Role Summary: 

The Regional Director, Patient Access and Education plays a critical leadership role within Dyne’s Patient Access and Education organization, owning regional execution of Dyne’s field‑based patient services strategy. This leader guides and develops a regional team of Nurse Case Managers, ensuring patients, caregivers, and healthcare providers receive seamless, compassionate, and compliant support throughout the treatment journey.

The Regional Director, Patient Access and Education partners closely with Payer Account Management, Hub Operations, Specialty Pharmacy, Medical Affairs, and Commercial field leadership to enable effective patient onboarding, prior authorization and access support, infusion education and coordination, and post‑prescribing support. This role drives operational excellence across the care team while maintaining a strong focus on patient experience, access, and ethical conduct.

This position is central to translating Dyne’s patient‑centric vision into consistent, high‑quality regional field execution and offers the opportunity to directly impact the experience of patients and families navigating complex rare disease treatment journeys.

This is a full-time, US field-based position.

 
Primary Responsibilities: 

• Leads, coaches, and develops a regional team of field‑based Nurse Case Managers, fostering a high‑performing, patient‑centric culture.
• Sets regional standards, priorities, and expectations for patient access and education delivery.
• Owns talent management including hiring, onboarding, performance management, development planning, and succession readiness.
• Owns regional execution of Dyne’s patient access and education strategy across the full patient journey, from onboarding through ongoing therapy support.
• Establishes and optimizes regional processes for coverage determination, prior authorization, appeals, reimbursement navigation, and therapy initiation.
• Ensures effective education and coordination models for infusion providers and infusion nurses supporting Dyne therapies.
• Serves as the regional escalation leader for complex patient access challenges, driving timely, patient‑focused resolution of barriers to therapy.
• Leads regional collaboration with Payer Account Management, Hub Operations, Specialty Pharmacy, Medical Affairs, and Commercial teams to align patient support strategies and execution.
• Provides regional insights, access trends, and operational learnings to inform national patient services strategy and program evolution.
• Builds and maintains strong relationships with healthcare providers, infusion centers, and specialty pharmacy partners.
• Owns regional performance metrics related to patient onboarding, time to therapy, reimbursement outcomes, and patient experience.
• Uses data and insights to drive continuous improvement, operational efficiency, and enhanced patient outcomes.
• Maintains deep knowledge of rare disease treatment pathways and payer dynamics to proactively adapt regional strategy.
• Ensures all activities align with Dyne policies, regulatory requirements, and ethical standards.

Education, Knowledge & Skill Requirements  

• Bachelor’s degree or equivalent experience; background in healthcare (e.g., nursing, social work, or allied health) preferred.
• 10+ years of experience in biotech, pharmaceutical, or healthcare environments.
• 6+ years of experience in patient services, field reimbursement, nurse case management, patient education, or related functions.
• Demonstrated experience leading regional or multi‑state, field‑based teams, with direct people management responsibility.
• Strong understanding of payer coverage, reimbursement pathways, prior authorization, and appeals for HCP‑administered therapies.
• Experience supporting specialty and/or rare disease therapies; launch experience preferred.
• Proven ability to translate strategy into scalable execution through people, processes, and metrics.
• Strong leadership, problem‑solving, and communication skills, with the ability to influence across functions and engage senior stakeholders.
• Domestic travel up to 30% required to support regional teams and key partners

Role Summary: 

The Regional Director, Patient Access and Education plays a critical leadership role within Dyne’s Patient Access and Education organization, owning regional execution of Dyne’s field‑based patient services strategy. This leader guides and develops a regional team of Nurse Case Managers, ensuring patients, caregivers, and healthcare providers receive seamless, compassionate, and compliant support throughout the treatment journey.

The Regional Director, Patient Access and Education partners closely with Payer Account Management, Hub Operations, Specialty Pharmacy, Medical Affairs, and Commercial field leadership to enable effective patient onboarding, prior authorization and access support, infusion education and coordination, and post‑prescribing support. This role drives operational excellence across the care team while maintaining a strong focus on patient experience, access, and ethical conduct.

This position is central to translating Dyne’s patient‑centric vision into consistent, high‑quality regional field execution and offers the opportunity to directly impact the experience of patients and families navigating complex rare disease treatment journeys.

This is a full-time, US field-based position.

 
Primary Responsibilities: 

• Leads, coaches, and develops a regional team of field‑based Nurse Case Managers, fostering a high‑performing, patient‑centric culture.
• Sets regional standards, priorities, and expectations for patient access and education delivery.
• Owns talent management including hiring, onboarding, performance management, development planning, and succession readiness.
• Owns regional execution of Dyne’s patient access and education strategy across the full patient journey, from onboarding through ongoing therapy support.
• Establishes and optimizes regional processes for coverage determination, prior authorization, appeals, reimbursement navigation, and therapy initiation.
• Ensures effective education and coordination models for infusion providers and infusion nurses supporting Dyne therapies.
• Serves as the regional escalation leader for complex patient access challenges, driving timely, patient‑focused resolution of barriers to therapy.
• Leads regional collaboration with Payer Account Management, Hub Operations, Specialty Pharmacy, Medical Affairs, and Commercial teams to align patient support strategies and execution.
• Provides regional insights, access trends, and operational learnings to inform national patient services strategy and program evolution.
• Builds and maintains strong relationships with healthcare providers, infusion centers, and specialty pharmacy partners.
• Owns regional performance metrics related to patient onboarding, time to therapy, reimbursement outcomes, and patient experience.
• Uses data and insights to drive continuous improvement, operational efficiency, and enhanced patient outcomes.
• Maintains deep knowledge of rare disease treatment pathways and payer dynamics to proactively adapt regional strategy.
• Ensures all activities align with Dyne policies, regulatory requirements, and ethical standards.

Education, Knowledge & Skill Requirements  

• Bachelor’s degree or equivalent experience; background in healthcare (e.g., nursing, social work, or allied health) preferred.
• 10+ years of experience in biotech, pharmaceutical, or healthcare environments.
• 6+ years of experience in patient services, field reimbursement, nurse case management, patient education, or related functions.
• Demonstrated experience leading regional or multi‑state, field‑based teams, with direct people management responsibility.
• Strong understanding of payer coverage, reimbursement pathways, prior authorization, and appeals for HCP‑administered therapies.
• Experience supporting specialty and/or rare disease therapies; launch experience preferred.
• Proven ability to translate strategy into scalable execution through people, processes, and metrics.
• Strong leadership, problem‑solving, and communication skills, with the ability to influence across functions and engage senior stakeholders.
• Domestic travel up to 30% required to support regional teams and key partners

Role Summary:

Dyne is seeking a motivated Co-op student to support the early drug discovery team. The Dyne Co-op program offers students the opportunity to learn about the biotech industry while performing hands-on projects. The student will join a team of chemists and biologists and interact with laboratory colleagues in a cross-functional setting. Working with a mentor, the student will learn to design, perform, and interpret various cell-based assays to enable the discovery of new therapeutics for genetic-based muscle diseases.

This role is based in Waltham, MA without the possibility of being remote. This is a 6-month position beginning in July.  

Candidates must be enrolled in an accredited college or university Co-Op Program.

Primary Responsibilities Include:

• Learn diverse lab techniques such as mammalian cell culture, including maintenance of iPSC-derived cells, qRCR, capillary electrophoresis, flow cytometry, and ELISA.
• Learn the principles of receptor-mediated drug delivery and apply them experimentally.
• With coaching from your mentor, you will learn to plan an independent project, evaluate relevant literature, optimize a protocol, conduct experiments, and communicate results to the team.
• Learn to maintain clear, accurate records of experiments.
• At the end of the program, you will present a summary of the project to the company.

Education and Skills Requirements:

• Currently enrolled in an undergraduate/ graduate program in a life science track.
• Interest in muscle cell biology and drug discovery.
• Understanding of biochemical and cell biology principles.
• Previous experience with mammalian cell culture and maintenance is a plus.
• Familiarity with software such as Excel and PowerPoint.
• Attention to detail and ability to multitask.
• Strong communication skills.

Role Summary:

Dyne is seeking a highly motivated Co-Op student to support process development in the Platform Development team. Dyne’s Co-Op program offers students the opportunity to learn and work at a cutting-edge company in the biotech industry. This is an exceptional opportunity for students to be exposed to many facets of the company and learn about drug discovery from Dyne’s muscle disease programs. The student will join a team of chemists and biologists and interact cross-functionally and collaboratively with scientists within the company. The student will work closely with mentors to develop skills in synthesis, purification, and characterization of therapeutic conjugates and their development through the research pipeline. The successful candidate will be collaborative, detail-oriented, motivated, enjoy learning new skills, and working in a fast-paced environment.

This role is based in Waltham, MA without the possibility of being remote. This is a 6-month position beginning in July.  

Candidates must be enrolled in an accredited college or university Co-Op Program.

Primary Responsibilities Include:

• Learn diverse lab techniques, including buffer preparation, SDS-PAGE, BCA, ELISA, and AKTA to support biological conjugations.
• Learn and assist biochemical analysis and interpretation on in-process and final purified conjugates using in-house analytical methods across instruments such as UPLC-RP/SEC, LC-MS/MS.
• Maintain accurate and clear records of experimental work.
• Communicate up-to-date findings and contribute to critical discussions with the group members.
• Present a summary of learnings and findings to the team at the end of the Co-Op program.

 Education & Skill Requirements:

• Currently enrolled in an undergraduate/ graduate program with a background in biology, chemistry, or a related track with at least one year of experience of general chemistry lab work (eg, molarity calculation, pipetting).
• Ability to follow experimental protocols and take the initiative to learn new skills.
• Good interpersonal skills, able to maintain positive working relationships with co-workers, and to work cooperatively with peers.
• Hands-on academic/ industry experiences with protein chemistry are desired.
• The candidate will be self-motivated and detail-oriented and have the ability to communicate ideas and document research effectively.

Real Chemistry ist ein weltweit tätiges Unternehmen für Gesundheitsinnovation mit Niederlassungen in ganz Europa und den USA. Wir sind überzeugt, dass echter, transformativer Wandel durch die einzigartige Kombination von Disziplinen, Technologien und unserem größten Kapital – unseren Mitarbeitern – entsteht. Wir suchen aktuell Verstärkung für unser Team von über 1.800 talentierten Fachkräften. Dies ist eine hervorragende Gelegenheit, Teil eines dynamischen, schnell wachsenden globalen Unternehmens zu werden, das sich für eine gesündere Welt für alle einsetzt.

Stellenbeschreibung: Real Chemistry sucht einen PR/Communications Group Account Director für unser neues deutsches Team mit Büros in München. Diese Position bietet Ihnen die Möglichkeit, unser deutsches Angebot im Bereich integrated Communications aktiv mitzugestalten und unsere Präsenz auf dem europäischen und deutschen Markt weiter auszubauen. Sie sollten motiviert sein, unser lokales Geschäft und unsere Kompetenzen zu stärken und unsere Expansion in die EMEA-Region maßgeblich mitzugestalten.

Aufgaben:

• Betreuung mehrerer Kundenprojekte unterschiedlicher Größe in einem dynamischen Umfeld
• Aufbau und Pflege starker Kundenbeziehungen durch exzellentes Stakeholder-Management
• Flexibler Wechsel zwischen strategischer Entwicklung, Ad-hoc-Beratung und operativer Umsetzung der zugehörigen Maßnahmen
• Beratung von Kunden bei integrierten Marketing- und Kommunikationsentscheidungen, Identifizierung neuer Möglichkeiten zur Steigerung der Markenbekanntheit, einschließlich beratendem Verkauf
• Entwicklung überzeugender Kommunikationspläne (jährlich, vierteljährlich etc.)
• Operative Leitung und Verantwortung für die finanzielle Performance von Projekten durch engmaschiges Budget- und Teammanagement
• Sicherstellung höchster Qualitätsstandards im Account-Team und strategische sowie zeitnahe Bearbeitung aller Kundenanfragen
• Partnerschaft mit Shared-Service-Leads zur Führung und zum Ausbau des integrierten Geschäfts (Social Media/Digital, Kreation, Analytics)
• Identifizierung, Leitung und Unterstützung bei der Entwicklung neuer Geschäftsmöglichkeiten
• Direkte Führung der Account-Mitarbeiter und Förderung kontinuierlicher Weiterbildung zur Schaffung einer leistungsstarken Unternehmenskultur

Erforderliche Kenntnisse und Erfahrungen:

• Erfahrung innerhalb des healthcare communications Oekosystems (Agentur oder Firmenseite)
• Erfahrung in der Betreuung von Healthcare-Kommunikationsprojekten sowohl auf lokaler Ebene in Deutschland als auch auf globaler/regionaler Ebene
• Erfahrung in der Strategieentwicklung und -umsetzung globaler Programme sowie deren lokale Implementierung in Deutschland
• Fundierte Kenntnisse der Branchenvorschriften in Deutschland
• Ausgezeichnete Geschäftskommunikationsfähigkeiten in Englisch und Deutsch (verhandlungssicheres Niveau erwartet), einschließlich formeller und informeller Präsentations- und Schreibfähigkeiten; sicheres Auftreten in internen und externen Gesprächen mit Kunden, Lieferanten und Partnern
• Fähigkeit zur Zusammenarbeit und Führung in funktionsübergreifenden Teams an verschiedenen Standorten
• Entwicklung vielschichtiger, kanalübergreifender und marktübergreifender Strategien und Kampagnen zur Erreichung der Geschäftsziele und strategischen Vorgaben
• Zusammenarbeit mit Analystenteams zur Identifizierung wichtiger Kunden-KPIs, Entwicklung von Mess- und Lernplänen zur Kommunikation der Programmleistung und Aufdeckung von Verbesserungspotenzialen
• Fähigkeit, komplexe wissenschaftliche Sachverhalte klinischer Studien oder Produkte zielgruppengerecht zu vermitteln
• Fähigkeit, neue Geschäftsbereiche selbstständig und im Team zu unterstützen und voranzutreiben
• Erfahrung in der Jahresplanung, Ressourcenplanung und Prognoseerstellung
• Professionelles Auftreten, hohe Einsatzbereitschaft und kundenorientiertes Arbeiten
• Erfahrung im Projektmanagement, nachgewiesene Fähigkeit, Termine einzuhalten, Prioritäten zu setzen und detaillierte Budgets zu verwalten
• Souveränes Auftreten gegenüber Vorgesetzten; Fähigkeit, diese bei Nichteinhaltung von Terminen oder absehbaren Problemen zu informieren
• Führungskompetenz mit der Fähigkeit, Nachwuchskräfte zu führen und zu fördern sowie effektiv mit Subunternehmern zusammenzuarbeiten
• Fortgeschrittene Kenntnisse im Umgang mit sozialen Medien

Die Position erfordert gelegentliche internationale Reisen zu Kundenterminen und Konferenzen.

Real Chemistry is a global health innovation company with offices across Europe and the US. We believe that the way to real, transformative change is through the uncommon combination of disciplines, technologies, and our greatest asset – our people. We are currently looking to add to our alchemic mix of more than 1,800 talented professionals. This is a great opportunity to join a dynamic, fast-growing global company committed to making the world a healthier place for all.

Job Summary:

Real Chemistry is looking for a  Group Account Director to join our brand new office in Munich. This is a really exciting position for someone who wants to help shape our German offering across Integrated Communications as we build further into the European and German local markets – someone who’s keen to help build out our local business and capabilities and be at the forefront of our expansion into EMEA.

Responsibilities:

• Manage multiple client engagements of varying sizes in a fast-paced environment
• Develop and maintain strong client relationships through exceptional stakeholder management skills
• Seamlessly flex between big picture strategic development/ad hoc guidance, and getting stuck in to assure execution of associated tactics are flawless
• Guide clients on integrated marketing/communications decisions, identifying new opportunities to increase visibility of their brand including consultative selling
• Develop high-level and persuasive communications plans (annual, quarterly, etc.)
• Lead operational efforts and be accountable for the financial performance of engagements through close management of budgets and team members
• Ensure the quality of the account team(s) is held to the highest standard and that all client requests are handled in a strategic and timely manner
• Partner with shared service leads to run and grow integrated business (social media/digital, creative, analytics)
• Uncover, lead and support new business opportunities
• Directly supervise account staff and promote continuous learning and development to help build a high performing culture

Required Skills & Experience:

• Experience within the healthcare communications space
• Experience leading healthcare communications accounts both at a local German market level and on global and regional level
• Experience in strategy development and execution of global programs, as well as local implementation in the German market
• In-depth understanding of industry regulations in Germany
• Excellent business communication skills in both English and German language (proficient level expected) including informal/formal presentation and writing skills; this includes confident public speaking both internally and externally with clients, vendors, and affiliates
• Ability to work within and lead cross-functional teams internally across multiple locations
• Develop multi-faceted, multi-channel and multi-market strategies and campaigns to deliver against business objectives and strategic imperatives
• Work with analyst teams to identify key client KPIs, develop measurement and learning plans that communicate program performance and reveal opportunities to increase success
• Ability to relay high science of clinical trials or products to audiences with different levels of knowledge
• Ability to support and drive new business operations alone and as part of bigger team
• Experience with annual planning, resourcing and forecasting
• Professional presence, performs with a sense of urgency and with a client service orientation
• Project management experience, demonstrated ability to meet deadlines, prioritize and manage detailed budgets
• Has confidence to manage upward when required; able to communicate with managers when deadlines will not be met or when issues are foreseeable
• Supervisory skills, with ability to manage and cultivate junior staff and effectively collaborate with subcontractors
• Intermediate to advanced capabilities in using social media

The position requires some international travel for client meetings and conferences.

About the Synthetic Chemistry, CMC and Logistics team

Our dynamic team of Synthetic Chemists and CRO Leads are dedicated to transforming drug design and manufacturing. We work in partnership with our AI/ML and drug discovery colleagues to support all phases of chemistry, from early to late stages, as well as managing our extensive external CRO team. We promote a supportive atmosphere where the diverse expertise of every team member is recognised and appreciated. We maintain a strong growth mindset, with continuous development and learning as a priority.

If you are a skilled and ambitious scientist looking to take the next step in your career, joining Isomorphic Labs will lift you out of your comfort zone and provide you with an amazing opportunity for personal growth and development.

Your impact

As part of the ongoing expansion of our Drug Design and Medical Research function, we are hiring Synthetic Chemists who are keen to impact medicinal chemistry projects and/or CMC projects. You will support the business alongside world-leading AI/ML Drug Design Platform teams. You will deliver scientific expertise and strategic direction to drive improvements in the Platform and the advancement of active drug discovery programs.

What you will do 

• Apply your Synthetic Chemistry expertise across Medicinal Chemistry and/or CMC projects.
• Act as a Synthetic Chemistry Lead in one or more active drug discovery programs.
• Collaborate both internally and with third party organisations, interacting within multidisciplinary teams to support the data-driven delivery of high quality scientific solutions to complex technical problems.
• Work cross-functionally with the Medicinal Chemistry, DMPK, Biology, and Technology teams.
• Represent the company externally, interacting with existing and prospective collaborators including Contract Research Organisations (CROs) and Contract Development & Manufacturing Organisations (CDMOs).
• Prepare detailed scientific proposals and reports to support new and ongoing programs.
• Embrace and champion our culture of inclusion and continuous professional development.

Skills and qualifications 

Essential:

• PhD in Synthetic Chemistry, or a related technical field, or equivalent industrial experience.
• 3+ years’ professional experience in a Chemistry role, operating within a biotech, pharma or CRO setting. 5+ years' experience for more senior positions.
• Solid technical foundation in synthetic chemistry with previous experience operating independently as an individual contributor.
• Excellent problem-solving and decision-making capabilities applied to complex synthetic chemistry challenges.
• Experience of working with and closely managing CRO and/or CDMO resources.
• A genuine passion for drug discovery and enthusiasm for the potential of AI/ML to transform the field.
• Excellent communication (written and verbal) and interpersonal skills, with an ability to work effectively in a cross-functional, collaborative team environment.
• Track record of creative problem solving with a strong growth mindset, adaptability, and eagerness to learn new concepts and techniques.

