What You’ll Do:

The Senior Specialist, GMP Quality Assurance will collaborate internally with QA, RA, and CMC departments. As needed, work with external Approved Service Providers to ensure oversight and compliance. The Senior Specialist will perform review of drug substance/drug product manufacturing records and associated documents (i.e. deviations) for product that will be released for use in Kailera phase I-III clinical programs. The Senior Specialist will help continuously improve Quality System Procedures related to GMP activities related to their function and will collaborate closely with internal cross-functional teams.

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

Responsibilities:

• Review and approve Service Provider GMP documentation
• Review and approve master batch/packaging records
• Review executed batch/packaging records for Intermediates, Drug Substance, and Drug Product
• Prepare batch file for final batch disposition for Kailera’s Phase I-III clinical programs
• Review GMP Quality Events, change controls, CAPA’s, and other GMP documentation as needed
• Identify and escalate issues effectively
• Compile data for Quality System Reviews
• Evaluate GMP activities for continuous improvement opportunities
• Support creation and continuous improvement of Kailera procedures
• Other Quality Assurance responsibilities as assigned

Required Qualifications:

• 6+ years of experience in an FDA regulated Pharmaceutical Industry with GMP experience
• Understanding and knowledge of industry standards, concepts, current cGMP (21 CFR Parts 210 & 211 & Part 11 and EudraLex), and other agency standards and guidance as they relate to quality systems/quality assurance
• Experience with review of GMP manufacturing/packing records (Master/Executed Batch Records, Deviations, Change Controls, etc.) associated with Phase I-III clinical studies
• Proficient in Veeva QualityDocs and Veeva QMS a plus
• Demonstrates proven track record of communication with internal and external Service providers
• Ability to identify quality issues requiring escalation
• Clear, concise writing skills and good verbal presentation skills
• Self-motivated, detail oriented, well organized, and able to manage multiple projects
• Ability to interact constructively and efficiently with co-workers within and across departments and Management, as well as with Service providers in a professional and collaborative manner

Preferred Qualifications:

• Biotech experience preferred

Education:

• BA or BS degree in a scientific discipline or supplemental Quality education

What You’ll Do:

The Senior Director, Quality Systems is a high-impact leadership role responsible for the architecture, implementation, and continuous improvement of our Enterprise Quality Management System (eQMS). You will report to the Vice President, Quality and will serve as the primary architect of our quality framework, ensuring our global operations remain compliant with GxP standards while maintaining the agility required of a growing biotech.

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

Responsibilities:

• Define and execute the long-term vision for the Quality Management System (QMS) to support global clinical development and future commercialization
• Provide Quality oversight for GxP systems change controls. Support validation planning, execution, approvals
• Act as the Business Owner for Veeva QualityVault. Lead the optimization of modules including Document Control, Training, Deviations, CAPA, and Change Control
• Establish and lead Quality Management Reviews (QMR). Develop and report on Key Quality Indicators (KQIs) and metrics to senior leadership to drive proactive risk management
• Ensure the QMS meets global regulatory requirements (FDA 21 CFR Parts 11, 210, 211, and 820; ICH E6; EudraLex Volume 4)
• Lead the QMS strategy for inspection readiness. Serve as a key interface during regulatory inspections (FDA, EMA, etc.) and oversee the internal and vendor audit programs
• Champion a culture of Quality. Streamline complex workflows to reduce cycle times for document approvals and deviation closures without compromising compliance
• Build and mentor a high-performing team of Quality professionals, fostering a collaborative environment that balances technical rigor with pragmatic problem-solving

Required Qualifications:

• 12+ years of experience in Quality Assurance within the Biotech/Pharmaceutical industry, with at least 5 years in a senior leadership capacity
• Direct experience implementing or managing Veeva QualityVault is mandatory. You should be proficient in configuring workflows and leveraging the platform for data-driven decision-making
• Proven track record in mid-sized companies navigating the transition from early-phase clinical trials to late-stage pivotal studies
• Deep knowledge of global GxP regulations and experience participating in (or leading) successful regulatory inspections
• Exceptional ability to translate complex quality requirements into actionable business strategies for non-quality stakeholders

Education:

• Bachelor’s degree required, scientific or engineering discipline preferred
• Advanced degree preferred

What You’ll Do:

This role offers an exciting opportunity to join a fast-paced, talented, and growing organization as the Associate Director, SEC Reporting and Technical Accounting. This role will report directly to the Vice President, Corporate Controller and be responsible for providing technical expertise and support for the SEC filing, compliance related reporting, internal controls compliance program, and technical accounting functions for a company that recently closed an IPO. This role will partner directly with accounting staff, legal, and other stakeholders across the organization. This role is a “hands-on” position and will require critical thinking skills, strong attention to detail, and excellent written communication skills. The successful applicant will have the opportunity to leverage a strong background in technical accounting and SEC reporting to enhance the Company’s compliance and reporting capabilities.

