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ProSidian Consulting

Senior Clinical Studies Physician | Healthcare and Life Sciences

washington, DC

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Job description

Senior Clinical Studies Physician

ProSidian Seeks a Senior Clinical Studies Physician - DPLH Est.: 1912 Hrs. ST | 0 Hrs. OT on a Exempt Full-Time Basis located CONUS - Washington DC Across The Mid Atlantic Region supporting Advanced Scientific Professional Staffing Support Services in the various areas of interest within the Medical Countermeasures field of Research and Development (R&D)/Analytical Research and Development (AR&D) of biotechnology and biopharmaceuticals supporting BARDA.

Seeking Senior Clinical Studies Physician candidates with relevant Healthcare And Life Sciences Sector Experience (functional and technical area expertise also ideal) to support professional services engagement for Healthcare And Life Sciences Sector Clients such as HHS. This as a Full-Time ProSidian W-2 Healthcare and Life Sciences Functional Area - Healthcare And Life Sciences Supply/Service Initiative and an employed position with commensurate benefits and competitive salary.

JOB OVERVIEW

Provide services and support as a Healthcare And Life Sciences (Senior Clinical Studies Physician) in the Healthcare And Life Sciences Industry Sector focusing on Human Capital Solutions for clients such as Department of Health and Human Services (HHS - ASPR | BARDA) | HHS Administration for Strategic Preparedness and Response (ASPR) Center for Biomedical Advanced Research and Development Authority (BARDA) Generally Located In CONUS - Washington DC and across the Mid Atlantic Region (Of Country/World).

RESPONSIBILITIES AND DUTIES

Support BARDA Program Office(s) as a subject matter expert in the fields of Chemical Threats, Radiological/Nuclear Threats, Burn and Blast Injuries, or Biological Threats (including viral and bacterial threats), Influenza and Emerging Infectious Diseases Division (IEIDD) as well as the research, development, manufacture, and regulatory approval/ licensure/ clearance of medical countermeasures against these threats including but not limited to diagnostics and other medical devices/infrastructure vaccines and other preventives, and therapeutics.

Serve as advisor(s) on Technical Evaluation Panels (TEPs) to include white papers/market research abstracts, technical proposals, and budget proposals.

Participate as subject matter experts on Program Coordination Teams (PCTs)

Provide expert assessments, recommendations, and guidance as well as educational material to PCT and COR as needed

Provide subject matter expertise and advisory support to federal staff for development of cost estimates for notional programs/proposed work

Review and comment on study protocols, study reports, regulatory documents, presentations, proposals, and related documents.

Develop work products (including but not limited to expert summary reports, expert opinion assessment reports, analysis reports, manuscript writing/contribution, and review and technical assessments on a wide variety of documents related to BARDA's mission, including solicitations, white papers, proposals, and post-award contract documents and deliverables), as requested in their SME area and at their required level of expertise.

Advise federal staff on the appropriateness and the probability of success of Contractor proposed statements of work Make suggestions on ways to improve those statements of work.

Experience distilling complex information into informative and concise summaries, including providing risk/benefit analyses and balanced recommendations.

Participate and aid in strategic discussions, working with USG, in building new program areas in alignment with BARDA's mission space.

Provide recommendations for project development level portfolio management and oversight as required.

Provide recommendations or advise on development, implement, and consciously improve Total Life Cycle Cost (TLCC) efforts; Participate in Market Research efforts.

Provide clinical development subject matter expertise support to BARDA's MCM Programs

Qualifications

Desired Qualifications For Senior Clinical Studies Physician Candidates:

At least 15 years of relevant industry experience beyond a doctoral degree.

Advanced experience in managing complex clinical studies, development of medical countermeasures, and working with vaccines, therapeutics, and antimicrobials

Education / Experience Requirements / Qualifications

Advanced degree in medicine (e.g., MD, DO) or pharmacy (e.g., PharmD) or a related field.

Skills Required

Proficiency in managing clinical studies and programs related to medical countermeasures.

Expertise in overseeing CROs conducting clinical trials in compliance with GCP, GLP, and regulatory requirements.

In-depth knowledge of relevant therapeutic areas, such as:

Infectious diseases

Thermal and chemical burns

Radiation/nuclear injury

Pulmonary medicine

Pediatrics

Hematology/oncology.

Competencies Required

Comprehensive understanding of Good Clinical Practice (GCP) and Good Laboratory Practice (GLP).

Ability to oversee regulatory compliance in clinical studies.

Capability to provide expertise in therapeutic areas relevant to BARDA's mission

Teamwork – ability to foster teamwork collaboratively as a participant, and effectively as a team leader

Leadership – ability to guide and lead colleagues on projects and initiatives

Business Acumen – understanding and insight into how organizations perform, including business processes, data, systems, and people

Communication – ability to effectively communicate to stakeholders of all levels orally and in writing

Motivation – persistent in pursuit of quality and optimal client and company solutions

Agility – ability to quickly understand and transition between different projects, concepts, initiatives, or work streams

Judgment – exercises prudence and insight in decision-making process while mindful of other stakeholders and long-term ramifications

Organization – ability to manage projects and activity, and prioritize tasks

Commitment - to work with smart, interesting people with diverse backgrounds to solve the biggest challenges across private, public and social sectors

Curiosity – the ideal candidate exhibits an inquisitive nature and the ability to question the status quo among a community of people they enjoy and teams that work well together

Humility – exhibits grace in success and failure while doing meaningful work where skills have impact and make a difference

Willingness - to constantly learn, share, and grow and to view the world as their classroom

ProSidian Employee Benefits and Highlights: Your good health and well-being are important to ProSidian Consulting. At ProSidian, we invest in our employees to help them stay healthy and achieve work-life balance. That's why we are also pleased to offer the Employee Benefits Program, designed to promote your health and personal welfare. Our growing list of benefits currently include the following for Full Time Employees:

Competitive Compensation: Pay range begins in the competitive ranges with Group Health Benefits, Pre-tax Employee Benefits, and Performance Incentives. For medical and dental benefits, the Company contributes a fixed dollar amount each month towards the plan you elect. Contributions are deducted on a Pre-tax basis.

Group Medical Health Insurance Benefits: ProSidian partners with BC/BS, to offer a range of medical plans, including high-deductible health plans or PPOs. ||| Group Dental Health Insurance Benefits: ProSidian dental carriers - Delta, Aetna, Guardian, and MetLife.

Group Vision Health Insurance Benefits: ProSidian offers high/low vision plans through 2 carriers: Aetna and VSP.

401(k) Retirement Savings Plan: 401(k) Retirement Savings Plans help you save for your retirement for eligible employees. A range of investment options are available with a personal financial planner to assist you. The Plan is a pre-tax Safe Harbor 401(k) Retirement Savings Plan with a company match.

Vacation and Paid Time-Off (PTO) Benefits: Eligible employees use PTO for vacation, a doctor's appointment, or any number of events in your life. Currently these benefits include Vacation/Sick days – 2 weeks/3 days | Holidays - 10 ProSidian and Government Days are given.

Pre-Tax Payment Programs: Pre-Tax Payment Programs currently exist in the form of a Premium Only Plan (POP). These Plans offer a full Flexible Spending Account (FSA) Plan and a tax benefit for eligible employees.

Purchasing Discounts & Savings Plans: We want you to achieve financial success. We offer a Purchasing Discounts & Savings Plan through The Corporate Perks Benefit Program. This provides special discounts for eligible employees on products and services you buy on a daily basis.

Security Clearance: Due to the nature of our consulting engagements there are Security Clearance requirements for Engagement Teams handling sensitive

Worksite address

washington, DC, 20022, US

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