What You Will Contribute To Altos

An exciting opportunity is available for a Scientist II to join the Larrieu group at Altos Labs, Cambridge Institute of Science (Cambridge, UK). At Altos, the Larrieu lab is exploring both fundamental questions and translational opportunities. We are seeking a very highly motivated, versatile, creative, and collaborative individual, who is passionate and dedicated about employing their expertise to unravel the deep biology of cell health and resilience. This includes the elucidation of the mechanism of action of specific interventions that can reverse, halt or mitigate the effects of ageing on cell health. 

Responsibilities

• Elucidate processes that contribute to the age-related erosion of cell/tissue resilience.
• Engage in ground-breaking and innovative science and in Altos scientific activities.
• Develop project-specific experimental strategies, techniques, and procedures including new assays and pipelines to support translational projects.
• Lead, design and execute in vitro and in vivo experiments for identification and validation of targets with therapeutic potential
• Develop and implement biochemical and cellular assays to support screening and characterization of potential candidate therapies
• Collaborate widely across Altos to multiply efforts, gain insight into the centrality of the nuclear envelope in ageing and identify potential new therapeutic avenues          
• Collaborate with multidisciplinary teams including chemists, pharmacologists, and bioinformaticians to advance drug discovery projects.
• Present data to a variety of audiences including senior executives through entry-level employees.

Who You Are

Minimum Qualifications

• PhD in life sciences with 3-5 years of relevant postdoc/industry experience
• Extensive experience in mammalian cell culture (including primary cells).
• Strong background in molecular and cell biology with experience in assay development and validation, to support pre-clinical studies.
• Experience in small rodent handling, with an ability to independently design and coordinate the execution of complex in vivo studies, including drug administration, tissue harvest and processing.
• Strong sense of collective ownership of projects within the group and Altos.
• Critical, visionary, and creative thinking with an ability to formulate scientific questions, design strategies, and implement plans effectively.
• Strong organizational skills to manage multiple tasks simultaneously, prioritize workloads, and meet deadlines.
• High level of rigor and precision in experimental procedures, data recording, and documentation.
• Problem-solving skills to identify potential issues, test, and develop innovative solutions.
• Excellent writing and communication skills
• Ability to maintain cooperative working relationships with a broad range of people, including staff colleagues, lab members and the community

Preferred Qualifications 

• Understanding of in vivo delivery systems such as AAV, LNP, lentivirus etc.
• Biochemistry skills, including biochemical and enzymatic assay development
• Some proficiency in R and Python to support data analysis
• Prior industry experience

The salary range for Cambridge, UK:

• Scientist II, Biological Sciences: £61,400 - £80,800

Exact compensation may vary based on skills, experience, and location.

#LI-NN1

For UK applicants, before submitting your application:

- Please click here to read the Altos Labs EU and UK Applicant Privacy Notice (bit.ly/eu_uk_privacy_notice)
- This Privacy Notice is not a contract, express or implied and it does not set terms or conditions of employment.

The Opportunity

The Manager, People Operations is a high-impact operator who combines technical rigor with strong empathy to deliver an exceptional employee experience. This role owns the execution and continuous improvement of core People programs, ensuring scalable, efficient workflows that support company growth. This position oversees the end-to-end employee lifecycle, including employee experience and engagement, HR systems administration, benefits, performance management and compliance. As a key cultural steward, the Manager, People Operations builds strong cross-functional relationships to support a high-performing, engaged workforce. This role reports to the Director, People and may manage direct reports.

This role is onsite in the San Francisco Bay Area. The compensation range for this role is market driven, with a salary range of $120,000-$150,000. Additionally, we offer a robust benefits package. This offering is aligned with our overall compensation philosophy. 

Applicants must be currently authorized to work in the United States on a full-time basis. Cala will not sponsor applicants for work visas.

AI Disclaimer: Cala does not permit the use of AI during interviews and technical testing so that we can property assess thought process and skillset.

Key Responsibilities

Recruiting:

• Own and optimize recruiting operations, including ATS management, agency partnerships, interview coordination, and offer execution
• Streamline processes to improve candidate experience and hiring efficiency

Financial & Benefits Operations:

• Lead end-to-end payroll for multi-state workforce with accuracy and compliance
• Manage 401(k) administration, including reporting and annual testing
• Support benefits administration and drive employee utilization and understanding

Employee Lifecycle & Experience:

• Serve as the primary point of contact for employee inquiries, delivering timely, service-oriented support
• Partner on employee engagement initiatives and programs
• Identify process gaps and implement scalable, automated solutions while maintaining a human-centered approach.

Compliance & Governance:

• Own HRIS administration, ensuring data integrity and delivering actionable reporting
• Maintain audit-ready employee records and documentation
• Monitor evolving labor laws and proactively update policies and the employee handbook

Qualifications

• Bachelor’s degree in business administration or related field
• 5+ years of progressive HR / People Operations experience, including experience in a high-growth environment (startup experience preferred)
• Experience administering 401(k) plans and working knowledge of US employment laws
• Experience in medical device, biotech, or other regulated industries is a plus
• Proven track record in a growth environment

Skills

• Ability to manage competing priorities in a fast-paced environment
• Strong project management skills with a track record of execution
• Process-oriented mindset with a focus on continuous improvement
• Clear and confident communication across all levels of the organization
• High level of discretion and judgment with sensitive information
• Consultative approach with strong listening and problem-solving skills
• High emotional intelligence and ability to navigate complex employee relations
• Detail-oriented with strong focus on data accuracy and compliance
• Effective change management skills with the ability to drive adoption of new programs

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

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

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

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

Rewarding Those Who Make the Mission Possible

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

Financial Benefits:

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

Health & Wellbeing:

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

Skill Development & Career Paths:

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

LAPORTE recherche un.e ingénieur.e sénior en procédés alimentaires ayant idéalement de 7 à 10 ans d’expérience en génie chimique ou des procédés alimentaires pour rejoindre son équipe à Montréal ou Brossard. Notre ingénieur.e sera responsable de la conception, de l’optimisation et de la mise en œuvre de procédés alimentaires pour des usines dans la grande région de Montréal.

Responsabilités :

• Participer à la définition des besoins des client.es pour des projets de procédés alimentaires ;
• Analyser les besoins des client.es pour déterminer les procédés optimaux (transformation, fermentation, pasteurisation, etc.) ;
• Effectuer des bilans de masses et d’énergie pour optimiser les procédés
• Concevoir et spécifier des équipements (pompes, échangeurs de chaleur, vannes de contrôle, réacteurs) et des installations de procédés ;
• Calculer les besoins en utilités (vapeur, eau refroidie, air comprimé) pour supporter les procédés ;
• Préparer des diagrammes de procédé (PFD) et des diagrammes de tuyauterie et instrumentation (P&ID) ;
• Réviser et approuver les livrables techniques, incluant les devis et les plans techniques
• Participer aux analyses de risques (HAZOP ou autres) pour garantir la sécurité et la conformité ;
• Coordonner l’installation, le démarrage, la validation et la mise en service des équipements sur site ;
• Gérer les relations avec les fournisseurs et les entrepreneur.es, incluant le suivi des livrables ;
• Collaborer avec des équipes interdisciplinaires pour assurer la conformité aux normes alimentaires (CFIA, FDA, GFSI) ;
• Établir et contrôler les budgets et échéanciers des projets, et présenter des rapports d’avancement aux client.es .

Exigences :

• Baccalauréat en génie chimique, biotechnologique, alimentaire ou autre spécialité pertinente ;
• 7 à 10 ans d’expérience, idéalement dans l’industrie alimentaire ou pharmaceutique, avec une expertise en conception et optimisation de procédés ;
• Membre de l’Ordre des ingénieur.es du Québec (OIQ) ;
• Connaissance approfondie des procédés alimentaires (transformation, stérilisation, séchage, etc.) ;
• Expérience avec des logiciels de simulation de procédés (ex. : SuperPro Designer, Aspen Hysys, Pipe-Flo) ;
• Connaissance des normes et standards alimentaires (CFIA, FDA, GFSI, ASME)
• Travailler en présentiel, chez le client, pour des mandats de toutes durées, selon les besoins du client ;
• Expérience en gestion de projet et en coordination interdisciplinaire ;
• Excellentes compétences en communication et en gestion des parties prenantes ;
• Baccalauréat en génie chimique, biotechnologique ou autre spécialité pertinente.

Avantages Sociaux
Ce que nous vous offrons :

• Des possibilités d’évolution rapide ;
• Un mode de travail hybride, minimalement 2 jours par semaine au bureau ;
• Un environnement qui favorise la responsabilisation et la croissance professionnelle ;
• Assurances collectives complètes avec couverture dès le 1er jour d'emploi (médicale, dentaire, visuelle) ;
• 3 semaines de vacances régulières dès votre embauche ;
• +1 semaine de vacances à Noël, fermée et payée ;
• +1 semaine de congé personnels additionnelle ;
• Régime de retraite REER à contribution de l’employeur de 4 % ;
• Frais de l'OIQ payés par Laporte ;
• Remboursement des frais de transport collectif ;
• Salle de sport, de musculation et de yoga au bureau de LAPORTE à Montréal;
• Bornes de recharge de véhicules électriques ;
• Un milieu de travail stimulant et non conformiste qui laisse une place à l’équilibre de vie et encourage l’efficacité au quotidien ;

#LI-Onsite
#LI-AD1
#mid-senior

LAPORTE recherche un.e ingénieur.e sénior en procédés alimentaires ayant idéalement de 7 à 10 ans d’expérience en génie chimique ou des procédés alimentaires pour rejoindre son équipe à notre bureau de Brossard, situé au quartier DIX30. Notre ingénieur.e sera responsable de la conception, de l’optimisation et de la mise en œuvre de procédés alimentaires pour des usines dans la grande région de Montréal.

Responsabilités :

• Participer à la définition des besoins des client.es pour des projets de procédés alimentaires ;
• Analyser les besoins des client.es pour déterminer les procédés optimaux (transformation, fermentation, pasteurisation, etc.) ;
• Effectuer des bilans de masses et d’énergie pour optimiser les procédés
• Concevoir et spécifier des équipements (pompes, échangeurs de chaleur, vannes de contrôle, réacteurs) et des installations de procédés ;
• Calculer les besoins en utilités (vapeur, eau refroidie, air comprimé) pour supporter les procédés ;
• Préparer des diagrammes de procédé (PFD) et des diagrammes de tuyauterie et instrumentation (P&ID) ;
• Réviser et approuver les livrables techniques, incluant les devis et les plans techniques
• Participer aux analyses de risques (HAZOP ou autres) pour garantir la sécurité et la conformité ;
• Coordonner l’installation, le démarrage, la validation et la mise en service des équipements sur site ;
• Gérer les relations avec les fournisseurs et les entrepreneur.es, incluant le suivi des livrables ;
• Collaborer avec des équipes interdisciplinaires pour assurer la conformité aux normes alimentaires (CFIA, FDA, GFSI) ;
• Établir et contrôler les budgets et échéanciers des projets, et présenter des rapports d’avancement aux client.es .

Exigences :

• Baccalauréat en génie chimique, biotechnologique, alimentaire ou autre spécialité pertinente ;
• 7 à 10 ans d’expérience, idéalement dans l’industrie alimentaire ou pharmaceutique, avec une expertise en conception et optimisation de procédés ;
• Membre de l’Ordre des ingénieur.es du Québec (OIQ) ;
• Connaissance approfondie des procédés alimentaires (transformation, stérilisation, séchage, etc.) ;
• Expérience avec des logiciels de simulation de procédés (ex. : SuperPro Designer, Aspen Hysys, Pipe-Flo) ;
• Connaissance des normes et standards alimentaires (CFIA, FDA, GFSI, ASME)
• Travailler en présentiel, chez le client, pour des mandats de toutes durées, selon les besoins du client ;
• Expérience en gestion de projet et en coordination interdisciplinaire ;
• Excellentes compétences en communication et en gestion des parties prenantes ;
• Baccalauréat en génie chimique, biotechnologique ou autre spécialité pertinente.

Avantages Sociaux
Ce que nous vous offrons :

• Des possibilités d’évolution rapide ;
• Un mode de travail hybride, minimalement 2 jours par semaine au bureau ;
• Un environnement qui favorise la responsabilisation et la croissance professionnelle ;
• Assurances collectives complètes avec couverture dès le 1er jour d'emploi (médicale, dentaire, visuelle) ;
• 3 semaines de vacances régulières dès votre embauche ;
• +1 semaine de vacances à Noël, fermée et payée ;
• +1 semaine de congé personnels additionnelle ;
• Régime de retraite REER à contribution de l’employeur de 4 % ;
• Frais de l'OIQ payés par Laporte ;
• Remboursement des frais de transport collectif ;
• Salle de sport, de musculation et de yoga au bureau de LAPORTE à Montréal;
• Bornes de recharge de véhicules électriques ;
• Un milieu de travail stimulant et non conformiste qui laisse une place à l’équilibre de vie et encourage l’efficacité au quotidien ;

#LI-Onsite
#LI-AD1
#mid-senior

LAPORTE recherche un.e chargé.e de projet pour l’industrie alimentaire ayant idéalement de 2 à 5 ans d’expérience pour rejoindre son équipe à Montréal.

Notre chargé.e de projet participera à la gestion, à la conception et à la coordination de projets d’ingénierie pour des usines alimentaires dans la grande région de Montréal.

Responsabilités :

• Participer à la définition et à la planification des projets auprès des clients ;
• Analyser les besoins techniques et proposer des solutions adaptées à l’environnement d’usine agro-alimentaire ;
• Concevoir des installations de procédés, des utilités et des équipements de conditionnement;
• Préparer les documents techniques (plans et devis);
• Gérer les appels d’offre pour la conception technique;
• Établir et contrôler les budgets et échéanciers des projets, et présenter des rapports d’avancement aux client.es.
• Superviser les entrepreneurs et coordonner les fournisseurs sur les chantiers ;
• Coordonner l’installation, le démarrage, la validation et la mise en service d’équipements et d’installations sur site ;
• Assurer la surveillance de chantier et le respect des normes de sécurité machine et santé-sécurité ;
• Collaborer avec des équipes interdisciplinaires pour garantir la conformité des livrables ;
• Participer à l’embauche et à la gestion des ressources externes (entrepreneurs, firmes de génie) ;
• Assurer le suivi technique et administratif des projets, de la conception à la mise en œuvre.

Exigences :

• Baccalauréat en génie mécanique, chimique, biotechnologique, industriel ou autre spécialité pertinente;
• 2 à 5 ans d’expérience en gestion de projets d’ingénierie, idéalement dans un milieu alimentaire ou manufacturier ;
• Membre de l’Ordre des ingénieurs du Québec (OIQ), un atout ;
• Compréhension approfondie des équipements de production manufacturière, procédés alimentaires, emballage et/ou systèmes mécaniques dans un environnement d’usine ;
• Expérience en gestion de projets;
• Expérience en conception de procédés manufacturiers, un atout ;
• Expérience dans la supervision de chantiers et la gestion de firmes de génie-conseil ou d’entrepreneurs ;
• Excellentes compétences interpersonnelles et capacité à travailler de manière autonome
• Connaissance des normes de sécurité et des risques en milieu manufacturier ;
• Connaissance des analyses de risques, un atout
• Membre de l’Ordre des ingénieurs du Québec (OIQ), un atout ;
• Certification ASP Construction, un atout ;
• Connaissances des classifications des zones dangereuses (gaz, vapeurs, poussières, fibres, etc), un atout ;
• Travailler en présentiel, chez le client, pour des mandats de toutes durées, selon les besoins du client.

Avantages Sociaux
Ce que nous vous offrons :

• Des possibilités d’évolution rapide ;
• Un environnement qui favorise la responsabilisation et la croissance professionnelle ;
• Assurances collectives complètes avec couverture dès le 1er jour d'emploi (médicale, dentaire, visuelle) ;
• 3 semaines de vacances régulières dès votre embauche ;
• +1 semaine de vacances à Noël ;
• +1 semaine de congé personnels ;
• Régime de retraite REER à contribution de l’employeur de 4 % ;
• Frais de l'OIQ payés par Laporte ;
• Remboursement des frais de transport collectif ;
• Bornes de recharge de véhicules électriques disponible au bureau Laporte ;
• Un milieu de travail stimulant et non conformiste qui laisse une place à l’équilibre de vie et encourage l’efficacité au quotidien.

#LI-Onsite

#LI-AD1

#engineering-services
#associate

LAPORTE recherche un.e spécialiste sénior en assurance qualité, conformité et validation ayant 7 à 10 ans d’expérience pour rejoindre son équipe de Québec, dont les bureaux sont situés à Sainte-Foy.

La personne retenue agira à titre de consultant auprès des clients de LAPORTE Experts‑Conseils. Elle interviendra directement sur les sites clients afin de planifier, exécuter et documenter les activités d’assurance de la qualité et de validation tout en assurant leur conformité aux exigences réglementaires applicables.

Responsabilités

Assurance qualité et conformité

• Agir comme expert qualité auprès des clients pour des problématiques complexes de conformité
• Évaluer l’état de conformité des systèmes, équipements et processus
• Rédiger ou réviser des procédures qualité (SOP)
• Effectuer la revue critique de dossiers de validation et de contrôle de changement
• Supporter les clients lors de constats d’audit et pour la rédaction aux réponses réglementaires
• Contribuer à l’amélioration continue des systèmes qualité clients
• Former les équipes clients aux exigences GMP et aux bonnes pratiques de validation
• Conseiller les clients sur l’interprétation des exigences réglementaires

Validation – Exécution terrain (CQV)

• Planifier les activités de qualification en collaboration avec les équipes client (ingénierie, maintenance, production, AQ)
• Préparer et réviser les protocoles IQ, OQ et PQ selon les standards internes et réglementaires
• Encadrer et supporter les ressources juniors lors des activités de validation sur site
• Effectuer la revue des dessins techniques, spécifications et P&ID avant qualification
• Vérifier la traçabilité entre les exigences, les tests exécutés et les résultats obtenus
• Assurer la conformité des essais réalisés avec les procédures et bonnes pratiques documentaires
• Participer à la résolution des problématiques techniques sur le terrain
• Recommander des actions correctives ou préventives en lien avec les déviations observée

Validation des systèmes informatisés (CSV)

• Évaluer la catégorisation et la criticité des systèmes informatisés (GxP)
• Définir les stratégies de validation basées sur le risque
• Rédiger ou soutenir la rédaction des matrices de traçabilité
• Réviser les configurations système et paramètres critiques
• Supporter les tests d’intégrité des données (Data Integrity – ALCOA+)
• Évaluer la conformité des fournisseurs et solutions (COTS, SaaS, infrastructure)
• Apporter un soutien lors des mises à jour, migrations ou décommissionnements de systèmes
• Participer à l’analyse d’impact des changements informatisé

Exigences

• Baccalauréat en sciences ou génie
• 7 à 10 ans d’expérience pertinente en industrie pharmaceutique réglementée;
• Excellente connaissance Santé Canada, FDA, EMA
• Capacité à gérer plusieurs mandats en parallèle dans des environnements clients variés
• Approche orientée solutions et pragmatique
• Leadership technique et crédibilité professionnelle auprès des clients
• Capacité d’adaptation et jugement professionnel en contexte réglementé
• Excellentes habiletés en communication écrite et verbale
• Membre de l’Ordre des ingénieur.es du Québec (un atout);

Avantages Sociaux
Ce que nous vous offrons :

• Des possibilités d’évolution rapide ;
• Un mode de travail hybride, minimalement 2 jours par semaine au bureau ;
• Un environnement qui favorise la responsabilisation et la croissance professionnelle ;
• Assurances collectives complètes avec couverture dès le 1er jour d'emploi (médicale, dentaire, visuelle) ;
• 3 semaines de vacances régulières dès votre embauche ;
• +1 semaine de vacances à Noël, fermée et payée ;
• +1 semaine de congé personnels additionnelle ;
• Régime de retraite REER à contribution de l’employeur de 4 % ;
• Frais de l'OIQ payés par Laporte ;
• Remboursement des frais de transport collectif ;
• Bornes de recharge de véhicules électriques ;
• Un milieu de travail stimulant et non conformiste qui laisse une place à l’équilibre de vie et encourage l’efficacité au quotidien ;

#LI-Hybrid
#LI-AD1
#mid-senior

LAPORTE recherche un.e spécialiste sénior en assurance qualité, conformité et validation ayant 7 à 10 ans d’expérience pour rejoindre son équipe de Québec, dont les bureaux sont situés à Sainte-Foy.