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

Responsibilities:

• Lead the preparation, review, and filing of all SEC reports, including Forms 10‑K, 10‑Q, 8‑K, proxy statements, and other registration statements, ensuring accuracy, completeness, and timeliness
• Serve as a technical accounting subject‑matter expert, providing guidance on complex accounting matters under U.S. GAAP
• Prepare and review technical accounting memoranda supporting significant or non‑routine transactions and key accounting judgments
• Monitor and assess the impact of new accounting standards and SEC rules; lead implementation efforts and updates to accounting policies and disclosures
• Partner closely with external auditors to support quarterly reviews, annual audits, and the review of other public filings
• Coordinate cross‑functionally with Legal, FP&A, Investor Relations, and external counsel on disclosure matters and public filings
• Prepare materials and run disclosure committee meetings with key stakeholders to ensure timely and accurate public disclosures
• Oversee the EDGARization and XBRL tagging processes, ensuring compliance with SEC requirements and consistency across filings
• Serve as the primary point of contact for all aspects of the Company’s SOX compliance program, including ownership of risk assessment, scoping, documentation, testing coordination, remediation of control deficiencies, and ongoing communication with internal stakeholders and external auditors to ensure effective internal controls over financial reporting
• Provide accounting support for special projects and ad-hoc reporting and analysis, as necessary

Required Qualifications:

• 10+ years of progressive experience in public accounting and/or SEC reporting and technical accounting roles with a Bachelor’s degree or 5+ years of experience with an advanced degree
• Advanced knowledge of U.S. GAAP, SEC reporting requirements, financial statement disclosures, and internal controls
• Hands‑on experience preparing and reviewing SEC filings and working directly with external auditors and advisors
• Strong ability to research, interpret, and apply accounting literature to complex transactions
• Strong, hands-on experience with IT and financial systems, leveraging ERP platforms, SEC reporting and disclosure tools, and financial reporting systems to support accurate reporting, SOX compliance, data integrity, and efficient close and reporting processes
• Proven project‑management skills with the ability to manage multiple deadlines in a fast‑paced environment
• Excellent written and verbal communication skills, with the ability to clearly explain complex accounting matters to non‑technical stakeholders
• High attention to detail, strong analytical skills, and sound professional judgment
• Strong team player that has a customer service approach and is solutions oriented
• Pharmaceutical or life science experience preferred

Education:

• Bachelor’s degree in Accounting, Finance, or a related field required
• Master’s degree in Accounting, Finance, or Business Administration preferred
• Current CPA license required

What You’ll Do:

The Manager of GxP Quality Systems will support Quality Management System processes, procedures, systems, training, and tools, ensuring quality and compliance are achieved and maintained across GxP functions. The role will report to the Senior Manager of GxP Quality Systems.

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

Responsibilities:

• Track and support closure of Quality Events (e.g., Deviations, CAPAs, etc.)
• Support management of GxP training program, maintenance of GxP training curriculum/matrix, and facilitation and scheduling of GxP trainings
• Conduct Document Control reviews on controlled quality documents and ensure timely periodic reviews and implementation of document change requests
• Support establishment, tracking, measurement, and reporting on metrics for the evaluation effectiveness of the Quality Management Systems
• Support the management of the electronic document management system (Veeva QualityDocs), the electronic learning management system (Veeva Vault Training), and the electronic quality management system (Veeva QMS) as Business Administrator
• Ensure the systems remain in a validated state, documenting changes via IT Change Controls, and executing scripts with evidence
• Evaluate opportunities for continuous improvements across the systems
• Work with stakeholders to ensure appropriate documentation of Service Provider selection, qualification, and evaluation/requalification
• Support development of metrics related to Service Provider qualifications and Service Provider Quality Events
• Manage and track Audit Schedule ensuring adherence to Audit Program and timeliness of deliverables

Required Qualifications:

• Minimum of 6+ years of experience in FDA regulated industry
• Previous hands-on experience with Veeva Quality Docs, Veeva Training, and Veeva QMS required
• A strong customer focus and ability to prioritize and adapt to business needs are required
• Strong business partner with all Functional Areas to ensure efficient collaboration and to drive results
• Self-motivated, detail oriented, well-organized, and able to demonstrate success with managing multiple projects simultaneously and other priorities
• Ability to resolve day-to-day issues efficiently while maintaining compliance with applicable industry standards
• Clear, concise writing skills and good verbal communication and presentation skills

Education:

• Bachelor’s degree in Life Sciences or a related field

What You’ll Do:

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

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

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

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

Responsibilities:

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

Required Qualifications:

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

Preferred Qualifications:

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

Education:

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

What You’ll Do:

The Patient Safety and Pharmacovigilance Intern (PSPV Intern) will report directly to the Senior Director, PV Operations and will work with PSPV and cross-functionally. This individual will be responsible for assisting members of the PSPV team with a variety of day-to-day tasks and support key PSPV projects/initiatives including safety vendor management, safety database oversight, ICSR review, signal detection and literature assessments, support projects, and participate in team activities.

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

Responsibilities:

• Research and understand the disease, symptoms, and treatment under investigation
• Participate in safety data analysis/signal detection (ICSR and aggregate data review)
• Understand the process of vendor management
• Review applicable Health Authority regulations and ICH guidelines to develop working knowledge of PSPV reporting obligations to ensure patient safety
• Lead a defined project (e.g. process optimization, data visualization, or data analytics) and prepare a final presentation for department and company leadership
• Opportunity to support PSPV projects

Required Qualifications:

• Proactive, engaged, eager and willing to learn approach to work
• Support and be part of the Kailera core values: Courageous, Collaborative, Compassionate, and Committed
• Excellent oral and written communication skills
• Interest and/or experience in drug safety and pharmacovigilance a plus
• Ability to work well in a fast-paced team environment

Education:

• Bachelor’s degree candidates who have completed two or more years and are pursuing a degree in life sciences (nursing, neuroscience, psychology, psychiatry, biology, pharmacy

What You’ll Do:

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

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

Responsibilities:

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

Required Qualifications:

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

Preferred Qualifications:

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

Education:

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

What You’ll Do:

The Senior Scientist, Analytical Development and Quality Control will support analytical development and quality control activities performed by our external partners for cGMP manufacturing, quality release, and stability. The Senior Scientist will work directly with technical counterparts at vendor sites to implement the required product controls and ensure the integrity of data generated by our external partners. This role will also provide critical support for regulatory filings and ensure compliance with global regulatory standards.

