Roche

Medical Director (Myeloid Diseases)

Company
Roche
Location
Welwyn
Salary
Competitive
Posted
28 Apr 2021
Closes
27 May 2021
Ref
202104-109171
Discipline
Medical Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
Roche's Clinical Development organization is structured by therapeutic area and is responsible for developing and executing the late development (Phase II - IIIA) clinical strategies and plans that deliver medically-differentiated therapies that provide meaningful improvement to patients. 

The PD Medical Director participates in the development of the Clinical Development (CD) strategy and is responsible for developing the CD plan and ensuring effective and efficient CD plan execution for the assigned molecule(s)/indication(s).

PRIMARY DUTIES AND RESPONSIBILITIES:
  • Supports and contributes to the Global Clinical Development Planning
  • Stays abreast of internal and external developments, trends, and other dynamics relevant to the work of CD
  • Maintains the highest standards and levels of scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment
  • Collaborates with a variety of internal and external partners and stakeholders, such as clinical investigators, clinicians, scientists, and key opinion leaders (KOLs), as well as multidisciplinary internal groups
  • May participate in meetings and other interactions regarding early development/Phase I studies to provide clinical science development input and guidance
  • Participates in development of the CD plan for assigned molecule(s)/indication(s) and/or other programs
  • Supports other CST members in preparing for HA meetings.
  • Clinical Development Plan Implementation
  • Consistently complies with all governing laws, regulations, Roche Standard Operating Procedures (SOPs), and other guidelines
  • Provides clinical support across all relevant studies and programs:
    • Participates in ongoing CST and relevant sub-team meetings, other interactions, and communications
    • Designs and develops clinical studies
    • May collaborate with others in the development of the product safety profile
    • May participate in the identification and selection of appropriate external investigators and sites
    • Collaborates with others in the development of study analytics and data management plans
    • Acts as a medical monitor for assigned studies
    • Conducts ongoing reviews of medical/safety data
    • Reviews study data to ensure correct medical/scientific data interpretation for interim and final study reporting
    • Participates in the development and implementation of communications strategies to support existing and concluded studies. Includes KOL interactions, advisory boards, and congresses


QUALIFICATIONS & EXPERIENCE

We are looking for an M.D. professional with relevant medical experience in Hematology. With 2 or more years of pharma/biotech industry experience OR is a recognized expert in the field and 2 or more years' experience with clinical trials across Phase II - III drug development. You will bring:
  • Experience developing product and safety profile
  • Experience working with the principles and techniques of data analysis, interpretation, and clinical relevance (e.g., ISS, ISE, competitor data, etc.)
  • Experience submitting an NDA/BLA to regulatory authorities in Europe and/or the U.S. is preferred
  • Experience authoring aspects of a global clinical development plan or full clinical study protocol is preferred


ABILITIES:
  • Has working knowledge of the multi-disciplinary functions involved in a company's drug development process, e.g. clinical operations, biostatistics, regulatory, commercial operations, etc.
  • Clinical leadership: is regarded as an expert in his/her field, is respected by others, can effectively contribute to longer-range drug development, and can lead cross-functional teams to successful results
  • Excellent project management skills
  • Good interpersonal, verbal communication, and influencing skills
  • Strong written communication skills
  • Good judgment and decision-making skills; knows how to make trade-off decisions while balancing ethics and efficacy
  • Works well within teams and is effective in collaborating with others internally and externally
  • Ability to travel globally


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