Director Oncology R&D - Physician Scientist
Company: Daiichi Sankyo, Inc.
Location: Atlanta
Posted on: October 15, 2024
Job Description:
Join a Legacy of Innovation 110 Years and Counting! -Daiichi
Sankyo Group is dedicated to the creation and supply of innovative
pharmaceutical therapies to improve standards of care and address
diversified, unmet medical needs of people globally by leveraging
our world-class science and technology. With more than 120 years of
scientific expertise and a presence in more than 20 countries,
Daiichi Sankyo and its 16,000 employees around the world draw upon
a rich legacy of innovation and a robust pipeline of promising new
medicines to help people. In addition to a strong portfolio of
medicines for cardiovascular diseases, under the Group's 2025
Vision to become a "Global Pharma Innovator with Competitive
Advantage in Oncology," Daiichi Sankyo is primarily focused on
providing novel therapies in oncology, as well as other research
areas centered around rare diseases and immune disorders. - -
Job Summary:Serves as a primary source of medical accountability
and oversight for one or more clinical trials. Matrix management
responsibilities across the internal and external network. Manages
Phase 1-3 studies (depending on assignment) with demonstrated
decision-making capabilities. Provides medical and scientific
expertise to cross-functional DSI
colleagues.Responsibilities:Medical Monitoring:
- For studies in which Medical Monitoring activities are
conducted in-house:
- Provides medical input regarding country feasibility. Consulted
on decisions related to clinical trial feasibility and contributes
to the site feasibility assessment from a physician's
perspective
- May provide clinical input into the eCRF (Case Report Form)
design, participate in the UAT (User Acceptance Testing) and CCG
(CRF Completion Guidelines) review
- Conducts clinical data review per Integrated Data Review Plan
(IDRP)
- Accountable for the assessment of protocol deviations
- Discusses medical eligibility questions and answers safety
questions (dose modifications, discontinuations, and management of
adverse events)
- May participate in Site Initiation Visit (SIV) and conduct
medical monitoring visits at any time during the conduct of the
study to provide medical input
- Provides medical guidance for coding of AEs, medical history,
and medications when needed
- Addresses medical questions directly from sites/ Institutional
Review Boards (IRBs), and other site personnel as needed
- Study-specific subject matter expert (SME) for internal audit
or Health Authority (HA) questions related to medical
monitoring
- For studies in which Medical Monitoring activities are
conducted by the Contract Research Organization (CRO) Medical
Monitor (MM):
- Provides oversight to the CRO MM for clinical data review
activities
- May support addressing eligibility and medical questions from
sites/ IRBs
- May provide medical guidance for coding of AEs, medical
history, and medications when needed
Clinical Development Expertise Strategy:
- In collaboration with the Global Clinical Lead (GCL), if
applicable, leads the development and execution of the Clinical
Development Plan (CDP). Ensures individual protocols are consistent
with CDP and aligned to achieve the Target Product Profile
(TPP)
- Development of clinical sections of trial-level regulatory
documents (e.g., response to HAs, briefing book, etc.) in
conjunction with Medical Writing
- Leads scientific components of IM (Investigators Meeting) and
SIV (Site Initiation Visit) Training: compound, Diagnosis (Dx)
Overview, in collaboration with Clinical Scientists (CS)
- Interpretation and presentation of clinical study(ies) data to
internal and external stakeholders
- Provides medical/scientific training on compound/disease and
dose modifications/discontinuations as well as management of
adverse events based upon approved Safety Management Team (SMT)
materials
- Supports overall program safety reporting (e.g., Periodic
Safety Update Reports (PSURs), Drug Safety Update Reports (DSURs),
and other safety-related documents, in collaboration with the
Safety Physician
- Maintains up-to-date knowledge of all-important advances within
a disease area through scientific literature, critical meetings,
and relationships with Key External Experts (KEEs). Contributes to
clinical/scientific training of relevant DSI stakeholders on the
disease area, competitive landscape, and compound/drug. May serve
as speaker for program/ franchise medical/scientific training in
collaboration with the GCL, if applicable
- Delivers all relevant components needed for maintenance of
product licenses (e.g., Core Data Sheet generation/revision;
clinical benefit-risk assessments for license renewals, responses
to Health Authority)
- Participant and voting member in the labeling development
process in the Labeling Working Team (LWT), in collaboration with
the CDL
- Contributes from a medical strategy standpoint to developing
the Clinical Study Report (CSR). May review tables, listings, and
figures (TLF) and CSR safety narratives
- May lead the development and updates of the Investigator's
Brochure (IB): author the clinical section and lead the development
of the other sections in collaboration with the other authoring
functions
- Accountable for Protocol content/study design development
- Contributes from a medical strategy standpoint to the
development of clinical sections of study-level documents (e.g.,
protocol, amendments) of safety data to mitigate risk to trial
participants for the assigned trial per protocol
- Development of charters for the Steering Committee (SC),
Endpoint Committee, and Data Monitoring Committee (DMC). Identify
committee members and coordinate/facilitate meetings
- Primary contact for DMC, Endpoint Committee, and SC: Reviews;
Presents study updates to the DMC in the open session
- Reports on/prepares presentation material of trial safety
information/data to internal and external safety boards (e.g., DMC,
Endpoint Committee, SC, Ad boards).
- TPP and EPP (Expected Product Profile) development in
collaboration with peer functions and CS
- Oversight of Academic Research Organization or Cooperative
Group partnership, if applicable.
Health Authority Interactions Publications:
- May contribute to addressing questions about medical decisions,
clinical data review, protocol deviations, etc., and/or scientific
aspects of the study during FDA, MHRA, EMA, and PMDA interactions,
such as pre-submissions, end of phase 1/2, and inspections
- May support the GCL in planning and executing the overall
publication and clinical communication strategy (overall or at the
individual trial level), providing input to key external
presentations, if applicable.
- Contributes to and serves as the medical point of expertise in
key HA interactions and Ad board meetings
Qualifications: Successful candidates will be able to meet the
qualifications below with or without a reasonable
accommodation.
Education:
- MD or equivalent required and
- Postgraduate training in TA or related specialty preferred
Experience Qualifications
- 4 or More Years industrial experience required
Travel:
- Ability to travel up to 20% Domestic and International travel
will be required.
Daiichi Sankyo, Inc. is an equal opportunity/affirmative action
employer. Qualified applicants will receive consideration for
employment without regard to sex, gender identity, sexual
orientation, race, color, religion, national origin, disability,
protected veteran status, age, or any other characteristic
protected by law.
Keywords: Daiichi Sankyo, Inc., Smyrna , Director Oncology R&D - Physician Scientist, Executive , Atlanta, Georgia
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