RockvilleMDRecruiter Since 2001
the smart solution for Rockville jobs

DIRECTOR, CLINICAL RESEARCH

Company: Supernus Pharmaceuticals, Inc
Location: Rockville
Posted on: September 12, 2020

Job Description:

Director Clinical Research Jobs in Rockville, MD. The Clinical Research Director is a key leadership position at Supernus Pharmaceuticals, Inc. The successful candidate will report to the Senior Director of Clinical Research. The candidate is expected to lead clinical research activities in support of key initiatives: (1) design and support the clinical development plans and regulatory filing of pipeline products; (2) support clinical research of postmarketing of current marketed products; (3) support evaluation of future research opportunities; (4) collaborate with medical affairs on clinical research activities. Individual will work with clinical research team and will be responsible for preparation of clinical documentation in support of Phase 1-4 clinical studies. The individual will be responsible for the clinical development plans and all the clinical regulatory documents. Experience in psychiatry/neurology is desired. This job summary is not inclusive.. · Design, implementation and execution of clinical protocols (phase 1-4), internal strategy and planning documents, final reports and peer-reviewed publications with commercial, statistical and operational input. · Previous proven experience in IND and NDA submissions and interaction with health authorities. · Co-monitor clinical and scientific adherence to protocols, ethical and good clinical practices. · Interact with academics, government officials, professional consultants and other external resources, including CROs, to facilitate clinical trials research. · Serve as clinical and scientific consultant to management, other research project teams, business development, and commercial teams. · Monitor and interpret results of clinical investigations in preparation for potential commercial partnerships and / or new-drug applications. · Leads or Co-leads (with commercial colleagues) effort in determining and articulating the attributes related to safety, efficacy, unmet medical need, regulatory approval and successful commercialization of ongoing development and pipeline candidates. · Identify and evaluate compounds or technologies as pipeline opportunities. · Monitor changes in the scientific/regulatory/medical environment, which may impact the global drug development process and pharmaceutical marketplace and communicate them appropriately within the organization. · Develop a recruitment strategy (with Clinical Operations Co-Lead) for all trials as needed. · Review and manage documents prepared internally and by outside contractors. · Manage and mentor clinical research scientists. Supervisory Responsibilities:. · This position may lead and manage team members.. Education:. · Pharm.D., M.D, or Ph.D. in scientific discipline, preferable in central nerves system (CNS). Knowledge and Other Qualifications:. · 8+ years of experience in clinical research, preferable in neurology/psychiatry. · A high sense of ethics in results driven environment. · Scientific background with understanding of scientific, clinical and operational aspects of the drug development process. · Skilled in scientific and clinical research writing. · Hands on Microsoft Office, e.g., power point, excel, and word documents. · Ability to clearly communicate clinical and scientific benefits and risks to team members and management;. · Ability to attain confidence of team and company through personifying professionalism and clinical/scientific knowledge. · Ability to maintain and eventually build appropriate relationships with academics, government officials, professional consultants and other external resources including CROs. · Ability to initiate project efforts in a self-motivated way, including acquiring certain resources (e.g. prospective investigators, publicly available information, etc). · Ability to work in a project team and lead or co-lead projects with operational counterpart. Other Characteristics:. · Ability to work independently and as part of a team. · Maintain high ethical standards of integrity and quality. · Capable of being innovative and dynamic in approach to work. · Capable of performing other duties as assigned by management. · Authorized to legally work in the United States without visa sponsorship. · Preference for the candidate to work from Rockville, MD,. · CNS drug development experience is highly desired. Supernus Pharmaceuticals is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, age or any other characteristic protected by law.. #CB. Get alerts to jobs like this, to your inbox.

· n/a

Essential Duties & Responsibilities:. Non-Essential Duites & Responsibilities:

Keywords: Supernus Pharmaceuticals, Inc, Rockville , DIRECTOR, CLINICAL RESEARCH, Other , Rockville, Maryland

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Other Jobs


Appointment Setting Entry Level
Description: We are currently seeking work from home customer service, appointment setting, telemarketing and data entry representatives. You're main responsibility is to supply specialized guidance to our current (more...)
Company: Tima
Location: Leesburg
Posted on: 09/21/2020

Director of Construction Mgmt, Projects and Eng
Description: For security reasons we had to close down your session
Company: Hirebridge
Location: Leesburg
Posted on: 09/21/2020

SHEETZ: Supervisor - 687 - Evenings/Overnight
Description: Supervisor 687 Evenings/OvernightLocation: Sheetz Stores 00687 INTER FORT EVANS RD amp BATTLEFIELD PKWY LEESBURG, VAStarting Rate of Pay: 15.50Full or Part Time: Full TimeShift Needed: Evenings/OvernightSUPERVISORSchedule:Full (more...)
Company: SHEETZ
Location: Leesburg
Posted on: 09/21/2020


Store Team Member - #267 - Overnight
Description: Store Team Member - 267 - Overnight br br If you are a current employee, click here to apply br br Location:Sheetz Stores 00267 - 915 EDWARDS FERRY RD NE LEESBURG, VA br br Starting Rate (more...)
Company: Sheetz
Location: Leesburg
Posted on: 09/21/2020

Jumbo Processor
Description: Job Snapshot Employee Type: Full-Time Location: Chantilly, VA Job Type: Finance Date Posted: 9/7/2020 IMAGE About Us Prosperity Home Mortgage, LLC, is a full service mortgage banker specializing
Company: Long Foster Insurance Agency
Location: Chantilly
Posted on: 09/21/2020

PeopleSoft HCM Apps Functional Consultant (Payroll and OAM (Oracle Absence Management)
Description: PeopleSoft HCM Apps Functional Consultant Payroll and OAM Oracle Absence Management Leesburg, VA Contract Company
Company: SA Technologies Inc.
Location: Leesburg
Posted on: 09/21/2020

Caregiver for In Home Care - set your own schedule
Description: Competitive Pay Check. Flexible Schedules Check. Yearly Benefits Check. Paid Time Off Check. Caregiver Training Opportunities
Company: CareInHomes
Location: Leesburg
Posted on: 09/21/2020

Systems Engineer- Cloud DevOps
Description: Technology is constantly changing, and our adversaries are digitally going dark at a rate that is exceeding law enforcement's ability to keep pace. Those charged with protecting the United States are (more...)
Company: Peraton
Location: Chantilly
Posted on: 09/21/2020

Amazon Warehouse Attendant (Multiple Shifts Available) - Earn $15/hr or more
Description: Shifts: Overnight, Early Morning, Day, Evening, Weekend Location: Lanham, Riverdale Park Job opportunities vary by location. We update postings daily with open positions. Hourly pay rate: (more...)
Company: Amazon
Location: Leesburg
Posted on: 09/21/2020

Senior Data Architect
Description: Description JOB DESCRIPTION SAIC, a leading provider of systems development deployment, targeting intelligence analysis, systems engineering integration, and training capabilities and solutions for the (more...)
Company: SAIC
Location: Chantilly
Posted on: 09/21/2020

Log In or Create An Account

Get the latest Maryland jobs by following @recnetMD on Twitter!

Rockville RSS job feeds