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

Responsibilities:

• Participate in the assessment and selection of Contract Development and Manufacturing Organizations (CDMOs)
• Oversee analytical activities conducted by these CDMOs to ensure external partners fulfill technical needs and quality standards
• Perform detailed review and provide data integrity oversight of data generated at CDMOs
• Ensure appropriate methods are developed and implemented for drug substance and drug product based on identified critical quality attributes
• Provide oversight of phase-appropriate method validation activities in alignment with current regulatory requirements
• Oversee stability programs to support product retest, shelf-life, and expiration dating
• Contribute to the preparation of data summaries and reports, and data review of regulatory submissions (INDs, NDAs, IMPDs)
• Ensure analytical methods and data meet regulatory requirements, generate data to justify specification limits, and assess trends in stability data
• Ensure all analytical activities comply with GMP, ICH guidelines, and other relevant regulations
• Participate in internal and external investigations of quality events (e.g., deviations, CAPAs, OOS, etc.)
• Work closely with Manufacturing and Quality Assurance teams to generate cGMP compliant data during product development and manufacturing
• Provide technical guidance and support to internal teams and external partners
• Oversee the preparation and review of technical documents, including protocols, reports, and SOPs

• Ensure data integrity and traceability in all analytical documentation

Required Qualifications:

• PhD with a minimum of 6 years, MS with a minimum of 10 years, or BS with a minimum of 12 years of experience in analytical development and quality control within the pharmaceutical or biotech industry
• Proven experience with peptides and small molecules in both injectable and solid oral dosage forms
• Experience managing outsourced activities with CDMOs
• Strong expertise in analytical techniques such as HPLC, UPLC, MS, GC, and spectroscopic methods
• Knowledge of regulatory requirements (FDA, EMA) and ICH guidelines related to analytical development
• Proven effective communication and interpersonal skills
• Ability to work effectively in a fast-paced, collaborative environment

Preferred Qualifications:

• Experience with combination drug/device presentations is preferred
• Experience with establishing peptide drug substance analytical control strategy for various peptide synthesis modalities (linear SPPS, hybrid approaches, LPPS, and/or recombinant) is preferred

Education:

• PhD or MS degree in Analytical Chemistry, Chemistry, Pharmaceutical Sciences, or related field, or a BS degree with a commensurate amount of directly applicable industry experience

What You’ll Do:

The Associate Director, Analytical Development and Quality Control will support analytical development and QC operations for clinical development and commercialization of Kailera’s pipeline compounds. The individual will provide technical expertise and will work closely with cross-functional stakeholders to ensure end-to-end drug development and manufacturing activities are executed seamlessly and in alignment with the company’s integrated development plans and program timelines.

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

Responsibilities:

• Support analytical development and QC activities related to characterization of peptide drug substances and drug products from early-stage clinical development through commercialization
• Maintain current knowledge in analytical methods and control strategies supporting a variety of molecule platforms and dosage forms
• Support development of analytical methods that support Kailera’s product pipeline, including analytical transfers and troubleshooting in CDMO laboratories
• Provide input for developing and implementing analytical development strategies, including managing execution of functional activities in support of clinical development, regulatory filings (IND/NDA/MAA), product approvals, and commercialization
• Support authoring of relevant CMC sections to enable global regulatory filings
• Participate on cross-functional CMC teams for the project(s) assigned to ensure adequate development and execution of CMC plan/strategies as needed
• Communicate CMC project status to key stakeholders cross-functionally and assist in driving decision-making
• Collaborate with cross-functional line functions to ensure CMC and program goals are met
• Travel to CDMOs and other service providers as needed for vendor technology transfers and analytical activities oversight

Required Qualifications:

• A bachelor’s degree and 10+ years of experience in the pharmaceutical/biotech industry with experience in all phases of innovative drug development and commercial launch in accordance with global CMC regulatory filings (IND/NDA/MAA, etc.)
  • Or an advanced degree with 5+ years
• Knowledge of peptide chemistry is required
• Demonstrated project and cross-functional team participation
• Experience in authoring regulatory documents
• Knowledge of drug development activities with respect to cGMP, quality systems, ICH guidelines, global regulatory requirements, and USP, EP, JP, and CHP requirements
• Experience with oversight of the analytical activities at CDMOs and/or CTLs
• Sound problem-solving skills with technically driven decision-making ability
• Effective written and verbal communication and interpersonal skills
• Innovative team-player with high energy for our dynamic company environment

Preferred Qualifications:

• Knowledge and experience in analytical development of peptide therapeutics (DS and DP)
• Knowledge and experience in analytical development of injectable products, and associated control strategies

Education:

• A Bachelors degree with 10+ years or an advanced degree with 5+ years of relevant experience
• Degree in Analytical Chemistry, Organic Chemistry, Physical Chemistry, Pharmaceutical Sciences, or closely related field.

Additional Information:

• This position requires some travel to domestic and international destinations
• This position requires working in environments where there may be specific gowning or dress code requirements

What You’ll Do:

This Senior Scientist will support ongoing activities for drug product formulation and manufacturing with external partners and CDMOs. This would include manufacturing process development and optimization, clinical supply manufacture, and commercial preparedness with a focus on oral solid dosage forms. The individual will have a working knowledge of drug product development through all stages of clinical development.

