Pharmaceutical Clinical Associates, LLC
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Philadelphia,
PA
This position will provide Company clients with expert input into the design and implementation of clinical development programs of pharmaceutical products and medical devices in the field of interest and the assigned therapeutic area. This individual will also provide scientific, medical, and strategic support to Company teams across all departments. In addition, this position will have a major role in Supporting Business Development activities aimed at winning new operational and consulting projects for Company.
PRIMARY FUNCTIONS:
* Scientific, medical, and strategic consultancy
* Provide expert advice and detailed clinical development strategies for allocated project, including protocol development, study design, investigator brochure development, regulatory strategy, planning, and submission.
* Liaise with both internal and external experts, as needed, to serve the best interest of the client and produce high quality clinical development programs and other deliverables.
* Provide expert review/opinion in regulatory documents, filings, and dossiers (INDs/IMPs, NDAs, CTAs etc.)
* Attend meetings with Regulatory/Competent Authorities if needed with and on behalf of the clients. Support to Clinical Operations
* Provide scientific & medical support and guidance to the operational teams in all relevant aspects Company projects.
* Liaise and identify suitable Key Opinion Leader via professional network or feasibility asGsessment.
* Offer both general and therapeutic training, including preparation of training materials.
* Offer medical monitoring and/or drug safety support when appropriate and requested.
* Review Medical/Scientific Data as requested from Premier Departments e.g. CTM, Biometrics.
* Review documents produced by Medical Writing department and provide feedback and comments as needed.
* Provide consultation with project teams (and/or other senior personnel) to assist client management and communication.
* Ensure appropriate and timely communication with the relevant members of the project team and departments to maximize operational efficiency. Support to Business Development activities
* Provide expert input on RFP/RFI, including (but not limited to) therapeutic overview, executive summary, patient recruitment strategy, and protocol considerations if needed.
* Attend client meetings in conjunction with specific proposals or general capabilities presentations as needed.
* Leverage strategic collaborations with clients to expand the relationship and the services offered by Company.
* Provide account managers and other relevant personnel with scientific information and training if necessary so as to facilitate the interaction with targeted clients.
* Contribute to the development of marketing materials of Company.
* Raise the profile and image of Company within the Pharmaceutical Industry by representing the company in scientific/industry meetings, present and chairing panel presentations, contributing to the publications on peer-reviewed scientific and industry journals.
OTHER RESPONSIBILITIES:
* Maintain current knowledge and overall awareness in the primary field of interest, clinical development in general, and the assigned therapeutic area.
* Participate in mentoring and training of Company staff.
* Provide coverage for other colleagues within the Medical Affairs & SPD if needed.
* All other projects assigned
Experience and Skills:
EDUCATION/SKILL/EXPERIENCE REQUIREMENTS:
* An advanced degree in medicine, life science, biostatistics, psychology, or related fields.
* Expert level of knowledge in the main field of interest and/or assigned therapeutic area, together with a thorough working knowledge in pharmaceutical medicine or medical device fields, clinical development, GCP and regulations pertinent to clinical research.
* Excellent verbal and written communication skills.
* Excellent interpersonal and presentation skills.
* The ability to work independently as well as a part of diverse and international teams
* The ability to display leadership and mentoring qualities when needed.
* Good business acumen within the CRO and drug development environment.
* Able to handle and prioritize multiple assignments and to meet the deadline in a fast-paced working environment.
* Fluency in English is essential and working knowledge of a second language is preferable.
* At least 7 years experience in clinical research in academic, pharmaceutical, or similar environment, with emphasis on clinical study protocol design.
* At least 3 years of experience in the pharmaceutical or medical device industry.
* Those with medical or nursing background require at least 5 years of clinical experience.
* Previous experience of working in a CRO environment is a plus.
* Travel to approx 30%.
Additional Information:
Job Level: Any
Number of Openings: 1
Years of Experience:
Level of Education: Any
Salary: TBD
Starting Date : TBD
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Pharmaceutical Clinical Associates is always accepting employment inquiries from professionals interested in our opportunites. If you are interested in career opportunities at Pharmaceutical Clinical Associates please use our online resume formto apply. Pharmaceutical Clinical Associates is an Equal Opportunity Employer.
Philadelphia, PA
Philadelphia, Pennsylvania
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