Therapeutic Development SME

THERAPEUTICS DEVELOPMENT SME

Position Qualifications and Requirements

Education and/or Certifications

• The contractor shall possess a Doctoral degree in Medicine, Pharmacy, or a related discipline.
• Desirable: The contractor may possess a Regulatory Affairs certification.

Experience

• The contractor shall possess ten (10) years of industry experience in pharmaceutical/biotechnology advanced development (i.e., IND to FDA approval).
• The contractor shall possess five (5) years of project management experience in cost, schedule, performance, risk analysis, and advice.
• The contractor shall possess experience in therapeutic small molecule advanced development; bio-marker development; clinical and/or regulatory policy; and/or manufacturing capacity construction.
• The contractor shall possess experience guiding and tracking execution of multiple planning lines of effort.

Systems and Programs

• The contractor shall possess strong proficiency in Microsoft Office applications, including Word, PowerPoint, Excel, and Outlook.
• The contractor shall possess working knowledge of remote/virtual meeting environments such as Zoom, Microsoft Teams, and WebEx.

Other Required Skills

• The contractor shall possess strong organizational skills (e.g. time management, communication, setting goals, delegation, working under pressure, self-motivation, analytical thinking, and attention to detail).
• The contractor shall possess strong analytical and problem-solving skills, as well as good organization skills to balance and prioritize work.
• The contractor shall possess strong interpersonal and communication skills, both oral and written.
• The contractor shall position demonstrated and experiential-based knowledge of the regulatory studies process and the medical countermeasure licensure process.

Performance-Based Tasks

• The contractor shall serve as a subject matter expert in relevant field of experience(s) for therapeutics related to the development, and management of regulatory studies and licensure programs with current and planned BARDA therapeutic advanced development and acquisition contracts.
• The contractor shall evaluate therapeutic candidates for the feasibility of successful advanced development.
• The contractor shall evaluate raw data generated from testing and data analyses
• The contractor shall make sound and timely recommendations to facilitate decision-making.
• The contractor shall review contract proposal and related documents and provide recommendations to USG
• The contractor shall provide senior-level briefing(s) to ASPR/BARDA as required; prepare regular reports to ASPR/BARDA management on various technical issues identified.
• The contractor shall draft briefings that include technical alternatives between competing technologies for USG review.
• The contractor shall provide project development-level portfolio management and oversight.
• The contractor shall provide support to BARDA's Production Coordination Teams.
• The contractor shall provide and summarize guidance documents and option papers on key issues related to the area(s) identified.
• The contractor shall develop milestones, targets, and metrics to support portfolio management, as needed.
• The contractor shall accelerate information flow and guidance from senior leaders to the staff to ensure synchronization and unity of effort.
• The contractor shall facilitate coordination across entities, with the single goal of providing actionable information and knowledge to enable decision-making by leaders.
• The contractor shall serve as the programmatic representative at conferences and stakeholder meetings.
• The contractor shall provide scientific/technology advice, technical oversight, and project management support in the areas of science and technology availability, technology maturity, and applicability of proposed candidate medical countermeasures through advanced development, DoD acquisition processes, production, and fielding.
• The contractor shall collaborate with both internal and external partners, contributing to data.
• The contractor shall engage in open and collaborative communication as a SME, at conferences (e.g., briefings, presentations, etc.) regarding science and technology innovations.
• The contractor shall develop drafts and/or review and provide edits/comments to technical documentation (i.e., development/technology transfer reports, batch records, standard operating procedures, and regulatory submissions).
• The contractor shall prepare and/or review draft protocols and study plans pertaining to a range of developmental efforts (i.e., manufacturing, non-clinical, clinical, and assay development), providing feedback in support of advanced development efforts.
• The contractor shall develop drafts and assist the project team to coordinate responsibilities, oversee quality and regulatory management, and encourage timeliness of completion of protocols, IND applications, other regulatory submissions, and technical reports.
• The contractor shall assist to identify and assess risks of new technologies and ongoing projects.

This position requires either U.S. Citizenship or a Permanent Resident Green Card with at least 3 years' residency in the U.S.

Tunnell is proud to be an Equal Opportunity / Affirmative Action / Female / Minority / Disabled / Veteran Employer and does not discriminate on the basis of race, color, religion, sex (including pregnancy, child-birth, or related medical conditions), national origin, ancestry, age, disability, family care status, veteran status, marital status, military status, sexual orientation, gender identity, or any other characteristic protected by law. Tunnell makes reasonable accommodation for persons with disabilities to apply for employment.

Please be advised that some of our client contracts, including contracts with the federal government, require us to validate that our employees and contractors are fully vaccinated against COVID-19, subject to legal requirements. If you are selected for this role or assignment, you will be required to confirm that you are fully vaccinated or engage in an interactive dialogue with Human Resources to determine if you are eligible for a religious or medical exception, and whether making such an exception would pose an undue burden or undue risk of harm.