- Serve as nonclinical safety subject matter expert on project teams from discovery into early development.
- Design and execute nonclinical safety strategies and provide development plans for biologics in oncology and immunology.
- Analyze, interpret and summarize GLP and non-GLP safety data to internal teams.
- Provide risk assessment and implement de-risking strategies in discovery teams to support candidate selection.
- Author regulatory documents including Investigator Brochures and IND/CTAs, and interact with regulatory agencies (US and ex-US) as needed.
- You will be responsible for oversight and interaction with consultants and CROs assigned to support nonclinical safety.
- DVM or PhD in toxicology, pharmacology, or related discipline.
- >5 years of experience in nonclinical safety supporting early development of biologics in a biotech or pharmaceutical organization.
- Prior nonclinical safety experience with biologics in oncology is required.
- Experience with regulatory submissions in early development is required.
- Experience working on T-cell based therapeutics, particularly multi-specific T-cell engagers is preferred.
-
Sales Representative/Sales Manager
2 weeks ago
BlueHorizon Solutions Philadelphia, United StatesEUROMASTER is a 100% subsidiary of the Michelin Group, one of the most successful European companies in the world. We are the market leader in tire and car services and strive for high quality and safety in our daily work. · To strengthen our team in Erfurt, Jena, Gera, Zwickau, ...
-
Catering Operations Manager
2 weeks ago
Aurora Ventures New Point, United StatesAs a full-time Operations Manager at Sodexo in 10245 Berlin, you are a team leader and customer advocate. You are responsible for achieving financial goals and driving growth at the location, with safety as the top priority. By building trusting relationships and ensuring custome ...
-
Food Safety Team Member – General Labor
6 days ago
PSSI Philadelphia, United States Full time$15.50 per hour · Hours: 5:00 PM - 5:30 AM · FOOD SAFETY TEAM MEMBER - GENERAL LABOR · Join our Team · At PSSI, we see our essential team members as industrial heroes – united in the value of food safety. · As a Food Safety Team Member, you will be joining the leader in food saf ...
-
Sr. Director, Public Safety
1 week ago
Thomas Jefferson University Philadelphia, United StatesResponsibilities · Provides oversight and leadership for the Public Safety functions of security, and emergency management for the Center City academic medical center, university, and supporting hospitals. Coordinates overall public safety for the Center City division in partner ...
-
Assembly Machine Set Up
1 week ago
Atkore Philadelphia, United States Full timeWho we are looking for: · We are currently looking for a Assembly Machine Set Up to be based out of Philadelphia, PA. Reporting to Manufacturing Supervisor, this person will be responsible for a variety of job duties as a Assembly Machine Set Up. · What you'll do: · Additiona ...
-
Medical Director
1 week ago
The Children's Hospital of Philadelphia Philadelphia, United States Full timeJOB DESCRIPTION SHIFT: · Day (United States of America) Seeking Breakthrough Makers · Children's Hospital of Philadelphia (CHOP) offers countless ways to change lives. Our diverse community of more than 20,000 Breakthrough Makers will inspire you to pursue passions, develop ex ...
-
Director of Culinary Operations
3 weeks ago
AVI Foodsystems Philadelphia, United StatesAVI Foodsystems is looking for a unique driver of cultural transformation as the Director of Culinary Operations to lead our culinary team at the Hospital of the University of Pennsylvania in Philadelphia, PA. The salary for this position is up to $135,000. · Founded in 1960, AV ...
-
Superintendent
2 weeks ago
Build Partners USA LLC Philadelphia, United Statesjob Title: Superintendent - Commercial Construction · Company Overview: Join a dynamic team at a leading General Contactors specializing in commercial projects. With a commitment to excellence and innovation, they strive to deliver superior results on every project they undertake ...
-
Restaurant Manager
3 weeks ago
Fearless Restaurants Philadelphia, United StatesWhat makes Fearless Restaurants special and a great place to work? · Cuz' we give a damn · We are part of Fearless Restaurant Group; a multi-concept group of independent restaurants based in Philadelphia, PA, and Long Beach Island, NJ. As a company, our talent, teamwork, resource ...
