Sr. Manager, Preclinical Research - Remote

We go where others won't, taking on some of the biggest public health challenges to protect and enhance millions of lives, and create a better, more secure world.Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect and enhance life.

JOB SUMMARY

The Senior Manager, Preclinical Research is responsible for providing scientific expertise, leadership and management of global preclinical development programs including the leadership and oversight of preclinical research scientists.

ESSENTIAL FUNCTIONS

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

* Develop, prioritize and meet measurable short- and long-term objectives for preclinical research programs.

* Responsible for nonclinical toxicology and pharmacology development plans, design, protocol development, data analysis/ review and interpretation of the data.

* Leads nonclinical programs from trial design to final study report

* Provide leadership and direction specifically safety to the project teams responsible for drug development programs

* Supports manufacturing on safety assessments on process impurities/residuals/E and L

* Collaborates with the biostatistics, data management, medical writing and preclinical clinical operations teams to ensure deliverables

* Review and provide guidance on drug development documents and strategies, study designs and various report documents

* Lead efforts to author nonclinical sections of regulatory documents including IND and BLA/NDS, investigator's brochure, developmental safety update reports, clinical overview and summaries

* Ensure studies are designed to meet desired endpoints and with appropriate methods and measurements

* Review, maintain and develop SOP's

* Responsible for department compliance with regulations, guidelines, GLP, GMP and procedures

* Track progress of development programs and addresses problems as necessary

* Ensure appropriate, comprehensive and professional scientific/medical communications both internally and externally.

* Collaborates with other internal groups including Clinical, Regulatory, Quality, Project management groups to ensure common goals are met

* Oversee financial and human resource management including work assignments, forecasting, planning and tracking

* Build, coach and mentor product development teams.

* Attends and contributes at regulatory meetings with FDA, Health Canada, EMA

* Manages identification and relationships with external CROs/consultants

The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions.

MINIMUM EDUCATION, EXPERIENCE, SKILLS

EDUCATION:

Qualified candidates will have an advanced degree in Life Sciences or Medicine (DVM, PhD, PharmD).

Toxicology Board certification is an asset.

EXPERIENCE:

* Must have extensive knowledge and understanding of Health Canada, FDA and ICH regulatory requirements and procedures applicable to nonclinical toxicology/pharmacology and Product Development.

* At least five year's experience in the pharmaceutical industry with direct experience in managing preclinical development programs and successful teams. Previous experience managing projects and people is necessary to provide leadership and guidance to staff. Experience in biostatistics and data management is an asset.

KNOWLEDGE, SKILLS & ABILITIES:

* Ability to set and communicate goals, and to drive efforts, overcome obstacles and achieves results within budget and timeline specifications.

* Experience in presentations in public or regulatory settings. Excellent organizational, analytical, leadership, problem solving and interaction skills.

* Ability to coordinate a variety of tasks in a highly diverse and fast paced, team environment.

* Excellent written/verbal communication and interpersonal skills as well as excellent computer skills required.

#LI-Remote

U.S. Base Pay Ranges and Benefits Information

The estimated annual base salary as a new hire for this position ranges from $155,500to $188,200. Individual base pay depends on various factors such as applicant's education, experience, skills, and abilities, as well as internal equity and alignment with market data. The salary may also be adjusted based on applicant's geographic location. Certain roles are eligible for additional incentive compensation, including merit increases, annual bonus, [and/or long-term incentives in the form of stock options.]

Additionally, Emergent offers a comprehensive benefits package*. Information regarding additional benefits can be found here: https://www.emergentbiosolutions.com/careers/life-at-emergent

(*Eligibility for benefits is governed by the applicable plan documents and policies).

If you are selected for an interview, please feel welcome to speak to a Human Resources Partner about our compensation philosophy and available benefits.

There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.

Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.

Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.

Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy .

Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.