Senior Clinical Advisor, Pharmacy

Location
Rockville, MD, US
Posted
Mar 25, 2021
Ref
2021-9981
Hotbed
BioCapital
Required Education
Doctorate/PHD/MD
Position Type
Full time
Overview

We are currently searching for a Senior Clinical Advisor, Pharmacy to provide support to the National Institutes of Health (NIH). This opportunity is a full-time position with MSC, and it is on-site in Rockville, MD.

Duties & Responsibilities

  • Attend a variety of scientific meetings/workshops and prepare meeting summaries. These may vary in length and complexity.
  • Participate in the review, planning and implementation of clinical trials. This will include the evaluation of study design, feasibility, pharmaceutical regulatory requirements, and identifying solutions for pharmaceutical and logistical problems that may impede the conduct of a study.
  • Develop the text for the study product section of the protocols in cooperation with members of the protocol team and the pharmaceutical manufacturers for existing pharmaceutical products as well as new chemical entities and modalities. This includes researching and analyzing background material from Investigator's Brochures, prescribing information, and literature reviews.
  • Advise the study team and program leadership regarding pharmacy aspects of proposed studies.
  • Develop protocol specific trainings for site pharmacists and clinic staff utilizing web-based systems, software, or other tools (ie., power point presentation).
  • Provide leadership in collaboration with Program Project Managers and Regulatory Officers for developing study-specific blind labeling and packaging plan and strategies.
  • Review and approve study-specific labels by the department.
  • Write and review Study Specific Pharmacy Manuals in collaboration with Project Managers.
  • Ensure that pharmaceutical concerns raised during meetings are addressed in a timely manner.
  • Advise the protocol team regarding pharmaceutical issues relating to department standards, FDA and other Health Authorities regulations, State and in-country requirements.
  • Evaluate the protocol and provide leadership with estimates of study product needs and or cost based on factors such as sample size, dose, formulation, strength, rate of accrual, and duration.
  • Perform calculations for study product dilutions and aliquots and for compounding pharmaceutical preparations.
  • Generate Study Product Request Letter/ Email for study-specific and division leadership's review and approval.
  • Provide pharmaceutical expertise during protocol conduct on pharmacy queries, product management issues, product availability and appropriate recommendations.
  • Conduct site visits as required to obtain information about existing infrastructure and processes to use to evaluate pharmacy personnel and infrastructure capacity at production facilities and Clinical Research Sites, as well as for-cause site visits as needed.
  • Review Pharmacy Establishment Plans with the site Pharmacist of Record and Program Project Managers to obtain information and clarity needed for final review and approval.
  • Evaluate and finalize all temperature excursions that occur during shipment and at Research Pharmacy Sites in collaboration with Regulatory Officers.
  • Receive and process product complaints with or without AES/SAEs from research site pharmacies.
  • Write/draft Standard Operating Procedures (SOPs) related to Program Pharmaceutical Services and participate in SOP review committees as needed.
  • Assist Program Regulatory Officers in writing the Chemistry, Manufacturing, and Control (CMC) section of the Investigational-new drug (IND) application.
  • Assist Program providing daily instructions, approvals and other duties as needed for program oversight.
  • Review and approve study-specific batch records submitted by the department.
  • Utilize pharmacy practice experience and pharmaceutical expertise in the design, review and revision of Program Pharmacy documents.
  • Participate in the department funded clinical network meetings, face-to-face protocol development meetings, and protocol team meetings as a pharmaceutical subject matter expert.
  • Attend and participate in U.S./Non-U.S. scientific meetings as required.
  • Review pharmacy monitoring assessment reports and provide input regarding pharmacy and protocol prioritization for Clinical Site Monitoring plan as needed.
  • Order, receive, ship to the department and maintain chain of custody of Investigational Products
  • (Ips) purchased by the program Procurement Facility.
  • Ensure proper storage conditions for IPs purchased by the procurement facility before they are transferred to the department.
  • Ensure orders received are properly reconciled in the FedMall in a timely fashion.
  • Update the database of purchased IPs and track cost saving activities on a monthly basis.
  • Perform other assignments as required.


Requirements

  • Ph.D. in Life Sciences or other related discipline is preferred. Or, three (3) years of specialized experience plus a Master's degree is equivalent to a Ph.D. Or, five (5) years of specialized experience plus a Bachelor's degree is equivalent to a Ph.D.
  • Experience in clinical research, protocol development and conduct, regulatory affairs (e.g., GMP manufacturing, IND filing, adverse events) and/or allergy or infectious diseses practice is required.
  • Minimum of three (3) years of related experience. Examples of desired experience include investigational drug related experience, serving on an Institutional Review Board, drug manufacturing experience, or clinical trial management experience.
  • Experience and proficient in communicating effectively orally and in writing.
  • Excellent analytical, organizational and time management skills.
  • Expertise in MS Office including; Word, Excel, Outlook, and PowerPoint.
  • Experience working in a quality-based environment.

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Company Description

We are a trusted government partner that blends deep domain expertise with advanced technologies to help our customers solve complex problems that improve, protect, and save lives. As a rapidly growing company, we combine entrepreneurial spirit, customer focus, and an outcomes-based approach to support agency missions in health IT, life sciences, public safety, and grants management.

The Dovel Family of Companies offers employees an opportunity to advance beyond a specific role or contract, we offer a path to develop an enriching career. We believe in empowering a culture of innovation, customer success, and employee growth.

What you'll get...
  • Time Off! Flexible schedules and company paid holidays allow you to take the time you need.
  • Investment in YOU! 401(K) company contributions are yours to keep with no waiting period.
  • Choices! Unique healthcare plans to choose from with options like fertility and orthodontia benefits.
  • Discovery! With our tuition assistance and training programs, we support your career advancement.
  • Tax Savings! Enroll in pre-tax Health or Dependent Care Flexible Spending, HSA with company contributions, parking, and/or transit commuter benefits.
  • Support! Working parents and busy professionals - we've got you covered with a supportive culture, confidential Employee Assistance Program and a membership to Care.com.
  • Perks! Employee discounts, peer recognition programs, company-wide wellness challenges, and fun community events.
  • A Voice! A unique culture where you can influence decisions and have your voice heard.


We are an Equal Opportunity Employer with a commitment to diversity. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, gender identity, disability, or veteran status.