.  Consistent with applicable law, compensation will be determined based on job-related, non-discriminatory factors including but not limited to work experience, skills, certifications, and geographical location. The Company reserves the right to modify this pay range at any time

POSITION OVERVIEW

Science 37 accelerates clinical research by expanding patient access to trials, leading to faster approvals and better health outcomes for all. Our solutions empower life sciences companies to reach diverse populations beyond traditional means of conducting clinical research

The Medical Director is a leader of the Science37 clinical team. Working within the department of Medical Affairs, this individual is responsible for a broad range of activities across several core functions. We are seeking an energetic physician to help drive innovation in the clinical research ecosystem​​.  This is a full-time, remote position and the individual chosen to fulfill this role can work from home. 

DUTIES AND RESPONSIBILITIES

Duties include but are not limited to:

Science 37 studies

• Function as the Principal Investigator for clinical trials when Science 37 is executing studies as either a Direct to Patient Site or fully decentralized trial
• Function as a Sub-Investigator for clinical trials for therapeutic areas/ indications that align with clinical expertise/ experience when Science 37 is executing studies.
• Coordination with Site Operations Manager to identify, onboard and train investigators for Science 37 studies
• Educate and train Science 37 study team about target patient population and treatment paradigms for given indication for Science 37 studies

Support for Science 37 Commercial Team

• Collaboration with Business Development counterpart to review study opportunity synopses/protocols to assess fit/feasibility for decentralized trial model 
• Support Business Development counterpart during sponsor/client meetings and teleconferences
• Support Science 37 study opportunities as a subject matter expert in the development of study opportunity proposals

Regulatory Engagement

• Collaborate with Science 37 Regulatory Affairs team to engage the FDA and other global regulatory bodies regarding the decentralized trial model, and its acceptance for global studies
• Work with sponsors/collaborators to identify clinical endpoints that are fit for decentralized clinical trial conduct
• Collaborate with sponsors and regulatory bodies to migrate endpoints from clinic-based conduct and validate their use for in-home conduct 

Thought Leadership

• Serve as Science 37 representative for decentralized clinical trial and therapeutic area-specific expertise at industry/clinical conferences and webinars
• Publish peer-reviewed articles and white papers related to therapeutic area-specific expertise and the decentralized clinical trial model

QUALIFICATIONS & SKILLS

Qualifications 

1. Advanced degree in Medicine (MD or equivalent)
2. Board-certification in Med/Peds or Pediatrics
3. 7+ years of demonstrating clinical & research excellence within academia and/or pharma
4. Experience as a Principal Investigator with a focus on pharmaceutical-sponsored studies

Skills/Competencies

1. Expertise in project management - Demonstrates ability to successfully lead/manage research personnel. Proactive problem-solving abilities and follow through.
2. Knowledge of field organizational strategies - The ability to adapt to a rapidly changing work environment. Successful decentralized team management and situational responsive decision-making.
3. Extensive knowledge of clinical research - Understands the drug development process. Knowledgeable about the critical elements for success in clinical trials; participation in and contribution to these activities. Ability to create and review protocols, programs, and assess the feasibility/pathway to success of a project.
4. Strong communication and presentation skills - Demonstrates strong written and verbal communication skills. Ability to establish and maintain positive sponsor, project team members and internal Science37 relationships. Ability to conduct effective presentations.
5. Computer skills - Working knowledge of MS Office suite and Google applications. Able to generate business correspondence, create forms and generate reports as required. 
6. Practices professionalism and integrity in all actions – Demonstrates ability to foster concepts of teamwork, cooperation, responsibility, and flexibility to get the work done.
7. Other – Ability to communicate in English (both verbal and written).
8. Preferred knowledge of Spanish

REPORTING

• Position Reports to the Chief Medical Officer

Science 37 is an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. 

Science 37 values the well-being of its employees and aims to provide team members with everything they need to succeed.

Submit your resume to apply!

About the Role >>> Lead Senior Medical Writer 

As the Lead Senior Medical Writer, reporting to the Director of Medical Writing, you will lead the development, and delivery of high-quality scientific and regulatory documents supporting Olema’s oncology portfolio. This role requires strong cross-functional leadership, partnering closely with Clinical Science, Clinical Development, Regulatory Affairs, Biometrics, and other stakeholders to translate complex clinical and preclinical data into clear, accurate, and compelling content for regulatory submissions, medical communications, and scientific publications. In addition, you will drive consistency, quality, and timelines across deliverables, contributing to the overall medical writing strategy and supporting key regulatory and clinical milestones. 

