Sr Scientist
at Ronin Staffing

Date Posted: 9/15/2019

Job Description

HERE’S THE JOB DESCRIPTION:
Title
: Sr Scientist 
Pay: up to $48.00/hr
Location: Thousand Oaks, CA 91320
Duration: 1 year contract with possible extension

Description:

  • Onsite- M-F normal core hours
  • Ideal candidate- MD with 2-3 years’ Pharmaceutical experience in Medical Affairs, Oncology or Hematology, experience in clinical trials. This is a high Visibility role.
  • The US Medical Sr. Medical Scientist for a US Product supports the implementation of US Medical strategies, including US launch and lifecycle management.

This role is responsible for:

  • Supporting the development and execution of US product medical strategy, via the US Medical Plan, including launch support and lifecycle management, in collaboration with Product Team/Portfolio Governance and alignment with Global strategy
  • Supporting definition of scientific evidence gaps, development of local evidence generation strategy in coordination with Global
  • Supporting clinical trial conduct
  • Participating in engagement of external key stakeholders (often in partnership with other functions)
  • Supports Medical input into label and regulatory interactions, in alignment and with deep understanding of global strategy and program clinical trial data
  • Supports implementation of Medical governance for respective product, which includes: Safety and pharmacovigilance as a key and effective partner with GRAAS Clinical trial conduct US risk management/minimization in collaboration with GRAAS Subject matter appropriateness (medical/scientific) of external interactions (e.g. copy review, multichannel, congresses, 1-1 interactions, etc.)
  • Ensuring appropriate medical support of compliance

Key Activities:

  • Maximizes value proposition of respective product(s) through management and delivery of all medical and scientific activities , including launch and lifecycle management, in alignment with Global strategy and Evidence Generation Team (EGT)
  • Participates in development of US cross functional strategy and supports medical execution.
  • Provides input into medical and scientific insight for incorporation into US product strategies, via the US Medical Plan, and provides insights into Global strategies, plans and tactics as a participant in the Commercialization process
  • Ensures understanding and incorporation of patient perspectives in all activities
  • Executes product-specific US evidence generation strategy, in alignment with EGT, and supports execution of data communication strategy
  • Supports product-specific US clinical trial execution
  • Medical / Scientific contribution to Value Dossiers, compendia and interactions with payers in collaboration with VA&P Medical input into label and regulatory interactions, in alignment and with deep understanding of global strategy and program clinical trial data
  • May participate in speaking engagements that represent Amgen to external and internal bodies on medical and scientific issues related to relevant product(s)
  • Participates in the review of investigator sponsored studies
  • Supports or implements external Stakeholder Strategy
  • Engagement strategy and execution with medical experts, professional societies, patient groups and other key stakeholders
  • Participates in advocacy from a medical perspective in partnership with Commercial, Government Affairs and GRAAS policy
  • Builds Amgen‘s reputation as a science-based and patient-focused reliable partner
  • Ensures Medical Governance
  • Ensures human subject safety for marketed product in cooperation and effective partnership with responsible functions (e.g. GRAAS, Global Development)
  • May support US clinical trial conduct
  • Participates with the MAC operating committee in the material reviews.
  • Actively participates in US risk management/minimization in collaboration with GRAAS
  • May decide subject matter appropriateness (medical/scientific) of external interactions (e.g. copy review, multichannel, congresses, 1-1 interactions, etc.)
  • Ensures appropriate medical leadership of compliance; accountable for the conduct of medical activities according to all relevant compliance standards, regulations and SOP`s; Role models appropriate and compliant behaviors and contributes to creating a climate of compliance adherence across the organization

Basic Qualifications

  • MD, or PhD, or Pharm Degree

Preferred Qualifications

  • Accredited fellowship in Oncology or Hematology
  • Board certified or board eligible
  • Pharmaceutical experience in Medical Affairs
  • Clinical research/medical affairs experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO) that includes collaborations with integrated delivery networks, accountable care organizations, and/or payers
  • Experience with clinical study management and conduct Familiarity with US health care compliance considerations Experience with opinion leader interactions
  • Experience with integrated delivery networks, accountable care organizations, and payers
  • Broad and formal leadership experience

Top Must Have Skill Set:

  • Accredited fellowship in Oncology or Hematology
  • Clinical research/medical affairs experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO) that includes collaborations with integrated delivery networks, accountable care organizations, and/or payers
  • Experience with clinical study management and conduct Familiarity with US health care compliance considerations Experience with opinion leader interactions

Job Snapshot

  • Employee Type: Contractor
  • Location: Thousand Oaks, CA
  • Job Type: Science
  • Experience: Not Specified
  • Date Posted: 9/15/2019

About Us

Founded in 1999 as a woman- and minority-owned IT staffing organization, Ronin Staffing has grown into a full-service staffing search firm that recruits and places qualified and quality candidates with expertise in a wide range of areas, including Engineering, Aerospace, Administration, Accounting/Financing, to name a few. We offer contract-only, contract-to-hire or direct-hire services to our clients and our contractors alike.

Our team of experienced, dynamic and tenacious recruiting specialists will provide you with the personal assistance you need to keep your career moving onward and upward. Whether you are looking for hourly, mid-management or executive level positions, you can be confident in our recruiters’ ability to match you with just the right assignments with just the right companies to suit your needs. Many members of our staff have backgrounds in the industries for which they now recruit, and Ronin has become one of the leaders in providing professionals to Fortune 100, 500, and 1000 companies.

We are proud to offer you a full line of services to help you to meet your career objectives, including resume assistance, human resources consulting, and expert guidance on professional interviewing techniques. We also offer direct deposit and a competitive benefits package.

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