La personne retenue agira à titre de consultant auprès des clients de LAPORTE Experts‑Conseils. Elle interviendra directement sur les sites clients afin de planifier, exécuter et documenter les activités d’assurance de la qualité et de validation tout en assurant leur conformité aux exigences réglementaires applicables.

Responsabilités

Assurance qualité et conformité

• Agir comme expert qualité auprès des clients pour des problématiques complexes de conformité
• Évaluer l’état de conformité des systèmes, équipements et processus
• Rédiger ou réviser des procédures qualité (SOP)
• Effectuer la revue critique de dossiers de validation et de contrôle de changement
• Supporter les clients lors de constats d’audit et pour la rédaction aux réponses réglementaires
• Contribuer à l’amélioration continue des systèmes qualité clients
• Former les équipes clients aux exigences GMP et aux bonnes pratiques de validation
• Conseiller les clients sur l’interprétation des exigences réglementaires

Validation – Exécution terrain (CQV)

• Planifier les activités de qualification en collaboration avec les équipes client (ingénierie, maintenance, production, AQ)
• Préparer et réviser les protocoles IQ, OQ et PQ selon les standards internes et réglementaires
• Encadrer et supporter les ressources juniors lors des activités de validation sur site
• Effectuer la revue des dessins techniques, spécifications et P&ID avant qualification
• Vérifier la traçabilité entre les exigences, les tests exécutés et les résultats obtenus
• Assurer la conformité des essais réalisés avec les procédures et bonnes pratiques documentaires
• Participer à la résolution des problématiques techniques sur le terrain
• Recommander des actions correctives ou préventives en lien avec les déviations observée

Validation des systèmes informatisés (CSV)

• Évaluer la catégorisation et la criticité des systèmes informatisés (GxP)
• Définir les stratégies de validation basées sur le risque
• Rédiger ou soutenir la rédaction des matrices de traçabilité
• Réviser les configurations système et paramètres critiques
• Supporter les tests d’intégrité des données (Data Integrity – ALCOA+)
• Évaluer la conformité des fournisseurs et solutions (COTS, SaaS, infrastructure)
• Apporter un soutien lors des mises à jour, migrations ou décommissionnements de systèmes
• Participer à l’analyse d’impact des changements informatisé

Exigences

• Baccalauréat en sciences ou génie
• 7 à 10 ans d’expérience pertinente en industrie pharmaceutique réglementée;
• Excellente connaissance Santé Canada, FDA, EMA
• Capacité à gérer plusieurs mandats en parallèle dans des environnements clients variés
• Approche orientée solutions et pragmatique
• Leadership technique et crédibilité professionnelle auprès des clients
• Capacité d’adaptation et jugement professionnel en contexte réglementé
• Excellentes habiletés en communication écrite et verbale
• Membre de l’Ordre des ingénieur.es du Québec (un atout);

Avantages Sociaux
Ce que nous vous offrons :

• Des possibilités d’évolution rapide ;
• Un mode de travail hybride, minimalement 2 jours par semaine au bureau ;
• Un environnement qui favorise la responsabilisation et la croissance professionnelle ;
• Assurances collectives complètes avec couverture dès le 1er jour d'emploi (médicale, dentaire, visuelle) ;
• 3 semaines de vacances régulières dès votre embauche ;
• +1 semaine de vacances à Noël, fermée et payée ;
• +1 semaine de congé personnels additionnelle ;
• Régime de retraite REER à contribution de l’employeur de 4 % ;
• Frais de l'OIQ payés par Laporte ;
• Remboursement des frais de transport collectif ;
• Bornes de recharge de véhicules électriques ;
• Un milieu de travail stimulant et non conformiste qui laisse une place à l’équilibre de vie et encourage l’efficacité au quotidien ;

#LI-Hybrid
#LI-AD1
#mid-senior

LAPORTE recherche un.e ingénieur.e en sécurité des machines ayant idéalement de 2 à 5 ans d’expérience en analyse et gestion des risques liés aux équipements industriels pour rejoindre son équipe à Montréal ou Brossard. Notre ingénieur.e jouera un rôle clé dans l’évaluation, la conception et la mise en œuvre de solutions de sécurité machine conformes aux normes industrielles.

Responsabilités :

• Réaliser des analyses de risques d’équipements et de machines dans divers environnements industriels ;
• Rédiger des rapports techniques détaillés sur les résultats des analyses de risques et les solutions à mettre en place ;
• Élaborer des recommandations pour améliorer la sécurité des machines en fonction des normes en vigueur (CSA, ISO, OSHA, etc.) ;
• Concevoir, tester et mettre en œuvre des systèmes de sécurité machine (automates et relais de sécurité, garde-corps, systèmes de verrouillage, capteurs de sécurité, etc.) ;
• Programmer des automates et interfaces utilisateur.trice.s ;
• Participer aux tests et à la mise en service des systèmes ;
• Maintenir et bonifier les standards de sécurité machine ;
• Préparer des spécifications, des plans et des devis ;
• Collaborer avec l’équipe de projet interdisciplinaire ;
• Rester à jour sur les évolutions réglementaires et technologiques liées à la sécurité des machines ;

Exigences :

• Baccalauréat en génie électrique, mécanique, ou dans un domaine connexe ;
• 2 à 5 ans d’expérience en sécurité machine ou en automatisation industrielle ;
• Connaissance des normes de sécurité industrielle (CSA, ISO, OSHA) ;
• Expérience avec les automates programmables et systèmes de sécurité ;
• Capacité à rédiger des rapports techniques détaillés ;
• Visites occasionnelles chez les client.es dans la grande région de Montréal, Brossard ou Québec ;

Avantages Sociaux
Ce que nous vous offrons :

• Des possibilités d’évolution rapide ;
• Un mode de travail hybride, minimalement 2 jours par semaine au bureau ;
• Un environnement qui favorise la responsabilisation et la croissance professionnelle ;
• Assurances collectives complètes avec couverture dès le 1er jour d'emploi (médicale, dentaire, visuelle) ;
• 3 semaines de vacances régulières dès votre embauche ;
• +1 semaine de vacances à Noël, fermée et payée ;
• +1 semaine de congé personnels additionnelle ;
• Régime de retraite REER à contribution de l’employeur de 4 % ;
• Frais de l'OIQ payés par Laporte ;
• Remboursement des frais de transport collectif ;
• Salle de sport, de musculation et de yoga sur place ;
• Bornes de recharge de véhicules électriques ;
• Un milieu de travail stimulant et non conformiste qui laisse une place à l’équilibre de vie et encourage l’efficacité au quotidien.

#LI-Hybrid
#LI-AD1
#mid-senior

LAPORTE recherche un.e ingénieur.e en sécurité des machines ayant idéalement de 2 à 5 ans d’expérience en analyse et gestion des risques liés aux équipements industriels pour rejoindre son équipe à Montréal ou Brossard. Notre ingénieur.e jouera un rôle clé dans l’évaluation, la conception et la mise en œuvre de solutions de sécurité machine conformes aux normes industrielles.

Responsabilités :

• Réaliser des analyses de risques d’équipements et de machines dans divers environnements industriels ;
• Rédiger des rapports techniques détaillés sur les résultats des analyses de risques et les solutions à mettre en place ;
• Élaborer des recommandations pour améliorer la sécurité des machines en fonction des normes en vigueur (CSA, ISO, OSHA, etc.) ;
• Concevoir, tester et mettre en œuvre des systèmes de sécurité machine (automates et relais de sécurité, garde-corps, systèmes de verrouillage, capteurs de sécurité, etc.) ;
• Programmer des automates et interfaces utilisateur.trice.s ;
• Participer aux tests et à la mise en service des systèmes ;
• Maintenir et bonifier les standards de sécurité machine ;
• Préparer des spécifications, des plans et des devis ;
• Collaborer avec l’équipe de projet interdisciplinaire ;
• Rester à jour sur les évolutions réglementaires et technologiques liées à la sécurité des machines ;

Exigences :

• Baccalauréat en génie électrique, mécanique, ou dans un domaine connexe ;
• 2 à 5 ans d’expérience en sécurité machine ou en automatisation industrielle ;
• Connaissance des normes de sécurité industrielle (CSA, ISO, OSHA) ;
• Expérience avec les automates programmables et systèmes de sécurité ;
• Capacité à rédiger des rapports techniques détaillés ;
• Visites occasionnelles chez les client.es dans la grande région de Montréal, Brossard ou Québec ;

Avantages Sociaux
Ce que nous vous offrons :

• Des possibilités d’évolution rapide ;
• Un mode de travail hybride, minimalement 2 jours par semaine au bureau ;
• Un environnement qui favorise la responsabilisation et la croissance professionnelle ;
• Assurances collectives complètes avec couverture dès le 1er jour d'emploi (médicale, dentaire, visuelle) ;
• 3 semaines de vacances régulières dès votre embauche ;
• +1 semaine de vacances à Noël, fermée et payée ;
• +1 semaine de congé personnels additionnelle ;
• Régime de retraite REER à contribution de l’employeur de 4 % ;
• Frais de l'OIQ payés par Laporte ;
• Remboursement des frais de transport collectif ;
• Salle de sport, de musculation et de yoga sur place ;
• Bornes de recharge de véhicules électriques ;
• Un milieu de travail stimulant et non conformiste qui laisse une place à l’équilibre de vie et encourage l’efficacité au quotidien.

#LI-Hybrid
#LI-AD1
#mid-senior

LAPORTE recherche un.e ingénieur.e en sécurité des machines ayant idéalement de 2 à 5 ans d’expérience en analyse et gestion des risques liés aux équipements industriels pour rejoindre son équipe à Montréal ou Brossard. Notre ingénieur.e jouera un rôle clé dans l’évaluation, la conception et la mise en œuvre de solutions de sécurité machine conformes aux normes industrielles.

Responsabilités :

• Réaliser des analyses de risques d’équipements et de machines dans divers environnements industriels ;
• Rédiger des rapports techniques détaillés sur les résultats des analyses de risques et les solutions à mettre en place ;
• Élaborer des recommandations pour améliorer la sécurité des machines en fonction des normes en vigueur (CSA, ISO, OSHA, etc.) ;
• Concevoir, tester et mettre en œuvre des systèmes de sécurité machine (automates et relais de sécurité, garde-corps, systèmes de verrouillage, capteurs de sécurité, etc.) ;
• Programmer des automates et interfaces utilisateur.trice.s ;
• Participer aux tests et à la mise en service des systèmes ;
• Maintenir et bonifier les standards de sécurité machine ;
• Préparer des spécifications, des plans et des devis ;
• Collaborer avec l’équipe de projet interdisciplinaire ;
• Rester à jour sur les évolutions réglementaires et technologiques liées à la sécurité des machines ;

Exigences :

• Baccalauréat en génie électrique, mécanique, ou dans un domaine connexe ;
• 2 à 5 ans d’expérience en sécurité machine ou en automatisation industrielle ;
• Connaissance des normes de sécurité industrielle (CSA, ISO, OSHA) ;
• Expérience avec les automates programmables et systèmes de sécurité ;
• Capacité à rédiger des rapports techniques détaillés ;
• Visites occasionnelles chez les client.es dans la grande région de Montréal, Brossard ou Québec ;

Avantages Sociaux
Ce que nous vous offrons :

• Des possibilités d’évolution rapide ;
• Un mode de travail hybride, minimalement 2 jours par semaine au bureau ;
• Un environnement qui favorise la responsabilisation et la croissance professionnelle ;
• Assurances collectives complètes avec couverture dès le 1er jour d'emploi (médicale, dentaire, visuelle) ;
• 3 semaines de vacances régulières dès votre embauche ;
• +1 semaine de vacances à Noël, fermée et payée ;
• +1 semaine de congé personnels additionnelle ;
• Régime de retraite REER à contribution de l’employeur de 4 % ;
• Frais de l'OIQ payés par Laporte ;
• Remboursement des frais de transport collectif ;
• Salle de sport, de musculation et de yoga sur place ;
• Bornes de recharge de véhicules électriques ;
• Un milieu de travail stimulant et non conformiste qui laisse une place à l’équilibre de vie et encourage l’efficacité au quotidien.

#LI-Hybrid
#LI-AD1
#mid-senior

Real Chemistry is seeking a Director, Client Experience (Paid Media) to join our growing team!

This role is ideal for a strategic media leader who can oversee the day-to-day management of a portfolio of mid-size healthcare clients while guiding integrated, audience-first paid media programs that drive measurable business outcomes for the brands we serve.

The Director will serve as a senior client-facing lead, partnering across Activation, Analytics, Creative, and Account teams to develop and optimize cross-channel media strategies aligned to each client’s goals. This individual will bring strong digital media expertise, a sharp analytical mindset, and the ability to turn insights into clear, actionable recommendations for clients and internal stakeholders alike.

The ideal candidate is an experienced people manager and trusted client partner who can balance strategic leadership with operational excellence. They should be comfortable navigating a matrixed organization, mentoring junior team members, and leading integrated media planning efforts in a fast-paced environment.

This is a hybrid role based in any of our U.S. offices—including New York, Boston, Chicago, Carmel, or Lambertville.

What You’ll Do

• Lead day-to-day media strategy and client management across a portfolio of mid-size healthcare accounts
• Oversee the development of audience-first, cross-channel paid media plans aligned to brand and business objectives
• Translate research, audience insights, and performance data into actionable planning recommendations
• Partner with Activation, Analytics, Creative, and Advertising Account teams to ensure integrated execution across workstreams with our full-service clients
• Guide budget allocation, deliverable development, and campaign planning with a focus on quality, efficiency, and business impact
• Work with Analytics teams to measure campaign performance and marketing ROI, identifying optimization opportunities and communicating clear implications and next steps to clients and activation teams
• Build strong client relationships through proactive communication, thoughtful consultation, and consistent delivery excellence
• Manage and mentor junior team members, providing oversight, feedback, and workload direction
• Navigate complex stakeholder environments with professionalism, sound judgment, and strong collaboration skills
• Contribute innovative thinking, test-and-learn strategies, and forward-looking recommendations that improve client outcomes

What You’ll Bring

• 8+ years of experience in digital media planning and activation; healthcare, pharma and/or B2B experience strongly preferred
• 2+ years of progressive leadership experience, including direct or indirect team management
• Deep experience with cross-channel and HCP/DTC media planning
• Experience across omni-digital channels; experience with traditional media channels (print, OOH, linear TV, radio) is a plus
• Strong understanding of audience segmentation, targeting, media research, and planning tools as well as the willingness and ability to learn internal proprietary tools
• Fluency in media measurement, campaign reporting, and ROI-focused decision-making as a strategic partner to Analytics teams
• Ability to synthesize data into strategic recommendations
• Experience partnering with Activation and Analytics teams to produce meaningful performance reporting
• Ability to communicate effectively with senior-level clients and cross-functional stakeholders
• Excellent organizational, prioritization, and project management skills
• Familiarity with ad servers, attribution models, and advanced performance media tactics
• Familiarity with channel and partner inventory to guide junior and Activation teams

This Role May Be a Good Fit If You Are

• A strategic thinker with a strong data-driven mindset
• A proactive and solutions-oriented client leader
• Comfortable managing multiple priorities in a fast-paced environment
• A collaborative team player who leads with accountability and clarity
• Adaptable and energized by change
• Motivated by Real Chemistry’s values: Best Together, Impact-Obsessed, Excellence Expected, Evolve Always, and Accountability with an “I”

Pay Range: $95,000 - $140,000

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 geographic location. The Company reserves the right to modify this pay range at any time.

About Re:Build Manufacturing

Re:Build Manufacturing is a growing family of industrial and engineering businesses combining enabling technologies, operational superiority, and strategic M&A to build America’s next generation industrial company. At Re:Build we deploy deep expertise in engineering, operations management, and technology to supercharge the performance of our member companies. We leverage deep professional expertise and a candid, principled operating culture to drive differentiated outcomes. Ours is a fast-paced environment where individuals can stretch and be challenged to pursue their fullest potential.

Re:Build was founded to pioneer a profitable model for the revitalization of US manufacturing. We’ve assembled a powerful set of complimentary capabilities and lines of business that enable us to pursue a wide range of end markets. Our acquired businesses are grounded in build-to-print and by-the-hour engineering and design services, and we’re leveraging their combined expertise to migrate to increasingly sophisticated program development and production, as well as the generation of our own products. Our unique set of capabilities lend themselves to highly complex systems and products, and we offer customers a range of services including product and systems design, automation, fabrication, assembly, and large volume contract manufacturing. Our customers span a wide array of industries including aerospace, defense, mobility, healthcare, pharma, biotech, clean tech, chemicals, energy, lifestyle, food production, and industrial equipment.

Who we are looking for

This is an exciting opportunity for an impactful role where you will enjoy considerable autonomy and variety. The Senior Marketing Manager is integral to the team, driving go-to-market initiatives for Re:Build’s cross-industry capabilities in industrial systems, automation, machine design/build, and battery technology. You will work closely with the business development, sales, marketing team, and technical domain experts to develop and support the entire client acquisition process and nurture ongoing relationships with existing clients and trade organizations.

The position requires a highly motivated, “roll-up your sleeves” professional fluent in business-to-business marketing of highly technical products and services. This is a very hands-on role requiring the implementation of the Re:Build marketing and business development process and supporting each company within the organization in meeting annual growth initiatives. It is a high-visibility role that impacts the entire organization.

What you get to do

• Lead the generation and flow of high-quality Marketing Qualified Leads into the sales funnel for the assigned businesses.
• Conduct targeted market and competitive research to identify trends, customer needs, and competitive positioning opportunities that advise strategic decisions.
• Develop, drive, and complete targeted campaigns to improve and sustain pipeline health in collaboration with the demand generation team.  
• Evaluate, adopt, and leverage AI-enabled marketing tools and workflows to improve campaign performance, content development, market research, lead generation, and operational efficiency.
• Champion the responsible use and adoption of AI technologies across marketing initiatives while identifying opportunities for innovation and process improvement.
• Develop, drive, and implement the marketing strategy for the capabilities in our industrial systems, automation, machine design/build, and battery technology.
• Serve as the marketing owner for designated market segments and capabilities, developing and delivering targeted go-to-market strategies that drive awareness, engagement, pipeline growth, and revenue generation.
• Own, plan, manage, and optimize spend for the annual demand generation budget to generate funnel growth and pipeline velocity.
• Develop, implement, and use creative and differentiated ideas to drive high-quality leads into the funnel and position Re:Build in the marketplace as a technical industry leader.
• Develop, drive, author, and compile technical content, including:
  • Case studies
  • Speaking engagements
  • Webinars
  • Print and digital sales/marketing
• Support overall company marketing goals and go-to-market strategy.
• Support and influence the tradeshow calendar by targeting relevant events for our product innovation and engineering services businesses
• Identify, develop, and implement strategy for non-traditional market segments.
• Track and report on the efficacy of marketing programs and initiatives and recommend adjustments to strategy.