This role is based out of our Boston, MA or San Francisco, CA office and will require 10-15% travel. 

Your work will primarily encompass: 

• Preparing and editing a wide range of scientific and medical writing deliverables, including but not limited to protocols, protocol amendments, clinical study protocols, investigator brochures, regulatory submission documents (e.g. IBs, DSURs, sections of IND/IMPD/MAAs), PowerPoint presentations related to the Medical Writing function
• Collaborating with internal stakeholders (clinical scientists, regulatory strategy, medical monitors, biometrics, medical affairs) to understand data, interpret results, and ensure accurate message conveyance
• Ensuring documents adhere to internal style guidelines, regulatory requirements (e.g., ICH, GPP), and appropriate therapeutic-area standards (e.g., oncology, breast cancer)
• Maintaining version control, track author/reviewer feedback, and delivering documents according to project timelines
• Providing  writing and/or QC editing support for associated submission documents (as applicable) to help elevate overall team deliverables
• Remaining current on therapeutic area (breast cancer / endocrine-driven tumors) trends, journal publications, and regulatory guidance relevant to oncology and women’s cancers

Ideal Candidate Profile >>>  

A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role. 

Knowledge: 

• Bachelor’s degree in life sciences, pharmacy, or related field; advanced degree (MS/PharmD/PhD) preferred
• Demonstrated and excellent scientific writing and editing skills — the ability to translate complex scientific data into clear, concise, accurate documents for varied audiences (regulatory agencies, KOLs, internal stakeholders)
• Familiarity with regulatory writing standards (e.g., ICH E3/E6, GPP)
• Oncology preferred 
• Veeva RIM experience is a plus 

Experience: 

• Minimum of 7+ years of medical or regulatory writing experience, oncology (especially breast cancer) preferred, or a closely related therapeutic area
• Strong project management skills: able to manage multiple deliverables, meet deadlines, handle feedback iterations, and coordinate with cross-functional teams
• Ability to work independently with minimal supervision, while also being a collaborative team player
• Detail-oriented, organized, with strong verbal communication skills
• Proficiency with standard technical and document-management tools (e.g., Microsoft Word, PowerPoint, Microsoft Excel, Smartsheet, Starting Point Templates, Veeva RIM)
• Prior experience in clinical-trial documentation for oncology (eg, IBs, protocols, DSUR and CSRs) preferred
• Experience working in hybrid/remote environments

Attributes: 

• Teamwork and collaboration; balances team and individual responsibilities; gives and welcomes feedback; puts success of team above own interests; supports everyone's efforts to succeed; shares expertise with others
• Self-motivated and enthusiastic; fast learner who can identify project challenges and expeditiously change course as required in a fast-paced organization
• Strong communicator who can tailor messaging to diverse audiences
• Highly organized with strong attention to detail and follow-through
• Ability in building strong cross functional working relationships 

The base pay range for this position is expected to be $160,000-$175,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits.

#LI-MT1

Job Title: Director, Clinical Quality Assurance

Location: Remote; Waltham, MA area candidates preferred. 

Role Overview:

The Director, Clinical Quality Assurance is responsible for providing strategic quality leadership, support, and oversight for Oruka’s clinical development activities, with primary focus on Good Clinical Practice (GCP) and related quality systems supporting clinical trials. This role will establish, improve, and lead phase-appropriate clinical quality processes, ensure robust oversight of clinical trial execution and vendor performance, and drive inspection readiness for global health authority inspections, including FDA Bioresearch Monitoring (BIMO) inspections.

This role will partner closely with Clinical Operations, Clinical Development, Biometrics, Pharmacovigilance, Regulatory Affairs, Medical Writing, and external service providers to ensure that clinical studies are conducted in accordance with GCP, applicable global regulations, internal procedures, and protocol requirements. The Director, Clinical QA will provide proactive quality input across the clinical trial lifecycle, support continuous improvement, and help build a quality-focused culture as the organization advances its pipeline.

