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 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 on 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 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 a M.D. professional with relevant medical experience in Hematology. With 2 or more years 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
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