Index Ventures

Position Purpose

This position is for an individual with clinical research/technical training to support the professional/doctoral level staff of medical research. The Clinical Research Specialist will provide support to the company’s medical directors and medical writers and assist in carrying out tasks that contribute directly to the success of medical research and new drug development. These functions include the support of clinical protocol writing, assembly and review, assistance with data handling and analysis for publications, publication preparation and review, and preparation of posters, regulatory documents, slide presentations, and materials for clinical investigator contacts and advisory boards.



ARIAD is a growing oncology pharmaceutical company with an exciting pipeline of new targeted agents and a diverse array of cancer clinical trials. The filing of a new drug application (NDA) is anticipated in the near future. The Clinical Research Specialist will assist the medical directors and writers on trial-specific and filing-specific tasks. The person in this supportive position will carry out the above described functions and will be a critical member of the clinical affairs team to facilitate the MDs and PhDs in fulfilling their roles in new oncology drug development.

Job Description


Provide support to the physician and medical writing staff of clinical research
Manage and oversee the clinical trial protocol writing process, consisting of assembly, review, amending, and archiving; interact with appropriate functions (e.g., regulatory affairs, clinical operations) in implementing protocols.
Manage the publication preparation process, including some data handling, review of draft manuscripts, abstracts and posters, and submitting to congresses and journals for publication.
Manage the production and review of internal documents, including supporting regulatory filings, yearly product updates, investigator brochures, and other related documents.
Assist in producing PowerPoint presentations for internal and external use.
Interact cooperatively and productively with the functions closely allied with medical research, including medical affairs, clinical operations and data management, biostatistics, safety and pharmacovigilance, regulatory affairs and commercial operations.
Also interact closely with business partners and/or alliance members in areas where joint production and review are requisite.
Report to the Vice President, Clinical Affairs

Key Skills and Attributes:

Technical Skills


Medical experience and background needed. Strong organizational, analytical and communication skills are required. Proficiency with computer software such as Word, PowerPoint, Excel, and Microsoft Project are desired. Knowledge and understanding of the oncology clinical trial process and GCP/ICH guidelines, and experience with NDA submissions/IND filings, medical publications or regulatory affairs are preferred.
Requirements


This position requires at least a bachelor’s degree. Advanced training in a medical field (e.g., nursing or pharmacy degrees) or a master’s degree would be supportive, although not required. Prior pharmaceutical or academic clinical research experience is preferred. Specific training or expertise in three broad areas would be ideal: 1) pharmaceutical or academic clinical research, 2) oncology and 3) medical writing. Regarding personal attributes, the qualified candidate will be motivated to succeed, possess strong oral and written communication skills, and be detail-oriented with organizational abilities. Excellent interpersonal skills, with a demonstrated ability to work in a team environment as well as independently, are required.

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