What you bring to the Team

• Extreme attention to detail and exceptional organizational skills
• Self-motivated with the ability to work independently
• Comfortable with multitasking in a fast-paced and time-sensitive environment  
• Excellent written and verbal communication skills
• Curious, fast-learning, and resourceful
• Demonstrated curiosity and adaptability in learning and applying emerging AI tools and technologies to enhance marketing effectiveness and productivity.
• Applied understanding of basic marketing principles
• Creative problem-solving skills
• Ability to work well with a remote team
• Ability to prioritize tasks and meet deadlines in a fast-paced environment
• Comfortable with using metrics to strive for continuous improvement and demonstrating the value of marketing initiatives

Education and/or Experience:

• Bachelor’s degree or equivalent experience in engineering, marketing, or a related field
• Minimum of 8 years of professional experience in a marketing position in an industrial systems, engineering, automation, or manufacturing company; experience in engineering-based role prior to working in marketing would be ideal
• Competency and fluency in Account Based Marketing (ABM), Paid Media, Automation, CRO, SEO, PLG, activation, and retention
• Strong background of driving demand-generation programs that deliver measurable business results, including pipeline and revenue
• Proven experience developing and accomplishing unified campaigns across multiple channels, including email, webinars, paid media, events, and social media
• Proficient with Microsoft Office 365 Suite
• Competent with the Adobe Creative Cloud Suite of products (Photoshop, InDesign, and Illustrator)
• Familiarity or experience with HubSpot
• Experience leveraging AI tools (e.g., generative AI, marketing automation, analytics, or content optimization platforms) to improve business outcomes is strongly preferred.

Export Control Requirement: Due to applicable export control laws and regulations, candidates must be a U.S. citizen or national, U.S. permanent resident (i.e., current Green Card holder), or lawfully admitted into the U.S. as a refugee or granted asylum.

The base salary range for this position is $ 105,000 – $150,000 per year. This range represents the Company’s good faith estimate of the base compensation for this role at the time of posting.  Actual compensation will be determined based on several factors, including but not limited to proven experience, skills, qualifications, internal equity, and geographic location. In addition to base salary, this role may be eligible for annual incentive compensation and/or long-term incentives, subject to Company plans. The Company offers a comprehensive benefits package including medical, dental, vision, retirement, paid time off, and other benefits. 

The BIG payoff

We are a company who is going to make a difference in the industries and the communities in which we choose to operate.  Every employee of Re:Build will share ownership in the company and will share in the financial rewards of the success we achieve together, at all levels of the company!

We want to work with people that reflect the communities in which we operate

Re:Build Manufacturing is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, marital status, parental status, cultural background, organizational level, work styles, tenure and life experiences. Or for any other reason.

Re:Build is committed to providing reasonable accommodations for qualified individuals with disabilities in our job application procedures. If you need assistance or an accommodation due to a disability, you may contact us at accommodations.ta@ReBuildmanufacturing.com or you may call us at 617.909.6275.

Responsibilities:

• Strategic Leadership: Develop and execute an innovative and family access strategy aligned with BridgeBio's objectives, aiming to ensure that people living with rare conditions can access the company's products

• Team Leadership: Manage a team of Family Access Managers (FAM); Provide leadership, coaching, and support to ensure the team's maximum effectiveness

• Family Access Strategy: Oversee the development of FAM tools and execution of access strategies, which may involve working with pharmacies, health systems, and providers to secure patient access for family

• Cross-Functional Collaboration: Evaluate and align with BridgeBio advocacy team on advocacy meetings to attend and represent BridgeBio

• Compliance: Ensure that all reimbursement and patient access activities adhere to healthcare regulations and corporate compliance requirements, including relevant laws and industry standards

• Stakeholder Collaboration: Collaborate with healthcare providers (prescribers and well as staff), payers, the Hub and pharmacies to facilitate patient access and address access challenges

• Data Analysis: Utilize data analysis and reporting tools to evaluate the efficiency and effectiveness of family access processes, finding areas for improvement and implementing necessary changes

• Policy and Market Analysis: Stay updated on changes in healthcare policy, market dynamics, and healthcare trends that may impact patient access

• Budget Management: Manage the budget for team of FAMs, ensuring cost-effective resource allocation

• Quality Assurance: Implement quality assurance measures to ensure each member adheres to the team’s standards and expectations

No matter your role at BridgeBio, successful team members are:

• Patient Champions, who put patients first and uphold strict ethical standards

• Entrepreneurial Operators, who drive toward practical solutions and have an ownership mindset

• Truth Seekers, who are detailed, rational, and humble problem solvers

• Individuals Who Inspire Excellence in themselves and those around them

• High-quality executors, who execute against goals and milestones with quality, precision, and speed

Education, Experience & Skills Requirements:

• Bachelor's or advanced degree in a relevant field (Healthcare Administration, Business, Nursing, Genetics, Pharmacy, etc.). Master's degree or equivalent is a plus

• 15+ years of Access and/or sales experience in the Pharmaceutical or Healthcare industries, including rare disease experience and launch experience

• 5+ years of leading and developing high performing teams

• Experience in Patient Services, Market Access, Reimbursement or Patient Access Management preferred

• Experience working with Specialty Pharmacy Networks and Patient Services Hubs

• In-depth knowledge of healthcare reimbursement processes and healthcare regulations

• Exceptional leadership and team management skills

• Strong knowledge of the payer environment, including government (Medicaid) and commercial payers

• Effective communication and interpersonal skills for collaboration with stakeholders

• Proficiency in data analysis, reporting tools, and AI

• Genetics, Endocrinology, Rare Disease experience is a plus

• Strong knowledge and understanding of Compliance with HIPAA regulations, OIG guidance, Advertising and Promotion requirements, the Anti-Kickback Statute, and applicable policies, best practices, and guidelines

• Commitment to patient-centered support and ensuring access to innovative treatments

• Up to 50-60% Travel; including occasional weekends

As a global company, our comprehensive benefits may vary based on location.  We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return.

For USA based roles:

Financial & Rewards 

• Market-leading compensation  

• 401(k) with employer match  

• Employee Stock Purchase Program (ESPP)

• Pre-tax commuter benefits (transit and parking) 

• Referral bonus for hired candidates 

• Subsidized lunch and parking on in-office days 

Health & Well-Being

• 100% employer-paid medical, dental, and vision premiums for you and your dependents 

• Health Savings Account (HSA) with annual employer contributions, plus Flexible Spending Accounts (FSA)

• Fertility & family-forming benefits

• Expanded mental health support (therapy and coaching resources) 

• Hybrid work model with flexibility 

• Flexible, “take-what-you-need” paid time off and company-paid holidays 

• Comprehensive paid medical and parental leave to care for yourself and your family 

Skill Development & Career Paths:

• People are part of our growth and success story - from discovery to active drug trials and FDA pipelines, there are endless opportunities for skill development and internal mobility

• We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, & BetterUp Coaching

• We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities

Position Overview

The Senior Clinical Data Manager (Sr. CDM) is responsible for leading end-to-end data management activities across one or more complex clinical trials. This role ensures high-quality, reliable clinical data that meets regulatory standards and supports timely clinical development decisions. The ideal candidate is a proactive problem solver with experience in data standards, EDC systems, and cross-functional collaboration. 

Responsibilities

Study Planning & Start-Up 

• Serve as the data management lead for assigned clinical studies, providing strategic input into protocol design and data collection strategy. 

• Develop and manage Data Management Plans (DMPs), CRF/ eCRF specifications, edit check specifications, and data validation plans. 

• Lead EDC system set-up, UAT, and deployment; coordinate with external vendors and internal biometrics teams. 

Execution & Oversight 

• Oversee all data review activities, including query management, data cleaning, discrepancy resolution, and ongoing data quality monitoring. 

• Ensure adherence to CDISC/CDASH/SDTM standards where appropriate, as well as applicable regulatory requirements (ICH-GCP, FDA, EMA). 

• Track study metrics, identifying risks and implementing mitigation strategies to maintain high-quality and timely deliverables. 

• Manage interactions with CROs, central labs, imaging vendors, and other data contributors. 

Close-Out & Reporting 

• Lead database lock activities, ensuring audit readiness and complete documentation. 

• Support statistical programming and medical writing teams in delivering data for interim analyses, CSR outputs, and regulatory filings. 

• Contribute to process improvements and knowledge sharing within the data management function. 

Qualifications

• Bachelor’s degree in relevant field 

• A minimum of 5 years of Clinical Data Management experience in the biotech/pharma industry. Oncology experience is strongly preferred.  

Knowledge and Skills

• Demonstrated expertise with EDC systems (e.g., Medidata Rave, Oracle InForm, Veeva CDMS). 

• Understanding of clinical trial methodology, regulations, and data standards. 

• Experience leading data management activities for Phase I–III global clinical trials. 

• Vendor oversight experience and ability to drive cross-functional alignment. 

• Knowledge of FDA, ICH-GCP, and 21 CFR Part 11 compliance. 

• Excellent communication, documentation, and project management skills. 

Position Overview

The Senior EDC (Electronic Data Capture) Programmer (Sr. EDCP) is responsible for leading the design, development, and maintenance of clinical trial databases in an EDC system. This role will work closely with Clinical Data Management, Biostatistics, Clinical Operations, and external vendors to ensure high-quality, compliant data collection systems that support efficient trial execution. 

Responsibilities

• Lead the design, build, validation, and deployment of a study build within an EDC system. 

• Develop and maintain edit checks, custom functions, derivations, and integrations. 

• Review study protocols and provide input on CRF design and database structure. 

• Collaborate with Data Management to ensure alignment with data standards (CDISC, SDTM where applicable). 

• Perform User Acceptance Testing (UAT) and support database releases and migrations. 

• Ensure EDC systems comply with regulatory requirements (FDA, ICH-GCP, 21 CFR Part 11). 

• Troubleshoot and resolve database issues in a timely manner. 

• Oversee and/or mentor junior programmers or external vendors. 

• Contribute to SOP development and process improvements. 

• Support data integrations with external systems (IRT, ePRO, labs, etc.). 

• Maintain documentation including specifications, validation records, and audit trails. 

Qualifications

• Bachelor’s degree in relevant field. 

• A minimum of 5 years of EDC programming experience in the biotech/pharma industry. Oncology experience is preferred.  

Knowledge and Skills

• Strong hands-on experience with at least one major EDC platform (Medidata Rave preferred). 

• Solid understanding of clinical trial processes and data flow. 

• Experience with CDISC standards (SDTM, CDASH) is preferred. 

• Familiarity with regulatory requirements (ICH-GCP, 21 CFR Part 11). 

• Strong problem-solving skills and attention to detail. 

• Ability to manage multiple studies and priorities. 

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.

The Senior Manager/Associate Director, Supplier and Audit Management will serve as a key Quality Assurance representative across cross-functional teams and with external contract service providers. This role drives inspection readiness for Neumora's Quality Management Systems, champions continuous improvement initiatives from concept through implementation, and provides direction and oversight to partnering Quality functions.

Drawing on deep pharmaceutical industry expertise, this individual will lead and execute high-impact Quality programs with a focus on compliance, operational excellence, and business alignment. The role works closely with CMC, Clinical Operations, and other core functions to ensure the QMS meets regulatory requirements and customer expectations throughout clinical development.

Responsibilities:

• Lead the end-to-end supplier management lifecycle and audit program, including process ownership, continuous improvement, and audit scheduling (supplier, clinical investigator, and internal audits); oversee Quality Agreement and Risk Management processes.
• Establish, maintain, and continuously improve QMS procedures, workflows, metrics, and practices to strengthen compliance and operational effectiveness.
• Oversee the internal audit program and ensure associated process improvements are established, executed, and monitored for effectiveness.
• Manage all aspects of documentation and records retention for supplier and audit management, including the routing and approval of documents, archival, and period review.
• Partner with Manufacturing, Quality Control, Validation, Regulatory Affairs, Supply Chain, Clinical Development, and Clinical Operations to ensure appropriate application of QMS requirements across operations.
• Lead, support and participate in regulatory authority inspections.
• Manage external contractors and, where applicable, lead, coach, and develop QMS personnel, including prioritization of work, performance oversight, and support for professional development.
• Serve as business owner for Quality-owned systems (e.g., Veeva Vault QMS), driving continuous improvement and ensuring systems remain in a validated state.
• Support internal audits, customer audits, and regulatory inspections by ensuring quality systems and associated records are inspection-ready at all times.
• Strengthen the Quality culture by leading cross-functional Quality initiatives.

Qualifications:

• Bachelor’s degree in chemistry, biology, microbiology, industrial pharmacy, or other related scientific discipline with a minimum of 10 years’ experience in Quality preferred
• Experience auditing suppliers, CRPs, CMOs, CTLs and clinical sites
• Practical knowledge of supplier and audit management across US, EU and ROW regulated environments
• Working knowledge of electronic quality management systems, learning management systems, data retrieval, and electronic file formats; Veeva Vault experience strongly preferred
• Experience working within a global Phase I though commercial QMS company
• Detail-oriented with strong communication, organizational, and time management skills a must
• Ability to multitask, work under time constraints, problem-solve, and prioritize
• Highly proficient in Microsoft Office, especially MS Excel
• Willingness to travel up to 25%

2026 Company benefits include:

• Medical, dental, vision, and life insurance
• 401(k) plan: Neumora matches 50% of an employee’s eligible contribution, up to the first 6% of salary (up to 3% employer contribution)
• Company Equity (New Hire Awards, Annual Awards, ESPP)
• Annual paid time off:
• Accrued Vacation Days: 15 days per year
• Sick Days: 10 days per year
• Company Holidays: 13 days plus summer recharge week in July and winter shutdown in December
• Leave of Absence: Paid Medical Leave, Paid New Parent Bonding Leave, Paid Family Leave, paid short-term and long-term disability
• Discretionary year-end bonus

The salary range posted describes the minimum to maximum base salary range for this position in the location listed.  Actual salary may vary based upon geographic location, work experience, education, licensure requirements and/or skill level and will be finalized at the time of offer. Base Salary Range:$163,200-$197,616

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.  Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

This role:

The Maintenance Technician (production, utilities, facilities) works as a key member of a high-performance team responsible for supporting daily manufacturing, utilities, and inspection & packaging operations in a pharmaceutical production environment. This position is 100% onsite at the Bloomington, Indiana facilities.

Responsibilities:

• Routine and non-routine checks and electrical/mechanical repair of production, utilities, and packaging & inspection equipment failures
• Troubleshoot and preventive maintenance
• Identify and implement continuous improvement projects
• Develop, monitor, and perform preventative maintenance procedures
• Review and track equipment component failures and help make recommendations for increased long-term reliability
• Maintain appropriate equipment documentation and change control according to internal procedures
• Participate in spare part analysis and inventory development
• Installation and startup of new equipment

Required qualifications:

• Must have a high school diploma or GED (Technical Associates degree preferred)
• 2-5 years industrial maintenance experience (or equivalent) in a multi craft environment - MAINTENANCE TECHNICIAN
• 5-8 years industrial maintenance experience (or equivalent) in a multi craft environment - SR. MAINTENANCE TECHNICIAN
• 8+ years industrial maintenance experience (or equivalent) in a multi craft environment and leadership/supervisory experience - LEAD MAINTENANCE TECHNICIAN
• Preferred experience in aseptic manufacturing environment
• Preferred HVAC/welding certification
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, Pilgrim, Trackwise, etc.)

Physical / Safety Requirements:

• Must be able to lift, push/pull, and carry up to 50 pounds
• May be required to stand for over 4 hours per day
• Must be able to lift 20 pounds overhead
• Must be able to wear personal protective as required.
• Duties may require overtime work, including nights and weekends
• Use of hands and fingers to manipulate office equipment and hand tools is required
• Must be able to gown qualify for Grade A/B areas, as needed.

In return, you’ll be eligible for[1]:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
  • Employee Ownership Plan
• Additional Benefits
  • Short and Long-Term Disability Insurance
  •  Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

[1] Current benefit offerings are in effect through 12/31/26

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:  https://simtra.com/privacy-policy/

Job Description

The Senior Account Manager (SAM) oversees projects within a vertical account team to ensure quality and provide continuity and tactical alignment while also leading high-profile projects from the client through to the project manager and cross-functional team. The SAM will partner with the Account Director to assist brand partners with the development and management of the tactical plan. This role requires a strong awareness of the account’s strategic direction, as well as knowledge of clients’ products and processes. The success of this position relies on the success of the team, meeting clients’ expectations, partnering with Avant colleagues, and individual performance. 

What you’ll do:

• Ensure quality and consistency across multiple tactics that are led by both Avant and   external partners  

• Provide oversight and consultation to Account Managers as it relates to project execution  

• Act as the in-house client at all times by communicating client expectations to the crossfunctional team  

• Act as the Customer Management Office (CMO) liaison within the respective   account (vertical)  

• Provide invoicing information and budget status updates to clients as requested  

• Provide direction and review job scope changes and closeouts as necessary  

• Provide peer-to-peer channel insights and recommendations  

• Drive strategic partnerships with clients by having and applying knowledge of their products and objectives  

• Lead and actively participate in strategic brainstorming sessions and annual   strategic planning  

• Assist the business owner as needed with the following tasks  

• Create proposals for projects within assigned accounts  

• Partner with finance team and project managers in budget development  

• Perform other strategic work as delegated by the Account Director

• Ensure strategic objectives are met with each client project  

• Support organic growth opportunities for the account through a strong understanding of Avant capabilities, client needs, and attention to buying signals  

• Partner successfully with Project Management Team to execute projects from the initiating and planning phases through the closing phase  

• Develop and manage project creative briefs and client scope statements  

• Supervise projects to ensure tactical and strategic goals are met  

• Follow all policies, procedures, industry standards, and compliance guidelines and ensure team members’ adherence  

• Execute client status meetings and prepare all meeting materials and follow-up items (agendas, notes, etc.)  

• Partner successfully with Project Management Team to execute projects from the initiating and planning phases through the closing phase (cont.)  

• Monitor the overall project scope from a client and account perspective and communicate scope changes when necessary   

• Provide final approval on all deliverables to ensure strategic objectives are met

• Develop and communicate status reports with management and the client, monitor project and team results against client expectations   

• Monitor and manage project-related risks and issues in partnership with the project manager; resolve and escalate risks and issues to the client when needed  

 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 highly organized self-starter, able to work independently and under tight deadlines. 

• You speak social media: X, Facebook, Instagram, LinkedIn, Snapchat, YouTube, Pinterest, you name it. You have in in-depth knowledge of today’s top social platforms 

What you should have:   

• BA/BS or equivalent required  

• 3-4 years of team leadership experience required  

• 3-4 years of client/customer management experience required  

• 2+ years in pharmaceutical sales/marketing preferred  

• 2+ years’ experience in strategic planning preferred

• Leadership experience in a corporate, marketing, or life sciences environment preferred  

• Project management experience preferred

Pay Range: $85,000-$95,000

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. 

About this opportunity:

To support Freenome’s rapid growth, we’re looking for a proven and collaborative Senior Manager, Accounting to join our team! This is a highly visible role that will support key financial reporting and compliance functions, including SEC reporting (10-K/10-Q filings and earnings releases), the SOX compliance, and revenue recognition activities. The ideal candidate is known as a solutions-oriented cross-functional partner and will have a significant impact on the continued growth of an organization dedicated to changing the entire landscape of cancer.

In this role, you will report directly to the Director, SEC Reporting and SOX Compliance and will closely collaborate with the accounting team. This role will be a Hybrid role based out of our Brisbane, California headquarters.

What you’ll do:

• Play a key role in accounting and SEC reporting functions, ensuring compliance and accurate presentation of financial statements and disclosures in accordance with U.S. GAAP and SEC rules.
• Support the preparation of monthly, quarterly and annual internal financial statements as well as S-1, 10-Q, 10-K, and any other SEC required filings including footnote preparation.
• Analyze peer company filings and industry reports to assess trends in financial disclosures.
• Support the preparation of the quarterly earnings release and related documents.
• Support revenue recognition and reporting including DSO analysis:
  • Revenue by product
  • Revenue by payors
  • Profit by product
  • Profit by Payors
• Collaborate with the accounting team in the development of processes and procedures that support the implementation of SOX 404 and ensure reporting requirements related to the Sarbanes-Oxley Act are met.
• Assist in the evaluation and continual improvement of accounting procedures, processes, and systems to ensure standardized close processes and efficient operations.
• Support internal and external audits and regulatory examinations.
• Support and execute on ad-hoc requests as assigned as necessary.

