Director, Clinical Development

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Job description

Director, Clinical Development

Join a Legacy of Innovation 125 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 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 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

• Postgraduate training in TA or related specialty preferred

Experience:

• 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.

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