{"id":3331512,"url":"https://alion.io/job/cyclepharma-senior-nonclinical-development-manager","title":"Senior Nonclinical Development Manager","company":{"id":720016,"name":"Cyclepharma","domain":"cyclepharma.com","url":"https://alion.io/company/cyclepharma","size_band":null,"is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Greenhouse","truth_index":null},"role":"Management","role_family":"Management","seniority":"lead","employment_type":"full_time","work_mode":"hybrid","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Cambridge, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":85000,"max_usd":205000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":2934},"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"GLP","optional":false},{"name":"ICH Guidelines","optional":false}],"status":"live","first_seen_at":"2026-10-27T08:37:03Z","employer_posted_date":"2026-10-27","last_verified_at":"2026-10-31T22:54:42Z","board_verified":true,"closed_at":null,"days_open":4,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":4},"description":"Senior Nonclinical Development Manager\nCycle Company: Cycle Pharmaceuticals Ltd\nPosition Summary: This full-time position is within the Research and Development department in our Cambridge office on a hybrid basis (minimum 3 days in the office).\nWe’re expanding our Research and Development team and recruiting for a Senior Nonclinical Development Manager to lead nonclinical and translational science across our development portfolio, helping turn promising science into robust development strategies for patients living with rare and complex diseases.\nIn this role, you’ll take ownership of nonclinical study design, oversight and interpretation, spanning pharmacology, disease models and GLP toxicology. Working across programmes in metabolic disease, neurology, immunology and oncology. You’ll ensure nonclinical development packages are scientifically rigorous, strategically aligned and designed to meet FDA expectations.\nFrom new molecular entities to reformulation programmes under the 505(b)(2) regulatory pathway, you’ll work closely with both internal teams and external experts to generate meaningful evidence, manage specialist CROs and bioanalytical partners, and translate study findings into clear recommendations that inform clinical development.\nIf you’re a nonclinical scientist who thrives on solving complex scientific challenges, brings strong study design and CRO management experience, and wants to see the impact of your work across the development journey, we’d love to hear from you.\n\nOur Company\nAt Cycle, we believe that Every Single Patient Matters. This is at the heart of why we work and were looking for people to join our team who share our vision. We know that life-changing treatments need life-improving product support to match, because when you put the two together, great things can happen.\nOur growing portfolio now covers oncology, haematology, neurology and rare metabolic genetic conditions where we improve existing drugs, repurpose them for new uses and bring generics back to market. Using cutting-edge drug delivery technologies, we enhance the efficiency of treatments, offering patients greater freedom and choice.\nHeadquartered in Cambridge, UK, with a significant US presence, Cycle has scaled rapidly and was named one of the UK’s fastest-growing private companies by The Sunday Times (Sunday Times 100 2024 & Sunday Times 100 Tech 2025). If you want to know more about what we do then, why not check out our website and take a look at some of our patient stories: Patient Stories - Cycle Pharma\nWhat you’ll be doing in this role:\nLead the design, placement, oversight and interpretation of pharmacology, proof-of-concept, PK/TK, ADME and GLP/non-GLP toxicology studies, including safety pharmacology, genotoxicity, reproductive toxicology and juvenile animal studies.\nDevelop integrated nonclinical development plans aligned with clinical and regulatory strategies, identifying data gaps and defining study requirements in collaboration with Regulatory Affairs, including bridging strategies for reformulation programmes.\nSelect and manage nonclinical CROs, bioanalytical laboratories and consultant toxicologists, overseeing study protocols, interim data, reports, timelines, budgets and issue resolution; act as sponsor representative for GLP studies where required.\nEnsure studies meet applicable GLP requirements, relevant ICH guidelines and regulatory expectations, while upholding high standards of animal welfare and the principles of Replacement, Reduction and Refinement (3Rs).\nInterpret nonclinical findings to inform clinical development, including NOAELs, safety margins, exposure limits, starting doses and dose escalation, working closely with Clinical Development.\nDefine translational hypotheses and biomarker strategies that connect mechanism of action and nonclinical findings to anticipated clinical outcomes, informing clinical protocols, safety monitoring plans and target product profiles.\nReview nonclinical content for Investigator’s Brochures, IND submissions, FDA meeting briefing packages and CTD Module 2 summaries and overviews, supporting regulatory interactions and maintaining awareness of evolving FDA, EMA and ICH guidance.