-
Cenacle Leadership Group Philadelphia, United StatesIf you are looking to make a difference in the community, apply to join the Cenacle Team. Cenacle Leadership Group is a social enterprise addressing the issue of quality education and academic achievement. · Cenacle Leadership Group's basic principles are founded on leadership. W ...
-
General Manager
3 days ago
Fearless Restaurants Philadelphia, United StatesWhat makes Fearless Restaurants special and a great place to work? · Cuz' we give a damn · We are part of Fearless Restaurant Group; a multi-concept group of 10 independent restaurants based in Philadelphia, PA, and Long Beach Island, NJ. As a company, we are defined by our talen ...
-
Senior Traffic Engineer
3 weeks ago
STV Philadelphia, United StatesDescription · STV, a nationally recognized leader for delivering value and excellence in engineering, construction management, architecture, planning and environmental services, is seeking an experienced Senior Traffic Engineer to join our growing transportation engineering tea ...
-
Process Chemist
2 weeks ago
Veolia Philadelphia, United States Full timeJob Description · As a Process Chemist you will work closely with the Manufacturing plants, Technology, Global Engineering and Regional Quality and EHS functions, being a key contact person for the development, roll out and sustainability of all initiatives relating to Veolia's ...
-
Project Manager
2 weeks ago
Alma Construction Group Philadelphia, United StatesAre you a natural-born leader who loves managing hard-working teams? Our construction company needs an experienced construction project manager to supervise project plans and oversee general contractors to ensure their work is high-quality, finished efficiently, and within the pr ...
-
Line Leader 1st shift
3 weeks ago
PCI Pharma Services Philadelphia, United States Full timeLife changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. · We are PCI. · Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to ...
-
Training Manager 1
1 week ago
Sodexo Philadelphia, United StatesUnit Description · Put your passion for people to work. · Sodexo is hiring a Training Manager supporting our healthcare location in Philadelphia, PA . This location is a Level 1 Trauma Center and full service union account for Sodexo. This is a day shift position with some w ...
-
Rollingstock Test and Commissioning Engineer
6 days ago
Teoresi Group Philadelphia, United StatesWe are looking for a: Rollingstock Test and Commissioning Engineer · The resource will be part of a team focused on the Railway System testing. · Technical requirements: · Focus on test, verification, and delivery of a CBTC signalling system including Onboard, Ground Based and O ...
-
NDT Level II Technician
3 weeks ago
HMT LLC Philadelphia, United States Full timeLevel II Technicians · Essential Duties and Responsibilities · Must be able to perform MFL, UT, MT, LT/BT and PT. Skills and knowledge to interpret NDT requirements, codes, and standards required by contract. · Collect and process data created by the inspections, in accordance w ...
-
Penn Medicine Clinician
16 hours ago
InsideHigherEd Philadelphia, United States Administrative Jobs ,· Penn Medicine Clinician · University Overview · The University of Pennsylvania, the largest private employer in Philadelphia, is a world-renowned leader in education, research, and innovation. This historic, Ivy League school consistently ranks among the top 10 universities in ...
-
Cook (On-Call)
3 weeks ago
Public Health Management Corporation Philadelphia, United States Full timePHMC is proud to be a leader in public health. PHMC requires that all employees have received the first Covid-19 vaccination dose by the first day of employment. We will offer the Covid-19 vaccination at no cost, via our Health Centers. · Job Description: · This position is an ...
Nonclinical Safety Leader - Philadelphia, United States - Christine Mathews Consulting, a OneDigital Company
Description
**Remote, Hybrid or onsite Philadelphia, PA**
Is this the role you are looking for If so read on for more details, and make sure to apply today.
Company Background:
Stealth, VC-backed, discovery-stage biotech company with significant funding focused on discovery and development of breakthrough biologics in Oncology and Immunology. This small but experienced team is currently expanding headcount to support the next phase of growth through IND submissions and clinical development.
Position Summary:
As Nonclinical Safety Lead, you will work in our early development teams with a responsibility for designing and executing on the nonclinical safety strategy for novel biologics, connecting the project from discovery into IND-enabling and FIH studies. As the nonclinical safety subject matter expert, you will be responsible for the nonclinical toxicology studies in support of IND submission.
Essential Functions:
Experience:
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity/expression, national origin, disability, medical condition, age, marital status, status as a protected veteran, or any other legally protected characteristic.