 Key Responsibilities:

• Clinical Quality Oversight: Provide Clinical QA oversight for new and ongoing clinical studies to ensure compliance with GCP, applicable regulatory requirements, and internal procedures. Serve as the primary quality business partner to Clinical Operations and other development functions to identify, assess, and mitigate quality and compliance risks across the clinical trial lifecycle. Review key study-level documents for quality and compliance, including protocols, informed consent forms, investigator brochures, monitoring plans, vendor oversight plans, data review plans, study reports, and essential trial documentation. Support development and implementation of phase-appropriate clinical quality procedures and processes.
• Quality Systems Support for Clinical Development: Provide quality support for clinical deviations, protocol deviations, investigations, root cause analysis, CAPA development, effectiveness checks, and change control activities related to clinical development. Ensure appropriate escalation, documentation, trending, and management visibility for significant quality issues. Partner cross-functionally to identify recurring themes, systemic risks, and opportunities for process improvement. Establish and maintain clinical quality metrics and dashboards to support management review and continuous improvement.
• Vendor and CRO Quality Oversight: Provide quality oversight of CROs, central laboratories, clinical software vendors, and other GCP-relevant service providers supporting Oruka’s clinical programs. Support qualification, selection, ongoing oversight, and performance evaluation of GCP vendors, including participation in vendor audits or due diligence activities as needed. Contribute to vendor governance processes to ensure appropriate quality expectations, responsibilities, and issue escalation pathways are defined and maintained.
• Audit Program Execution: Develop and execute a phase-appropriate GCP audit strategy and annual audit program based on risk, program priorities, and business needs. Conduct and/or manage investigator site, vendor, study-specific, and for-cause audits as needed. Author audit plans, reports, observations, and follow-up actions, and ensure timely resolution of audit findings through appropriate CAPA management and verification of effectiveness. Travel to clinical sites, vendors, and investigator meetings as needed.
• Inspection Readiness and Health Authority Support: Lead GCP inspection readiness activities across the organization, including development of inspection readiness plans, mock inspections, storyboards, SME preparation, document review, and inspection response coordination. Serve as the primary Clinical QA lead for FDA BIMO inspection readiness and support for other global regulatory inspections involving clinical trial activities. Partner with internal teams and external vendors to ensure inspection-facing documentation, processes, and responsibilities are inspection-ready at all times.
• Risk-Based Quality Management: Embed risk-based quality management principles into study oversight and clinical quality processes. Partner with Clinical Operations and cross-functional teams to support quality risk assessments, critical data/process identification, quality tolerance considerations where appropriate, and evaluation of key risk indicators and centralized quality signals. Ensure quality oversight activities are focused on matters most relevant to subject safety, rights, data integrity, and trial reliability.
• Inspection-Ready Documentation and TMF Support: Provide quality support and oversight related to Trial Master File (TMF) health, inspection-ready documentation practices, and completeness of essential records. Collaborate with study teams and vendors to ensure that documentation standards, reconciliation processes, and issue escalation practices support an inspection-ready state throughout study conduct.

Minimum Qualifications:

• Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or related discipline; advanced degree preferred.
• 10+ years of experience in Clinical QA/GCP Quality within biotechnology, pharmaceuticals, or a CRO environment.
• Strong knowledge of GCP and applicable global clinical regulatory requirements.
• Experience supporting quality oversight for Phase 1–3 clinical trials.
• Demonstrated experience with GCP audits, including investigator site and/or vendor audits.
• Experience supporting clinical deviations, investigations, CAPAs, and related quality system activities.
• Experience leading or supporting inspection readiness and regulatory inspections, including FDA BIMO inspections.
• Strong working knowledge of sponsor oversight expectations for CROs and other outsourced clinical vendors.
• Excellent judgment, communication, and collaboration skills, with the ability to influence across functions in a fast-paced environment.
• Willingness to travel as needed for audits, site visits, and inspection readiness activities (10-15%).

Preferred Qualifications:

• Experience as an early Clinical QA hire in a growing biotech company.
• Experience supporting biologics development programs.
• Familiarity with eQMS tools and clinical systems relevant to quality oversight.
• Experience with risk-based quality management and quality metrics.

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 $213,000 - $240,000. 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.

 Job Location:

• Remote; Waltham, MA candidates preferred

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.

Associate Director/Director, Scientific Communications, Cognito Therapeutics, Inc.