Must haves:

• Bachelor’s Degree in Accounting/Finance/Business.
• Minimum of 6+ years of relevant accounting experience in a fast-paced, high- growth biotech, diagnostic, medical device environment.
• Public accounting experience a plus.
• Must have Xifin RCM experience.
• Strong working knowledge of SAP.
• Strong accounting background with a good knowledge of U.S. GAAP, SOX 404, and SEC reporting standards.
• Demonstrated ability to think strategically while maintaining a command of the details.
• Ability to draft financial statements presentation and footnote disclosures as part of filings with the SEC (10-Q and 10-K).
• Demonstrated ability to independently coordinate multiple priorities in a dynamic environment.
• Strong interpersonal and written communication skills enabling effective communications with all levels of management.
• Proactive, organized, and takes ownership of projects and deadlines.
• Meticulous and superior attention to details.
• Strong work ethic including sound judgement, outstanding interpersonal skills and ability to work independently.
• Continuous learning mindset with a passion for improving policies, procedures for compliance, effectiveness, and efficiency.

Nice to haves:

• MBA or Big-4 a plus.
• Industry experience in diagnostics.
• Strong working knowledge of Netsuite.
• Ability to prioritize and organize work effectively, with exceptional cross-functional collaboration and communication skills.

Benefits and additional information:

The US target range of our base salary for new hires is $161,500 - $205,538. You will also be eligible to receive equity, cash bonuses, and a full range of medical, financial, and other benefits depending on the position offered.  Please note that individual total compensation for this position will be determined at the Company’s sole discretion and may vary based on several factors, including but not limited to, location, skill level, years and depth of relevant experience, and education. We invite you to check out our career page @ freenome.com/job-openings/ for additional company information.  

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

Applicants have rights under Federal Employment Laws.  

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

#LI-HYBRID

About The Role:   

As a Technical Training Manager within the Quality Management Training team, you’ll play a lead role in training and developing associates on GMP-regulated processes that support our AAV Manufacturing operations. Reporting to the Director, GMP Quality Training, you’ll own the delivery of training through hands-on and classroom instruction, actively observe performance, and mentor associates to ensure they are trained, qualified, and confident in their work. You’ll lead qualification and requalification activities, document results in compliance with GDP, and maintain your own process and gowning qualifications to serve as a subject matter expert. While this position is primarily focused on training delivery and mentoring, you’ll also shape the program by identifying training gaps, sharing feedback with supervisors, and recommending improvements to strengthen training methods, content, and overall effectiveness. 

Responsibilities: 

Training Delivery and Qualification: 

• Serve as a subject matter expert and technical lead for GMP Manufacturing operations, owning the delivery of training through classroom instruction, one-on-one coaching, and hands-on, on-the-job practice. 

• Mentor associates throughout their development, actively observe and evaluate performance, and ensure their successful transition to independent work. 

• Coordinate and lead qualification and requalification activities by assessing proficiency, verifying proper execution of GMP-regulated processes, and ensuring all results are accurately documented in compliance with GDP. 

Training Coordination and Compliance: 

• Take ownership of Manufacturing training program compliance by providing clear, actionable feedback to associates and management on training progress, performance observations, and identified gaps. 

• Be accountable for upholding GMP/GDP expectations through accurate qualification documentation and consistent reinforcement of training standards. 

• Be cross-trained in the Training Management System (e.g., Veeva Vault) to provide oversight and ensure accuracy in recordkeeping, compliance tracking, and reporting when required. 

Program Development and Content Management: 

• Take ownership of developing and maintaining training programs that directly support Manufacturing, working in close partnership with Manufacturing leadership and the Training team. 

• Lead the design of area-specific training content, on-the-job training initiatives, and qualification processes to ensure associates are fully prepared for independent work. 

• Own the revisions, updates, and periodic reviews of training materials, ensuring they remain current with SOPs, process changes, and continuous improvement activities. 

Continuous Improvement and Support: 

• Take ownership of continuous improvement within training programs by monitoring effectiveness, proactively communicating findings to leadership, and driving remediation or enhancements where needed. 

• Identify training gaps, recommend improvements, and implement stronger training methods to elevate associate performance and compliance. 

• Maintain gowning and manufacturing process qualifications to serve as a subject matter expert and technical lead during training activities, ensuring associates are consistently prepared for independent work. 

Qualifications: 

• Associate’s degree in Life Sciences, Biotechnology, or a related technical field required; Bachelor’s degree strongly preferred. Equivalent experience may be considered. 

• 3-5 years of experience in GMP-regulated manufacturing (biotech, pharmaceutical, or medical device), with advanced knowledge of AAV bioprocess manufacturing and aseptic techniques/practices. 

• Demonstrated experience leading training activities, mentoring associates, and serving as a recognized Subject Matter Expert within Manufacturing operations. 

• Proven ability to deliver hands-on, on-the-job training and conduct qualification assessments in compliance with GMP/GDP requirements. 

• Advanced communication and facilitation skills, with the ability to simplify complex technical concepts and engage diverse audiences. 

• Experience working cross-functionally with Manufacturing, Quality, Process Development, and Training teams to align training with both business objectives and compliance requirements. 

• Strong organizational and leadership skills, with the ability to manage multiple training priorities and influence program outcomes. 

• Knowledge of adult learning principles and training design methodologies (e.g., ADDIE). 

• Ability to work onsite in Columbus, Ohio 3-4 days/week on average. 

• Ability to work in a cleanroom environment, that requires wearing full Personal Protective Equipment (PPE), including gowns, gloves, masks, and safety glasses. 

Preferred Skills: 

• Demonstrated success in leading training initiatives, mentoring associates, and serving as a recognized SME within GMP-regulated environments. 

• Expertise in AAV bioprocess manufacturing, including cell culture operations, aseptic techniques, and cleanroom behaviors. 

• Proficiency with electronic training systems such as Veeva Vault or similar platforms, with the ability to interpret and leverage training data. 

• Proven ability to identify training gaps, recommend improvements, and implement enhancements that strengthen program effectiveness. 

This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities and activities may change or new ones may be assigned.  

Forge Your Future with Us:

At Forge Biologics, we believe in turning bold ideas into life-changing realities. Our mission is simple yet powerful: to enable access to life-changing gene therapies and help bring them from ideas into reality. We partner with scientists, physicians, biotech and pharma innovators, and patient communities — all united by one goal: improving lives. If you’re driven by purpose and excited to make a tangible impact, this is where your journey begins.

Our team works out of The Hearth, a state-of-the-art, 200,000-square-foot cGMP facility in Columbus, Ohio. Here, you won’t just watch innovation happen — you’ll be part of it. Whether you’re scaling AAV manufacturing, collaborating on cutting-edge therapies, or supporting complex technical projects, you’ll play a key role in bringing hope to patients with genetic diseases.

What sets Forge apart is our culture of H.O.P.E. We are hardworking, showing up each day with determination and grit. We are open, creating a space where ideas flow freely and every voice is valued. We are purpose-driven, with every task directly tied to changing lives. And we are engaged, energized by the challenges we face and the milestones we achieve together.

At Forge, your growth matters. We’re committed to helping you expand your skills, take on new challenges, and develop your career through mentorship, hands-on learning, and opportunities for advancement. Our people are our greatest investment, and we’re proud to see team members grow with us.

If you’re ready to use your talent to help deliver hope to patients around the world, join us — and be part of something bigger than yourself.

About the Role: 

The Senior Quality Systems Specialist provides quality systems and operational expertise for the Forge GMP facility in Grove City, OH. The Quality Systems Specialist will provide expertise and guidance in authoring, reviewing, and approving quality events such as deviations, CAPAs, change controls, and investigations. The Quality Systems Specialist will also be responsible for monitoring and improving the internal quality systems policies and workflows at Forge.  

Prior experience/specialized skills may result in additional responsibilities and/or development opportunities. The Sr. Quality Systems Specialist must demonstrate accountability, transparency, and effective communication cross-functionally and within the Quality team. 

What You’ll Do:

• Serve as a quality resource for quality system principles, including documentation control, change control, deviations, CAPAs, and investigations. 

• Proactively identify and implement items to enhance quality through continuous improvement (CAPA). 

• Make fact-based, scientifically and/or statistically sound, quality / regulatory compliant decisions that have impact on product release. 

• Author or review and approve investigations, CAPAs and change controls to drive for resolution through root cause analysis. 

• Author or review and approve controlled documentation including Standard Operating Procedures (SOPs), Work Instructions, and Forms. 

• Work with other technical groups to resolve issues, close gaps and seek quality compliant outcomes which are efficient and robust. 

• Support internal and external audits as needed. 

What You’ll Bring:

• Bachelor’s Degree (B.A. or B.S.) in biological or STEM-related field (or equivalent work experience)  

• Strong expertise in deviation management processes including in-depth root cause analysis and CAPA implementation. 

• Thorough knowledge and application of Good Documentation Practices (GDP). 

• Experience in a GxP environment. 

• Must be self-motivated, organized, and proactive. 

• Demonstrated knowledge and understanding of cGMP regulations and Food and Drug Administration (FDA) and EU requirements/guidance documents. 

• Ability to maintain a high degree of accuracy and attention to detail. 

• Ability to deliver results in a fast-paced, multi-tasking environment, and prioritize objectives effectively. 

Preferred Skills: 

• Experience with root cause analysis and investigations, including technical writing skills. 

• Working knowledge of global pharmacopeias such as USP, EP, JP, BP, Ph. Eur. 

• Knowledge of biopharmaceutical manufacturing process workflows. 

• Experience supporting inspections performed by FDA and foreign Regulatory Authorities. 

• Experience within a pharmaceutical, biotech, or related industry. 

• Sterile injectable pharmaceuticals or biologics experience is preferred.  

• Experience with Veeva Vault QMS. 

We’ve Got You Covered: 

At Forge Biologics, we believe our people deserve to be taken care of – in and out of the workplace. We’ve built a comprehensive compensation and benefits package designed to help you thrive, grow, and feel valued every step of the way:

Health from day one

• Health, dental and vision insurance start your first day – with 90% of premiums covered for you and your family.

Time to recharge

• A competitive paid time off plan – because rest fuels innovation.
• 12 weeks of fully paid parental leave so you can focus on family when it matters most.

Rewarding your impact

• Annual bonus opportunities for all full-time team members.
• 401(k) with company match to help you plan for the future.
• Special employee discounts, including childcare and dependent care savings.

Your wellness, supported

• Onsite fitness facility at The Hearth.
• Mental health counseling and financial planning services through our Employee Assistance Program.
• Employer-paid short and long-term disability coverage to protect your peace of mind.

Fuel for your workday

• A fully stocked kitchen with free snacks and beverages – we keep you energized and ready for what’s next.

Grow with us

• Ongoing professional development resources, training, and mentorship programs to help you build your care and grow within Forge.

About Loyal

Loyal is a clinical-stage veterinary medicine company developing longevity drugs for dogs. Our mission is to help dogs live longer, healthier lives.

We're pioneering a new category of veterinary prescription drugs that proactively and preventatively target the underlying drivers of aging, delaying the onset of disease and preserving quality of life as dogs age. We've already made significant progress in our mission to develop the first FDA-approved drugs to extend canine lifespan: as of early 2026 we've completed two of three major FDA review sections for our lead program, LOY-002, and are targeting submission of the third and final section later this year.

Loyal is a well-funded startup with teams of scientists, veterinarians, engineers, operators, and creatives. You'll help us continue on our path of earning FDA approval for the first lifespan extension medicine for any species, and change what's possible for the dogs we love.

About the role

The Senior Director of Clinical Development leads the team responsible for design, execution, and strategic direction of clinical programs across Loyal’s veterinary product portfolio. This role is responsible for driving end-to-end clinical strategy, from target product profile  to study design and regulatory-facing protocol development  through field execution, data interpretation, and evidence package generation.

This is a highly cross-functional role that partners closely with R&D, Clinical Operations, Project Leadership, Regulatory (FDA-CVM),CMC, and Commercial to ensure our studies are scientifically sound, operationally feasible, and aligned with pathways to approval.

You will be reporting to our VP, Clinical and Veterinary Medicine .

Your daily work will include:

Clinical Strategy & Program Development

• Own the clinical development strategy for our portfolio of veterinary drug programs, including target product profiles, pivotal pathway planning, and key endpoints aligned with CVM expectations.
• Build and manage detailed timelines for product development 
• Communicate strategy and development timelines across multiple teams within Loyal

Study Design & Protocol Development

• Design companion animal clinical trials (pilot, field safety, and pivotal effectiveness studies) with appropriate statistical powering, endpoint justification, inclusion/exclusion parameters, and handling of operational constraints (e.g., heterogeneous populations, compliance variability).
• Develop protocols, investigator brochures, SAP inputs, and essential documents tailored for investigators and staff in veterinary practice settings.
• Work closely with statisticians on statistical design, randomization schemes, interim analyses, and data quality plans.
• Partner with clinical operations to execute protocols with GCP compliance and serve as medical expert throughout in-life phase.

Study Execution & Medical Oversight

• Provide medical and scientific oversight for all clinical studies, including:
• Eligibility decisions
• Case reviews and AE/SAE reporting
• Protocol deviations and issue escalation
• Interpretation of clinical data trends during trial execution
• Support Clinical Operations with site engagement strategy, investigator training, and owner-facing communication frameworks.
• Partner with Veterinary Affairs on real-world applicability, disease models, and clinician feedback loops.

Regulatory Leadership (FDA-CVM)

• Lead clinical components of regulatory interactions, including:
• Pre-Submission meetings
• Technical section responses
• Study protocol reviews with regulators
• Evidence summaries for FOI packages
• Ensure that all clinical components meet VICH, GCP, and CVM guidance standards.

Cross-Functional Collaboration

• Work tightly with:
• R&D to vet new drug targets and mechanisms and interpret pre-clinical data 
• Regulatory to align development plans with CVM requirements.
• Veterinary Affairs to ensure clinic workflows and veterinary input shape study design.
• Clinical Operations on execution strategy, site selection, and quality.
• Commercial to ensure label-enabling claims are supported by data.

Data Interpretation & Evidence Generation

• Lead clinical data review, analyses, and messaging strategy.
• Develop authoritative veterinary medical clinical narratives for regulatory submissions, publications, and scientific communications.
• Author study reports, abstracts and external presentations as needed.

Team Leadership

• Build and mentor a growing, high-functioning clinical development team with both veterinary medical and technical backgrounds.
• Foster a culture of scientific excellence, operational pragmatism, and veterinary investigator-centered study design

About you: 

• DVM or equivalent.
• 10 -12+ years of experience in clinical development in animal health clinical development.
• Demonstrated experience designing and leading clinical trials, including protocol authorship, data review, and cross-functional collaboration.
• Prior oversight of safety evaluation, study conduct, and interpretation of clinical endpoints.
• Strong understanding of evidence requirements for regulatory approval.
• Ability to lead in a fast-paced, high-accountability biotech environment.

Required

• Direct experience with FDA-CVM VICH guidelines.
• Experience in companion animal medicine, bonus if experience is in aging/longevity or quality-of-life endpoints.
• Background working with veterinary clinics, practice networks, or decentralized trial models.

Salary range: $230,000 - $270,000

Loyal benefits

• Full-coverage health insurance — medical, dental and vision — for you and your dependents
• $1,000 home office equipment stipend
• $1,200/year learning budget for books, courses, etc.
• $250/month wellness budget for gym, cleaners, spa, food, etc.
• All 3-day weekends are turned into 4-day weekends 🎉
• Unlimited vacation and paid holidays
• Paw-ternity leave — adopt a dog and get a day off with your new family member 🐶
• Competitive salary
• Company equity options grant for new hires

Loyal is founded and led by a first-gen female CEO and is proud to be an equal opportunity employer. We do not discriminate against applicants based on gender, race or color, ethnicity or national origin, age, disability, religion, sexual orientation, gender identity or expression, veteran status, or any other applicable characteristics protected by law. 

Our values

Lean into moonshots

We don’t settle for incremental change. We have the bravery to take risks and shoot for the impact we want to have.

Opportunity is at the intersection

We lean into combining disciplines, expertises, and perspectives not normally adjacent. We design our organization to facilitate cross-pollination and cross-collaboration. We reject silos.

Expertise without ego

Titles do not determine who has a voice. We work on hard technical problems and have a ton of fun while at it.

Learning by doing

Our path is novel and many things we are doing have never been done before. We lean into MVPs and are open to unexpected outcomes.

Lead with context

We value leading with context. We equip people with the context and background necessary to make their own decisions and act in the best interest of Loyal. We empower teams to succeed.

Empathy and respect for all life

Our patients are not just numbers. Our work is intentional, thoughtful, and guided by respect for life. We take our responsibility to pets and pet parents seriously.

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.  Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

This role:

We are looking for Automation Engineers (level depends on experience) that are responsible for leading the identification, implementation, optimization, and maintenance of process automation and controls systems in pharmaceutical processing, packaging, and facilities. These engineers ensure efficient, quality, functional, and compliant process automation systems and supports engineering systems, capital projects, technical services, and plant support, as applicable. These positions are 100% onsite at the Bloomington, Indiana facility and reports directly to the Sr. Manager, Automation Engineering.

The responsibilities:

• Lead various aspects of support needed in the design, development, and implementation of the site process automation and controls systems
• Develop, modify, and troubleshoot PLC & HMI programs
• Specify and configure ins
• Identify and drive improvement opportunities for equipment, instrument, and process optimization, efficiency, and cost reduction through automation technologies and lead initiatives to implement projects
• Lead the deployment of the full system lifecycle for process automation and control systems including the design, assessment, selection, commissioning, validation, and implementation of systems
• Troubleshoot automation and controls systems issues, conduct root causes analysis, and implement corrective actions to minimize downtime and ensure continuous operations
• Conduct risk assessments of automation and controls systems
• Ensure automation and controls systems meet regulatory requirements by conducting and assisting with validation activities

Required qualifications:

• BS in Engineering (Computer, Electrical, Computer Science, Systems Engineering and Design, or related field), plus 2+ years of relevant experience; or HS diploma/GED and 10+ years of relevant experience
• Work experience in process automation and controls systems (including programming PLCs, SCADA, and HMI systems) in pharmaceutical and/or manufacturing environments
• Experience in reading and interpreting electrical schematics and Process & Instrumentation Diagrams (P&IDs)
• Experience in Ignition SCADA/HMI
• Knowledge of coding in Rockwell and Siemens (PLCs and HMIs)
• Knowledge of automation and controls hardware and software systems
• Ability to prioritize projects and workload
• Excellent verbal communication and technical writing skills

Physical/safety requirements:

• Duties may require overtime work, including nights and weekends
• Position requires sitting for long hours, but may also involve walking or standing for long periods of time
• Variable travel of 0-10% could be expected
• Must be able to lift, push, pull, and carry up to 50 lbs
• Must be able to lift 20 lbs overhead
• Must be able to wear personal protective equipment (PPE), as required

In return, you’ll be eligible for[1]:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
  • Employee Ownership Plan
• Additional Benefits
  • Short and Long-Term Disability Insurance
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

[1] Current benefit offerings are in effect through 12/31/26

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:  https://simtra.com/privacy-policy/

Why Join Us?

As a member of the Parabilis Medicines team, you will be a part of an organization dedicated to creating extraordinary medicines for diseases with urgent unmet needs, harnessing our proprietary peptide platform to transform treatment possibilities for patients. Parabilis is a clinical-stage biopharmaceutical company dedicated to unlocking high-impact protein targets long-considered undruggable. The company has developed a new class of stabilized, cell-penetrant alpha-helical peptides – Helicons™ – capable of modulating intracellular proteins that are inaccessible to traditional drug modalities.

