Medical Advisor Support (Warfighter Readiness Performance and Brain Health)

Knowesis Inc.; Frederick (MD); Hybrid; USD 130,000 - 180,000; Full time

Benefits offered by this job

Health Insurance

Dental

Vision

401k Company Match

Short-Term Disability

Job summary

Knowesis Inc. is seeking a Medical Advisor Support for Warfighter Readiness Performance and Brain Health to provide high-level clinical management expertise for DoD-sponsored and non-DoD-sponsored clinical research activities.

The role focuses on advising on medical devices, diagnostics, drugs, and biologics, with emphasis on PTSD and traumatic brain injury. The position is hybrid/telework eligible and requires eligibility for a Tier 1 clearance.

Qualifications

• Advanced degree in medical, clinical, or scientific field.
• At least 10 years of full-time work experience in medical product development and clinical trial research.
• In-depth knowledge of development processes for drugs, biologics, and medical devices.

Responsibilities

• Provide clinical management expertise for planning, designing, coordinating, managing, and conducting clinical trial research.
• Assist in writing and preparing clinical protocols and other trial documents.
• Interpret, synthesize, and incorporate new information from the FDA and policy bodies into organizational strategy.
• Assist in development of Integrated Master Plans for FDA and non-FDA regulatory and clinical activities.
• Advise product managers on regulatory requirements at each stage for drugs, biologics, and devices.

Education

MD/DO/PhD or equivalent

Job description

Brief Description

Position: Medical Advisor Support (Warfighter Readiness Performance and Brain Health)

Location: Fort Detrick, MD

Work Environment: Hybrid / Telework Eligible (Routine and situational telework is authorized.)

Clearance Required: TIER 1: Non-critical sensitive position (Must be able to obtain and maintain)

Status: Contingent

Anticipated Salary Range: $130,000 - $180,000

Knowesis is seeking a Medical Advisor Support for Warfighter Readiness Performance and Brain Health who provides high-level clinical management expertise for DoD-sponsored and non-DoD-sponsored clinical research activities. This expert advises on the development of medical devices, diagnostics, drugs, and biologics, with a specific focus on post-traumatic stress disorder and traumatic brain injury.

The Job Duties and Responsibilities

• Provide clinical management expertise for the planning, designing, coordination, management, and conduct of clinical trial research.
• Assist in the writing and preparation of clinical protocols and other clinical trial documents.
• Interpret, synthesize, and incorporate new information from the FDA and other policy bodies into organizational strategy.
• Assist in the development of comprehensive Integrated Master Plans for FDA and non-FDA regulatory and clinical activities.
• Advise product managers on the product development lifecycle, identifying regulatory requirements at each stage for drugs, biologics, and devices.

Required Qualifications

• Advanced Degree (MD, DO, PhD, or equivalent) in a medical, clinical, or scientific field.
• At least 10 years of full-time work experience in medical product development and clinical trial research.
• In-depth knowledge of the development processes for drugs, biologics, and medical devices.

Preferred Qualifications

• Expertise in pharmaceutical development within the disease areas of psychiatry or neurology (specifically PTSD and TBI).
• Extensive experience interacting with the FDA and managing clinical trial protocols.

Benefits

• Health (PPO & HDHP) Insurance, Dental, Vision, STD & LTD, Basic Life Insurance, 401k Company Match, & Voluntary Products.

Knowesis is committed to providing equal employment opportunities to all individuals based on merit and qualifications. We prohibit discrimination in all aspects of employment as required by Title VII of the Civil Rights Act and other applicable federal laws. Our company values all applicants and employees and fosters a work environment where everyone is treated with respect and dignity.