Location: Cambridge, MA, USA, Full-time

Company Description

Cognito Therapeutics, Inc. is a venture-backed (Morningside Ventures, FoundersX, IAG, Starbloom) late clinical stage company translating scientific findings from MIT into therapeutic approaches for brain health, including Alzheimer’s disease and other neurodegenerative conditions. We were awarded a Breakthrough designation by the FDA in December 2020 based upon our feasibility data that showed our therapy’s strong safety profile and a notable preservation of cognition and function in patients with mild-to-moderate Alzheimer’s. We completed enrollment in our pivotal study, HOPE, in June 2025 and expect to release topline data from the trial in summer 2026. We are a fast-moving, highly motivated team of innovators with the ambitious goal of helping millions of patients and caregivers around the world who are impacted by neurodegenerative conditions. With our patented brain stimulation technology, we are committed to developing convenient, safe and effective neuroprotective therapies to improve brain health and well-being for all.

About the Job

The Associate Director/Director, Scientific Communications will play a pivotal role in shaping and executing an integrated scientific communications strategy to support Cognito’s pipeline and future commercialization efforts. Reporting to the Head of Medical Affairs, this individual will be a key member of the Medical Affairs team, responsible for leading medical education initiatives, publication strategy, and support of the Brain Health Collaboratories.

This role is central to translating complex preclinical, clinical, and real-world data into clear, accurate, and compliant communications for both internal and external stakeholders, including healthcare professionals, payers, and scientific communities. The Director will ensure timely and effective dissemination of scientific data while aligning communications with congress activities and subject matter expert (SME) engagement strategies.

The position may be remote or hybrid (Cambridge, MA) and requires both strategic leadership and hands-on execution in a fast-paced, innovative environment.

Roles and Responsibilities

Strategic Leadership & Planning

• Develop and execute an integrated scientific and medical communications strategy aligned with corporate objectives and evolving standards of care.
• Define and lead publication planning, including identification of key data milestones, communication opportunities, and stakeholder alignment.
• Ensure seamless integration of communication plans with congress strategy and SME/KOL development.

Scientific Communications & Content Development

• Translate complex scientific and clinical data into clear, compelling, and compliant communications for diverse audiences.
• Lead the development of medical communication materials, including:
• Abstracts, posters, manuscripts, and presentations
• Unbranded disease state education materials (e.g., slide decks, training tools)
• Support data dissemination across multiple platforms and audiences.

Omnichannel Execution

• Implement omnichannel communication strategies to ensure consistent, effective delivery across digital, print, and live channels.
• Support and participate in scientific congresses, including presentation of data as appropriate.

Cross-Functional Collaboration & Stakeholder Engagement

• Serve as a central point of contact for scientific communications, coordinating with internal teams, external partners, and publication authors.
• Build and maintain strong relationships with key opinion leaders (KOLs), investigators, and professional societies, particularly in Alzheimer’s disease and related neurodegenerative disorders.
• Support advisory boards, roundtables, and scientific exchange initiatives to capture external insights and inform strategy.

Training & Internal Enablement

• Develop and deliver medical and scientific training for internal stakeholders, including commercial, clinical, and cross-functional teams.
• Ensure alignment and scientific rigor across all internal education initiatives.

Governance, Compliance & Operations

• Lead Medical (MLR) review processes, along with Legal, and Regulatory partners to ensure all materials meet compliance and scientific accuracy standards.
• Manage external vendors and agency partners supporting medical communications.
• Ensure adherence to regulatory, ethical, and company standards across all activities.

Qualifications & Experience

• Advanced degree in a relevant scientific or clinical discipline (MD, PhD, PharmD, or equivalent) preferred.
• 5+ years of experience in Scientific or Medical Communications within biotech, biopharma, or medical device industries; experience in neuroscience or neurodegeneration strongly preferred.
• Demonstrated ability to translate complex scientific data into clear, impactful narratives.
• Proven success in KOL engagement, publication strategy, and medical communications execution.
• Experience collaborating across functions and managing external partners, including academic institutions and vendors.
• Strong leadership, communication, and organizational skills; ability to thrive in a fast-paced, matrixed, and entrepreneurial environment.
• Willingness to travel (~15–20%) for scientific congresses and internal meetings.

