Vice President Clinical Development

Vice President Clinical Development

Therapeutic Area: Solid Tumor

Location: New York City

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Our publicly traded clinical stage biotechnology client has tasked Scientific Search in finding them a Senior Medical Director/Vice President Clinical Development - Solid Tumors. The primary responsibility of the role is to lead all aspects of the clinical development of one or more assets in solid tumors. This includes the planning and execution of clinical trials, thus playing a leadership role in integrating medical activities, Clinical Operations activities, and Clinical Research Organization (CRO) activities towards the goal of efficiently completing clinical trials and clinical development programs.

Responsibilities

• Responsible for the planning and execution of clinical studies in order to successfully move programs though the clinical research process in a timely manner, in adherence with Good Clinical Practice (GCP), appropriate Standard Operating Procedures (SOPs) and government regulations.
• Work closely with the CMO to carry out clinical research priorities of the company
• As Program Director for one or more clinical development programs, lead clinical development strategy in solid tumor as well as the execution of the clinical development plans
• Manage a clinical development team that will include other physicians and clinical operations staff, as appropriate for the development stage of the project
• Supervise the writing and execution of clinical protocols and all supporting documents, including Informed Consent Forms (ICFs); Investigator Brochures (IBs); Imaging, Nursing, and Pharmacy Manuals; Data Monitoring Committee (DMC) and Endpoint Adjudication Committee (EAC) Charters; and all CRO-specific plans, and maintain these documents as needed due to protocol amendments
• Oversee clinical trial site selection, CRF design, and other clinical trial activities.
• Perform clinical review of data listings and review essential study data
• Supervise the negotiation of clinical budgets, including investigator fees and vendors
• Create and/or review clinical slides for internal and external meetings
• Plan and lead investigator meetings
• Participate in Safety Advisory Boards and track or analyze any potential safety event within a given study and across studies
• Work with Regulatory Affairs in drafting clinical sections of pre-FDA meeting packages and participate in FDA, or other health authority, meetings as needed
• Lead cross-functional project team meetings
• Manage relationship with outside vendors, such as National Marrow Donor Program or specialty laboratories
• Hire staff for clinical development and clinical operations positions
• Travel to sites to develop relationships with key stakeholders, as well as travel to meet with key vendors

Requirements

• MD degree
  • Minimum of 8-10+ years of experience in clinical research required
    • Minimum of 5 years' oncology experience - strongly prefer clinical research experience be mostly in the field of solid tumor
• Prior pharmaceutical industry experience essential
• Experience with radio-immunotherapy drugs is a plus
• Strong interpersonal and communication skills
• Strong presentation skills
• Training in GCP and knowledge of the research process, of the importance of adherence to protocols, and of the accuracy needed in collection and documentation of research data
• Must have the ability to obtain and interpret clinical data as it relates to the diagnosis and treatment of research subjects in company clinical trials
• Adherence to the highest ethical standards

For immediate consideration please email Tom O'Hanlon, at Tom@Scientificsearch.com

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• Type: Direct Hire
• Category: Biopharmaceutical Company