Headquartered in Cambridge, Mass., Parabilis is advancing a focused pipeline of multiple first-in-class therapies across both rare and common cancers. Its lead asset, zolucatetide (FOG-001), is a first-in-class, clinically validated direct inhibitor of the interaction between β-catenin and the T-cell factor (TCF) family of transcription factors, implicated in millions of cancer cases annually, including in colorectal cancer, desmoid tumors, hepatocellular carcinoma and a range of other Wnt/β-catenin-driven tumors. In Phase 1 clinical trials, zolucatetide produced the first-ever clinical evidence that it can directly inhibit this interaction, once previously considered “undruggable” despite its role across multiple cancer types. Parabilis is also advancing investigational degraders of ERG and ARON into clinical development for the treatment of prostate cancer, as well as progressing other preclinical programs. Backed by a recent $305 million Series F financing, Parabilis is entering an exciting phase of growth and execution.

What’s the opportunity?

The VP, Development Data Science will build and lead a cross functional data centric matrix to accelerate drug development, support regulatory submissions and guide the Real-World Data (RWD) / Real-World Evidence (RWE) function at Parabilis. This role is responsible for end-to-end strategy and execution of RWD/RWE and clinical data science to inform trial design, contextualize clinical results, support biomarker and translational work, and optimize site and patient selection.

The VP will partner closely with Clinical Development, Clinical Operations, Biostatistics, Translational/Computational Biology, Regulatory, and the broader Data Science & Engineering team to maximize the probability of success of our clinical programs.

• Strategy & Leadership
  • Define and own the Clinical Data Science strategy.
  • Serve as the senior Clinical Data Science leader and primary point of contact for RWD/RWE across programs aligned with portfolio and corporate objectives.
  • Represent Clinical Data Science on cross-functional governance and portfolio forums.
• RWD/RWE & Clinical Analytics
  • Design and oversee RWE studies to contextualize clinical trials, including synthetic/external control arms, patient matching, and trial emulation.
  • Use RWD to inform clinical trial design (eligibility criteria, endpoints, enrichment strategies), dose/regimen selection, and go/no-go decisions.
  • Contribute data science insights for feasibility and site selection, including epidemiology, patient journeys, referral patterns, and diversity/access.
  • Integrate RWD with internal clinical and biomarker data to support forward and reverse translation, target and indication strategy, and mechanism-of-resistance analyses.
  • Establish and maintain best practices in causal inference, comparative effectiveness, and time-to-event modeling relevant to RWE in oncology.
• Data Assets, Partnerships & Infrastructure
  • Identify, evaluate, and prioritize RWD sources (EHR, claims, registries, genomic/omic datasets, imaging, PROs) to support current and future clinical needs.
  • Lead collaboration and contracting with RWD providers and academic/industry partners in coordination with Commercial, Business Development, Legal, and Procurement.
  • Partner with Engineering and Data Science to define requirements for secure, scalable, compliant RWD infrastructure and analytic environments.
  • Ensure data quality, interoperability, and governance suitable for regulatory-grade analyses.
• Team Building & Management
  • Build and lead a high-performing Clinical Data Science team (e.g., RWE epidemiologists, clinical data scientists, etc).
  • Set clear objectives, provide regular feedback, and support growth and succession planning.
  • Foster a culture of scientific rigor, transparency, and effective collaboration with Clinical Development, Biostatistics, and other partners.
• Cross-Functional Collaboration & Communication
  • Work in an integrated way with Clinical and Development teams to define key questions and translate them into analytic and RWE plans.
  • Communicate complex methods, assumptions, and results clearly to clinical, technical, and executive stakeholders.
  • Support regulatory and payer/Health Technology Assessment interactions where RWE and clinical analytics contribute to program strategy (e.g., briefing documents, responses, meeting preparation).
  • Collaborate with Translational and Computational Biology to align biomarker and patient selection strategies with integrated clinical and RWD analytics.
• Governance, Quality & Compliance
  • Ensure RWD/RWE activities meet regulatory, ethical, and privacy standards (e.g., GCP, data de-identification and privacy requirements).
  • Implement documentation, reproducibility, and quality standards for Clinical Data Science analyses.
  • Monitor evolving external expectations for use of RWE in regulatory and payer settings and adapt internal practices accordingly.

What you’ll need to be successful:

• PhD, MD, PharmD, or MS in Epidemiology, Biostatistics, HEOR, Data Science, or a related quantitative field.
• 12–15+ years of experience in pharma/biotech, healthcare technology, or related sectors, with significant focus on RWD/RWE and clinical development; oncology experience strongly preferred.
• Proven track record designing and delivering impactful RWE studies to inform clinical, regulatory, or payer decision-making.
• Strong understanding of clinical trial design, biostatistics fundamentals, and translational/biomarker concepts, ideally in oncology or immuno-oncology.
• Demonstrated experience building, leading, and developing high-performing quantitative teams in a matrixed environment.
• Hands-on familiarity with major RWD types (EHR, claims, registries, genomic/omic datasets) and key vendors/platforms.
• Proficiency with modern analytic tools and programming environments (e.g., R, Python, SQL) and with guiding development of robust, reproducible analytic workflows.
• Excellent communication and influencing skills with the ability to engage effectively with clinicians, statisticians, senior leaders, and external partners.

Core Values

Parabilis Medicines is a team of passionate pioneers who are trailblazing the future of precision medicine with the aim of making a meaningful difference in the lives of patients. The company is committed to promoting an inspiring and flourishing working environment for all employees across the business, in all departments, and driving innovation for patient benefit.

• Growth-Minded. We’re inventing a new class of medicines—one applicable to therapeutic targets that have been dreamt about, but always considered impossible to drug. Our work requires us to be curious, humble and adaptable.
• In(ter)dependent. We are fiercely independent as a leader in defying the limitations of current therapeutic modalities, and interdependent as a team as we work collaboratively to shift drug discovery paradigms and provide patients with better treatment options.
• Patient-focused. We are deeply focused on patient outcomes, and all energy in the company is focused on science as it translates to patient impact.
• All-In. We’re All-In on solving some of the hardest scientific challenges and delivering one of the most effective new classes of drugs in history.

The base salary range for this position is $325,000-$380,000 per year, depending on experience, qualifications, and internal practices. Parabilis’s total compensation package also includes an annual target bonus, equity, and a comprehensive suite of competitive benefits designed to support our employees’ overall well-being.

As an equal opportunity employer, Parabilis Medicines values an inclusive workplace and welcomes applicants of all backgrounds and experiences. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.

30 Acorn Park Drive    |     Cambridge, MA 02140    |    www.parabilismed.com

Legend Biotech is seeking participants for Legend's Manufacturing Management, Leadership Development Program as part of the Technical Operations team based in Raritan, NJ.

Role Overview

The Early Career Leadership Program at Legend Biotech is a strategic, enterprise-focused development experience designed to accelerate the growth of high-potential professionals early in their careers. Rooted in our commitment to cultivating enterprise-minded, value-driven leaders, this program provides structured rotational exposure, executive mentorship, and real-time business impact across scientific, operational, and corporate functions.

Legend’s U.S. manufacturing network supports clinical trials and commercial CAR-T therapies for patients across the United States, with CARVYKTI® available at more than 140 treatment centers nationwide. Through our collaboration with Johnson & Johnson, we continue to expand manufacturing capabilities across both regions to meet growing patient demand. top

Join us in redefining what’s possible and build a career where your growth and patient impact go hand in hand

Key Responsibilities

• The Manufacturing Hi-Po Leadership Development Program at Legend Biotech is a 2.5–3 year leadership accelerator designed for high-potential Master’s graduates seeking to build careers at the intersection of advanced therapy manufacturing, operational strategy, and global supply.
• Participants will complete multiple-functional rotations (12 months each) within areas of Global Manufacturing; including Manufacturing Science & Technology (MSAT), Quality, Manufacturing, or Supply Chain over the course of the program. Rotations are tailored based on individual development goals, business needs, and participant interests, allowing candidates to gain targeted experience across key operational functions.
• This structured program integrates high-impact operations experiences, executive mentorship, and a Leadership Development Series focused on developing leaders at every level — from leading self and others to influencing senior stakeholders and driving enterprise-wide business outcomes.
• At Legend Biotech, we believe our people are our greatest asset. This program reflects our unwavering commitment to professional development, career mobility, and long-term leadership growth; empowering early-career talent to take on meaningful challenges, expand their impact, and shape the future of our organization.

Requirements

• Recent M.S or M.A Graduate (Class of 2023-2026)
• 2-3 years of professional experience in life sciences, manufacturing, engineering, or supply chain environments
• Strong analytical, problem-solving, and cross-functional collaboration skills.
• Demonstrated leadership potential and aspiration to grow into future operational and enterprise leadership roles.
• Degree in Biomedical Engineering, Supply Chain/Manufacturing, or related discipline.

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Legend Biotech is seeking a HR Management, Leadership Development Program as part of the Human Resources team based in Somerset, NJ.

Role Overview

The Early Career Leadership Program at Legend Biotech is a strategic, enterprise-focused development experience designed to accelerate the growth of high-potential professionals early in their careers. Rooted in our commitment to cultivating enterprise-minded, value-driven leaders, this program provides structured rotational exposure, executive mentorship, and real-time business impact across scientific, operational, and corporate functions.

Key Responsibilities

• As an HR Management participant within this program, you will build the strategic, operational, and leadership capabilities required to drive talent outcomes in a fast-growing, mission-driven biotech organization. The experience is intentionally designed to strengthen succession readiness for critical leadership roles while equipping you with the cross-functional perspective and business acumen needed to lead at scale.
• At Legend Biotech, we believe our people are our greatest asset. This program reflects our unwavering commitment to professional development, career mobility, and long-term leadership growth; empowering early-career talent to take on meaningful challenges, expand their impact, and shape the future of our organization.
• Complete 3-4 cross-functional rotations over a 3-year structured leadership program (8-12 months per rotation) across Talent Acquisition, HR Operations, HR Business Partnering, Total Rewards, and/or Learning & Organizational Development.
• Lead and support high-impact HR initiatives aligned to talent strategy, organizational design and workforce planning.
• Partner with senior leaders to solve complex organizational challenges and drive scalable HR solutions aligned to enterprise growth.
• Participate in a Leadership Development Series focused on strategic thinking, executive presence, and enterprise leadership readiness.
• Deliver measurable business impact and progressively increase scope, influence and accountability across rotations.

Requirements

• Recent MBA or MA graduate (Class of 2023-2026) in Human Resources or related field.
• 2–3 years of professional experience (HR or related business experience preferred).
• Preferred experience in a Life Sciences organization or related business.
• Demonstrated leadership potential, strong analytical and communication skills, and a desire to grow into future leadership roles.

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#Li-Hybrid

Legend Biotech is seeking participants for Legend's Commercial Management Leadership Development Program as part of the Commercial team based in Somerset, NJ.

Role Overview

The Early Career Leadership Program at Legend Biotech is a strategic, enterprise-focused development experience designed to accelerate the growth of high-potential professionals early in their careers. Rooted in our commitment to cultivating enterprise-minded, value-driven leaders, this program provides structured rotational exposure, executive mentorship, and real-time business impact across scientific, operational, and corporate functions.

Join us in redefining what’s possible and build a career where your growth and patient impact go hand in hand.

Key Responsibilities

• The Commercial Management Hi-Po Leadership Development Program at Legend Biotech is a 2–3-year enterprise leadership accelerator designed for high-potential MBA graduates who aspire to shape the future of biotech commercialization. This program develops leaders capable of translating scientific innovation into meaningful patient access and market impact.
• Participants will complete three strategic rotations (8–12 months each) that may include Marketing, Market Access & Branding, Commercial Operations, Sales, and Business Insights & Analytics. Rotations are designed to provide both broad commercial exposure and the opportunity to pursue areas aligned with individual interests and development goals. Participants will develop the strategic, analytical, and leadership capabilities needed to influence commercial strategy and drive business growth
• This structured program integrates high-impact business experiences, executive mentorship, and a Leadership Development Series focused on developing leaders at every level — from leading self and others to influencing senior stakeholders and driving enterprise-wide business outcomes.
• At Legend Biotech, we believe our people are our greatest asset. This program reflects our unwavering commitment to professional development, career mobility, and long-term leadership growth; empowering early-career talent to take on meaningful challenges, expand their impact, and shape the future of our organization.

Requirements

• Recent MBA graduate (Class of 2023–2026)
• 3-5 years of professional experience demonstrating analytical and leadership capability.
• Background in life sciences, healthcare, marketing, sales, business analytics, or management consulting preferred.
• Strong analytical, communication, and strategic problem-solving skills.
• Demonstrated leadership potential and aspiration to grow into future commercial and enterprise leadership roles.

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#Li-Hybrid

Legend Biotech is seeking candidates for Legend's R&D Management Leadership Development Program as part of the R&D team based in Somerset, NJ / Philadelphia, PA.

Role Overview

The R&D Leadership Program at Legend Biotech is a highly selective, enterprise leadership accelerator designed for high-performing PhD scientists with 7–10 years of industry experience who are ready to transition from deep scientific expertise to enterprise-level leadership.

At Legend Biotech, we are advancing the frontiers of cell and gene therapy to deliver transformative cures for patients worldwide. We believe breakthrough science starts with bold thinkers, collaborative teams, and leaders who are ready to make an impact early in their careers.

Join us in redefining what’s possible and build a career where your growth and patient impact go hand in hand.

Key Responsibilities

The R&D Management Hi-Po Leadership Development Program is a 2-3 year project-based enterprise leadership accelerator designed for high-potential experienced PhD graduates who aspire to shape the future of cell and gene therapy

As a participant, you will take on three enterprise-critical projects, each aligned to key business priorities and pipeline milestones. You will:

• Lead complex, cross-functional projects that directly impact R&D strategy, clinical advancement, or manufacturing scalability
• Partner with senior leaders across Research, Clinical, Regulatory, and Technical Operations to drive decision-making
• Translate scientific insights into actionable business and development strategies
• Contribute to the advancement of cell and gene therapy programs from early discovery through commercialization
• Present recommendations and insights to executive leadership, influencing enterprise priorities

By the end of the program, participants are equipped with the scientific, strategic, and leadership capabilities required to advance into director-level roles across the R&D organization.

At Legend Biotech, we believe our people are our greatest asset. This program reflects our unwavering commitment to professional development, career mobility, and long-term leadership growth; empowering early-career talent to take on meaningful challenges, expand their impact, and shape the future of our organization.

Requirements

• PhD required in Biological Sciences, Molecular Biology, Microbiology, Immunology, Biochemistry, Chemistry, Cell Biology, or related life sciences disciplines. 
• 7–10 years of industry experience in biotech, pharmaceutical, or related industry
• Demonstrated experience advancing scientific or clinical programs in R&D
• Proven ability to lead complex projects and collaborate across cross-functional teams
• Strong business acumen and ability to connect scientific work to broader org. strategy
• Experience in Cell Therapy preferred.
• Demonstrated record of scientific rigor, innovation, and cross-functional collaboration.
• Clear aspiration and potential to grow into scientific and enterprise leadership roles.

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#Li-Hybrid

Legend Biotech is seeking candidates for Legend's Finance Management Leadership Development Program as part of the Finance team based in Somerset, NJ.

Role Overview

The Early Career Leadership Program at Legend Biotech is a strategic, enterprise-focused development experience designed to accelerate the growth of high-potential professionals early in their careers. Rooted in our commitment to cultivating enterprise-minded, value-driven leaders, this program provides structured rotational exposure, executive mentorship, and real-time business impact across scientific, operational, and corporate functions.

Join us in redefining what’s possible and build a career where your growth and patient impact go hand in hand. 

Key Responsibilities

• The Finance Management Hi-Po Leadership Development Program is a 2-3-year enterprise leadership accelerator designed for high-potential MBA graduates ready to influence financial strategy in a fast-growing, innovation-driven biotech organization. Through 3-4 strategic rotations (8-12 months each) which may include Finance & Accounting, Procurement, Corporate Finance, and Internal Audit, you will gain deep technical expertise and broad enterprise perspective.
• This structured program integrates high-impact business experiences, executive mentorship, and a Leadership Development Series focused on developing leaders at every level, from leading self and others to influencing senior stakeholders. and driving enterprise-wide business outcomes.
• At Legend Biotech, we believe our people are our greatest asset. This program reflects our unwavering commitment to professional development, career mobility, and long-term leadership growth; empowering early-career talent to take on meaningful challenges, expand their impact, and shape the future of our organization.

Requirements

• Recent MBA graduate (Class of 2023–2026), with concentration in Finance, Accounting, or related field preferred.
• 2-3 years of professional experience demonstrated progressive responsibility and analytical rigor.
• Strong financial modeling, problem-solving, and communication skills.
• Demonstrated leadership potential and aspiration to grow into Director-level and broader enterprise finance leadership roles.
• Demonstrated skills in developing and implementing enterprise technology automation, visualization and analytics solutions to improve productivity and performance. 

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#Li-

POSITION SUMMARY:

Lead translational functional validation for Natera’s Therapeutics & Innovations group. You will direct external Contract Research Organization (CRO) and academic partnerships to advance our immuno-oncology therapies, generating the decision-enabling data needed to move from pre-clinical research to clinical impact. Every sample represents a real person, and the data you generate will directly shape therapeutic development. While initial work relies on external partners, you will evaluate the 'build vs. buy' roadmap and take ownership of building Natera’s internal translational research capabilities over time.

PRIMARY RESPONSIBILITIES:

• Own the external pre-clinical research model, leading CRO and academic partnerships for functional validation, including immunogenicity, Mechanism of Action (MOA), and T-cell assays
• Define experimental strategies, frameworks, and govern partner performance through rigorous statements of work (SOWs) and budgets; use data to identify risks and take ownership of corrective actions
• Direct immune functional assays and lead the experimental validation of targets and biomarkers identified by AI/ML platforms using patient-derived samples
• Incorporate high-throughput screening to validate drug-target interactions, ensuring data packages meet internal, regulatory, and clinical translation standards
• Think team by partnering directly with R&D, Clinical Development, and Regulatory to align assay outputs with milestones without needing translation layers
• Build a scalable external network across immunology and tumor biology while developing a long-term roadmap to establish an internal wet-lab engine
• Deliver unvarnished, data-backed updates to leadership, translating complex results into direct, actionable program recommendations
• Mentor scientific staff and contractors, fostering a rigorous, outcome-focused culture as the function scales

QUALIFICATIONS:  

• PhD (or equivalent) in Immunology, Biology, Pharmacology, or a related field, with 8+ years of post-graduate experience in biotech, pharma, or translational academic settings; or an MS with 12+ years of directly relevant experience
• Proven track record of managing complex external research programs and building translational research capabilities

KNOWLEDGE, SKILLS, AND ABILITIES:  

• Deep expertise in immuno-oncology, immune functional assays, and mechanistic evaluation
• Experience with high-dimensional data (e.g., single-cell sequencing) to validate AI-driven insights
• Proven track record leading externalized R&D through CROs, managing governance, experimental design, and milestone delivery
• Strong project management capabilities spanning scoping, budgeting, and risk management across parallel studies
• Experience with assay development, transfer, and reproducibility best practices, treating quality as a standard
• Clear communication skills to influence cross-functional teams and external partners
• Operate without a finished playbook, applying an ownership mindset to build or buy capabilities as the science dictates
• Expertise in neoantigen biology, antigen presentation validation, or tumor model systems is preferred

#LI-DNI

Position Summary:

The Senior Director, Commercial Strategy lead is responsible for understanding the evolving needs of the Stargardt community and shaping the brand strategy, including the execution of comprehensive marketing plans. This role will lead brand planning, product launches, and lifecycle management, working closely with cross-functional teams across commercial, medical, regulatory, and clinical functions.

This is a leadership role on the commercial team that will own the go-to-market strategy, lifecycle planning, ensuring seamless collaboration across functions and support market access research ultimately driving meaningful patient impact and delivering strong business results.