Who We Are:

Cogent Biosciences is a publicly traded biotechnology company focused on developing novel precision therapies to treat a broad range of patients with unmet medical needs. Cogent’s lead program, bezuclastinib, is designed to selectively and potently inhibit exon 17 mutations found within the KIT receptor tyrosine kinase, including KIT D816V. KIT D816V is responsible for driving a rare and serious condition called Systemic Mastocytosis, and exon 17 mutations are also found in patients with gastrointestinal stromal tumors (GIST), a type of cancer with strong dependence on oncogenic KIT signaling. Bezuclastinib has exhibited promising initial data across all three trials: APEX in AdvSM, SUMMIT in NonAdvSM and PEAK in GIST, including an encouraging safety profile across 600+ patients in single agent and combination dosing. 

The Role: 

Cogent Biosciences is preparing for its first commercial launch and we are seeking a motivated self-starter Director, IT Business Partner for Commercial, Medical Affairs and Corporate Applications. You will be a strategic and tactical technology leader, partnering closely with cross-functional business leaders and teams to document and execute on Commercial, Medical Affairs and Corporate Applications technology roadmap. This is a hands-on role and you will partner with the business leaders and teams to support multiple existing and new system implementations in a fast paced environment.

This role will report to the Vice President of Information Technology. This position is a hybrid position and the candidate should be located near our Waltham MA office.

Responsibilities:

What You’ll Do:

We are seeking an experienced, highly motivated Medical Director, Clinical Development to join our growing team. This individual will play a pivotal role in designing and executing clinical development programs that advance our pipeline of innovative therapeutics. The successful candidate will bring strong clinical insight, a deep understanding of drug development in a biotech setting, and a proven ability to work cross-functionally in a dynamic, fast-paced environment.

Required location: Waltham, MA (hub-based, onsite 3-4 days per week)

Responsibilities:

• Responsible for medical monitoring/reporting and safety activities
• Provide medical leadership in the design, planning, and execution of clinical development strategies across multiple studies
• Acts as the medical contact at the company for clinical/medical issues
• Interprets, reports, and prepares oral and written results of product research, in concert with senior clinical personnel
• Serve as the medical expert for assigned assets studies
• Contribute to regulatory interactions and strategy, including IND/CTA submissions and briefing packages
• Collaborate and work closely with Clinical Operations to ensure appropriate site selection, patient recruitment strategies, and high-quality trial execution
• Oversee and support data interpretation, analysis, and clinical study reports
• Work closely with internal stakeholders, including Regulatory, Safety, CMC, Medical Affairs, and Translational Science teams
• Partner with external collaborators, KOLs, CROs, and investigators
• Support scientific publications, conference presentations, and other external communications
• Participate in safety review meetings and provide clinical input into adverse event evaluation and reporting

Required Qualifications:

• 3+ years of industry experience in clinical development, preferably in a biotech or small pharma environment
• Hands-on experience designing and executing clinical trials
• Understanding of GCP, clinical trial design, regulatory requirements, and safety monitoring
• Excellent written and verbal communication skills, including protocol and regulatory document writing
• Demonstrated ability to engage with KOLs, investigators, and cross-functional teams
• Can work independently, self-starter attitude
• Advanced PowerPoint skills; working knowledge of Excel and other commonly used clinical systems/tools
• Ability to manage multiple studies and deadlines in a fast-paced environment
• Must be exceptionally detail oriented

Preferred Qualifications:

• Experience in cardiometabolic therapeutic area is advantageous
• Proven track record of contributing to IND submissions and global regulatory filings is a strong plus

Education:

• MD or equivalent is required

Company Overview:

Strand Therapeutics is a clinical stage biotechnology company utilizing synthetic biology to genetically program mRNA to deliver truly revolutionary immunotherapies to patients.

Building on the idea of creating smart therapies based on Boolean logic circuits, Strand was started by biological engineers working together at MIT who were seeking to apply the concept of the emerging field of mRNA therapeutics. Strand's technology is therapeutic-area and mRNA modality agnostic where therapeutic proteins are encoded onto modified, self-replicating, or circular mRNA backbones which in turn are programmed with cell-specific sensors and circuits.

Today, Strand has established multiple programmable mRNA platforms with one clinical stage asset and several programs in preclinical development as well as early discovery. Our lead program, STX-001, is currently being evaluated in a Phase 1 clinical trial for solid tumors. Our corporate headquarters is located in the Fenway district of Boston, Massachusetts.

Become the next standout single strand!