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

Responsibilities:

• Support technology transfer, formulation, and process development, optimization, scale-up, and manufacturing of clinical supplies, acting as Kailera’s person-in-plant for activities critical to program success
• Collaborate closely with internal cross-functional teams, including Drug Substance, Analytical Development, Supply Chain, Clinical, Quality Assurance, and Regulatory Affairs to ensure seamless progression of projects
• Review master batch records and executed batch records to ensure product quality
• Author change controls, review specifications, change notifications, and manage manufacturing deviations as necessary, working closely with Kailera’s quality group
• Present formulation development and manufacturing updates to internal and external stakeholders periodically
• Author, review, and update CMC specific documents to support worldwide regulatory submissions (i.e., IND, IMPD, and NDA)

Required Qualifications:

• 5+ years of experience in solid-oral dosage form development. Technical expertise in unit operations common to solid oral dosage form (e.g., milling, wet/dry granulation, compression, and film-coating)
• Extensive experience with management of day-to-day activities at CDMO’s
• Strong troubleshooting skills with the ability to quickly provide input in a fast-paced environment
• Strong working knowledge of Microsoft suites and common scientific software
• Experience with design of experiment (JMP/Minitab)
• Experience using quality systems such as Veeva to author and approve documents
• Excellent verbal, written, and interpersonal skills
• Ability to travel up to 10-20% (domestic and international)

Preferred Qualifications:

• Experience in the GLP-1 space, late-stage development

Education:

• B.S. and 12+ years of experience, advanced degree with 10+ years, or a PhD with 5-8 years of experience
• Degree in Engineering, Pharmaceutical Sciences, Chemistry or closely related field

What You’ll Do:

The Director, Global Supply Chain reports to the Senior Director, Global Supply Chain and possesses a working understanding of commercial and clinical supply management and strategy, global regulatory requirements, and project management practices. The Director, Global Supply Chain partners with relevant internal functional groups to ensure uninterrupted supply of both Investigational Medicinal Product (IMP) for clinical studies as well as inventory of commercial drug products.

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

Responsibilities:

• Support commercial launch readiness, including vendor management, distribution planning, and leading the Supply and Operations Planning team
• Managing drug product supply and logistics activities including, but not limited to, demand forecasting and supply planning (clinical and commercial), IRT, label generation and approval, packaging and labeling operations, release and distribution, expiry extension, cold chain management, and inventory management
• Communicating supply strategies and supply needs to CMC stakeholders and providing input for developing manufacturing strategies to support those needs
• Providing oversight in monitoring inventory levels throughout the life of a clinical trial or commercial product, including taking preventative actions to avoid potential supply issues
• Providing day-to-day oversight of Packaging and Labeling/Distribution vendors, including relationship management
• Contributing to the preparation of clinical protocols, clinical trial pharmacy manuals, packaging methods, batch records, drug labels, shipping documents, destruction certification, and coordinating the origination, proofing, and translation of clinical study labels and generation
• Proactively identifying potential issues, notifying Management in a timely manner, and developing mitigating actions
• Coordinate the development of the commercial forecast
• Interpret clinical synopses and protocols to create clinical IMP demand forecasts and develop supply plans
• Oversee the execution of multiple clinical trials and proactively identify potential supply chain issues, including providing analysis and recommending solutions with appropriate support from SMEs
• Support clinical study close-out activities, including returned goods reconciliation and inventory destruction
• Manage and execute drug supply delivery through coordination of CMC efforts assigned to the entire project team (including but not limited to CMC, Supply Chain, Legal, Procurement, Commercial, Regulatory, Clinical Development, and Clinical Operations)
• Ensure temperature excursion processes are executed as required
• Guide the IRT System Leads as necessary with regards to user requirement specifications and management module(s) as applicable
• Leverage inventory management capabilities of the IRT to appropriately manage clinical and commercial drug supply

Required Qualifications:

• Experience with global pharmaceutical development and manufacturing operations for development-stage and commercial products, including formulation development (pre-filled syringes, solid oral dosage forms, etc.), analytical development, and device development
• Bachelor’s degree and 10+ years of relevant biopharmaceutical industry experience or an advanced degree with 8+ years
• 8+ years of experience in clinical supply management
• Ability to cross-functionally communicate effectively with a high degree of emotional intelligence
• Deep understanding of IRT systems
• Ability to create a collaborative environment and manage multiple project activities with global contract CDMOs
• Strong computer skills including MS Office
• Hands-on, roll-up-your-sleeves, collaborative approach with a high sense of urgency and personal accountability to drive toward results
• Ability to think outside of the box and challenge the status quo
• Desire to work in a fast-paced, innovative environment
• Domestic or international travel is required (up to 20%)

Preferred Qualifications:

• Experience with pharmaceutical development and manufacturing operations for development-stage clinical products
• Experience with combination product device(s)

Education:

• Bachelor’s degree in pharmaceutical science, engineering, life sciences, or another relevant field. Advanced degree preferred

What You’ll Do:

The candidate selected for Director, Drug Product Manufacturing and Development will oversee drug product manufacture from the clinical stage through the commercial stage for Kailera’s pipeline compounds. This role will have high-visibility and will be responsible for providing technical oversight of late-stage process development activities, ensuring the necessary framework is in place for the manufacture of robust aseptic drug products at the commercial scale. The selected individual will work closely with cross-functional teams across Kailera and external manufacturing partners to develop late-stage strategies for process scale-up, with a focus on commercial readiness.

