Talent.com
Allucent
Sr. Director, CMCAllucent • Cary, NC, United States
Sr. Director, CMC

Sr. Director, CMC

Allucent • Cary, NC, United States
30+ days ago
Job type
  • Full-time
Job description

Sr. Director, Cmc

At 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 products

About the role

As the Sr. Director, CMC, you will:

  • Lead end-to-end CMC strategy across drug substance, drug product, and analytical developmentfrom 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.
Create a job alert for this search

Sr. Director, CMC • Cary, NC, United States

Similar jobs

Sr. Director, CMC

AllucentCary, NC, United States
Full-time

At 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 acro... Show more

 • Promoted

Senior Director, Clinical Development

Asahi KaseiCary, NC, United States
Full-time

Director, Clinical Development.Director, Clinical Development is responsible for ethical, medical, and scientific rigor in supporting the development, conduct, and reporting of assigned clinical de... Show more

 • Promoted

Director, PMO - New York or Charlotte, NC

World Wide TechnologyRaleigh, NC, United States
Full-time

Director, PMOLocation:New York, NY or Charlotte, NC AreaWhy WWTAt World Wide Technology, we work together to make a new world happen.Our important work benefits our clients and partners as much as ... Show more

 • Promoted

Director, FP&A (remote Virginia / North Carolina)

Thermo Fisher ScientificCary, NC, United States
Remote
Full-time

Work ScheduleStandard (Mon-Fri)Environmental ConditionsOfficeJob DescriptionThermo Fisher Scientific Inc.Our Mission is to enable our customers to make the world healthier cleaner and safer.Whether... Show more

 • Promoted

Project Manager-Life Sciences Facility MEP Infrastructure

CBREWake Forest, NC, United States
Full-time

About the role** The Project Manager is responsible for providing consulting services to our life sciences client account to help achieve the company's strategic business objectives.Focus on mecha... Show more

 • Promoted

Sr Director, Account Development

Avery Healthcare Group Ltd.Morrisville, NC, United States
Full-time

Senior Director, Account Development.The Senior Director, Account Development leads the regional strategy and execution of account development across a specific region.This role is responsible for ... Show more

 • Promoted

Clinical Solution Director

AscomMorrisville, North Carolina, United States
Full-time

The Director, Clinical Solutions is responsible for leading the strategic growth, development, and overall effectiveness of Ascom’s Clinical Application Consulting function.This role ensures the or... Show more

Sr. Manager or Director, Corporate FP&A

TrialCardMorrisville, NC, United States
Full-time

Valeris is a fully integrated life sciences commercialization partner that provides comprehensive solutions that span the entire healthcare value chain.Formed by the merger of PharmaCord and Mercal... Show more

 • Promoted

Director, Deal Management & Program Strategy

OracleRaleigh, NC, United States
Full-time

Job Description** We are seeking an exceptional Director of Deal Management & Program Strategy to join the OCI Dedicated Cloud Enablement organization.This high-impact leadership role sits at the ... Show more

 • Promoted

Sr Director of Product Management

Cengage GroupRaleigh, NC, United States
Full-time

We believe in the power and joy of learningAt Cengage Group, our employees have a direct impact in helping students around the world discover the power and joy of learning.We are bonded by our shar... Show more

 • Promoted

Director, Manufacturing Technical Services

AlcamiMorrisville, NC, United States
Full-time

Director, Manufacturing Technical Services.At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partne... Show more

 • Promoted

Director, Business Development (CRO Services)

ProPharma GroupRaleigh, NC, United States
Full-time

Business Development Representative.For the past 25 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharma... Show more

 • Promoted

Southeast Regional CDL A Job - 21 Days Out-Top 50% Avg. $81,505 /$.58 to $.61 cpm - Lillington, NC

Crete CarrierLillington, NC, US
Full-time

Crete Carrier offers a 21-Day Out Southeast Regional.Top 50% average $81,505 per year.One-year verifiable tractor trailer experience with a class A CDL. Show more

 • Promoted

Clinical Director

Mosaic Pediatric TherapyRaleigh, NC, United States
Full-time

Mosaic Pediatric Therapy is a leading provider of life-changing therapy for children with autism and learning disabilities across North Carolina and Virginia.We are confident our unwavering focus o... Show more

 • Promoted

Sr. Manager or Director, Corporate FP&A

Mango HealthMorrisville, NC, United States
Full-time

Valeris is a fully integrated life sciences commercialization partner that provides comprehensive solutions that span the entire healthcare value chain.Formed by the merger of PharmaCord and Mercal... Show more

 • Promoted

Director, Arc - Capital Markets Strategy & GTM

CircleRaleigh, NC, United States
Full-time

Director, Arc - Capital Markets Strategy & GTM.Circle (NYSE: CRCL) is one of the world's leading internet financial platform companies, building the foundation of a more open, global economy throug... Show more

 • Promoted

Area Clinical Director (Southeast)

RxsightRaleigh, NC, United States
Full-time

RxSight is an ophthalmic medical technology corporation headquartered in Aliso Viejo, California that has commercialized the world's first and only adjustable intraocular lens (IOL) that is customi... Show more

 • Promoted

Sr. Director, Client Services

Kobie MarketingRaleigh, NC, United States
Full-time

Senior Director, Client Services for the Retail Vertical.Named a Top Workplace in the USA and Top Remote Workplace, Kobie is where the best minds in loyalty come together, driven by passion and inn... Show more

 • Promoted

Regional Sales Director South Atlantic - Specialty MS Franchise

BiogenRaleigh, NC, United States
Full-time

The Regional Sales Director, reporting into MS Director of Sales EAST, provides leadership and strategic direction to Territory Business Managers to achieve performance objectives within our Specia... Show more

 • Promoted

Sr. Manager IVD Manufacturing and Operations CDx

Personal Genome Diagnostics (pgdx)Morrisville, NC, United States
Full-time

Senior Manager IVD Manufacturing and Operations CDx.Labcorp is a leader in diagnostics, drug development and healthcare innovation.Across every role, we harness data and AI to work smarter, move fa... Show more