Job Summary:

Strand is looking to build a team that understands the value of working at a start-up.  Joining Strand now places you alongside the founding executive team and world-leading advisors. We are looking for people who have the enthusiasm and motivation to be a highly contributing member of a small but extremely productive team.  This opportunity will offer the employee the ability to work closely with the founding team and be a part of the growth strategy of the company.

We are looking for a highly motivated and enthusiastic leader for the role of Vice President of Clinical Development Operations. Reporting to the Chief Medical Officer, the Vice President of Clinical Development Operations will lead all clinical trial activities and operations for the organization. This individual will drive all trial activities for our 2 clinical stage programs as well as support the planning and development of other company programs as they advance throughout pre-clinical development into first-in-human clinical trials. This will also be an opportunity to work closely with various cross functional teams internally and externally to prepare for regulatory interactions and drive the development of our programs forward. 

Primary Responsibilities:

• Serve as the clinical operations expert for all clinical stage and preclinical stage programs for the company. 
• Accountable for delivery of assigned clinical program/trial budgets, managing study timelines, and resource management with focus on quality, including making recommendations and decisions regarding operational strategies to support study and/or program objectives
• Develop operational strategy and clinical operations plans in support of execution of the Clinical Development Plan
• Develop clinical timelines, budget forecasts and ensure accountability for tracking and deliverables.
• Develop and maintain departmental resource and budget plans.
• Ensures oversight and study-specific Risk Management Plans (RMP) (e.g., milestones, metrics, and critical path), ensuring appropriate escalation when required. Evaluate study-level issues for broader impact (e.g., cross-study, cross-program etc.) and ensure resolution
• Partner and collaborate with cross-functional stakeholders, external consultants, and other relevant stakeholders
• Lead and oversee execution of clinical trials in compliance with ICH/GCP, local regulations, and Strand Therapeutics’ SOPs to ensure quality and data integrity
• Support the selection, oversight, and management of CROs and other vendors including financial aspects of the partnerships.
• Oversee site feasibility/capability assessments in collaboration with the CRO and cross-functional team.
• Develops site recruitment, enrollment, and engagement strategies for all clinical trials
• Review and provide clinical operations input into relevant clinical documents such as the protocol, investigator brochure, regulatory documents, clinical study reports and other documents and plans as appropriate
• Manage and provide oversight to the cross functional teams and CRO/vendor(s) related to all aspects of clinical trial operations
• Responsible for representing Clinical Operations on cross-functional project teams and vendor/CRO operational meetings and ensuring compliance with operational standards and procedures. Manages content, agenda, and discussions at clinical operations sub-teams and ensures action items are closed
• Along with other Clinical Development personnel, represent Strand Therapeutics externally to Investigators, site staff, and Key Opinion Leaders
• Perform and document study level Sponsor Oversight of outsourced clinical activities
• Communicate study-status, cost, and issues to ensure timely decision-making by senior management
• Oversee/collaborate with Clinical Quality Assurance on and contribute to inspection readiness activities that support audits and regulatory inspections related to clinical trial conduct
• Maintain oversight and participate in the creation/review/training/maintenance of departmental and organizational SOPs to ensure compliance
• Lead and/or participate in clinical operations workstreams related to departmental and operating model related initiatives
• Develop and foster strong, collaborative relationships with key stakeholders both within and external to Strand Therapeutics
• Provide oversight and mentorship to assigned Clinical Operations staff by providing clinical operations/functional area expertise and support identification and prioritization of study and program level work. Will have direct line management of Clinical Operations staff.
• Strive for continuous improvement and more efficient ways of working in clinical operations
• Supervise Clinical Operations Team (CTMs, CRAs, CTAs, etc.) and ensure team member’s adherence to the regulatory requirements, ICH-GCP guidelines, and other relevant procedures.
• Participate in the design, development and review of clinical trial protocols and study-specific documents, e.g., informed consent forms, study guidelines, operations manuals, oversight plans, process developments (including Trial RACI).
• Keep up to date with industry practice and communicate key messages back to Strand Therapeutics, providing recommendation accordingly.

