This listing was posted on ApplicantPro.
Director, Nonclinical Development
Location:
San Diego, CA
Description:
Director, Nonclinical Development FULLY REMOTE Job #23-01A Mapp Biopharmaceutical, Inc. "Mapp" is a San Diego based, innovative biopharmaceutical company focused on addressing unmet medical needs through the development of life-saving monoclonal antibody treatment options to combat a variety of neglected and tropical infectious diseases, and in support of biodefense programs. The Early Research and Development Group (ERDG) and the Advanced Research and Development Group (ARDG) at Mapp Biopharmaceutical are responsible for the execution of high quality Research and Development activities to ensure the achievement of a robust portfolio through CMC, Nonclinical, Regulatory and Clinical activities consistent with Mapp's product development objectives. The Director, Nonclinical Development will provide overall nonclinical support for our projects including design, execution, supervision, analysis, interpretation and communication of nonclinical studies. Additionally, the Director, Nonclinical Development will serve as sponsor representative for execution of nonclinical studies and serve as a nonclinical representative on multidisciplinary project teams to support the advanced development of candidate therapeutics. Basic Qualifications PhD (MS with equivalent experience) in a related scientific discipline 10 years of relevant industry experience in nonclinical discovery and/or development Prior hands-on experience working with antibody-based therapeutics or biologics Working knowledge of GLP regulations, ICH, and other regulatory guidance documents Demonstrated ability to work closely with Quality Assurance and Regulatory groups to develop and deliver GLP-compliant studies Experience designing, conducting, monitoring, and interpreting nonclinical studies Excellent organizational, interpersonal, and verbal/written communication skills Ability to thrive in a fast-pace and dynamic environment Preferred Qualifications Provides direct nonclinical pharmacodynamic, toxicology, and pharmacokinetics support to all product development programs in the Mapp portfolio Supports custom designs and implementation of non-GLP and GLP in vivo, ex vivo, in vitro, and biochemical studies Candidate will perform the following activities: Lead pharmacodynamic (PD), toxicology, and pharmacokinetic (PK) activities to support drug development programs Use of PD and PK principles, modeling, and other appropriate tools and approaches to define initial first-in-human clinical target doses and safe and effective usage throughout product life-cycle Design, coordinate, and monitor nonclinical studies at CROs to support program milestones Author, review, and approve statements of work, study protocols, study reports, and regulatory documents Develop high quality nonclinical plans and content for regulatory submissions such as INDs, IBs, briefing books, and BLAs Serve as nonclinical subject matter expert on multi-disciplinary project teams. Interpret, summarize, and present data to internal project teams and external partners and collaborators. Collaboration across a multi-discipline team including Clinical, CMC, Quality Assurance, Project Management Technical writing to support preparation and review of study reports and appropriate sections of regulatory and government funding agency documents Responsibilities Provides direct nonclinical pharmacodynamic, toxicology, and pharmacokinetics support to all product development programs in the Mapp portfolio Supports custom designs and implementation of non-GLP and GLP in vivo, ex vivo, in vitro, and biochemical studies Candidate will perform the following activities: Lead pharmacodynamic (PD), toxicology, and pharmacokinetic (PK) activities to support drug development programs Design, coordinate, and monitor nonclinical studies at CROs to support program milestones Author, review, and approve statements of work, study protocols, study reports, and regulatory documents Develop high quality nonclinical plans and content for regulatory submissions such as INDs, IBs, briefing books, and BLAs Serve as nonclinical subject matter expert on multi-disciplinary project teams. Interpret, summarize, and present data to internal project teams and external partners and collaborators. Collaboration across a multi-discipline team including Clinical, CMC, Quality Assurance, and Project Management Mapp offers a competitive compensation and benefits package in addition to this exciting and challenging job. Mapp's anticipated pay scale for this position is $130,000 to $250,000, plus any applicable bonuses. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the candidate's level of education, and type and length of experience within the job and/or within the industry. Medical, dental, and vision insurance benefits are available to eligible employees and their families. Mapp also provides basic life insurance, short and long term disability, and a 401K plan that includes Company contributions to eligible employees. Full time employees will be provided 7 days of sick time, 14 paid holidays, and will also accrue 18 days of vacation throughout the calendar year. If your job responsibilities allow, you may choose to work remotely. Willingness to Travel (Domestic Travel = Approximately 10% + International Travel = Approximately Mapp wants you to join their team and invites you to apply by submitting your information through https://mappbio.applicantpro.com/jobs/ . No Solicitors, agents or placement agencies please. Mapp utilizes E-Verify. Mapp is an Equal Opportunity/Affirmative Action/Disability/Veterans Employer - Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected Veteran status, or any other characteristic protected by applicable federal, state, or local law. Job Posted by ApplicantPro
Company:
Mapp Biopharmaceutical
Posted:
December 26 2023 on ApplicantPro
Visit Our Partner Website
This listing was posted on another website. Click here to open: Go to ApplicantPro
Important Safety Tips
- Always meet the employer in person.
- Avoid sharing sensitive personal and financial information.
- Avoid employment offers that require a deposit or investment.
To learn more, visit the Safety Center or click here to report this listing.
More About this Listing: Director, Nonclinical Development
Director, Nonclinical Development is a Executive Director Job at Mapp Biopharmaceutical located in San Diego CA. Find other listings like Director, Nonclinical Development by searching Oodle for Executive Director Jobs.
Director, Nonclinical Development is a Executive Director Job at Mapp Biopharmaceutical located in San Diego CA. Find other listings like Director, Nonclinical Development by searching Oodle for Executive Director Jobs.