Medical Director Early Clinical Development
Location: Greater Boston Area
Contact: Janene Cleary, email@example.com
Medical Director Early Clinical Development | Growing Biopharmaceutical Company
This retained Medical Director Early Clinical Development search is being conducted on behalf of our pre-IPO clinical-staged bio-pharmaceutical client. They are focused on opportunities in-licensing or co-development of clinical-stage product candidates on indications highly relevant to Chinese and Asians and in the commercialization of orphan and other specialty products in China, Taiwan and Korea.
This individual is responsible for the medical and scientific integrity and oversight of the study and well-being of the patient enrolled in the study. Serving as the protocol owner, the Medical Director applies technical and clinical excellence to ensure the design of cost-efficient clinical trials that meet the needs of internal and external customers.
We seek an individual who possess self-motivation, creativity and a willingness to take a “roll-up the sleeves” approach to operating in a start-up environment. One must have proven ability to get results in a virtual environment with internal colleagues in multiple locations.
ADDITIONAL INFORMATION ABOUT THIS COMPANY AND ROLE:
A privately held bio-pharmaceutical company with a mission to accelerate development and commercialization of life-changing specialty healthcare products in China and North Asia.
Our client develops partnerships with Western bio-pharmaceutical companies with clinical-stage pharmaceutical, medical device or diagnostic products that are either unavailable in China/North Asia or address medical needs that are underserved in the region.
This individual must have demonstrated knowledge of and a track record of developing and providing oversight for clinical trial strategies, methods and processes either small molecule or biologics.
Must have experience in conducting and executing clinical trials on a global basis.
Reports to the Chief Medical Officer.
HIGHLIGHTS OF RESPONSIBILITIES:
Leads clinical programs in partnership with Clinical Operations from the IND-enabling stage through Phase 2 proof-of-concept.
Designs and implements clinical research strategies and is accountable for the development and execution of clinical research programs for novel agents in a variety of therapeutic areas and disease states.
Directs study design, protocol development and implementation of clinical studies. Partners with Clinical Operations to define clinical study parameters, deliverables, and resource needs. Participate in study recruitment efforts, enrollment, help interpret study results and present it internally and all partners externally or the study investigators.
Reviews and evaluates clinical research results to inform development strategy, operational tactics and future marketability. Safeguards compliance and internal and external standards, proactively mitigates risk and manages emerging clinical issues.
Serves as the medical monitor for a set of portfolio assets.
Contributes to the preparation of submission documents for INDs and CTAs to regulatory agencies. support appropriate interpretation and communication of clinical trial data including high quality regulatory submissions and protocol defense activities.
Acts as the primary point of contact with external partners, investigators and the internal study team for questions related to clinical/ medical aspect of the protocol.
Location: Our client is located in a convenient and easily accessible area in the heart of Kendall Square.
DESIRED SKILLS & QUALIFICATIONS:
MD or MD-PhD with a minimum of 5 years’ industry experience in a global biotech or biopharmaceutical environment is required. Industry experience should include translational medicine with early stage drug development experience preferred. Experience with Oncology or Rare Disease therapeutic areas preferred but not required.
Experience in conducting and executing clinical trials (recruitment, investigator performance and investigator site relations) on a global basis, with preference for China and South East Asia experience.
Proven track record of proactive management of regulatory issues related to protocol s and programs, including comprehensive experience of interaction with regulatory authorities.
Experience interacting with regulatory authorities in Asia such as CFDA is a plus.
Thorough knowledge of clinical research concepts, practices, and GCP & ICH.
Janene Cleary, Director Life Sciences Recruiting
Phone: 267.483.5233 ext. 103
The Bandish Group, LLC
Life Sciences Executive Search
1432 Easton Road, Suite 2B
Warrington, PA 18976