Primary Responsibilities:

Brand Strategy & Tactical Execution:

• Develop integrated brand strategies and lifecycle activities to support differentiation and commercialization goals
• Drive disease area strategy, market segmentation, and product positioning based on unmet needs, competitive landscape, and evolving science
• Responsible for creating external (promotional/educational) communication materials for external use with customers (ECPs and Patients)
• Partner with Corporate Communications to support development of the Corp Communications tactics and messages as needed
• Lead the cross-functional workshops for the development of strategic and tactical plans for gildeuretinol

Competitive Strategy and Response:

• Assess emerging trends, market dynamics, and competitive activity to inform commercial decisions
• Lead competitive scenario planning and collaborate with medical, corp. comms, strategic planning and clinical to develop competitive response strategy
• Translate scientific and market insights from ECPs and patients (through market research, ad boards, etc.) into differentiated product strategy and value stories
• Evaluate strategic implications of evolving regulatory, pricing, and access landscapes globally
• Provide input into forecasting assumptions and evaluate ROI for activities
• Collaborate closely with regulatory, medical affairs, market access and corporate communications to ensure alignment of brand vision and execution

Program Team and key workstreams participation:

• Lead development/optimization of TPP
• Generate and communicate ECP/Patient insights to inform Program strategy
• Be the commercial voice on program team and inform decisions impacting commercialization
• Participate in the evidence generation, pubs planning and LCM strategy sub teams to represent the commercial POV

Qualifications:

• Education and Certification
• Advanced degree (MBA) in marketing/ business, or scientific degree preferred
• Requires 12+ years of experience or the equivalent combination of education and experience

• Skills and Key Success Factors:
  • Entrepreneurship spirit with a passion to build, learn and evolve with the team
  • Highly organized and detail oriented with a passion to deliver quality results
  • Excellent verbal and written communication skills, with experience translating complex concepts for various audiences
  • Demonstrated record of intellectual curiosity, innovation and creative problem solving with an entrepreneurial spirit
  • Ability to lead fast-paced projects with a keen sense of urgency to get the job done well
  • Evidence of "hands-on" experience and expertise
  • Proven and successful track record as a team-player and collaborator in small working environments
  • Highest levels of professionalism, confidence, personal values and ethical standards

Other Relevant Information:

• Travel:  Able to travel up to 25% of time

Compensation

• Base Salary Range: $235K - $275K, with the actual contingent upon several factors such as the selected candidate’s education/work experience/training, and other factors (travel requirements, etc.)
• Discretionary Bonus: up to 25% of Base Salary, contingent upon meeting performance components
• Equity: initial grant of incentive stock options
• Benefits: Eligible to participate in group medical/dental/vision insurance plans; short- and long-term disability plans; life insurance; 401(K) plan; flexible time off policies and others. Eligibility and participation requirements vary by plan.

What You’ll Do:

An exciting new opportunity has opened up for a Contracts and Legal Systems Manager to assist with our day-to-day legal systems and contracting needs, including for clinical trials, supply, commercial, finance, and other key contracting areas.  Reporting to the Company’s Sr. Director, Corporate Counsel, this individual will play a key role in a growing legal team, with many opportunities to grow their career with the company.

The ideal candidate should have significant experience working with contracts management systems, including acting as the key legal point of contact for business users, training clients, and managing contracts workflows within a cross-functional team. The ideal candidate should also have significant experience drafting, negotiating, and managing agreements for clinical and commercial-stage pharmaceutical and life sciences companies, including non-disclosure agreements, master services agreements, consulting agreements, manufacturing and supply agreements, clinical trial agreements, and other commercial agreements.  Experience as a corporate paralegal or legal support analyst at life sciences companies or law firms is considered a plus.

The successful candidate must be able to take ownership of the legal function’s role in a company’s legal, procurement, and financial systems architecture, as well as work independently to draft, revise and negotiate agreements, with a flexible and collaborative approach.

Responsibilities:

• Be responsible for the operation and administration of the company’s contract management system, acting as the key point of contact for the business
• Coordinate and assist in developing policies, procedures and systems to support and facilitate efficient contract development and analysis
• Draft, review and negotiate a variety of day-to-day contracts, including non-disclosure agreements, master service agreements, consulting agreements, manufacturing and supply agreements, clinical trial agreements and other clinical documents, independently and with limited supervision
• Negotiate to conclude agreements as efficiently as possible while meeting client needs and safeguarding MapLight’s interests
• Effectively manage outside vendors, including working with and supervising outside counsel, as required
• Create, improve, and implement applicable forms, templates, processes, and procedures to improve efficiency
• Obtain and maintain a strong working knowledge of the Company’s business, scientific capabilities, and key strategic business objectives

Other Skills and Abilities:

• Solid business judgment and strategic thinking. Ability to recognize risk and develop practical, workable strategies to mitigate such risk
• Flexibility and willingness to work on a broad variety of matters
• Strong written and oral communications skills required to work both internally and externally.
• Ability to independently work with minimal day-to-day oversight
• Ability to meet deadlines while managing a substantial workload in a fast-paced environment
• Ability to engender confidence when advising clients at all levels
• Ability to work with the highest level of integrity
• Willingness to travel when required

Qualifications:

• Bachelor’s degree with a minimum of 5 years of progressive responsibility with recent experience in contract negotiation, administration and/or management
• Experience with pharmaceutical and life sciences companies
• Familiarity with design and administration of contracts management systems (e.g., Ariba, Coupa, Concur, NetSuite)
• Paralegal certification or equivalent legal education or training is considered a plus
• Comprehensive computer skills including Microsoft Office

Key MapLight Behaviors:

We consider these behaviors we seek in all MapLight employees.

• You can participate and work effectively with multiple cross-functional teams.
• You have strong interpersonal skills and understand relationships are key to being successful.
• You are a leader. Teams love working with you, and you are someone who takes pride in mentoring and supporting the careers of others.
• You’re a team player who is willing to roll-up your sleeves and get the job done.

Location: Candidates for this role must be within commuting distance of MapLight’s Burlington, MA office.

Travel: Minimal travel (1-2 times per year) is expected.

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.

Summary of Job:

The Specialist II, Quality Control Microbiology plays a key role in establishing and executing microbiological testing activities within the QC organization at Kyowa Kirin’s new monoclonal antibody drug substance manufacturing facility in Sanford, NC. This position begins in a greenfield environment and evolves through GMP readiness, technology transfer, and facility licensure for Phase III and early commercial products.

You apply technical knowledge to routine and moderately complex microbiological tasks, collaborate across functions, and begin demonstrating independent problem-solving. Responsibilities include executing microbiological methods, maintaining compliance with current GxP standards, and ensuring alignment with global, regional, and site-specific procedures within Kyowa Kirin’s Quality Management System. This role is essential to building a reliable, compliant, and science-driven QC Microbiology function that supports the broader manufacturing and quality strategy.

As an individual contributor, you will take a compassionate and people-focused approach to your work. You will proactively collaborate with others to create a supportive and inclusive environment, always acting in line with the organization’s values. By using strong interpersonal skills, you will work effectively with diverse viewpoints, manage relationships thoughtfully, and make decisions that meet both individual and team needs. You will be accountable for delivering results, adapting to challenges, and helping achieve business goals. Additionally, you will take ownership of your tasks, act with initiative, and continuously seek opportunities to learn and grow. You will handle change with resilience and clarity, staying flexible in a fast-paced environment while keeping the needs of patients at the center of your efforts.

Reporting Relationship: Senior Manager, Quality Control

Essential Functions:

Technical Skills, Knowledge, and Experience: 

• Perform routine and moderately complex microbiological tasks to enable QC operations and contribute to business processes. Collaborate cross-functionally during early-stage site activities, including identifying user requirements and prioritizing implementation of equipment, instruments, analytical methods, and electronic quality systems (e.g., LIMS, ELN, LES).
• Execute and assist in the qualification and transfer of compendial and non-routine microbiological methods in accordance with GxP standards, SOPs, and specifications. Techniques include bioburden (TAMC/TYMC), bacterial endotoxins (LAL), growth promotion, microbial identification, and rapid microbiological methods.
• Apply working knowledge of sampling, culturing, microscopy, and aseptic techniques across a variety of sample types (e.g., water, air, gases, raw materials, surfaces, in-process, drug substance, stability, investigations).
• Contribute to the development and maintenance of site-specific QC procedures within the global Veeva electronic Quality Management System (QMS) to enable operational readiness of the Microbiology Laboratory.
• Participate in Site Risk Management activities, documenting risk-based decisions using compliant methodologies and supporting data. Collaborate with peers to apply risk principles in daily QC operations.
• Implement GxP procedures related to the Environmental and Utility Monitoring Program and Contamination Control Strategy in coordination with cross-functional teams.
• Train and qualify team members in microbiological methods and contamination control practices. Assist in onboarding junior staff and contractors per approved staffing plans.
• Assist with utilities qualification and environmental monitoring performance qualification (EMPQ) to ensure facility readiness and alignment with production goals.
• Review validation and qualification documentation for facility systems, microbiological instruments, and computerized systems to confirm commissioning and operational readiness.
• Coordinate and perform sampling and testing activities. Review QC laboratory results for accuracy and completeness under moderate supervision.
• Maintain core lab operations, including gowning protocols, personnel and material flow, sample handling, inventory management, lab safety, waste disposal, and cleaning procedures.
• Prepare and contribute to laboratory reports, including microbial trend reports, EM/UM recoveries, excursion reports, OOS, and invalid assay documentation.
• Collaborate with Operations, Quality Assurance, and Compliance teams to align QC Microbiology activities with global and regional policies and inspection readiness expectations.
• Participate in investigations of non-conformances, deviations, and laboratory exceptions. Assist in drafting and implementing corrective and preventive actions (CAPAs).
• Monitor and report key performance indicators (KPIs) for Site Quality Metrics, including deviations, CAPAs, change controls, OOS, invalid assays, OOT, equipment failures, EM data trends, stability trends, and product disposition cycle times.
• Demonstrate ownership of assigned tasks and contribute technical input to build a reliable, compliant, and science-driven QC Microbiology function aligned with Kyowa Kirin’s manufacturing and quality strategy.
• Track progress against individual and team goals and communicate updates to the Site Leadership Team and key stakeholders.

Subordinates: Individual Contributor with responsibility to lead or work with cross-functional project teams.

Job Requirements: 

Education

• Bachelor’s degree in Microbiology, Biotechnology, or a related Life Sciences discipline required.
• Master’s degree or graduate-level studies preferred.

 Experience

• Minimum of 2 to 4 years of experience in a Quality Control Microbiology laboratory, providing technical and compliance expertise within GxP-regulated biopharmaceutical manufacturing operations.
• Experience investigating microbial contamination incidents, laboratory non-conformances (e.g., OOS), and interpreting data within the framework of Quality Management Systems (QMS), laboratory controls, and applicable regulatory standards.
• Experience contributing to the start-up of a QC Microbiology laboratory in a new facility is a plus.
• Familiarity with engineering and GxP documentation related to equipment, facilities, and process qualification efforts (e.g., validation protocols, reports, test plans, verification plans, validation master plans, site master file) is also preferred.

 Technical Skills

• Proficient in MS Office Suite, and Lean Labs or Agile Lean.

Non-Technical Skills

• Results-oriented and able to navigate ambiguity.
• Set clear outcomes, track progress, follow through on commitments, and ensure actions lead to measurable results that advance organizational objectives.
• Respond promptly, take accountability, and manage tasks efficiently, and adapt to change with clarity, patience, and understanding, guiding teams through evolving challenges.
• Exhibit strong organizational skills, attention to detail, and a solid work ethic while demonstrating cultural sensitivity and the ability to foster alignment in a global environment.
• Communicate with care by actively listening and considering others' perspectives, fostering productive, engaging interactions, and managing relationships with kindness.
• Embrace personal growth through continuous learning and knowledge sharing, maintaining a growth mindset and promote inclusive collaboration by respecting diverse perspectives and creating a welcoming work environment.
• Contribute positively by recognizing achievements and encouraging a healthy work-life balance and collaborate with respect, integrity, and humility, prioritizing collective success over individual gain.
• Resourceful and proactive, challenge the status quo, drive innovation, and develop creative solutions.
• Apply an enterprise-wide, holistic mindset, working beyond siloed thinking to deliver cohesive, integrated solutions.
• Results-oriented and able to navigate ambiguity.
• Set clear outcomes, track progress, follow through on commitments, and ensure actions lead to measurable results that advance organizational objectives and respond promptly, take accountability, and manage tasks efficiently.
• Adapt to change with clarity, patience, and understanding, guiding teams through evolving challenges and exhibit strong organizational skills, attention to detail, and a solid work ethic while demonstrating cultural sensitivity and the ability to foster alignment in a global environment.
• Communicate with care by actively listening and considering others' perspectives, fostering productive, engaging interactions, and managing relationships with kindness.
• Embrace personal growth through continuous learning and knowledge sharing, maintaining a growth mindset and promote inclusive collaboration by respecting diverse perspectives and creating a welcoming work environment.
• Contribute positively by recognizing achievements and encouraging a healthy work-life balance and collaborate with respect, integrity, and humility, prioritizing collective success over individual gain.
• Resourceful and proactive, challenge the status quo, drive innovation, and develop creative solutions.

Physical Demands:

Initially this position requires working on a construction site and ultimately in a biotech manufacturing laboratory. Must be able to work in an office and regulated manufacturing environment, including construction/start-up phases. During the construction and start-up phases, employees may be required to wear appropriate personal protective equipment (PPE), including hard hats, safety glasses, steel-toe boots, and high-visibility vests. Once transitioned to the GMP laboratory environment, PPE will include lab coats, gloves, safety goggles, and other gear as defined by site safety protocols. This position is based on-site in Sanford, NC. Work is 100% on-site. Other standard company policies for flexible work arrangements do not apply to this role. This is not a hybrid or remote role.

Working Conditions: Requires up to 10% domestic and limited international travel. Travel to Japan may be required for training and qualification activities during technology transfer process.

The anticipated salary for this position will be $76,200 to $104,800.  The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.

The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:

• 401K with company matching
• Annual Bonus Program (Sales Bonus for Sales Jobs)
• Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days
• Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)
• HSA & FSA Programs
• Well-Being and Work/Life Programs
• Long-Term Incentive Program (subject to job level and performance)
• Life & Disability Insurance
• Concierge Service
• Pet Insurance
• Tuition Assistance
• Employee Referral Awards

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions

It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.

When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment. 

Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.

Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment.  Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com.

Recruitment & Staffing Agencies

Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.

#L!-JC1

The Impact You’ll Make

As the Executive Assistant to our CMO (Chief Medical Officer), and other senior leaders, you will support a clinical leadership team driving the development of innovative therapies to get better drugs to patients faster. You will partner closely with the CMO to enable them to operate at maximum effectiveness by managing priorities, streamlining operations, and anticipating needs across a fast-paced, science-driven environment. Your work will directly influence the CMO’s ability to focus on advancing our clinical pipeline, shaping development strategy, and delivering meaningful outcomes for patients.

You’ll play a critical role connecting internal teams, external partners, and clinical stakeholders; ensuring seamless execution across clinical, regulatory, and cross-functional initiatives in the U.S., UK, and Canada. This is a highly impactful position for an experienced professional who thrives on complexity, precision, and bringing structure to dynamic environments - someone who values both strategic alignment and the energy of working alongside a collaborative team. 

In this role you will:

• Manage all aspects of the CMO’s calendar, travel, and communications with discretion and foresight
• Anticipate scheduling conflicts, track key deliverables, and proactively adjust plans in alignment with clinical priorities and development milestones
• Serve as a point of contact for internal and external stakeholders, including clinical, regulatory, and research partners, demonstrating sound judgment and professionalism at all times
• Plan and coordinate internal and external meetings, ensuring high-quality materials and seamless execution across clinical and cross-functional teams
• Arrange detailed domestic and international travel itineraries as needed 
• Partner with internal teams to support clinical leadership activities, advisory boards, investigator meetings, and key scientific engagements
• Maintain confidentiality while ensuring clear and timely information sharing between the CMO, leadership team, and external collaborators

The Team You’ll Join

You will be joining the executive support team at Recursion, working closely with the CMO and partnering with C-level executives across the company. You will collaborate with teams including Clinical Development, Regulatory, Research, People, Finance, Workplace Environment, and Communications.

The executive support team is responsible for enabling our senior leadership team to do their best work and stay focused on advancing Recursion’s mission. 

The Experience You’ll Need

• At least 5+ years of experience as an Executive Assistant supporting C-suite executives, ideally in a public biotech organization 
• Passion for science, innovation, and improving human health, with an appreciation for the clinical development process and the fast-moving world of biotechnology
• Ability to think ahead, anticipate needs, and propose thoughtful solutions - not just execute tasks
• Exceptional organizational, written, and verbal communication skills, with a track record of managing competing priorities gracefully
• Flexibility to adapt in real time, prioritize effectively, and deliver high-quality work in a dynamic environment
• Comfort working across time zones and managing frequent international travel
• Discretion in handling sensitive information and building trusted relationships
• Proficiency in Google Workspace and Slack

Working Location & Compensation:

This is an office-based, hybrid position at our New York City, New York, office. Employees are expected to work in the office at least 50% of the time.

At Recursion, we believe that every employee should be compensated fairly. Based on the skill and level of experience required for this role, the estimated current annual base range for this role is $108,200 to $136,200 (USD). You will also be eligible for an annual bonus and equity compensation, as well as a comprehensive benefits package. 

#LI-DB1

Legend Biotech is seeking a Legal Operations Manager, Contracts & Privacy as part of the Legal team based in Bridgewater, NJ.

Role Overview

The Legal Operations Manager, Contracts & Privacy supports the Legal Department by managing day-to-day contract lifecycle administration, coordinating operational aspects of the company’s Global Privacy program and assisting with legal operations processes and tools. This role is highly execution-oriented and works closely with attorneys and cross-functional partners to ensure efficient, compliant, and well-organized legal workflows in a fast-paced biotech environment. The position will coordinate closely with Legend Biotech’s Chief Privacy Officer and reports to Legend Biotech’s Deputy General Counsel.

Key Responsibilities

Contract Lifecycle Administration

• Coordinate the end-to-end contract process, including intake, routing, approvals, execution, and filing
• Maintain and update contract records in the company’s CLM system, ensuring accuracy and completeness of data
• Ensure contracts comply with company standards, regulatory requirements, and approval processes
• Populate basic contract template agreements (e.g. NDAs, consulting agreements, etc.)
• Track contract status, key dates (e.g., expirations, renewals), and obligations
• Assist in maintaining contract templates, standard forms and clause libraries
• Respond to internal inquiries regarding contract status and process
• Perform other contracts-related activities and tasks as assigned

Privacy Program Support

• Support day-to-day operations of the company’s Global Privacy program
• Assist with privacy impact assessments, security risk assessments and other privacy reviews and documentation
• Maintain records related to data processing activities and ensure compliance with data subject right requests
• Help coordinate privacy training, awareness initiatives and policy updates
• Track and escalate privacy-related issues and requests to appropriate stakeholders
• Organize and coordinate privacy champions meetings to ensure privacy requirements are understood and implemented
• Coordinate implementation of data mapping plan to maintain up to data inventory, liaising with system/business owners, and assist with other EU GDPR operational matters
• Track key privacy metrics (e.g., breaches report, PIAs conducted, DSARs received)
• Assist with clinical trial privacy matters, including informed consent (ICF) updates, investigator/HCP notice, and related matters

Legal Operations Support

• Maintain organized legal files, databases, and corporate records
• Support subsidiary management across US & EU jurisdictions
• Support reporting efforts by compiling basic KPIs, metrics and data for the Legal Team
• Assist with invoice processing and vendor onboarding as needed
• Support implementation and ongoing management of legal systems and tools

Requirements

• Bachelor’s degree or equivalent experience required
• 4+ years of experience in legal coordination, contract administration, paralegal support or legal operations
• Experience with contract management systems or similar tools strongly preferred
• Basic familiarity with data privacy concepts and regulations (e.g., GDPR, CCPA, HIPAA) is a plus
• Strong organizational and administrative skills with high attention to detail and accuracy
• Ability to manage multiple tasks and deadlines effectively
• Effective communication and responsiveness
• Ability to follow established processes and identify opportunities for improvement
• Comfort working with systems, data and cross-functional teams

#Li-FB1

#Li-Hybrid

Legend Biotech is seeking a Leadership Excellence & Acceleration Pathway Associate as part of the Commercial team based Remotely (South Central Region).