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

Responsibilities:

• Develop and design strategies for all aspects of late-stage process development, scale-up, optimization, and commercial readiness initiatives for aseptic drug products manufactured by external manufacturing partners
• Implement initiatives to enhance manufacturing efficiency, ensure robustness, mitigate risks, reduce costs, and improve product quality through experimental design, providing technical expertise, and program leadership
• Coordinate drug product campaign activities with leads from cross-functional groups across the Kailera organization to ensure seamless progression of timelines, updating the broader program team with regular updates
• Provide technical expertise for process performance qualification campaigns, ensuring that materials, equipment, and process controls consistently produce high-quality sterile drug products
• As necessary, act as Kailera’s person-in-plant for process development, engineering, and cGMP activities critical to program success
• Support authoring, review, and approval of SOPs, batch records, change controls, deviations, OOS/OOT investigations, CAPAs, and campaign summary reports
• Author, review, and update CMC specific documents to support worldwide regulatory submissions (i.e., IND/IMPD, NDA and BLA)
• Provide scientific input and expertise to drug product activities related to life-cycle management initiatives for sterile drug products

Required Qualifications:

• 10+ years’ experience in the pharmaceutical/biotech industry with a proven track record of technical expertise and leadership in aseptic manufacture of sterile drug products
• Extensive experience in the oversight of aseptic process development unit operations and equipment used for late-stage filling of vials, pre-filled syringes, and cartridges
• Working knowledge and experience in aseptic drug product development and manufacturing with respect to cGMP, quality systems, ICH guidelines, FDA, EMA, and associated regulatory requirements
• Demonstrated contribution to project and cross-functional teams
• Strong problem-solving skills with strategic and sound technically driven decision-making ability
• Effective interpersonal, written, and verbal communication skills
• Innovative team-player with high energy for Kailera’s fast-paced company environment

Preferred Qualifications:

• Prior experience in supporting the scale-up and commercialization of aseptic drug products, including process validation

Education:

• Bachelor of Science degree in Pharmaceutical Sciences, Life Sciences, Engineering, or related field. Advanced degree preferred

What You’ll Do:

We are seeking an experienced programmer to join us as Associate Director, Statistical Programming. This is a critical role responsible for leading statistical programming activities on the assigned disease area(s). This role will support clinical trials, regulatory submissions, and other key initiatives.

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

Responsibilities:

• Lead statistical programming efforts for clinical studies, including the development and review of programming specifications to ensure clarity, integrity, and compliance with internal and external standards
• Lead the execution of ad-hoc and post-hoc analyses to support emerging clinical questions, publications, and internal decision-making
• Oversee and coordinate activities with Contract Research Organizations (CROs), focusing on the implementation of CDISC standards, creation of SDTM, ADaM datasets, and TFLs, and ensuring high-quality deliverables
• Conduct independent validation and quality checks of statistical programming deliverables from CROs
• Collaborate closely with statisticians and cross-functional study teams to deliver results in a timely and accurate manner
• Manage multiple projects simultaneously, ensuring tasks are prioritized effectively to meet deadlines

Required Qualifications:

• Proven hands-on experience in programming for clinical development, preferably in a leadership role, with a strong preference for late-phase clinical trial support
• Experience in regulatory submissions, including NDAs, BLAs, and other filings, with experience in ISS/ISE highly desirable
• Expertise in SAS programming and comprehensive knowledge of CDISC standards
• Familiarity with ICH/GCP guidelines and global regulatory submission requirements (e.g., FDA, EMA)
• Extensive experience overseeing CROs, including independent validation of datasets and statistical deliverables

Preferred Qualifications:

• Background in cardiometabolic diseases or related therapeutic areas is preferred

Education:

• Advanced degree (MS/PhD) in Biostatistics, Statistics, or a related field
• MS: Minimum of 8+ years of relevant experience
• PhD: Minimum of 6+ years of relevant experience

What You’ll Do:

Reporting to the Senior Vice President, Deputy General Counsel, Kailera is seeking an exceptional and experienced leader to drive efficiency, scalability, and operational excellence within the Legal Department, overseeing processes, technology, budgeting, vendor management, and cross-functional initiatives to ensure the legal team can operate at peak performance. A key responsibility of the role will be the management of our entire end-to-end contract lifecycle process. The ideal candidate combines operational expertise with a strong understanding of legal workflows and business strategy, particularly within the biotechnology and/or pharmaceutical sectors.

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

Responsibilities:

• Manage the end-to-end contract life cycle process in Kailera’s contract management system and its integration with Kailera’s finance/procurement system, from intake, to review/negotiation, approval, execution, monitoring and archiving
  • Serve as primary point of contact for contract process related inquiries, assisting end users with entering requests, checking contract status, and other queries
  • Coordinate review, redlines, and approvals among internal and external stakeholders and outside counsel efficiently
  • Draft, review, edit, and negotiate a variety of routine agreements, such as CDAs, SOWs, amendments, and change orders, ensuring that contracts align with company policies and industry best practices
  • Partner with Finance and IT to implement system integrations, changes and upgrades, and to troubleshoot issues
  • Create key metrics, reports, and analytics to assess health of contracts management function (volume, contract turn-around times, etc.)
  • Contribute to the development, maintenance, and optimization of contract templates, playbooks, workflows, and standard operating procedures
  • Recommend strategies to enhance contract turnaround time and operational efficiency
• Develop, implement, and refine legal department processes, workflows, and standard operating procedures
• Identify opportunities to streamline work through automation, technology, and improved resource allocation
• Track KPIs, department metrics, and analytics to support continuous improvement
• Lead selection, implementation, and administration and optimization of legal technology tools (e.g., contract management, eBilling, document management, generative AI)
• Drive cross-functional understanding of legal processes through training on new systems, monthly new hire training, ad hoc training, office hours, and self-service tools
• Manage legal department budget, including vendor oversight, forecasting, variance tracking, and reporting

Required Qualifications:

• 10+ years of experience in legal operations and/or contracts management, preferably including in an in-house legal department
• Experience with end-to-end contracts management, preferably within the biotechnology and/or pharmaceutical sectors
• Proficiency with legal technology platforms such as contract management systems, eBilling and document management
• Ability to manage multiple priorities in a fast-paced environment
• Superb customer service orientation toward internal and external stakeholders
• Strong analytical, organizational and communication skills
• Solid understanding of contract language, negotiation principles and legal terminology

Education:

• Bachelor’s degree in business administration, legal studies or related field, or equivalent experience
• Advanced certification in legal operations and/or contracts management a plus

What You’ll Do:

The primary responsibility for the Scientist II, Toxicology will be to function as a key pharmacology and toxicology liaison/subject matter expert in support of external contract research organization (CRO) activities. The Scientist II, Toxicology is expected to ensure non-clinical studies are conducted in accordance with protocols and are aligned with the overall development strategy. In addition, the successful candidate will actively participate in scientific discussions within the non-clinical group for all compounds across the portfolio.

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

Responsibilities:

• Serve as the primary Kailera representative (Study Monitor) for non-clinical (pharmacology and toxicology) studies conducted at CROs
• Collaborate with Non-clinical Project Leaders and other scientists to design and develop study protocols, ensuring CROs have the technical capabilities to meet study requirements
• Conduct site visits to CROs to assess technical capabilities and ensure studies are executed in strict accordance with protocols
• Act as the first line of contact for study-related issues, assessing their impact on study integrity and escalating as needed
• Ensure GLP compliance, adherence to Good Laboratory Practices, and alignment with company Standard Operating Procedures (SOPs)
• Maintain study timelines and ensure non-clinical studies are conducted in accordance with overall program objectives
• Communicate study findings to non-clinical leadership and program teams in a timely and comprehensive manner
• Review and edit study protocols and reports to ensure scientific rigor, regulatory compliance (GLP, animal welfare, and safety), and high-quality study interpretation
• Serve as the point of contact for the receipt, review, and dissemination of study data across the department
• Collaborate with Non-clinical Project Leaders to interpret and analyze pharmacology and toxicology data, supporting risk assessment and decision-making
• Coordinate and oversee internal study data reviews to ensure alignment with project timelines
• Consolidate and communicate internal feedback on study reports to CROs, ensuring clarity and consistency
• Assist Non-clinical Project Leaders in integrating and assembling toxicology data for regulatory submissions (e.g., IND, NDA, BLA)
• Lead and contribute to cross-functional initiatives within the non-clinical department and across other teams to advance Kailera’s research objectives
• Actively participate in scientific discussions to assess toxicology findings and implications for drug development
• Provide mentorship and guidance to junior scientists, fostering a culture of scientific excellence and collaboration
• Take on additional responsibilities as assigned by non-clinical leadership

Required Qualifications:

• Hands-on experience in animal husbandry and in vivo study conduct within a pharmacology or toxicology setting
• Strong understanding of scientific principles and study design in toxicology research
• Knowledge of regulatory policies and procedures related to GLP study design, execution, and reporting
• Familiarity with current trends in non-clinical safety assessment and the CRO landscape
• Excellent written and verbal communication skills, with the ability to author clear, concise, and accurate documents for global regulatory submissions and health authority interactions
• Solid understanding of ICH, FDA, and EMA guidelines related to the nonclinical assessment of drug candidates

Education:

• PhD in Biology, Animal Sciences, Toxicology, or a related field with 2-5 years of relevant experience OR Master’s degree with 8+ years of experience OR Bachelor’s degree with 10+ years of relevant experience

What You’ll Do:

The Senior Clinical Oversight Manager (COM) is responsible for executing the Clinical Monitoring Oversight visit process and Clinical Oversight Metrics. The Senior COM represents Kailera during Clinical Oversight visits and oversees study execution to ensure compliance with ICH GCP, and applicable regulations. The Senior COM is involved in planning, execution, and delivery of oversight processes including Standard Operating Procedures (SOP) and work instructions. 

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

Responsibilities:

• Develops the Clinical Monitoring Oversight strategy across studies, including development and oversight of Clinical Monitoring Oversight SOPs and templates, Clinical Oversight Monitoring plans, managing Monitoring Oversight Service Provider (SP) activities, providing study/program/SP level reporting, and leading monthly TMF health checks
• Evaluates and provides recommendations to the study team on Oversight Service Provider activities to ensure the appropriate scope of work, oversight, and training of clinical oversight CRAs to achieve study milestones within agreed upon timelines, budget and quality
• Assigns oversight visits at trial sites based on strategic criteria to evaluate compliance of trials with local regulatory requirements; overall data quality and integrity; and human subject protection
• Provides oversight on service provider execution of clinical trial activities in accordance with Kailera SOPs, ICH Guidelines, and Good Clinical Practice (GCP)
• Develops key performance indicators (KPIs) and evaluates service provider operational data against KPIs to identify potential performance gaps
• Collaborates with the Clinical Oversight team, Clinical Quality Management, and Clinical Study Team to implement corrective actions and monitor progress through resolution
• Facilitate resolution of region specific and site management related challenges
• Acts on behalf of Business Operations on cross-functional project teams; interacts with internal and external groups
• Assist with creation and delivery of department initiatives, improvement plans, and/or training
• Selects and oversees Oversight CRAs globally, driving the team to ensure study deliverables are met with efficiency and quality in accordance with applicable SOPs, regulations, GCP, Key Performance Indicators (KPIs), and study-specific requirements
• Responsible for ensuring Oversight CRAs maintain their sites/studies as inspection ready, including the TMF, for health authority inspections
• Conduct periodic quality visits for Oversight CRAs, as needed
• Ensure the oversight CRAs are reviewing and ensuring data integrity, accuracy, and completeness at the clinical study sites
• Support and liaise with clinical site personnel, as needed
• Review contracts and approve vendor invoices

