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INDUSTRY EXP REQ Sr. Scientist I/II-Nonclinical Pharmacology/Toxicology(exp in molecular biology or

Employer
A New Beginning Genesis 2
Location
California, Kentucky, US
Salary
Competitive
Closing date
Nov 28, 2022

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Sector
Academic / Research
Field
Conservation science
Discipline
Genetics, Biology
Salary Type
Salary
Employment Type
Full time
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Please read the entire job description, Industry Experience only with the preparation of regulatory submissions (IND/CTDs, NDA/BLA, etc.) and communicating/ interacting with health authorities. We are receiving all unqualified responses
Extensive Molecular Biology exp (in industry)
Gene Therapy exp (examples AAV, CRISPR - gene editing, Oligos, Lenti)
Oncology experience
Open to learning Reg. Tox

This role sits in the Pharm/Tox group (non clinical). We've been searching for toxicologists and had issue so changed role components to above. If someone is only small molecule unlikely to be considered.
I will do my best for you and never charge you anything for our time and efforts if you are qualified, so, please have some common courtesy for others and do not respond to this job unless you are what we are looking for 100% in the job description
Felxible work from home days, so be an expert with the job needs. PLEASE READ THE COMPLETE JOB POSTING
2 openings

Nonclinical pharmacology with molecular biology/genetics background and with 5+ years of experience in the pharmaceutical, CRO, and/or biotechnology field at a Scientist level.
Expertise in in vivo pharmacology or experience with animal models of disease
Strong understanding of drug development and regulatory process, as well as a good understanding of Good Laboratory Practices (GLPs)
Experience in the design, conduct, and interpretation of GLP or non-GLP nonclinical pharmacology and toxicology studies
Experience supporting the development of gene therapy, small molecules, oligonucleotides, biologics, gene therapies and/or other therapies, including determining non-clinical program strategy and design. Experience in genotoxicity, especially as related to gene therapy is a big plus
Experience with the preparation of regulatory submissions (IND/CTDs, NDA/BLA, etc.) and communicating/ interacting with health authorities

People from outside North America with no paid PHARMA experience, I cannot help you at this time, sorry. These are not entry level jobs, sorry. These are experience level jobs; please have extensive pharma experience and be a perfect fit for either job. We get paid to deliver stellar people/resumes

Please have extensive paid - experience in the USA, These jobs are open to existing H1b, TN & Green Card holders, US citizens, in some cases OPT, with extensive USA paid experience
Do you know anyone please? Would you please accept/forward this message to people, groups, to help others
We are willing to help you, your company fill job openings also
I will accept LinkedIn requests as long as you fit the prior criteria
We will help you & work with you 1 on 1 & never charge you anything for our time

I hope you/family/staff have been safe from COVID & good luck to you in 2022

Please call 860 889 4141 until 8PM EST 7 days a week & when you can take notes, after you email "a word doc resume"
Thank you
Joe

POSTED SALARIES CAN BE HIGHER, all jobs have the potential to be fully remote

Sr. Scientist I or II - Nonclinical Pharmacology / Toxicology (experience in molecular biology or genetics with oncology exp preferred) Molecular Biologist must have both Gene Therapy & Oncology experience
Candidate is interested in learning Regulatory Toxicology

EDUCATION: Required: Masters (M.Sc.) or Doctorate (Ph.D.) or equivalent experience in molecular biology/genetics, pharmacology, toxicology or a related, relevant discipline.
5+ years of industry experience. U niversity experience is NOT industry exp
Intention to obtain Diplomate of the American Board of Toxicology (DABT) certification is a plus

Job is fully remote, no location specified. 2 openings, two levels so please note COMPENSATION range reflects the top of Sr. Sci 2 (vs. Sr Sci 1). Will need to travel on occasion to Headquarters on a limited basis

The Pharmacology and Toxicology Department at the company is seeking an experienced Senior Scientist I/II to provide nonclinical pharmacology and/or toxicology expertise for the development of the company's novel drug candidates This individual will provide scientific leadership and play a pivotal role providing nonclinical expertise in support of all phases of the drug development process from research through market application and commercialization.

The successful candidate will contribute to the strategic development of the company's therapeutics by creating a best-evidence synthesis of existing knowledge and by designing, implementing, interpreting, investigating and reporting data that elucidates the pharmacological / toxicological profile of drug candidates
This individual will work collaboratively with internal and external cross-functional sub-teams, collaborators and consultants to contribute to integrated development pathways throughout the drug development cycle.

The successful candidate will have a strong pharmacology background with experience in molecular biology/genetics (especially related to oncology) as well as a strong understanding of pharmacological mechanisms of disease and will provide broad-based support to align nonclinical efforts with the company's opportunistic philosophy of drug development The candidate will interact with collaborators and scientists across the company in order to provide a balanced assessment as to the risk/benefit profile associated with a drug candidate's advancement. The individual will be responsible for the planning, implementation and organization of nonclinical studies along with the use of drug exposure to bridge across species, presentation of data (written and verbal) to cross-functional core teams and sub-teams, external collaborators, and the scientific community. This individual will actively participate in representing Pharmacological Sciences on cross-functional project teams and/or lead project sub-teams; the Pharmacology & Toxicology team at the company is willing to train this individual to achieve to that competency if required.

RESPONSIBILITIES:
Contribute to and implement an overall drug development strategy to support nonclinical and clinical pharmacology development during all stages of drug development
Work closely with collaborators on animal models of disease including an in-depth understanding of disease etiology
Be able to serve as a nonclinical consult in tumor development based on the molecular biology of genetic alteration(s) following gene therapy (or other modalities) treatments
Help Design, implement, report and interpret nonclinical study data of gene therapy, small molecule, oligonucleotides, biologic or other novel drug candidate constructs across all stages of development
Prepare study synopses, protocols, study reports and regulatory documents to support nonclinical development of the company's drug candidates
Interact/collaborate with various company functions, CROs, university or analytical laboratories, business partners, as necessary to ensure appropriate/timely progression of company projects
Effectively communicate nonclinical findings and their relevance to senior management, project teams, collaborators, and regulatory agencies
Participate in multi-disciplinary drug development teams including lead sub-teams and serving as a program representative at cross functional program meetings
Excellent written and verbal communication skills
Ability to build/foster productive cross-functional collaborations both within and external to our company.

EXPERIENCE:
Nonclinical pharmacology with molecular biology/genetics background and with 5+ years of experience in the pharmaceutical, CRO, and/or biotechnology field at a Scientist level.
Expertise in in vivo pharmacology or experience with animal models of disease
Strong understanding of drug development and regulatory process, as well as a good understanding of Good Laboratory Practices (GLPs)
Experience in the design, conduct, and interpretation of GLP or non-GLP nonclinical pharmacology and toxicology studies
Experience supporting the development of gene therapy, small molecules, oligonucleotides, biologics, gene therapies and/or other therapies, including determining non-clinical program strategy and design. Experience in genotoxicity, especially as related to gene therapy is a big plus
Experience with the preparation of regulatory submissions (IND/CTDs, NDA/BLA, etc.) and communicating/ interacting with health authorities desirable
Strong critical, scientific, and strategic thinking skills; Strong problem solving and decision making abilities
Strong communication (verbal and written) skills
Experience and ability to work collaboratively in cross-functional teams

Base Salary - USD $160,000 to $180,000 or more
Relocation Assistance Available - Yes
5+ to 7 years experience
Seniority Level - Mid-Senior
Minimum Education - Doctorate Degree
Willingness to Travel - Occasionally
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