Role Overview

The Leadership Excellence & Acceleration Pathway (LEAP) Associate is a selective, high-impact role designed to accelerate the development of the next generation of commercial leaders at Legend Biotech.

LEAP Associates participate in a structured, end-to-end commercial development experience spanning key commercial functions, paired with real accountability, senior leader exposure, and hands-on ownership of meaningful business work. The program is intentionally designed for high-potential professionals who have demonstrated strong execution, leadership maturity, and a desire to grow into broader commercial leadership roles within biotech.

Unlike traditional entry-level or functional roles, LEAP Associates are positioned as enterprise-minded contributors, expected to think strategically, execute rigorously, operate across functions, and continuously elevate how work gets done, including through modern, AI-enabled ways of working.

Upon successful completion, participants are expected to be ready for expanded-scope commercial roles within the organization.

Preferred Locations/Territories:

• • Albuquerque, NM
  • Houston, TX
  • New Orleans, LA

Program Overview

• 18-24 month structured rotational development program.
• Exposure across core commercial functions such as: Field Sales, Marketing, Market Access.
• Embedded learning curriculum focused on:
  • End-to-end commercial strategy and execution.
  • Cross-functional leadership and influence.
  • Decision-making in complex, data-rich environments.
  • Responsible and practical application of AI in commercial work.
  • Ongoing mentorship, performance feedback, and senior leader engagement.

(Specific rotation assignments and sequencing will be determined based on business priorities and developmental needs.)

Key Responsibilities

• Across the program, LEAP Associates will be expected to:
• Drive execution by contributing to priority commercial initiatives and business-critical projects across functions.
• Translate strategy into action, supporting planning, analysis, and execution efforts that directly impact commercial performance.
• Operate cross-functionally, effectively partnering with Sales, Marketing, Market Access, Commercial Operations, and other stakeholders.
• Bring structure and insight to ambiguity, using data, judgment, and stakeholder input to support sound decision-making.
• Demonstrate ownership and accountability for outcomes—not just deliverables.
• Build influence without authority, navigating complex stakeholder environments with professionalism and credibility.
• Continuously elevate ways of working, including identifying opportunities to improve efficiency, rigor, and scalability.

AI-Enabled Ways of Working

A core expectation of the LEAP program is the development of applied AI fluency. LEAP Associates will:

• Leverage approved AI tools to support:
  • Commercial analysis and insight generation.
  • Planning and scenario evaluation.
  • Content development and communication.
  • Workflow efficiency and execution effectiveness.
• Apply AI responsibly and in alignment with company governance and standards.
• Identify and share best practices for integrating AI into everyday commercial work.
• Help translate AI-enabled capabilities to teams and stakeholders, supporting broader adoption and impact.

AI is treated as a practical leadership capability, not a theoretical skillset.

Requirements

Required:

• Bachelor’s degree.
• 5–7 years of professional experience.
• Demonstrated track record of execution, ownership, and results delivery.
• Strong analytical, communication, and problem-solving skills.
• Interest in biotech/pharma and commercial leadership pathways.

Preferred:

• Experience in disciplined, performance-driven environments (e.g., military service or similarly structured settings).
• Exposure to commercial, operational, analytical, or customer-facing roles.
• Experience using data, analytics, digital tools, or AI-enabled solutions to support decision-making.
• Comfort working in complex, matrixed organizations.

Developmental Opportunities:

• Exposure to senior leadership.
• Cross-functional rotations.
• Mentorship and coaching.
• Potential placement into full-time commercial roles upon program completion.

#Li-JK1

#Li-Remote

Legend Biotech is seeking a Leadership Excellence & Acceleration Pathway Associate as part of the Commercial team based Remotely (Midwest Region).

Role Overview

The Leadership Excellence & Acceleration Pathway (LEAP) Associate is a selective, high-impact role designed to accelerate the development of the next generation of commercial leaders at Legend Biotech.

LEAP Associates participate in a structured, end-to-end commercial development experience spanning key commercial functions, paired with real accountability, senior leader exposure, and hands-on ownership of meaningful business work. The program is intentionally designed for high-potential professionals who have demonstrated strong execution, leadership maturity, and a desire to grow into broader commercial leadership roles within biotech.

Unlike traditional entry-level or functional roles, LEAP Associates are positioned as enterprise-minded contributors, expected to think strategically, execute rigorously, operate across functions, and continuously elevate how work gets done, including through modern, AI-enabled ways of working.

Upon successful completion, participants are expected to be ready for expanded-scope commercial roles within the organization.

Preferred Locations/Territories: 

• Chicago, IL
• Detroit, MI,
• Minneapolis, MN

Program Overview

• 18-24 month structured rotational development program.
• Exposure across core commercial functions such as: Field Sales, Marketing, Market Access.
• Embedded learning curriculum focused on:
  • End-to-end commercial strategy and execution.
  • Cross-functional leadership and influence.
  • Decision-making in complex, data-rich environments.
  • Responsible and practical application of AI in commercial work.
  • Ongoing mentorship, performance feedback, and senior leader engagement.

(Specific rotation assignments and sequencing will be determined based on business priorities and developmental needs.)

Key Responsibilities

• Across the program, LEAP Associates will be expected to:
• Drive execution by contributing to priority commercial initiatives and business-critical projects across functions.
• Translate strategy into action, supporting planning, analysis, and execution efforts that directly impact commercial performance.
• Operate cross-functionally, effectively partnering with Sales, Marketing, Market Access, Commercial Operations, and other stakeholders.
• Bring structure and insight to ambiguity, using data, judgment, and stakeholder input to support sound decision-making.
• Demonstrate ownership and accountability for outcomes—not just deliverables.
• Build influence without authority, navigating complex stakeholder environments with professionalism and credibility.
• Continuously elevate ways of working, including identifying opportunities to improve efficiency, rigor, and scalability.

AI-Enabled Ways of Working

A core expectation of the LEAP program is the development of applied AI fluency. LEAP Associates will:

• Leverage approved AI tools to support:
  • Commercial analysis and insight generation.
  • Planning and scenario evaluation.
  • Content development and communication.
  • Workflow efficiency and execution effectiveness.
• Apply AI responsibly and in alignment with company governance and standards.
• Identify and share best practices for integrating AI into everyday commercial work.
• Help translate AI-enabled capabilities to teams and stakeholders, supporting broader adoption and impact.

AI is treated as a practical leadership capability, not a theoretical skillset.

Requirements

Required:

• Bachelor’s degree.
• 5–7 years of professional experience.
• Demonstrated track record of execution, ownership, and results delivery.
• Strong analytical, communication, and problem-solving skills.
• Interest in biotech/pharma and commercial leadership pathways.

Preferred:

• Experience in disciplined, performance-driven environments (e.g., military service or similarly structured settings).
• Exposure to commercial, operational, analytical, or customer-facing roles.
• Experience using data, analytics, digital tools, or AI-enabled solutions to support decision-making.
• Comfort working in complex, matrixed organizations.

Developmental Opportunities:

• Exposure to senior leadership.
• Cross-functional rotations.
• Mentorship and coaching.
• Potential placement into full-time commercial roles upon program completion.

#Li-SD1

#Li-Remote

Legend Biotech is seeking a HR Policy & Risk Manager (Contractor) as part of the Human Resources team based in Somerset, NJ.

Role Overview 

The HR Policy & Risk Manager plays a critical role in ensuring that HR operations and programs align with internal controls, external regulation and company risk management strategies. The role functions across multiple workstreams focused on risk identification, control implementation, policy compliance and internal auditing. This is a second line of defense role, providing oversight of HR risks, compliance and governance in alignment with broader enterprise risk management

Key Responsibilities

• Oversee the implementation and monitoring of controls across HR policies and processes, ensuring ownership by functional leads.
• Conduct quarterly control assessments and support function leads in evaluating control effectiveness.
• Lead or support internal HR audits, both scheduled and ad hoc, documenting findings and driving remediation actions.
• Monitor and assess HR risks using data-driven metrics (e.g., attrition, time-to-fill), investigate root causes and support resolution efforts
• Partner with reporting team to track HR risk indicators and ensure timely mitigation of emerging issues.
• Maintain oversight of employee investigations conducted to ensure objectivity and compliance monitoring.
• Monitor data privacy-related activities to ensure alignment with legal and regulatory standards
• Develop, maintain, and govern HR policies and procedures in accordance with internal standards and regulatory expectations.
• Own SOX-related HR controls, ensuring documentation, testing and remediation are completed accurately and on time.
• Contribute to company-wide compliance and risk management by representing HR-related risks.
• Prepare risk reports and audit summaries for HR leadership, internal audit and as needed.
• Serve as a central point of contact for HR risk, audit, and policy-related inquiries across the organization.
• Decides when to escalate HR risks, compliance issues, and investigation outcomes to leadership.
• Determines control priorities and remediation actions based on risk assessments and audit findings
• Evaluates and approves updates to HR policies, procedures, and SOX controls to meet regulatory and business needs.
• Identifies data trends and root causes to inform risk mitigation strategies.

Requirements

Education

• Bachelor’s degree in Human Resources, Business Administration, Risk Management, Compliance or a related field required.
• Master’s degree in HR, Business, Law, or a related discipline a plus.
• Relevant certifications preferred (e.g., PHR/SPHR, SHRM-CP/SCP, Certified Compliance & Ethics Professional – CCEP).

Experience

• Minimum of 5 years of experience in HR, compliance, internal audit, risk management or a similar function.
• Experience in a fast-paced professional environment and working with cross-functional teams.
• Strong understanding of risk management principles and compliance frameworks.
• Familiarity with HR systems, data privacy laws (e.g., GDPR, CCPA), and internal audit practices.
• Strong analytical skills to interpret HR metrics and identify trends or red flags.
• Excellent communication and stakeholder management, especially when partnering with HR, Legal, Audit, and Risk functions.
• High attention to detail, integrity, and ability to maintain confidentiality.
• Critical thinking and problem-solving mindset with a proactive approach to compliance.

IT Skills 

• Advanced Excel skills for data analysis and risk reporting (pivot tables, lookups, dashboards). 
• Proficiency with HRIS (Workday) and audit/compliance tools.
• Familiarity with data visualization or reporting tools (e.g., Power BI). 
• Experience with document management and workflow tools (e.g., SharePoint, SmartSheet).

#Li-FB1

#Li-Hybrid

Legend Biotech is seeking a Facility Engineer as part of the Technical Operations team based in Raritan, NJ.

Role Overview

This position will be responsible for facilities engineering support, design, and implementation for mechanical systems and equipment, and work order management for cGMP Clinical and Commercial Cell Therapy Manufacturing. This individual will partner with various Technical Operation functions in support of personalized cell therapy production through safe and compliant manufacturing operations according to cGMP requirements. This individual will support the organization in maintaining commercial production at a state-of-the-art cell therapy facility. The role will require proven leadership and expertise that drives effective communication, coordination and collaboration across relevant cross functional groups to enable robust production, testing and release of product to patients.

Key Responsibilities

• Demonstrates professional execution of the planning, development, and implementation of construction and/or repair programs for engineering driven initiatives.
• Serves as SME on engineering design projects; sets project requirements, evaluates compliance with project and engineering standards, and approves final designs and installations.
• Identifies, investigates, and analyzes a wide range of complex facilities, utilities, systems, equipment or manufacturing issues and develops a robust solution for remediation.
• Oversees, reviews, and approves the work of external engineering design and planning consultants; ensures that engineering designs are consistent with contract specifications and all relevant regulations and engineering standards.
• Supports the review of equipment, building, and other job plans within the CMMS for effectiveness, applicability, and compliance. Ensure all equipment is operated and maintained within a validated/qualified/certified state.
• Gathers and analyzes data, blueprints, and reports.
• Supports tracking and achievement of annual maintenance goals and objectives including metric improvement targets. Support continuous improvement activities such as preventive maintenance optimization, risked based asset management programs, and analyze equipment for proper balance of preventive to corrective work order ratio.
• Supports maintenance driven quality events including but not limited to Deviations/Investigations, Out of Tolerances (OOTs), Change Controls, Root Cause Analysis and FMEA’s.
• Ensures regulatory and job training remains current by promptly completing required training.
• Complies with all company and/or site policies and procedures.
• Demonstrates willingness to learn new skills as required.
• Available for other duties as required.
• Ensures site compliance with all local, state and federal regulations including and equivalent to Federal Drug Administration (FDA), Environmental Protection Agency (EPA), Occupational Safety and Health Administration (OSHA), and Drug Enforcement Agency (DEA) as applicable (TSA) Transportation Security Administration.
• Ability to work independently and with minimal guidance/oversight.
• Job duties performed routinely require exposure to and handling of biological materials and hazardous chemicals. 

Requirements

• B.Sc./M Sc. in chemical, mechanical, electrical, industrial engineering or similar field is required
• Minimally 5+ years of experience as a facility engineer or working within an industrial manufacturing or regulated environment is required, ideally has cGMP cleanroom manufacturing experience under aseptic conditions
• Experience with HVAC and building management systems is required
• Experience with SAP and MS Office is required
• Proficiency in English (verbal and written) and strong communication skills
• Experience with a CMMS or similar maintenance management system is preferred
• cGMP manufacturing familiarity is preferred
• Ability to apply engineering principles and techniques to the solution of equipment, buildings, and infrastructure.
• Construction/project management principles. 

Legend Biotech is seeking an Associate Corporate Counsel as part of the Legal team based in Bridgewater, NJ.

Role Overview

The Associate Corporate Counsel will be responsible for the review, drafting, and negotiation of a wide range of commercial agreements, while providing practical, business-oriented legal advice to internal stakeholders. This role will serve as primary legal partner for day-to-day contracting needs of designated business functions and works closely with senior attorneys and cross-functional stakeholders to provide practical, risk-based legal advice while helping to drive efficient contracting processes in a dynamic biotech environment. The position reports to Legend Biotech’s Deputy General Counsel.

Key Responsibilities

• Primary responsibilities include leading the drafting, review, negotiation, and execution of a broad array of commercial, procurement, and other contracts supporting the company’s US and EU commercial, R&D and clinical operations, including master service agreements and related statements of work, manufacturing and supply agreements, quality agreements, confidentiality agreements, consulting agreements (including with healthcare professionals), SAAS agreements, staffing agreements and other contracts.
• Partner with internal stakeholders (e.g. Procurement, Finance, IT, Commercial, R&D, Clinical, Medical) and other subject matter experts to serve as primary legal partner for contracting needs of designated business functions and effectively drive contracts and transactions to conclusion.
• Support contract intake and prioritization in coordination with Legal Operations.
• Support continuous improvement of contracting processes and workflows and assist in the implementation, maintenance, training and enforcement of contract-related policies, procedures and systems.
• Assist in the development and maintenance of standard contract forms, templates and playbooks
• Secondary responsibilities include supporting other members and functions of the Legal Department on ad hoc legal matters and cross-functional special projects, as assigned.

Requirements

• 5+ years of relevant experience, including drafting, reviewing, revising, and negotiating complex agreements and providing legal counsel on contracts and transactions. In-house experience in the life sciences or pharmaceutical industry is preferred.
• J.D. degree from an accredited U.S. law school (or the equivalent); high academic achievement.
• Licensed to practice law in one or more U.S. states; either admission to the New Jersey Bar or eligibility for in-house qualification in New Jersey.
• Knowledge of the legal and regulatory environment applicable to a global life sciences company preferred, including: the Federal Food, Drug and Cosmetic Act, the False Claims Act (and similar state laws), the Anti-Kickback Statute (and similar state laws), and the Foreign Corrupt Practices Act (and similar anti-bribery laws).
• Proficiency with Microsoft Office Suite and digital contract lifecycle management tools.
• Clear and practical communication style.
• Team player with collaborative mindset and willingness to learn in a fast-paced environment.
• Strong organizational skills and ability to manage multiple matters.
• Ability to prioritize work to meet changing needs.
• Strong ability to influence and present complex information to senior leaders.
• Demonstrated success in proactively and independently driving transactions and processes.

#Li-FB1

#Li-Hybrid

Who we are:

Kymera is a clinical-stage biotechnology company pioneering the field of targeted protein degradation (TPD) to develop medicines that address critical health problems and have the potential to dramatically improve patients’ lives. Kymera is deploying TPD to address disease targets and pathways inaccessible with conventional therapeutics. Having advanced the first degrader into the clinic for immunological diseases, Kymera is focused on building an industry-leading pipeline of oral small molecule degraders to provide a new generation of convenient, highly effective therapies for patients with these conditions. Founded in 2016, Kymera has been recognized as one of Boston’s top workplaces for the past several years. For more information about our science, pipeline and people, please visit www.kymeratx.com or follow us on X (formerly Twitter) or LinkedIn. 

How we work:

• PIONEER: We are courageous, resilient and rigorous in our mission to improve patients’ lives through our revolutionary degrader medicines.
• COLLABORATE: We value trust + transparency from everyone. Our goals are shared, our decisions data-driven and our camaraderie genuine.
• BELONG: We recognize our differences, inviting curiosity and inclusivity, so that our people are valued, seen, and heard.

How you’ll make an impact:

• Contribute to the planning, implementation and execution of a global clinical trial
• Responsible for management of vendors to support clinical trial execution
• Plan, execute, and lead study-specific meetings (e.g., internal core team meetings, investigator meetings, etc), as needed
• Provide input for the design of the Informed Consent Form(s), eCRFs, monitoring conventions, edit checks, etc.
• Provide study-specific training and leadership to clinical research staff, CRO, CRAs, sites and other contract personnel.
• Manage study timelines and metrics to ensure completion of study deliverables
• Support site selection, qualification, initiation, and monitoring activities.
• Review monitoring reports to ensure quality and resolution of site-related issues.
• Ensure timely enrollment and data collection at clinical trial sites.
• Collaborate with the data management team to ensure data integrity and timely database lock.
• Review and analyze clinical trial data to identify trends and potential issues.
• Ensure tracking and review of protocol deviations and assess impact on study data
• Develop relationships with investigators and site staff
• Work closely with CRO and Medical Monitor to ensure safety and efficacy data appropriately summarized to facilitate review.
• Work closely with translational medicine team to ensure appropriate incorporation of bioanalytical sampling plan into clinical protocols and relevant data output of the trial is provided to functional groups for review.
• Maintain accurate and complete trial documentation.
• Proactively identify and resolve clinical project issues

Skills and experience you’ll bring:

• Bachelor of Science in Life Sciences and 3+ years (CTM)/5+ years (Sr. CTM) as a project/clinical trial manager in biotech/pharmaceutical industry.
• Experience working on large, global, complex Phase 2 clinical trial(s).
• Broad knowledge of regulatory and ICH GCP guidelines, HIPAA, Protection of Human Research Subjects.
• Strong project management skills with the ability to manage multiple trials simultaneously.
• Excellent problem-solving, leadership, and communication skills.
• Ability to work in a fast-paced, dynamic environment with cross-functional teams.

Kymera Therapeutics is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment.  All applicants will receive consideration for employment without regard to race, color, religion, creed, gender, national origin, age, disability, veteran status, pregnancy, sex, marital status, gender expression or identity, genetic information, sexual orientation, citizenship, or any other legally protected class.

Compensation

• Kymera offers a competitive compensation package that recognizes both results and capabilities through market-based, performance-driven pay.
• The anticipated base salary range for this role is $115,000 – $200,000, with eligibility for annual bonus, equity participation, and comprehensive benefits.
• Actual salary is based on a holistic evaluation of the specific role/level as well as each candidate’s depth of experience and the capabilities they bring to the position.