Qualifications:

• 15+ years of clinical trial operations experience in biotech; Experience working in a smaller, fast paced environment highly preferred with 5+ in management or leadership roles.
• Experience running oncology trials required.
• Experience in and understanding of end-to-end management of clinical trial conduct, the pharmaceutical industry, clinical drug development, clinical trials operations and regulatory components is essential.
• Experience with all aspects of clinical trial management including streamlining operational activities of trial protocols and ensuring deliverables are attained in a timely manner. 
• Proven success participating in cross-departmental clinical strategy, planning and implementation activities. (Departments include executive leadership, regulatory, QA, CMC, translational development, program management, finance, business development, medical affairs and medical writing).
• Extensive experience with the identification, negotiation, management, and oversight of external vendor partnerships, such as CROs, for monitoring, database management, statistics, and safety reporting. 
• Experience building an internal clinical program management function, managing a team of employees and consultants as well as hiring internal stakeholders to support trial needs and leveraging external consultants as needed. 
• Experience with regulatory submissions, including INDs, NDAs and BLAs highly preferred. 
• Experience interacting with domestic health authorities, such as the FDA, required; Experience interacting with global regulatory health authorities, such as the EMA, PMDA, and/or Australian CTN is a plus. 
• Strong interpersonal skills with the ability to interact and communicate effectively with individuals from multiple departments at all levels of the organization. 
• Strong organizational and time management skills. 

Strand offers a fast-paced, entrepreneurial, team-focused small company environment. We also offer a top-notch benefits package (health, dental, life, open PTO, onsite lunch catering, commuter support and more) and work/life flexibility and integration. Being part of the Strand team allows you to become part of a small team that supports professional development while working together to meet Strand’s goals. 

Strand Therapeutics is an equal opportunity employer. We do not discriminate on the basis of race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability, protected veteran status or any other basis protected by applicable law. Strand does not accept unsolicited resumes from any source other than directly from candidates.

Job Type: Full-time

Salary: $316,000 - $356,000 annually plus bonus and equity incentives 

Ironwood Pharmaceuticals is a leading global gastrointestinal (GI) healthcare company on a mission to advance the treatment of GI diseases and redefine the standard of care for GI patients. We are pioneers in the development of LINZESS® (linaclotide), the U.S. branded prescription market leader for adults with irritable bowel syndrome with constipation or chronic idiopathic constipation. Ironwood is also advancing apraglutide, a next-generation, long-acting synthetic GLP-2 analog being developed for rare gastrointestinal diseases, including short bowel syndrome with intestinal failure, as well as several earlier stage assets. Building upon our history of GI innovation, we keep patients at the heart of our R&D and commercialization efforts to reduce the burden of GI diseases and address significant unmet needs. 

Purpose / Summary:

Reporting to the Head of Regulatory Affairs CMC, the Director, Global Regulatory Affairs – CMC is responsible for owning and leading the global CMC regulatory strategy and execution to enable clinical development, commercialization, and lifecycle management of the company’s products. This individual ensures that global CMC regulatory requirements are proactively identified, strategically addressed, and fully integrated into development and commercial plans.

The Director serves as the single-point CMC regulatory lead for assigned programs, accountable for regulatory strategy, health authority engagement, submission quality, and inspection readiness. This role requires close collaboration with senior leadership and cross-functional stakeholders to define regulatory objectives, manage risk, and support timely, high-quality global submissions and approvals.

Essential Functions:

• Lead and own the global CMC regulatory strategy for assigned programs across development, registration, and lifecycle management, identifying key risks, remediation activities, and opportunities for acceleration while ensuring approvability and inspection readiness.
• Serve as the regulatory CMC representative on internal CMC teams, core submission teams, and cross-functional governance forums, providing authoritative regulatory input and decision-making support.
• Provide strategic global Regulatory Affairs–CMC guidance to project teams and ensure timely development and execution of integrated regulatory project plans.
• Assess, interpret, and communicate global CMC regulatory requirements to ensure all development and commercial activities comply with applicable regulations, guidelines, and regional expectations.
• Initiate, lead, and strategically manage interactions with global health authorities (FDA, EMA, PMDA, and other national competent authorities) to obtain alignment on CMC strategy, negotiate data requirements, resolve issues, and support timely approvals.
• Lead preparation of high-quality CMC briefing packages and regulatory narratives for health authority meetings, including definition of regulatory positions, risk mitigation strategies, and alignment of supporting data; participate in or lead agency interactions as a key spokesperson.
• Provide strategic regulatory leadership for GMP inspections and PAI readiness, including inspection preparation, response strategy, and alignment of regulatory commitments with Quality and Tech Ops execution.
• Coordinate, review, and be accountable for the quality and timeliness of global CMC regulatory submissions and lifecycle filings, including original INDs, CMC amendments, IMPD amendments, annual reports, meeting requests, briefing packages, marketing applications, and post-approval changes.
• Work directly with external contractors and collaborators, managing regulatory deliverables, communication pathways, and project plans to ensure accuracy, compliance, and executional success.
• Establish and lead CMC regulatory governance for assigned programs, including defining review cadence, risk escalation pathways, and communication of status, risks, and decisions to senior leadership and executive management.
• Remain current on evolving global regulations, standards, policies, and guidance issued by relevant regulatory authorities and assess impact to development and commercial programs.
• Partner with cross-functional stakeholders to proactively identify, escalate, and resolve CMC regulatory issues impacting development timelines or approval readiness.

