Sign up to access all features of our service.
  • Job search
  • Favorites
  • Create a CV
    New
  • Salaries
  • Subscriptions

Associate Director/Director, Development Program Management, CMC

Xenon Pharmaceuticals Inc.

Who We Are: Xenon Pharmaceuticals (NASDAQ:XENE) is a neuroscience-focused biopharmaceutical company dedicated to drug discovery, clinical development, and commercialization of life-changing therapeutics for patients in need. We are looking for great people who thrive in a respectful, collaborative, inclusive, and productive culture to join the Xenon team. What We Do: We are advancing an exciting product pipeline to address indications with high unmet medical need, including epilepsy, depression and pain. Our Phase 3 azetukalner program represents the most advanced, clinically validated potassium channel modulator in late-stage clinical development for multiple indications. In March 2026, we announced positive topline data from our Phase 3 X-TOLE2 study of azetukalner in focal onset seizures (FOS), and we anticipate submitting a New Drug Application to the Food and Drug Administration in the third quarter of 2026. Our Phase 3 epilepsy program also includes a second FOS study, X-TOLE3, which would support regulatory submissions outside the U.S., and the X-ACKT study in primary generalized tonic-clonic seizures, which would support regulatory submissions for an additional epilepsy indication. We also have multiple Phase 3 azetukalner clinical trials underway in major depressive disorder (MDD) and bipolar depression (BPD), based on topline data from our Phase 2 X-NOVA clinical trial. In addition, we are proud of our strong heritage in human genetics, deep understanding of ion channel biology, and expertise in novel chemistries to enable potent, selective ion channel targeting. We continue to advance an early-stage pipeline of novel therapeutic candidates, including Phase 1 studies for XEN1701 and XEN1720 (targeting Nav1.7) and XEN1120 (targeting Kv7), which are being developed for pain. Backed by a strong balance sheet to support our growth plans, we continue to build a fully integrated, premier neuroscience company with strong discovery, clinical development, corporate, and commercial operations. About the Role: We are seeking an Associate Director/Director, Development Program Management, CMC to join our team. The Associate Director/Director, Development Program Management, CMC will provide strategic and operational project management leadership for CMC teams, with an initial focus on phase 1 and 2 compounds. This role will drive integrated planning, execution support, governance, and communication across multiple cross-functional programs and initiatives. The successful candidate will partner closely with CMC and program stakeholders to translate strategy into clear, actionable execution plans; maintain high-quality project plans, dashboards, milestone trackers, risk and action logs; and ensure timely follow-up on key deliverables, decisions, dependencies, and risks. The role will also help strengthen project management practices through scalable tools, clear meeting governance, financial tracking, continuous improvement, and appropriate use of emerging technologies. This position reports to the Senior Vice President, Portfolio and Alliance Management and will be based out of Boston, MA, USA in our Needham office. We will consider remote locations for exceptional candidates. The level of the position will be commensurate with the candidate’s education and industry experience. Hybrid positions require a minimum of two onsite days per week. RESPONSIBILITIES: Plan and manage budget proposals and approved budgets in accordance with the Company’s strategic and operating plans and Finance policies. Partner with CMC, Development Program Management, Program Team Leaders, and functional stakeholders to translate program strategy into integrated CMC execution plans, project charters, and team ways of working for assigned programs and initiatives. Lead project management for assigned CMC activities, including new molecules, tech transfer, scale-up, lifecycle management, and other development initiatives, ensuring alignment of scope, timelines, milestones, dependencies, deliverables, and risks. Develop, baseline, and maintain project management tools and reporting, including CMC project plans, dashboards, milestone charts, action logs, risk logs, status reports, and financial tracking, as appropriate. Drive team execution and governance through effective meeting management, decision and action documentation, follow-up with accountable owners, and clear communication of progress, risks, issues, and key decisions. Monitor project progress, identify risks or execution gaps, and partner with stakeholders to develop mitigation plans, escalation recommendations, and decision-ready updates. Improve CMC project management effectiveness through scalable tools, templates, Smartsheet solutions, automation, AI-enabled approaches, and other process improvements that enhance planning, visibility, and execution. Act in accordance with Company policies, including, for example, the Code of Business Conduct and Ethics and ensure policies are understood and followed by direct reports, if any. Some international travel may be required. Other duties as assigned. QUALIFICATIONS Bachelor’s degree in a scientific, technical, business, or related discipline required; advanced degree preferred. Typically requires 8+ years of relevant biotechnology or pharmaceutical industry experience for Associate Director level, or 10+ years for Director level, including significant experience in CMC, pharmaceutical development, technical operations, or related drug development environments. Experience supporting small molecule drug substance and drug product development required; experience with API development and solid oral dosage forms strongly preferred. Demonstrated experience managing cross-functional CMC deliverables, timelines, risks, and documentation in support of early-stage regulatory submissions, including INDs and/or IMPDs; exposure to NDA/MAA or other late-stage submission activities preferred. Proven ability to influence without authority, drive alignment across technical and non-technical stakeholders, and ensure execution discipline across complex, matrixed development teams. Experience developing and maintaining CMC-specific project plans, dashboards, milestone charts, action logs, risk logs, and related project management tools. Strong analytical, facilitation, problem-solving, written communication, and verbal communication skills, with the ability to communicate effectively with both technical and non-technical stakeholders. Proficiency with Smartsheet, Microsoft Project, Microsoft Office, and related project management tools required. PMP certification or equivalent project management training preferred. Our Total Rewards program includes base salary, target bonus, and stock options, as well as a full range of benefits including medical, dental, vision, short-& long-term disability, accidental death & dismemberment, and life insurance programs, Employee Assistance Program, travel insurance, and retirement savings programs with company matching contributions. Xenon encourages time to rest and re-charge through vacation, personal days, sick days, and an end-of-year company shutdown. Xenon highly values employee development and has an expanding Training, Learning & Development program, including a Tuition Assistance program for advanced degrees. #J-18808-Ljbffr Xenon Pharmaceuticals Inc.

Vacancy posted 1 day ago
Similar jobs that could be interesting for youBased on the Associate Director/Director, Development Program Management, CMC in Needham Heights, MA vacancy
  • Xenon Pharmaceuticals Inc. in Needham/Boston, MA, is seeking an Associate Director/Director of Development Program Management, CMC, to lead strategic and operational planning for CMC programs across early development. The role partners with CMC and program teams to translate... 
    Suggested
    Remote job

    Xenon Pharmaceuticals Inc.

    Needham Heights, MA
    1 day ago
  • $164.02k - $221.91k

     ...transforming your career.Associate Director, Commercial Drug...  ...part of Amgen’s Process Development organization, Drug...  ...processes, high-quality CMC sections, and...  ...individual drug product programs for technical activities...  ...commercialization and lifecycle management of parenteral and/or... 
    Suggested
    Full time
    Temporary work
    Flexible hours

    Amgen

    Cambridge, MA
    4 days ago
  • $159k - $195k

     ...company is advancing clinical programs for Duchenne muscular...  ....Role Summary:The Associate Director, Oligonucleotide Development will lead the chemical synthesis...  ...ASO payload molecules, managing execution both internally...  ...core member of multiple CMC teams, the Associate Director... 
    Suggested
    For contractors
    Local area
    Remote work
    Shift work

    Dyne Therapeutics

    Waltham, MA
    2 days ago
  • $170k - $230k

     ...and PNPLA3 I148M liver disease programs and includes clinical...  ...the Preclinical and Clinical Development Sciences team in Lexington, Massachusetts...  ...other functions including CMC, Regulatory Affairs, Clinical...  ...toxicity for the proactive management of potential safety... 
    Suggested
    Temporary work
    Summer work
    Local area

    Wave Life Sciences

    Lexington, MA
    3 days ago
  • $142.5k - $256.5k

     ...RoleModerna is seeking an Associate Director, Process Development to lead upstream/fermentation...  ...platforms and pipeline programs.This role translates strain...  ...technology transfer, and CMC support.The successful candidate...  ...biological materials.Manage a team and translate... 
    Suggested
    Permanent employment
    Full time
    Work at office
    Work from home

    Moderna Therapeutics

    Norwood, MA
    19 hours ago
  • $160k - $240k

     ...you’ll make an impact:As the Associate Director, Analytical Development, you will contribute to CMC activities supporting mid and...  ...resultsDesign and monitor ICH stability programs for drug substance and drug...  ...designing, implementing, and managing cGMP stability studies for DS... 
    Contract work

    Kymera Therapeutics

    Watertown, MA
    3 days ago
  • $160k - $240k

     ....Opportunity OverviewAs an Associate Director, Device Development, you will lead the development and lifecycle management of drug-device combination...  ...of device strategy across CMC, regulatory, clinical, and...  ...lifecycle managementCommunicate program status, risks, and... 
    Work at office

    Rhythm Pharmaceuticals

    Boston, MA
    3 days ago
  • $195k - $330k

     ...How you’ll make an impact:Drive end-to-end CMC program management for mid to late-stage programs, including timeline development, critical path identification, risk assessment...  ...or 15+ years (M.S.) of CMC experience; Sr. Director level requires commensurate additional... 

    Kymera Therapeutics

    Watertown, MA
    3 days ago
  • $174k - $235k

     ...APRIL monoclonal antibody in development for IgA nephropathy....  ...seeking a highly motivated Associate Director/Director, Clinical Program Lead to serve as the...  ...functional trade-off decisions. Manage program-level risks,...  ...Development, Regulatory, CMC, Data Management, Biostats... 
    Contract work
    Temporary work
    Local area
    Remote work

    Climb Bio

    Wellesley, MA
    2 days ago
  • Overview The Director of Program Management will serve as a strategic and operational leader for priority...  ...driving assets from mid- to late-stage development through regulatory submission. This...  ...partner closely with Clinical, Regulatory, CMC, Nonclinical, Biomarkers,... 
    Shift work

    Monte Rosa Therapeutics Inc.

    Boston, MA
    1 day ago
  • $172k - $202k

     ...is advancing a robust development portfolio of genetic medicines...  ...lead oligonucleotide programs are in development for...  ...the life cycle management of the analytical methods...  .... You will work with CMC technical SMEs, QA and...  ...and developing associated limits/specifications.... 
    Work at office
    Local area
    Remote work
    1 day per week

    Entrada Therapeutics

    Boston, MA
    16 hours ago
  • $142.5k - $256.5k

     ...diverse mRNA portfolio spanning development, clinical, and commercial...  ...stability data into actionable program, regulatory, and supply...  ...life reassessments, lifecycle management, and continuous improvement of...  ...operating within cross-functional CMC team structures.Experience in... 
    Permanent employment
    Full time
    Work at office
    Work from home
    Worldwide

    Moderna Therapeutics

    Norwood, MA
    1 day ago
  • $142.5k - $256.5k

    The Role:The Associate Director, Global Regulatory-CMC will be responsible for coordinating...  ...will need to successfully manage multiple projects in a fast...  ...medicines for patients. Development of regulatory strategy...  ...environment to drive meeting each program’s critical regulatory... 
    Permanent employment
    Full time
    Work at office
    Work from home

    Moderna Therapeutics

    Norwood, MA
    3 days ago
  • $166.4k - $249.6k

     ...The Chemistry Manufacturing Controls (CMC) Associate Director leads and executes global regulatory...  ...Leads preparation, review, and lifecycle management of CMC sections of global regulatory...  ...the Winter), educational assistance programs including student loan repayment, a... 
    Full time
    Summer work
    Remote work
    Flexible hours
    2 days per week

    Vertex Pharmaceuticals

    Boston, MA
    4 days ago
  • Position Summary The Associate Director, Formulation Development will play a key role on MBX Biosciences’ CMC team, supporting the development of peptide therapeutics across our pipeline. Reporting into our Senior Director, Drug Product, this person will lead formulation... 

    MBX Biosciences, Inc.

    Burlington, MA
    4 days ago
  •  ...Role Moderna is seeking an Associate Director, Process Development to lead upstream/...  ...technology platforms and pipeline programs. This role translates strain...  ...technology transfer, and CMC support. The successful...  ...related biological materials. Manage a team and translate... 

    RXinsider LTD.

    Norwood, MA
    3 days ago
  • Associate Director, Formulation Development Key Responsibilities Lead and contribute to the design, development, and optimization of pharmaceutical formulations...  ..., and analytical testing. Familiarity with end-to-end CMC drug development, critical milestones, and bottlenecks.... 

    Scorpion Therapeutics

    Burlington, MA
    2 days ago
  • $200k - $270k

     ...Job Description Description: Associate Director/Director Drug Product Development At Merida Biosciences, we are...  ...appropriate. Collaborate with CMC colleagues to ensure suitable DP...  ...Manual, ancillary assessment). Manage the strategy of DP development by... 
    Contract work
    Local area

    Merida Biosciences

    Cambridge, MA
    13 days ago
  • Job DescriptionGeneral Summary:The Associate Director, CMC Quality Compliance and Inspection Readiness...  ...inspection readiness and compliance programs for external operations. Works cross-...  ...but not limited to: inspection management and risk managementContinuous improvement... 
    Full time
    Summer work
    Remote work
    Flexible hours
    2 days per week

