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Sr. Vice President of Clinical Development

Cambridge, MA

Posted: 01/14/2021 Employment Type: Direct Hire Job Category: Clinical: Clinical Operations and Development Job Number: 2603

Job Description

Our client, a small biopharmaceutical company in Cambridge, MA, is looking to add a senior leader to their team on a permanent basis. Reporting to the CMO, the Sr. Vice President of Clinical Development will be responsible for setting and driving the medical and clinical strategies to meet or beat the timescales for regulatory approval.  They will supervise and lead teams to ensure the timely execution of clinical trials, and work  collaboratively with other members of the cross-functional team.  High-level inputs / oversight to such activities: Working with pre-clinical / translational medicine to bring new molecules to clinic; Relationships with Health Authorities (HA); Trial progress / CRO performance; Medical Affairs and the competitive landscape around cancer treatment modalities; and, Supporting business development and investor relations activity.

Responsibilities include:
  • Day– to-day leadership and direction of the combined Clinical Development, Clinical Science, Clinical Operations and Biometrics functions
  • Work closely with Chief Medical Officer to shape the medical and clinical strategies
  • Develop and drive the Clinical and Medical strategies leading to execution and delivery of timely regulatory approvals
  • Collaborate with colleagues in discovery research and pre-clinical development functions to move product candidates towards entry into clinical investigation
  • Responsible for driving Clinical Development plans, clinical trial protocols, clinical pharmacology, data analyses, clinical study reports, and other related clinical documents
  • Work with opinion leaders and expert consultants to keep development plans up to date with advances in clinical, scientific, regulatory and competitive environments
  • Work closely with Program Management to integrate resources, align operational activities between functions to maximize efficiency and meet timescales
  • Provide medical/clinical insight into competitive developments
  • Ensure the timely preparation of presentations reporting results of clinical trials to internal and external audiences
  • Line management
  • Work closely with Senior Management to coordinate clinical trial planning with budgets

Requirements / Qualifications:
  • An MD or MD PhD with at least 10 years of experience in Clinical Development
  • Ideally Board Certified (or the equivalent)
  • Solid experience in trial design and development planning
  • Familiar with the ancillary functions of biostatistics, regulatory affairs, pre-clinical, pharmacology, pharmaceutical sciences
  • Has led and shaped a successful multidisciplinary team
  • Can point to a record of successful drug development ideally having brought products to market
  • Knowledgeable of the main Regulatory bodies and capable of preparing for and helping the team manage interactions with the FDA, EMA etc.
  • Experienced in selecting and managing CROs and other third parties
  • Has a strong publication record in high impact oncology journals
  • Commercial awareness to allow contribution to R&D strategic operational decisions
  • Previous experience managing direct reports
  • Experience working on clinical trials with wide range of therapeutic areas
  • Strong leadership, planning and project management skills
  • Excellent interpersonal and negotiation skills
  • Strong verbal and written communications and presentation skills
  • Strong problem-solving skills with the ability to contribute creative, practical solutions to problems
  • Ability and willingness to travel up to 20% of the time

Meet Your Recruiter

Aaron Goldman
Principal Clinical Recruiter

Aaron is a spirited guy who likes to make things happen. He has been a Clinical Recruiter for the past nine years, and says his greatest reward comes when a candidate accepts an offer and he hears the excitement in their voice - You know you have helped someone change their life!

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