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 Associate PD Medical Director participates in development of the Clinical Development (CD) strategy and plan and helps ensure effective and efficient CD plan execution for the assigned molecule(s)/indication(s).
JOB DESCRIPTION – PRIMARY DUTIES AND RESPONSIBILITIES:
Provides clinical support across all relevant studies and supports the clinical lead and overall team with cross-functional integration, coordination and alignment to enable effective CD plan execution.
Acts as a medical monitor for assigned studies.
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, as well as multidisciplinary internal groups, including other groups in Product Development, research, regulatory, business development, commercial operations, legal, etc.
Participates in development of the CD plan for assigned molecule(s)/indication(s) and/or other programs.
QUALIFICATIONS & EXPERIENCE:
M.D. with relevant medical experience in Pulmonary or Allergy and Clinical Immunology.
Candidates with 2 or more years pharma/biotech industry experience who do not have fellowship training in Pulmonary or Allergic Diseases will also be considered.
Academic background is a plus.
Experience working with the principles and techniques of data analysis, interpretation and clinical relevance.
Versed in medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMEA, NICE and other relevant guidelines and regulations.
Has impeccable ethics. Demonstrates, or proven abilities to demonstrate, Roche Values.
Excellent project management skills: can prioritize multiple tasks and goals.
Good interpersonal, verbal and written communication skills.
Works well within teams and is effective in collaborating with others internally and externally.
Ability to travel globally (<30%).
Who We Are
A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry
for more than 40 years, using human genetic information to develop novel medicines for serious and
life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious
illnesses. Please take this opportunity to learn about Genentech where we believe that our employees
are our most important asset & are dedicated to remaining a great place to work.
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