VP Clinical Research and Development

  PolyMedix

 

VP of Clinical Research and Development

PolyMedix has just received $23 million in financing and is currently located at the Science Center in Philadelphia,

PolyMedix is developing entirely novel computational and synthetic chemistry approaches that should be broadly applicable to developing novel small molecule and oligomer therapeutic drugs for membrane targets and protein:protein interactions. The compounds and methods of design are de novo and proprietary, and provide a novel platform for the design of inhibitors that have been difficult to develop using traditional small molecule approaches. PolyMedix's protein computational technologies were developed by Drs. William DeGrado, Michael Klein, and Jeffery Saven at the University of Pennsylvania. This work is of potentially monumental importance, with vast commercial opportunities. 

The unifying element underlying all of PolyMedix's computational platform is the ability to build compounds to fill protein spatial coordinates: These compounds can be designed based on either pair of a ligand:receptor or protein:protein interaction pair. This computational technology platform as used to develop its first program: a line of unique anti-infective drugs for which bacterial resistance has so far proven highly unlikely to develop

Shortly, we will be relocating to a new facility in Radnor, PA as soon as the new labs are completed.  PolyMedix is currently looking to add to its team:

 

VP of Clinical Research and Development

VP/Director Drug Development

Director Chemistry

Director Biology

Director Toxicology

Director Microbiology

Analytical Chemists

Organic/Medicinal Chemists

Biochemists

Chief Medical Officer

 

Please e-mail your resume to:  rmainc1@comcast.net

 

Please see our website at:  http://www.polymedix.com

 

VP of Clinical Research and Development

VP of Clinical Research will be responsible for the full scope of Clinical and Medical Affairs functions, including clinical trials, clinical research, data collection, safety and medical information programs. This individual will be responsible for working closely with Research & Development to ensure an effective linkage to Phase I, II and III clinical trial design, strategy, and ultimately to NDA filing. He/she will provide leadership to the whole organization in moving compounds effectively into, and through, the clinic. We are looking for a dynamic high energy executive. 


RESPONSIBILITIES:

The VP of Clinical Research is responsible for ensuring effective design of experimental protocols, reviewing promotional materials for scientific accuracy, serving as the clinical lead for advisory meetings, and advising all levels of executive management in development and implementation of clinical strategy.


The VP of Clinical Research will provide leadership in establishing the studies essential for determining the safety, efficacy, and marketability of drug candidates. He/she will also serve as the principal medical monitor responsible for overseeing contract research organization (CRO) activities, the implementation of clinical trials, and for the interpretation of the results from investigations. The VP of Clinical Research serves as a key member of the executive team responsible for identifying/implementing the actions necessary to achieve corporate goals.


SPECIFIC DUTIES

?  Designs clinical trial protocols and selects Clinical Investigators and Clinical Research Organizations

?  Writes clinical sections of all regulatory documents, including the Investigational New Drug Application and Applications for marketing approval

?  Evaluates safety data from clinical trials and reports safety findings to regulatory authorities and licensing partners

?  Writes clinical study reports according to regulatory (FDA/ICH) guidelines

?  Reports status of clinical programs to Project Teams and Management

?  Supports Business Development licensing activities including the evaluation of the competitive landscape

?  Identifies and maintains liaison with leading investigators in the areas of medicine where products are being developed

?  Reports clinical study findings at professional meetings

?  Manages clinical trial budget for both CROs and study sites

?  Promotes continuing education and development of personnel system

?  Assists project teams to identify clinical indications appropriate for the investigational drugs

?  Assists research teams with the identification of new therapeutic areas of focus for potential drug candidates

 

ADDITIONAL REQUIREMENTS:

?  MD or MD/PhD degree with specialty/certification in internal medicine and subspecialty experience preferably in anti infectious drugs

?  Minimum 5+ years experience in a pharmaceutical or biopharmaceutical company, preferably in a fast-paced, dynamic environment.

?  Demonstrated expertise in managing complex collaborations and teams in support of executing clinical trials effectively, including effective management of projects and timelines and interpretation/evaluation of clinical data.

?  Must be knowledgeable with FDA requirements, good clinical practices, and pharmaceutical clinical development.

?  Demonstrated leadership experience, including excellent analytical, planning and communication skills in a dynamic environment.

?  Excellent oral, written, and interpersonal communication skills.

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