Qualifications:

• Minimum of 8+ years of clinical trial experience with strong knowledge of the clinical development process
• Experience with Phase I–III clinical trials, risk-based monitoring, and CRA Management
• Proficient in oversight tools and systems (CTMS, eTMF, dashboards, Microsoft Office)
• Experience with Vendor oversight, KPI tracking, and issue management
• Strong leadership, collaboration, and communication skills with the ability to manage and motivate team members (e.g., internal staff and external investigators/consultants)
• Excellent organizational, analytical, and interpersonal skills; able to work independently and in teams
• In-depth knowledge of ICH-GCP, FDA, EMA, and global regulatory requirements
• Ability to manage complexity in a fast-paced environment
• Must have strong clinical study management, communication (oral and written), and analytical skills
• Must be able to travel

Education:

• Bachelor’s degree in a scientific or healthcare-related field

What You’ll Do:

The Senior Director of Toxicology is a strategic and externally recognized expert responsible for driving the non-clinical safety strategy across multiple development programs. This role combines deep scientific and regulatory expertise with cross-functional leadership, operational excellence, and organizational development. The Senior Director is a functional leader in complex, multidisciplinary teams, developing and executing departmental strategy to ensure alignment with clinical development, corporate goals, regulatory compliance, and organizational vision.

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

Responsibilities: 

• Develop and lead non-clinical strategies across development programs, serving as the functional lead for non-clinical on cross-functional Program Teams
• Execute functional business plans and contribute to the development of broader functional strategy to achieve key business objectives
• Make program decisions guided by functional priorities and company strategy that impact the results of core business functions and facilitate cross-functional collaboration
• Provide technical leadership on strategically critical initiatives, including study design, data interpretation, and risk assessment, maintaining external recognition as an expert in the field
• Oversee CROs conducting non-clinical development studies (e.g. chronic tox, carcinogenicity, DART, mechanistic studies), ensuring scientific rigor and regulatory compliance
• Author, review, and approve regulatory submissions (e.g., INDs, NDAs, Investigator’s Brochures, PIPs, briefing books, white papers) and represent Kailera and non-clinical development in meetings with regulatory agencies
• Apply in-depth knowledge of own function and broad industry awareness to differentiate Kailera from the competition
• Solve highly complex problems and lead others in addressing issues of diverse scope, applying ingenuity, sophisticated analytical thought and creative solutions
• Apply broad industry and commercial awareness to drive financial and operational performance ensuring accurate budgeting and resource allocation
• Review information and data in the context of mid- and long-term project goals, directing the course of research and influencing organizational vision
• Use independent judgement to determine methods, techniques, and criteria for obtaining broad results
• Present non-clinical findings and strategic recommendations to senior leadership and external stakeholders
• Influence decision-making across functions by translating complex data into actionable insights
• Take the perspective of others into account when making final decisions related to operational and administrative matters
• Lead and mentor a high-performing non-clinical development team, fostering a culture of scientific excellence, collaboration, and continuous feedback and development
• Lead with trust, understanding, and adaptability to drive followership across the organization
• Direct the activities of cross-functional, complex, multi-disciplinary projects or teams, including prioritization and resource planning
• Mentor team members to achieve project goals and support career development

Required Qualifications: 

• Proven track record of leading non-clinical contributions to complex, multi-disciplinary projects and teams
• Proven track record of successful preparation, submission, and acceptance of non-clinical component of regulatory filings such as INDs, PSPs, NDAs, BLAs
• Deep understanding of GLP, regulatory requirements, and non-clinical development strategies
• Strong communication, leadership, execution and strategic thinking skills

Preferred Qualifications: 

• DABT or equivalent strongly preferred

Education:

• Bachelor’s degree with 12+ years of relevant experience, or an advanced degree (PhD, PharmD, DVM) with 10+ years of experience in toxicology or related field

What You’ll Do:

The Director, Clinical Scientist is a senior, hands-on scientific leader responsible for the scientific execution of clinical trials. This role partners closely with Clinical Operations and cross-functional teams to ensure high-quality trial conduct, rigorous data review, and clear scientific communication from study start-up through reporting.

This position requires deep clinical trial experience, strong organizational skills, and comfort working directly in trial data. An MD is not required for this role.

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

Responsibilities:

• Support the Medical lead for one or more Phase I–III clinical studies
• Support studies across the full trial lifecycle, from start-up through database lock and reporting
• Lead ongoing review of clinical trial data listings, including adverse events, laboratory data, concomitant medications, vitals, ECGs, and safety outputs
• Identify data trends, inconsistencies, and potential issues; partner with Data Management, Biostatistics, and Safety to resolve them
• Act as a close scientific partner to Clinical Operations to deliver on trial execution
• Collaborate effectively with cross-functional teams including Clinical Operations, Data Management, Biostatistics, Programming, Safety, and Regulatory
• Author, review, and contribute to trial documents, such as protocols, amendments, Investigator’s Brochures, and Clinical Study Reports
• Develop and deliver clear, well-structured presentations to study teams and internal leadership
• Drive execution, follow-through, and accountability across multiple concurrent deliverables
• Be flexible with travel and attend site related clinical development activities; form and maintain relationships with KOL’s

Required Qualifications:

• 8+ years of extensive hands-on experience supporting clinical trials in a clinical development role
• Demonstrated experience reviewing and interpreting clinical trial data listings
• Strong understanding of clinical trial conduct and cross-functional trial workflows
• Proven ability to partner effectively with Clinical Operations
• Exceptional organizational, prioritization, and execution skills
• Strong written and verbal communication skills
• Advanced PowerPoint skills; working knowledge of Excel and other commonly used clinical systems/tools
• Ability to manage multiple studies and deadlines in a fast-paced environment

Education:

• Advanced degree in life sciences discipline (PhD, PharmD, MS, or equivalent)

What You’ll Do:

We are seeking an experienced Associate Director, Device Engineering, to lead the development and launch of drug-device combination products, with a strong emphasis on autoinjectors, pre-filled syringes, and multidose pens. This role will drive cross-functional collaboration across CMC, quality, regulatory, manufacturing, clinical, and commercial teams to ensure robust product development aligned with meeting patient needs, global standards, and regulatory expectations.

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

Responsibilities:

• Lead combination product development projects (prefilled syringes, autoinjectors, and/or multidose pens) from concept through commercialization
• Build and execute project plans with clearly defined risks and milestones
• Develop device and combination product requirements, including user and stakeholder needs and technical requirements, and ensure appropriate engineering translation and subsequent verification and validation of requirements
• Oversee and ensure compliance with design controls per FDA and ISO 13485 requirements
• Manage risk management activities in accordance with ISO 14971, including hazard analysis, FMEA, and risk mitigation strategies
• Drive design verification and validation activities, including test method development, protocol execution, and documentation
• Oversee human factors and usability engineering efforts, ensuring compliance with FDA guidance and IEC 62366
• Facilitate design transfer to manufacturing, ensuring smooth transition and scalability
• Partner cross-functionally with CMC, quality, regulatory, clinical development, commercial/marketing, supply chain, and other key functions to ensure critical inputs are integrated into device development activities
• Author relevant portions of regulatory submissions (INDs, IMPDs, NDAs, BLAs, etc.) for devices and combination product programs
• Manage and collaborate with vendors, including Contract Design and Manufacturing Organizations (CDMOs) and suppliers, to ensure components and products meet quality and technical requirements and to integrate deliverables into the project Design History File at various stages of development and manufacturing
• Manage and collaborate with contract test labs to ensure testing strategy, method validation, and test execution are aligned with relevant standards and quality and technical requirements and integrate testing results into the Design History File
• Ensure product development aligns with relevant standards including ISO 11608-1, ISO 11040, ASTM D4169, ISO 14971, IEC 62366

Required Qualifications:

• Minimum of 10+ years of experience in medical device or combination product development, with at least 3 years in a team leadership role
• Proven experience with autoinjector, pre-filled syringe, or multidose pen development and launch, including authoring clinical and commercial regulatory submissions
• Deep understanding of design controls, design verification, test method development and validation, risk management, human factors, and design transfer
• Strong knowledge of applicable regulatory standards and guidance documents
• Excellent communication, leadership, and cross-functional collaboration skills

Preferred Qualifications:

• Experience working in a regulated pharmaceutical or biotech environment
• Familiarity with combination product regulations (21 CFR Part 4)
• Experience with supplier management of external development, testing, and manufacturing partners
• PMP certification or formal project management training is a plus

Education:

• Bachelor’s degree in mechanical engineering, Biomedical Engineering, or related field. Advanced degree preferred.

What You’ll Do:

The Associate Director, Program Management will collaborate with cross-functional teams, including clinical, regulatory, non-clinical, and technical operations, to drive the overall program and several ad hoc projects forward. This individual will oversee the development and execution of project plans from initiation to completion, ensuring the plan is completed on time, in scope, and within budget. Additionally, they will work closely with teams to proactively identify potential risks and implement effective solutions. A successful candidate must have experience managing drug development projects in a fast-paced environment, with a strong willingness to build relationships with cross-functional teams, dive into details, and address gaps as needed to ensure program success.

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

Responsibilities:

• Support the Program Leader with planning, execution, and delivery of multiple projects across asset development
• Collaborate with cross-functional teams (e.g. clinical, regulatory, nonclinical, and technical operations, etc.) to ensure alignment with company and program objectives
• Collaborate with Program Leader to ensure agenda topics and outputs are aligned with the overall strategic development plan for the program
• Develop and own detailed integrated project plans, including goals, deliverables, timelines, and resource requirements
• Identify and manage program risks, issues, and dependencies, and proactively implement mitigation strategies
• Monitor project progress and provide regular updates to Program Leader and other stakeholders, ensuring clear communication and transparency
• Own program reports / dashboards to executive and other governance teams

Required Qualifications:

• 10+ years of relevant experience or at least 8 years with an advanced degree of project management experience in the biotech, pharmaceutical, or life sciences industry
• Strong understanding of drug development and how biotech functions integrate
• Experience in managing cross-functional teams and complex projects, with late-stage drug development experience preferred
• Demonstrated project management and interpersonal skills
• Excellent problem-solving and organizational skills, attention to detail, and analytical skills
• Ability to manage multiple priorities in a fast-paced, dynamic environment
• Comfortable navigating ambiguity and driving clarity
• Responds to changing priorities and uncertainty by maintaining composure, resilience, and an open mind while embracing change in an evolving environment
• Proven record of collaboration and excellent communication
• Proficient in project management tools (e.g., Smartsheet, MS Project, Excel, think-cell, OnePager)

Education:

• Bachelor’s degree in science, engineering, or a related field; advanced degree preferred

What You’ll Do:

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

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

Responsibilities:

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

Required Qualifications:

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

Preferred Qualifications:

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

Education:

• MD or equivalent is required