Director, Non-Clinical Sciences

Job Description
% of Travel Required : 0-10%

Job Type : Full Time

Career Level : Manager (Manager/Supervisor of Staff)

Education : Doctorate

Category : Biotech/R&D/Science

Job Description :

At PharmAthene, our commitment is reflected in all that we do. We are a company driven by the desire to make a difference and recognize that our success depends on the creativity, dedication and performance of our team.

PharmAthene’s primary objective is the development of effective countermeasures to a range of potential biological and chemical weapons. We aim to recruit talented scientists and management to lead its programs and oversee the outsourcing of various program activities with an urgency to develop these countermeasures as rapidly as possible.

In any organization, it is the people who make it all happen, and that is especially true at PharmAthene. We offer prospective employees exciting challenges, unique opportunities for career growth and a fast-paced environment that emphasizes innovation and achievement.

Currently, PharmAthene is searching for qualified candidates for the position noted below. If you believe your credentials meet our expectations, apply today!

Director, Non-Clinical Sciences (12-005)

The Director, Nonclinical Sciences is responsible for the strategic planning and integrity of the nonclinical development of PharmAthene’s biodefense product candidates. This includes interactions with PharmAthene’s key collaborators and funding partners (e.g., BARDA, DoD, NIH) and regulatory agencies (i.e., FDA, CDC). The Director,
Nonclinical Sciences manages overall technical operations including project planning, budgeting, resource management and contract research organization (CRO) management.

The Director, Nonclinical Sciences participates on internal project team(s), attends relevant scientific meetings, and performs other duties as may be assigned related to the development of PharmAthene’s product candidates.

Responsibilities/duties may include but are not limited to:

Prepare product development plans for the nonclinical program.

For those products being developed under the Animal Rule, work with teams to insure that the nonclinical, clinical, and bioanalytical plans are harmonized to meet both safety and efficacy requirements.

Serve as the Sponsor Representative with the CRO(s) and manage the performance, budget and schedule of studies. Ensure compliance with applicable regulations.

Determine design of nonclinical trials and finalize all related study reports. Ensure the overall integrity of PharmAthene’s nonclinical programs.

Provide scientific guidance to the internal project teams.

Review and interpret data from nonclinical studies in support of FDA submissions and product licensure.

Interact with regulatory agencies as needed to ensure that the nonclinical program is meeting requirements for licensure.

Participate in industry working groups to forward the overall goals of approving biodefense products via the Animal Rule.

Serve as subject matter expert (e.g., perform necessary literature searches, attend industry meetings, network with colleagues) to gather pertinent information to keep a finger on the pulse of the biodefense industry.

Assist the Business Development team to assess and evaluate potential product candidates.

Attend program team meetings as appropriate to provide scientific guidance and input.

Assist in the generation of scientific responses to government solicitations.

Assist in the development and implementation of Departmental Standard Operating Procedures (SOPs).

Develop and/or oversee development of study document templates (e.g., reports).

Requirements include:

PhD in a relevant field

Knowledge of Good Laboratory Practice guidelines and procedures

Experience with non-clinical studies to support the Animal Rule

5+ years experience in designing and executing studies in animal models

Experience in FDA interactions related to design and execution of nonclinical programs

Experience with animal models for vaccine development preferred

Working knowledge of principles of toxicology study design and interpretation preferred

Experience in the biodefense industry preferred

Use excellent oral and written communication skills

Demonstrated ability to maintain objectivity and confidentiality

Ability to gather and analyze data and make recommendations and decisions

Ability to identify problems, research contributing factors, and develop and implement recommendations for resolution in a proactive problem solving approach

Ability to handle multiple priorities, manage projects and deliver on or before dates required

Use coaching and supervision techniques to manage others

As PharmAthene’s operations are focused in biodefense, which is subject to special restrictions under International Traffic in Arms Regulations, U.S. Citizenship or U.S. Permanent Resident status may be required. PharmAthene offers a challenging, dynamic environment with growth opportunity, competitive compensation and a full benefits program. Only those candidates meeting the requirements noted below and selected for an interview will be contacted.

Company

PharmAthene, Inc.

Job Code

State or Province

Maryland

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