Requirements:

• Bachelor’s degree in a scientific discipline such as Biology, Chemistry, or Pharmaceutical Sciences; advanced degree preferred.
• Minimum of 10 years of progressively increasing responsibility in CMC Regulatory Affairs within the biopharmaceutical industry.
• Demonstrated experience leading successful global marketing application submissions and approvals.
• Proven experience preparing CMC sections of global clinical trial applications (IND, IMPD, CTA).
• Experience with drug-device combination products preferred.
• Demonstrated ability to develop and defend CMC regulatory strategies supporting new product development, commercialization, and lifecycle management.
• Strong track record of successful global regulatory interactions and submissions for biologics, innovative medicines, and/or combination products in the US, EU, and other regions.
• Demonstrated ability to provide risk-based regulatory decision-making and strategic recommendations to senior leadership.
• Strong leadership, communication, and interpersonal skills with the ability to influence decision-making diplomatically across functions.
• Ability to work independently and effectively within matrixed, cross-functional teams and with external partners.
• Excellent written and verbal communication, organizational, and project management skills.
• Ability to operate in a fast-paced environment while managing multiple priorities.

Ironwood is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Ironwood currently anticipates that the initial base salary for this position could range from between $208,000K - $243,600K. The actual base salary will depend, in part, on the successful candidate’s qualifications for the role, including education and experience.  Ironwood offers a comprehensive compensation and benefits program to eligible employees, including Restricted Stock Unit awards; eligibility to participate in either a bonus or sales incentive program; company-sponsored 401(k) with matching contributions; eligibility for medical, dental, vision and prescription drug benefits; wellness stipends; and a generous vacation/holiday schedule.

#LI-Hybrid

Who We Are:

Cogent Biosciences is a publicly traded biotechnology company dedicated to developing precision therapies for genetically defined diseases. By leveraging validated biology and a rational drug discovery approach, Cogent aims to create real solutions that address the underlying drivers of disease and offer meaningful hope to patient's.

The company’s lead therapeutic candidate, bezuclastinib, is a highly selective tyrosine kinase inhibitor designed to potently target KIT D816V and other mutations in KIT exon 17. These mutations are known drivers of systemic mastocytosis (SM) and advanced gastrointestinal stromal tumors (GIST) - both serious conditions driven by oncogenic KIT signaling. Bezuclastinib is currently being evaluated in multiple registration-directed trials across Non-Advanced SM (NonAdvSM), Advanced SM (AdvSM), and GIST.  In July 2025, Cogent announced that its registration-direct SUMMIT trial in patients with NonAdvSM achieved statistical significance across all primary and key secondary endpoints, and the company is on track to file its first New Drug Application for this patient population by the end of 2025.  The company also remains on track to announce top-line results for its APEX trial in patients with AdvSM in the second half of 2025 and for its PEAK trial in patients with GIST by the end of 2025.  The company also has an ongoing Phase 1 study of its novel internally discovered FGFR2 inhibitor, and the Cogent Research Team is developing a portfolio of novel targeted therapies to help patients fighting other serious, genetically driven diseases targeting mutations in ErbB2, PI3Kα and KRAS.

Through its commitment to precision medicine and targeted innovation, Cogent Biosciences is working to transform the treatment landscape for patients with serious and underserved diseases. By leveraging validated biology and a rational drug discovery approach, Cogent aims to create real solutions that address the underlying drivers of disease. Our culture of inquisitiveness fuels continuous learning and innovation; we challenge assumptions, ask bold questions, and embrace a mindset of discovery to uncover transformative insights.

The Role: