Senior Medical Director - Drug Development - Boston

Posted 06 September 2019
Salary US$120 - US$200 per hour
LocationBoston
ReferenceBBBH89036_1567802079
Contact NameElizabeth Kennedy

Job description

Investigo are working with a Biotech in Boston to source a contract Senior Medical Director. You will be responsible for working with the CMO in the overall clinical development strategy and design of specific clinical to include the design of modelling and simulation-based assessments for all clinical projects. Along with this, the Medical Director will serve as the primary Medical Monitor responsible for monitoring the safety of enrolled subjects on assigned trials. This individual will work on multiple trials in Phases 1 through 3.

Job Description

  • Participates in the development of Study Protocols, Investigator's Brochures, Clinical Development Plans and other key study documents in conjunction with other line functions and with minimal guidance
  • Participates in the preparation of regulatory documents in support of regulatory submissions, including clinical section of IND's and CTA's, IND safety reports and annual reports for assigned trials, responses to regulatory authorities and Ethics Committees/IRBs, and other documents as appropriate
  • Provides scientific and clinical input to study-related documents and analysis plans including Informed consent forms (ICF), clinical research forms (CRF), statistical analysis plans (SAP), clinical pharmacology analysis plans (CPAP), and clinical study reports (CSR)
  • Acts as liaison between Clinical Development and other internal groups for assigned studies
  • Develop and execute life-cycle management plan, lead data generation activities such as medical affairs studies to unmet medical needs and data gap
  • Partner with pharmacovigilance to assess the safety profile of compounds
  • Maintain a high level of clinical and scientific expertise in the disease area(s) by reviewing the literature, attending medical/scientific meetings, and through personal interchanges with consultants, thought leaders, investigators and internal stakeholder
  • Author manuscripts and collaborate with cross-functional colleagues and thought leaders to meet publication plan objectives
  • As required by program needs, contribute in partnership with Discovery colleagues to the design and implementation of translational strategies
  • Has overall responsibility for leading clinical study teams, monitoring overall study integrity, and review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule
  • Present at scientific, medical and regulatory meetings globally
  • Develop and maintain relationships with academic investigators, pharmaceutical partners/sponsors, KOL's, and patient advocacy groups
  • Contribute to activities in support of the company's planned NDA submissions
  • Author clinical sections for INDs, NDAs, and other related documents

Requirements

  • MD, DO or equivalent ex-US medical degree
  • 5-10 years clinical research experience in an academic or industry setting
  • Pharmaceutical/Biotech industry experience, including time managing clinical trials and/or clinical development program(s)
  • Excellent oral and written communication skills
  • Ability to work collaboratively in a fast-paced, team-based matrix environment and to function independently as appropriate

For more information on this role or any others throughout the US, then please reach out to Lizzie Kennedy at Investigo on 646-887-9267 or email lizzie.kennedy@investigo-us.com