Associate Director/Director, Development Program Management, CMC
Xenon Pharmaceuticals
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, delivery, 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- Xenon Pharmaceuticals is seeking an Associate Director/Director, Development Program Management, CMC to lead strategic and operational PM for CMC programs beginning in phase 1 and 2. The role collaborates with CMC and program stakeholders to translate strategy into executable...SuggestedRemote job
- Associate Director, CMC Product Development - Small Molecule About Beeline Medicines: Beeline Medicines is a clinical... ...activities on assigned programs, driving work from early formulation... ...manufacturing, direct CDMO technical management experience, and the ability to deliver...SuggestedContract workLocal areaImmediate start2 days per week
$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...SuggestedWork at office$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...SuggestedContract work$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...Suggested$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 timeSummer workRemote workFlexible hours2 days per week$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...Temporary workSummer workLocal area$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 workLocal area- 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 timeSummer workRemote workFlexible hours2 days per week
$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 timeTemporary workWork at officeLocal areaFlexible hours$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 wageTemporary workLocal areaRemote workWorldwide- 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 timeTemporary workLocal areaFlexible hours
$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 wageLocal area$174k - $184.95k
...lives across multiple disease areas. The Program Toxicologist will be expected to take on... ...expertise in toxicology to advance the company’s development pipeline by working closely with program... ...development. Partner with Research, CMC, Device, and other cross-functional teams...Local areaWorldwide$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 timeSummer workSeasonal workVisa sponsorshipWeekend workAfternoon shift$136.51k - $204.77k
...Job Title: Associate Director, CMC Lead Introduction to role: Are you ready to lead... ..., CMC Lead, you will steer development across a portfolio of alpha-emitting... ...material. Portfolio Leadership: Manage multiple early-stage programs; set priorities, balance...Hourly payTemporary work- Design, execute, interpret, and communicate toxicology strategies supporting the pipeline from discovery through development Partner with Research, CMC, Device, and other cross-functional teams on study plans and design Identify safety-related knowledge gaps and propose...Local area
$170k - $195k
Description Of Role Centessa’s CMC group is currently seeking an (Associate) Director of Drug Product within... ...our early stage programs. The successful candidate... ...as well as managing CROs and CDMOs. The candidate... ...nonclinical formulation development, with flexibility to support...Full timeContract work$170k - $220k
Associate Director, Regulatory CMC - Solid Biosciences Charlestown, MA HQ Solid Biosciences is a precision... ...in science, technology, disease management, and care. Patient-focused and... ...controls is at the forefront of development of our programs and regulatory CMC provides a...Full timeTemporary workRemote workFlexible hours- ...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
$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 timeTemporary workWork at officeLocal areaShift work3 days per week- ...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
$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...For contractorsLocal areaRemote workShift work$173k - $285.33k
...outcomes. What You'll Do As a Director/Senior Director, CMC Drug Substance Development, you will be an integral part of... ...commercialization. Lead and Manage Team Execution : Lead a group... ...a team working on projects and programs that truly matter. We offer a supportive...$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...Permanent employmentFull timeWork at officeWork from home$133.5k - $192.83k
Job title: Associate Director, Field Learning & Development - Gastroenterology Location: Cambridge, MAAbout the Job:... ...following work streams:New hire training programs and curriculumContinuing education... ..., e-learning modules, WebEx, etc.Manage the Product Review Board process...Full timeTemporary work- Vertex Pharmaceuticals Incorporated is seeking an Associate Director to lead CMC Quality Compliance and Inspection Readiness. You will drive inspection readiness for external operations, collaborate across functions, and guide risk assessments and CAPA closures to sustain...Remote work
- Director/Associate Director, Cell Therapy CMC & Manufacturing We are seeking a highly experienced and visionary leader... ...to lead our cell therapy development programs. The successful candidate will help lead CMC strategy, manage process development and manufacturing...
$165k - $185k
...unmet need. With Arbor’s lead program, ABO-101 for the treatment... ...to focus their research and development efforts on genomic diseases... ...read on.About the Role: The Associate Director, Biomarker and Assay Development... ...CROs/vendorsSelect, manage, and oversee CROs to ensure...Work at office$180k - $195k
Associate Director, Quality Assurance - CMC Seaport Therapeutics is a clinical-stage biopharmaceutical... ...company advancing the development of novel... ...Quality Assurance CMC to manage GMP quality assurance activities... ...clinical development programs, ensuring compliance with...
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!
- associate marketing manager Boston, MA
- associate director clinical operations Boston, MA
- retail associate manager Boston, MA
- associate scientific director Boston, MA
- associate media manager Boston, MA
- associate product manager web Boston, MA
- associate manager Boston, MA
- associate director biostatistics Boston, MA
- associate director market research Boston, MA
- associate director regulatory affairs cmc Boston, MA

