Sr. Director, CMC

DescriptionAt Allucent, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.We are looking for a Sr. Director, CMC to join our A-team (hybrid*/remote) in the USA. As a Sr. Director, CMC at Allucent, you are responsible for assisting clients with Chemistry Manufacturing and Control (CMC) and related pharmaceutical development activities of drug, biologic or medical device productsAbout the role As the Sr. Director, CMC, you will:Lead end-to-end CMC strategy across drug substance, drug product, and analytical development—from early-stage evaluation through regulatory submission and commercial launch with a focus on scientific aspects.Drive regulatory excellence by authoring and reviewing CMC submissions, leading Health Authority communications, and ensuring compliance with FDA, EMA, and ICH guidelines.Prepare product development plans from early development through Phase 4.Manage and lead direct reports through development and performance management and by providing training on current and new regulatory requirements.Perform other related duties, as needed.RequirementsMinimum 9 years as a CMC strategy consultant as an independent contractor/consultant or as an employee at a CRORequires a B.S., R.Ph., M.S., Ph.D., or equivalent degree, in a scientific area, and equivalent combination of relevant experience in drug, biologic, or device developmentAdvanced scientific and regulatory knowledge of drug, biologic, or device developmentExperience in pre-approval products; large biologics experience required.Line management experience required.Prior CRO experience preferred.Skills:Critical thinking and analytical skills, financial acumen, influencing and leading teams, risk assessment, strong written and verbal communication skills in EnglishStrong computer skills, including SharePoint, Word, Excel, and PowerPointQuality focusStrong emotional intelligence, customer focused leadership and decision-making skillsInnovative, creative, and practical thinking including problem-solving skills>10 years’ post-degree of directly relevant experience in drug, biologic, or device development desirableBenefitsBenefits of working at Allucent include:Comprehensive benefits package per locationCompetitive salaries per location Departmental Study/Training Budget for furthering professional development Flexible Working hours (within reason) Opportunity for remote/hybrid* working depending on locationLeadership and mentoring opportunities Participation in our Buddy Program as a new or existing employeeInternal growth opportunities and career progression Financially rewarding internal employee referral program 'Disclaimers:*Our office-based work policy encourages a dynamic work environment, prescribing a minimum of 2 days in office per week for employees within reasonable distance from one of our global offices.“The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively “Allucent”). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources.”#LI-Remote #LI-TCWJob SummaryID: 68B6607B48Department: Product Development Strategy (PDS), Regulatory & Drug Development Consulting (RDC)Type: full time