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 ...
22 Allucent Jobs Hiring Near You
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 ...
The role In this role, you'll be responsible for setting the department strategy and overall utilization and profitability of Allucent Medical Affairs and Pharmacovigilance. This position controls ...
The role In this role, you'll be responsible for setting the department strategy and overall utilization and profitability of Allucent Medical Affairs and Pharmacovigilance. This position controls ...
As a Director, Clinical Pharmacology at Allucent, you are responsible for independently leading Clinical Pharmacology activities within the Clinical Pharmacology, Modeling, and Simulation unit of ...
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As a Director, Clinical Pharmacology at Allucent, you are responsible for independently leading Clinical Pharmacology activities within the Clinical Pharmacology, Modeling, and Simulation unit of ...
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 ...
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 ...
As a Project Director at Allucent, you are responsible for overseeing and managing all aspects of the clinical study trials for Neuroscience or Immunology and Infectious Diseases . Experience in Cell ...
As a Project Director at Allucent, you are responsible for overseeing and managing all aspects of the clinical study trials for Neuroscience or Immunology and Infectious Diseases . Experience in Cell ...
Director, Clinical Pharmacology
Cary, NC · On-site +1
As a Director, Clinical Pharmacology at Allucent, you are responsible for independently leading Clinical Pharmacology activities within the Clinical Pharmacology, Modeling, and Simulation unit of ...
Director, Clinical Pharmacology
Cary, NC · On-site +1
As a Director, Clinical Pharmacology at Allucent, you are responsible for independently leading Clinical Pharmacology activities within the Clinical Pharmacology, Modeling, and Simulation unit of ...
As a PD at Allucent, you are responsible for coordinates and oversees operational project teams, customer satisfaction and continuous improvement of processes within the Global Clinical Operations ...
As a PD at Allucent, you are responsible for coordinates and oversees operational project teams, customer satisfaction and continuous improvement of processes within the Global Clinical Operations ...
As a D/SrDBiosC at Allucent, you are responsible for assisting in the coordination of statistical consulting services within the Biostatistics and Statistical Programming Department. About the role:
As a D/SrDBiosC at Allucent, you are responsible for assisting in the coordination of statistical consulting services within the Biostatistics and Statistical Programming Department. About the role:
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 ...
Clinical Trial Leader
Cary, NC · On-site +1
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 ...
Clinical Trial Leader
Cary, NC · On-site +1
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 ...
Clinical Trial Leader
Cary, NC · On-site +1
As a CTL at Allucent, you are providing leadership, management and oversight to the Clinical Research Associates (CRAs) and other clinical functional groups, in their day-to-day clinical trial ...
Clinical Trial Leader
Cary, NC · On-site +1
As a CTL at Allucent, you are providing leadership, management and oversight to the Clinical Research Associates (CRAs) and other clinical functional groups, in their day-to-day clinical trial ...
When you work at Allucent, that means rolling up your sleeves and applying your unique skill set, expertise, and knowledge to build partnerships with our clients in their pursuit to develop new, life ...
When you work at Allucent, that means rolling up your sleeves and applying your unique skill set, expertise, and knowledge to build partnerships with our clients in their pursuit to develop new, life ...
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 ...
Quick apply
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 ...
Chez Allucent , nous nous engageons a aider les petites et moyennes entreprises biopharmaceutiques a naviguer efficacement dans le monde complexe des essais cliniques afin d'apporter des traitements ...
Chez Allucent , nous nous engageons a aider les petites et moyennes entreprises biopharmaceutiques a naviguer efficacement dans le monde complexe des essais cliniques afin d'apporter des traitements ...
Chez Allucent , nous nous engageons a aider les petites et moyennes entreprises biopharmaceutiques a naviguer efficacement dans le monde complexe des essais cliniques afin d'apporter des traitements ...
Chez Allucent , nous nous engageons a aider les petites et moyennes entreprises biopharmaceutiques a naviguer efficacement dans le monde complexe des essais cliniques afin d'apporter des traitements ...
When you work at Allucent, that means rolling up your sleeves and applying your unique skill set, expertise, and knowledge to build partnerships with our clients in their pursuit to develop new, life ...
When you work at Allucent, that means rolling up your sleeves and applying your unique skill set, expertise, and knowledge to build partnerships with our clients in their pursuit to develop new, life ...
Chez Allucent, nous nous engageons a aider les petites et moyennes entreprises biopharmaceutiques a naviguer efficacement dans l'univers complexe des essais cliniques afin d'offrir des traitements ...
Chez Allucent, nous nous engageons a aider les petites et moyennes entreprises biopharmaceutiques a naviguer efficacement dans l'univers complexe des essais cliniques afin d'offrir des traitements ...
En tant que directeur principal CMC chez Allucent, vous serez chargé d'accompagner nos clients dans les domaines de la chimie, de la fabrication et du contrôle (CMC) ainsi que dans les activités ...
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En tant que directeur principal CMC chez Allucent, vous serez chargé d'accompagner nos clients dans les domaines de la chimie, de la fabrication et du contrôle (CMC) ainsi que dans les activités ...
$120 - $160/hr
En tant que directeur CMC chez Allucent, vous serez chargé d'accompagner nos clients dans les domaines de la chimie, de la fabrication et du contrôle (CMC) ainsi que dans les activités connexes de ...
$120 - $160/hr
En tant que directeur CMC chez Allucent, vous serez chargé d'accompagner nos clients dans les domaines de la chimie, de la fabrication et du contrôle (CMC) ainsi que dans les activités connexes de ...
$90 - $130/hr
Travailler chez Allucent, c'est retrousser ses manches et mettre à profit ses compétences, son expertise et ses connaissances uniques pour établir des partenariats avec nos clients dans leur ...
$90 - $130/hr
Travailler chez Allucent, c'est retrousser ses manches et mettre à profit ses compétences, son expertise et ses connaissances uniques pour établir des partenariats avec nos clients dans leur ...
Allucent Jobs Information
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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