Sr. Director, CMC
Cary, NC · Remote
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 ...
Sr. Director, CMC
Cary, NC · Remote
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 ...
Sr. Director, CMC
Cary, NC · Remote
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 ...
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Sr. Director, CMC
Cary, NC · Remote
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 ...
Sr. Director, CMC
Cary, NC · On-site +1
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 ...
Sr. Director, CMC
Cary, NC · On-site +1
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 ...
Allucent information
What types of clinical research projects do Allucent team members typically work on, and how do they collaborate within project teams?
At Allucent, team members typically work on early-phase to late-phase clinical trials, often focusing on small to mid-sized biotech and pharmaceutical clients. Projects can range from first-in-human studies to post-marketing surveillance, with a strong emphasis on innovative therapies. Collaboration is central to Allucent's approach—project teams usually include clinical project managers, clinical research associates, data managers, and regulatory experts who work closely together using digital platforms and regular meetings to ensure project milestones are met efficiently and compliantly.
What is Allucent and what does the company do?
Allucent is a global contract research organization (CRO) that specializes in providing clinical development services to small and mid-sized biotechnology and pharmaceutical companies. The company supports drug development throughout the clinical trial process, including study design, regulatory support, data management, and medical writing. Allucent focuses on helping clients bring new therapies to market efficiently by leveraging scientific expertise and tailored solutions for complex clinical trials.
What is the difference between Allucent vs Clinical Research Coordinator?
| Aspect | Allucent | Clinical Research Coordinator |
|---|---|---|
| Required Credentials | Bachelor's degree, often in health or science fields; certifications like CCRP or RAC beneficial | Bachelor's degree in health, science, or related field; certifications like CCRP or CCRC often preferred |
| Work Environment | Pharmaceutical and biotech research settings, often in labs or offices | Clinical trial sites, hospitals, or research centers |
| Employer & Industry Usage | Biotech, pharmaceutical companies, and research organizations | Hospitals, clinics, research institutions, and contract research organizations |
Allucent primarily focuses on clinical research services within biotech and pharmaceutical industries, often involving data management and regulatory support. Clinical Research Coordinators (CRCs) are directly involved in managing clinical trial activities at research sites. While both roles require similar credentials and work in the clinical research industry, Allucent roles tend to be more specialized in research support services, whereas CRCs are hands-on in trial execution at clinical sites.
What are the key skills and qualifications needed to thrive as a Clinical Research Associate at Allucent, and why are they important?
To thrive as a Clinical Research Associate, you need a solid background in life sciences or a related field, along with knowledge of Good Clinical Practice (GCP) guidelines and relevant regulatory requirements. Familiarity with electronic data capture (EDC) systems, clinical trial management software, and often a certification such as ACRP or SOCRA is highly valuable. Strong attention to detail, organizational skills, and effective communication are crucial soft skills for managing trials and collaborating with multidisciplinary teams. These competencies ensure high-quality trial execution, compliance, and reliable results in the dynamic environment of clinical research.
What are popular job titles related to Allucent jobs in Raleigh, NC? For Allucent jobs in Raleigh, NC, the most frequently searched job titles are:
What job categories do people searching Allucent jobs in Raleigh, NC look for? The top searched job categories for Allucent jobs in Raleigh, NC are:
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Job description
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 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.
Requirements
- Minimum 9 years as a CMC strategy consultant as an independent contractor/consultant or as an employee at a CRO
- Requires 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 development
- Advanced scientific and regulatory knowledge of drug, biologic, or device development
- Experience 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 English
- Strong computer skills, including SharePoint, Word, Excel, and PowerPoint
- Quality focus
- Strong emotional intelligence, customer focused leadership and decision-making skills
- Innovative, creative, and practical thinking including problem-solving skills
- >10 years' post-degree of directly relevant experience in drug, biologic, or device development desirable
Benefits
Benefits of working at Allucent include:
- Comprehensive benefits package per location
- Competitive salaries per location
- Departmental Study/Training Budget for furthering professional development
- Flexible Working hours (within reason)
- Opportunity for remote/hybrid* working depending on location
- Leadership and mentoring opportunities
- Participation in our Buddy Program as a new or existing employee
- Internal 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."
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