Associate Medical Director

Associate Medical Director

 

 

Tolerx is seeking an Associate Medical Director to play a critical role in designing and carrying out clinical studies in type 1 diabetes and other immune-mediated indications.  This position reports to the Senior Medical Director.

 

Responsibilities of this position:

·        Participate in all aspects of new and ongoing studies with compounds currently in development (including studies in new patient populations) as well as the design and execution of clinical studies with new compounds advancing in the pipeline.

·        Serve as a medical monitor and medical contact with study sites and investigators.

·        Conduct clinical data reviews and analyses.

·        Assist with study design and protocol development.

·        Participate in the generation of study reports.

·        Prepare IRB/EC and regulatory documents.

·        Solicit expert feedback, synthesize and present clinical data, and provide medical input regarding operations and study execution.

·        Conduct ongoing reviews of the medical literature and related new technologies and assess external clinical research proposals involving company products.

·        Interact with all departments in the company, including other divisions within clinical development, discovery, preclinical, manufacturing, and business development.

·        This position will require sporadic travel; for example, to investigational sites, to meet with experts and consultants, for investigator meetings, and to clinical and scientific meetings (approximately 15% anticipated travel time).

 

Requirements of the ideal candidate:

·        Doctorate in medicine (MD) or equivalent (e.g., DO).

·        Board certification in internal medicine or pediatrics and a relevant subspecialty area (e.g., endocrinology; allergy/immunology; hematology/oncology; infectious disease; rheumatology). Pediatrics, immunology, rheumatology, and/or endocrine expertise strongly preferred.

·        Background in clinical research with at least 2 years’ relevant experience in pharmaceutical drug development. Specific skills required include experience with protocol development, study initiation and follow-up, IRB/EC submissions, technical writing, clinical data analysis (including safety data analysis), and oral data presentations. Research, clinical, or pharmaceutical experience with monoclonal antibodies, biologics, or closely related compounds is a plus.

·        Experience interacting with regulatory agencies, supervising CROs and central laboratory vendors, reviewing clinical study data listings, and preparing clinical study reports is highly desirable. 

·        Solid clinical skills and patient care experience as a physician are required, with a publication track record in relevant areas. At least two years of post-subspecialty direct patient care responsibility, either before or during pharmaceutical drug development positions, is highly desirable

·        The successful candidate will have a basic understanding of scientific and immunologic concepts and their relevance to clinical research, and he/she will be able to translate the results of preclinical and scientific findings to the clinical arena.

·        The successful candidate will enjoy working in a collaborative, team environment, and must be able to build and maintain excellent interpersonal relationships both within and outside the company at all levels.  

·        Excellent written and oral communication skills, including fluency in English, are required.  

 

 

Job Code:  AMD 4/2008