Director, Clinical Development

Do you have experience in Clinical Development?  Have you planned, conducted and monitored sites in clinical trials? Have you been successful?  Do you have experience preparing clinical sections of INDs, PLAs or NDAs? Are you interested in working at a small pharmaceutical company that have 3 drugs in PhII/PhIII clinical trials?



A well-funded, small pharmaceutical company, located in the Boston area, is searching for a Director of Clinical Development. This company needs someone that can lead clinical and technical professionals in a commercialization environment to bring their drugs to market. We need a person that can work in a small company and who can create good relationships with sites, internal colleagues, manufacturing, etc.  You have to be able to take the leadership role and handle the responsibility of all aspects of your drug.  This role is a critical one in the company as the directors have global responsibility for their drug product and must be able to take total responsibility of all milestones associated with the timeline.  We are looking for experienced people that have great experience and strong leadership skills.

 

This company has been in business for 7 yrs and is building up it's clinical team. We will consider Clinical Project Managers or Clinical Study Managers with extensive experience handling trials (especially on the sponsor side), but then finding themselves unable to move up in other companies.



Responsibilities:

*Plan, conduct and monitor sites during clinical trials (full responsibility)

*Represent the Company on teams, task forces, and meetings with others to exchange technical data and negotiate courses of action on behalf of Clinical Affairs

*Supervise activities of clinical staff

*Assist in the identification, evaluation, and recruitment of investigators, negotiation grants and project budget

*Independently prepare clinical sections of protocols, amendments, investigator brochures, interim and final reports; Reviews and interpret pertinent clinical data

*Conduct investigator and expert meetings relevant to the applicable indication

*Resolve patient eligibility and protocol deviation issues

*Manage protocol specific activities of outside contractors (independents, contract research organizations, central laboratories, etc.)



Experience:

*7-8 years of related experience in clinical research or clinical trial supervision

*4-6 years of clinical development experience (including CRA), and previous formal supervisory management experience (vendors, CRAs)

*Demonstrates comprehensive and current knowledge in relevant therapeutic or product area

*Demonstrates ability to use scientific knowledge to conceptualize clinical study design with minimal guidance

*Detailed knowledge of regulations and guidelines coupled with experience, judgment and ability to anticipate and resolve problems

*Demonstrates ability to write clearly and document activities and effectively present ideas (both written and oral)

*Good communication skills including appropriate use of medical scientific terminology; Ability to work effectively in a team environment, demonstrates interpersonal, organizational and planning skills

*Proficiency in independent preparation review of clinical sections of Investigator Brochure, study reports

*Demonstrates supervisory skills, including effective coaching and counseling of subordinates

*Proficiency in independently developing budgets and overseeing expenditures

*Demonstrates successful outside collaboration skills, e.g. selection, contract negotiation, and management of CRO or other vendors

*Demonstrates scientific knowledge, e.g. experience in preparation and presentation of clinical data poster at a scientific meeting, presentation at Journal Club, or in service programs to study site personnel

*Experience in at least 2 phases, products, or therapeutic areas of pre-approval clinical trials

*Computer operation skills

*Demonstrates ability to maintain a constructive problem-solving attitude while dealing with time demands, incomplete information or unexpected events

*Demonstrates ability to use scientific knowledge to independently conceptualize clinical study design

*Demonstrates scientific contribution in related product or therapeutic area

*Depth of knowledge to represent the Company to evaluate strategies for clinical development in one or more product or therapeutic areas and to critically evaluate outside expert advice

*Proficiency in clinical studies involving complex design issues (e.g., multiple arms, crossover, double blind, multi-center), typically acquired with experience in all phases of pre-approval clinical trials

*Experience in independent preparation of clinical sections of IND, PLA, or NDA.

*MS, MPH PhD or Pharm degree preferred



Are you the right person for this position? If so, please forward your resume as a word document with a daytime phone number so that we may discuss this opportunity. Only qualified candidates will be contacted.



Thank you for your consideration.



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