\nCollaborate with Product Development (CMC) to coordinate test article supply and formulation, and work across Clinical Development, Regulatory Affairs, Quality, Clinical Operations and Pharmacovigilance to support programme progression.\nEvaluate nonclinical aspects of investigator-initiated research and academic collaborations within established governance frameworks, engaging with academic collaborators and key opinion leaders to inform disease model selection and translational priorities.\nContribute to departmental budgeting, resource planning and prioritisation, drive improvements in nonclinical procedures and CRO oversight processes.\n\n The following skills and experience will be important in helping to set you up to succeed in this role:\nPhD in pharmacology, toxicology, physiology or a related life science discipline.\nSignificant pharmaceutical, biotechnology or CRO experience designing, placing and monitoring non-clinical in vivo studies, including GLP toxicology.\nDemonstrated experience managing non-clinical CROs, including protocol and report review and resolution of study issues.\nStrong working knowledge of GLP and non-clinical regulatory guidance, including ICH M3(R2), S-series guidelines and FDA expectations for IND-enabling and marketing application packages.\nExperience translating non-clinical findings into clinical starting doses and safety margins.\nExperience authoring non-clinical sections of regulatory submissions, including Investigator’s Brochures and CTD Module 2.4 and 2.6 (preferred).\nExperience with rare disease models, juvenile toxicology or 505(b)(2) programmes (desirable); toxicology certification such as DABT or ERT (desirable).\nStrong scientific judgement and analytical capability, with excellent written and verbal communication skills and the ability to influence across disciplines without direct authority.\nWhat can we offer to you:\nIn addition to being part of a great team and doing things that will make a real difference to patients’ lives, you will enjoy all the benefits that brings:\nCompetitive salary based on experience\nA collaborative high performing work environment\nPerformance based bonus\nOpportunity to join a fast growing and ambitious business\nCompany pension scheme\n100% employer paid membership for Private Health Insurance\nLife and Critical Illness Insurance\nCorporate Gym membership\nRegular team building events and an agile working environment\nDiversity and Inclusion statement:\nAt Cycle Pharmaceuticals, we are committed to creating an inclusive, respectful, positive and diverse workplace. We do not discriminate on the basis of race, colour, religion, gender, age, disability, or any other protected characteristic. We actively support and embrace diversity, and we are working to build a team that reflects a wide range of backgrounds and perspectives.\nWe value your unique contributions and encourage you to join us in shaping a more inclusive future. If you require any reasonable adjustments - whether during the application process or in the workplace - we will be happy to support your needs. At Cycle, equality, inclusion, and respect are at the core of everything we do. We fully comply with all applicable employment laws, including those related to non-discrimination, work authorization, and employment eligibility verification.","description_format":"text","description_chars":7534,"description_truncated":false,"requirements":{"experience_years_min":null,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"phd","optional":false},"security_clearance":false,"languages":[]},"benefits":["Gym membership","Health insurance","Performance based bonus"],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Prescription Drugs","Rare Disease Therapeutics"],"lifecycle":[{"event":"open","at":"2026-10-27T12:15:23Z"}],"visa":[],"liveness":{"score":86,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.86,"p_room":1,"age_days":3,"expected_fill_days":35,"reasons":["conf:1","win:early"],"computed_at":"2026-10-31T05:58:55Z"},"pay":null,"html_url":"https://alion.io/job/cyclepharma-senior-nonclinical-development-manager","json_url":"https://alion.io/job/cyclepharma-senior-nonclinical-development-manager.json","meta":{"generated_at":"2026-10-31T23:56:03Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":37530,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-01T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":720016},"rest":"https://alion.io/mcp/rest/get_company?id=720016"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fcyclepharma-senior-nonclinical-development-manager"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Fcyclepharma-senior-nonclinical-development-manager"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Fcyclepharma-senior-nonclinical-development-manager"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/cyclepharma-senior-nonclinical-development-manager\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fcyclepharma-senior-nonclinical-development-manager"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3331512}},{"tool":"search_jobs","arguments":{"company":"cyclepharma.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3331512},"note":"people open to offers who fit this vacancy"}],"note":"The same data through MCP tools: https://alion.io/mcp/open needs no sign-in (compact searches, postings, people); https://alion.io/mcp with an Alion account has everything. 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