    Vertex Pharmaceuticals

    Boston, MA
    2 days ago
  • $154.4k - $242.55k

     ...Chemistry Manufacturing & Controls (CMC) and Devices organization,...  ...Regulatory, Pharmaceutical Development, and Commercial project teams...  ..., plans, executes and manages regulatory submissions per the...  ...issues and risks through assigned programs / products development... 
    Minimum wage
    Temporary work
    Local area
    Remote work
    Worldwide

    Takeda

    Boston, MA
    19 hours ago
  • $170.9k - $231.3k

    Overview The Associate Director, Regulatory Affairs CMC Development is responsible for developing and implementating global...  ...for development-stage programs. This role will play a critical...  ...communication, collaboration, and project management skills. This individual will... 
    Full time
    Temporary work
    Work at office
    Local area
    Flexible hours

    Alnylam Pharmaceuticals

    Cambridge, MA
    19 hours ago
  • $174k - $184.95k

     ...than ourselves. Description of Position The Program Toxicologist will be expected to take on...  ...in toxicology to advance the company’s development pipeline by working closely with program...  ...through development. Partner with Research, CMC, Device, and other cross-functional teams... 
    Local area
    Worldwide
    Shift work

    BlueRock Therapeutics LP

    Cambridge, MA
    4 days ago
  • Overview At Alnylam, development-stage programs are managed by Program Leadership Teams, led by a Program Leader and a Program Manager, responsible...  ...for the success of the Program.  The role of the Associate Director, Program Management CNS is to partner with Program Leaders... 
    Full time
    Temporary work
    Local area
    Flexible hours

    Alnylam Pharmaceuticals

    Cambridge, MA
    2 days ago
  •  ...achieving this goal every day.Reporting to the Program Lead for the TED portfolio, the Associate Director, Program Management will support the coordination and planning...  ...milestones. Communication of progress, development and maintenance of timelines, identification... 
    Temporary work
    Work at office
    Local area
    Immediate start
    3 days per week

    Viridian Therapeutics

    Waltham, MA
    19 hours ago
  • $169.4k - $266.2k

     ...DescriptionObjective/Purpose:Provide strategic program leadership at the asset level for...  ...confidence by integrating milestone management, dependency tracking, risk signaling, budget...  ...outcomes.PMO contribution and team development: applies and reinforces PMO standards and... 
    Minimum wage
    Local area

    Takeda

    Cambridge, MA
    19 hours ago
  • $142.5k - $256.5k

    Role Overview The Associate Director, Global Regulatory-CMC will coordinate regulatory CMC activities...  ...with stakeholders, and manage multiple projects to...  ...CMC aspects of product development projects. Review documents...  ...and impact on internal programs. Basic Qualifications BS,... 

    Moderna

    Norwood, MA
    19 hours ago
  • $104.4k

    Posting Description ASSOCIATE DIRECTOR, MITES PROGRAMS, School of Engineering - MIT Introduction to Technology...  ...safety of students and staff; and manages the recruitment and onboarding of...  ...experience in program planning and development; Bachelor’s degree in science,... 
    Full time
    Summer work
    Seasonal work
    Visa sponsorship
    Weekend work
    Afternoon shift

    Massachusetts Institute of Technology

    Cambridge, MA
    3 days ago
  •  ...the IT solutions roadmap for CMC digital transformation. Oversee...  ...implementation and lifecycle management of digital CMC solutions to...  ...speed new pipeline products from Development Candidate through IND/NDA...  ...and trending tools; enable CMC program management digitization and... 
    Flexible hours

    Alnylam Pharmaceuticals

    Cambridge, MA
    3 days ago
  • $193k - $226k

     ...Therapeutics is seeking an Associate Director of FP&A for Development who will provide critical...  ...and global manufacturing/CMC/supply chain operations...  ...launch and ongoing lifecycle management activities. This role...  ...Chain, Quality, Regulatory & Program Management)Partner with... 
    Full time
    Temporary work
    Work at office
    Local area
    Shift work
    3 days per week

    Bicara Therapeutics

    Boston, MA
    19 hours ago
  •  ...Pharmaceuticals, Inc. is seeking an Associate Director, Quality Operations to...  ...of clinical and development manufacturing processes....  ...distribution for non-commercial programs, ensuring compliance with...  ...and reviewing IND CMC submissions, managing quality systems, supporting... 
    Remote job

    Amylyx Pharmaceuticals, Inc.

    Cambridge, MA
    4 days ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Associate Director/Director, Development Program Management, CMC. Be the first to apply!