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Senior Medical Director

Location:

Boston

Work type:

Business sector:

Healthcare & Medical

Salary:

$250000.00 - $280000 per annum

Job reference:

JO-1903-528246

Start date:

2019-03-07

Contact email:

jimmy.mooney@talentinternational.com

Advertiser:

Jimmy Mooney

MEDICAL DIRECTOR

The Medical Director will provide clinical support to one or more Clinical Project Teams to ensure the successful design and implementation of Clinical Development Plans. This position will report to the Head of Metabolic Medicine. Major areas of responsibility include clinical trial design, medical monitoring of company ponsored clinical trials, clinical data analysis, internal and external communication of project information and plans and contributions to regulatory submissions, publications and presentations.

RESPONSIBILITIES:
  •  Lead the creation of clinical strategies and development plans for assigned programs in Phase I, II, or III of development, in consultation with cross-functional team members and outside consultants, to meet all requirements of the product development strategy
  •  Assist in the design of clinical trials and writing/review of clinical protocols and other critical study documents (Investigator Brochures, IND submissions, Clinical Study Reports, NDAs, etc.)
  • Provide ongoing medical monitoring for clinical trials including but not limited to assessment of eligibility criteria, toxicity management, and drug safety surveillance
  •  Play a key role in the development of analysis plans, and in the review, interpretation and communication of clinical trial data from Phase I to IV safety and efficacy trials; assist in generating the study reports and publications from these trials
  •  Participate in and lead investigator meetings
  •  Provide clinical, scientific and development expertise to regulatory activities as needed
  • Provide clinical, scientific and development expertise to business development initiatives as needed * Interact with external medical/scientific advisors, thought leaders and clinical investigators in the therapeutic area and with internal management and drug development staff to prepare/revise/maintain and efficiently execute the drug development plan * Assist in developing external advocates for the company's technology, products, and direction
  •  Facilitate the effective conduct of clinical trials: o Develop and maintain excellent working relationships with investigators o Ensure that all GCP requirements are consistently met
  • Deliver high quality scientific presentations on company technology, investigational agents and/or clinical study issues to investigators and clinical site staff
  • ​Provide guidance and/or training for external personnel/parties involved in Akcea's clinical studies 
  •  Perform clinical study data review and analyses in conjunction with Biometrics
  •  Support the Clinical Scientist and provide clinical education support for internal company customers
  •  Facilitate, assist and/or participate in the preparation of clinical study manuscripts by Investigators, internal personnel, and/or contract writers
  •  Maintain clinical and technical expertise in the therapeutic area; review scientific journals, attend scientific and key technical meetings and partner with company medical, research and commercial teams
  • Assist in accomplishing department and corporate objectives * Other duties as assigned


REQUIREMENTS
  • MD required; clinical practice and drug development experience highly preferred
  • Training in internal medicine or endocrinology with lipid management experience highly preferred
  • Previous industry experience as a study medical monitor or pharmacovigilance monitor or medical affairs role is preferred
  • Advanced knowledge of Good Clinical Practice (GCP) for conduct of clinical studies and associated FDA regulations for pharmacovigilance/safety reporting is required; international experience with safety reporting for foreign regulatory agencies is preferred
  • Experience with technical writing of clinical sections for FDA dossiers, study reports, clinical protocols, and SAE narratives is preferred 

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