Medical Director, Respiratory and Allergic Diseases

South San Francisco
California, United States of America


Return to Search Results

The Position

Roche/Genentech is seeking a Medical Director/Senior Medical Director to participate in the clinical development of a novel agent entering Phase III development for idiopathic pulmonary fibrosis. The role involves clinical representation on cross-functional teams responsible for the design, implementation, medical monitoring, data interpretation, reporting and publishing of studies. It will also include working with internal partners in the completion and submission of regulatory filings and supporting other regulatory processes. Additional responsibilities will involve collaboration with Research and with external partners including clinical investigators, clinicians, scientists and experts in the field. 

Key Accountabilities:

Assisting in the overall management, planning, evaluation and documentation of projects and studies.

Participation in on-going medicine development activities including:

  • Lead the clinical support across all relevant studies and support the Global Development Lead and overall team with cross-functional integration, coordination and alignment to enable effective clinical development execution.
  • Maintain the highest standards and levels of scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment
  • Act as medical monitor on clinical trials
  • Monitor and review data
  • Preparation of regulatory documents and interaction with global regulatory authorities
  • Analysis, presentation and interpretation of studies and published data
  • Interactions with health authorities and expert bodies
  • Close collaboration with drug safety, regulatory affairs, medical affairs and clinical trial operations
  • Participation in the preparation of abstracts, posters and presentations for scientific meetings and congresses
  • Developing and writing clinical plans and protocols ensuring that they are scientifically sound

QUALIFICATIONS & EXPERIENCE:

  • M.D. with relevant fellowship training in Pulmonary/Respiratory.
  • Candidates with 2 or more years pharma/biotech industry experience in Pulmonary who do not have fellowship training in Pulmonary 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.

ABILITIES:

  • Has impeccable ethics. Demonstrates, or proven abilities to demonstrate, Roche Values.
  • Outstanding attention-to-detail.
  • 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.

The next step is yours. To apply today, click on the "Apply online" button.

Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page.


Return to Search Results