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Manager, Translational Research
Job Description
DEPARTMENT: Product Development
POSITION REPORTS TO: Vice President, Product Development
JOB TYPE: Full Time
GENERAL SUMMARY:
Juventas Therapeutics is a venture-backed, clinical-stage biotechnology company developing novel therapies for treatment of a cardiovascular disease. The Manager, Translational Research will be responsible for overseeing all aspects of developing novel therapeutic strategies through pre-clinical studies into human clinical trials. Preferred candidates will have significant cardiovascular research experience preferably within the heart failure and/or regenerative medicine fields. The position will require a strong technical background with demonstrated capabilities in designing and managing animal studies and transitioning technologies from pre-clinical to clinical stages through submission of Investigational New Drug (IND) applications.
Adaptability and comfort working in a fast-moving, highly-dynamic start-up environment are a must.
Highly developed interpersonal written and oral communication skills, attention to detail, effective computer skills and project management skills are required. The successful candidate will be highly organized and capable of working within a team to assure assignments are completed on time. Key responsibilities will include managing all aspects of pre-clinical study design and execution including IND preparation and submissions. In addition, candidates must have flexibility to take on new tasks as they arise within the company. We are looking for self-motivated individuals interested in science and drug development as part of their career development.
MINIMUM QUALIFICATIONS:
Education, Knowledge, Skills and Abilities
The successful candidate at a minimum should have a doctoral degree, preferably in cardiovascular research and/or regenerative medicine. A master’s degree in engineering or life sciences with significant work experience may also be appropriate. The proper candidate will have strong therapeutic product development experience preferably in the area of transitioning technologies into early stage clinical trials. Strong technical writing skills are a must and experience working with the FDA on therapeutic product approvals is preferred. The proper candidate will be a self-starter and willing to work in a dynamic, high-paced start-up environment.
Required Length and Type of Experience
The successful candidate will have minimum of 3 years experience working at a biotechnology or pharmaceutical company having developed products for clinical trials. Experience in gene therapy, biologics and/or cardiovascular product development a plus. Must have experience in organizing, summarizing, and communicating scientific results through publication or engagement with the FDA. Experience with negotiating or managing contracts with contract vendors is a plus.
PRINCIPLE DUTIES AND RESPONSIBILITIES:
1. Designing and managing all aspects of pre-clinical animal studies
2. Overseeing vendor and contractor relationships related to development of new products
3. Involvement in developing regulatory strategy to introduce new therapies to the clinic
4. Writing Investigational New Drug (IND) applications
5. Sourcing grant funding to develop emerging therapeutic opportunities
6. Other tasks as assigned
Company
Juventas Therapeutics, Inc.
Job Code
State or Province
Ohio
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