VP, Clinical Development

Responsibilities

  • Leading the development of all clinical protocols
  • Assisting in the identification of clinical investigators and coordinating their activities in conducting clinical trials and medical advisory board meetings
  • Managing and maintaining strong, effective relationships with our global vendors, consultants, investigators, and other external clinical trial participants to ensure that the primary goals of the clinical development programs are met
  • Managing medical strategy, questions, and internal and external relationships that are related to our clinical programs
  • Monitoring/analyzing clinical trials for safety and, when appropriate, efficacy, and working in conjunction with external Drug Safety vendors to insure timely reporting of safety signals to regulatory authorities
  • Providing medical review and author content for the Informed Consent Form template and subsequent drafts as necessary
  • Reviewing clinical data and authoring its translation into the investigational brochure updates and DSUR
  • Leading submission of essential documents to the TMF and Regulatory Department, as necessary;
  • Managing and coordinating deliverables, per vendor and CRO contracts, to ensure project deliverables are met on time and within budget
  • Reviewing and contributing the necessary templates and documentation (i.e., manuals, guides, communication plans) for each clinical study
  • Assisting with the generation, analysis, and presentation of clinical data, including manuscripts, abstracts, and oral presentations (including authoring documents and slide preparation as appropriate)
  • Communicating in a timely and effective manner with executive management and others, on clinical trial status and activities
     

Qualifications and Experience

  • Ten or more years of experience leading or overseeing Oncology related pharmaceutical development projects to include managing such projects across multiple functional areas.
  • Demonstrated ability to successfully execute development plans
  • Phase 2/3 experience is preferred
  • Significant experience with NDA/BLA preparation and submissions
  • Experience with projects relating to Oncology
  • Demonstrated ability to lead and influence experienced professionals
  • Ability to lead in a fast changing environment
  • Broad knowledge and exposure across all R&D functions
  • Deep understanding of pharmaceutical development
  • Strategic thinker
  • Strong execution skills

 

Aileron has an engaging culture of innovation and team work and we are continuing to build a top-tier team to rapidly advance our programs in a fast-paced, collaborative work environment. We offer a robust benefits package including premium health/dental plans with industry leading company contribution, 401(k) retirement plan, incentive stock options, 3 weeks vacation, frequent catered lunches, and professional and career development.
 

Please forward your CV/resume to Careers@aileronrx.com

Aileron Therapeutics, Inc. 281 Albany Street, Cambridge, MA 02139

www.aileronrx.com

Brenda Duane