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Medical Director (BioDevice) - 61709

Medical/HealthPosted 41 days 4 hours 35 minutes ago. Viewed: 59 times.

Description

You will:

 

Design and implement Clinical Development Plans.  Support commercial development with medical and clinical expertise. Demonstrate understanding and expertise in clinical trial design for Phase I-IV clinical studies; ability to integrate trials to meet objectives of the clinical development plan.

 

You need to:

  

·         Recruit clinical investigative sites and negotiate study design and costs.

·         Monitor and manage CRO adherence to national and international regulations and standards (GCP, MDD, ICH).

·         Review adverse events, monitor safety and prepare analysis and regulatory submission.

·         Participate in the review and editing of regulatory submissions and quality documentation.

·         Interact with Regulatory Affairs for positioning of regulatory strategy and coordinate and develop information for reports submitted to the FDA.

·         Understand, advise and monitor clinical aspects of US and international regulations in relation to clinical trials.

·         Interact with Marketing and Global Scientific Affairs for support of clinical trials and needed medical data. 

·         Partner with Regulatory Affairs Department for FDA interactions

·         Manage team members with a focus on supporting clinical development plans, corporate goals and individual development; establish goals and expectations, perform timely performance reviews and mid-year check ins

 

 

Requirements:

 

·         M.D. or equivalent with a minimum of 10 years clinical trials experience with in-industry experience.

·         Post-graduate clinical training leading to specialty is useful particularly in hematology, oncology or transfusion medicine.

 

If you have a deep desire to work within a supportive - team oriented enviornment with cutting-edge technology call me! This is a leadership role, managing a team as well as hand-ons, with flexible duties.

Relocation assistance available!

Industry: Biotech/Pharma
Discipline: Biotech, Pharma, Med. Device R&D
Compensation: $100K+
Company: Medical Device Company

Contact information

Apply Online at TheLadders.com