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Search for Jobs by Sheryl Horowitz

VP, Clinical Research and Development (Science & Biotech)
Lexington, MA 02421
Recruited by: Sheryl Horowitz | Owner | F-O-R-T-U-N-E Personnel Consultants, Inc. See all my Jobs

  • Hiring Company: F-O-R-T-U-N-E Personnel Consultants, Inc.
  • Industry: Science & Biotech
  • Compensation: to be determined
  • Expires: Oct 03, 2019
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Job Description

Our client, a growing pharmaceutical company located in Mass., is currently growing their team!
We are currently looking for the company's new VP Clinical Research and Development. Responsibilities include, but are not limited to:

Under the direction of the Chief Medical Officer, the Clinical Lead will be responsible for building and executing on the clinical development plan for late stage product pipeline including, design, implementation, monitoring, analysis, and reporting of clinical studies. This person will also collaborate with the program team in developing the long-range strategic plans for programs for transition from early development phase(s) to late development phase(s) and approval(s)/launch(s). This position involves both high level strategic planning as well as hands-on responsibilities to support the growing pipeline. Provides on-going evaluation of additional potential therapeutic targets for diseases facilitating deep clinical due diligence.
• Act as a medical resource to the Company as a whole and provide advice on the medical field for the Company's general pipeline development
• Assisting in the overall management, planning, evaluation and documentation of programs and clinical studies
• Leading program-specific clinical development activities including:
• Integrate scientific rationale, regulatory requirements, product development plan, and commercial goals to build a solid strategic framework for Clinical Development Plans (CDP).
• Designing clinical studies and writing clinical trial protocols ensuring scientific integrity.
• Aligns with clinical operations and program management to establish appropriate clinical development timelines, incorporating key decision points and Go/No Go criteria and executing on said plans
• Preparation of regulatory documents and leading interactions with global regulatory authorities.
• Monitoring and reviewing clinical data for safety and ongoing study conduct
• Provide medical expertise in the review of adverse events (AEs) and contribute to pharmacovigilance activities
• Act as the Safety and/or Medical Monitor for Clinical Protocols
• Lead translational research programs to explore two additional indications with this program.
• Develops and maintains relationships with KOLs and other key medical experts.
• Collaborate with clinical operations and CRO in overseeing the medical conduct of clinical studies
• Provide medical expertise in the development, review and approval of Case Report Form (CRF) design, Informed Consent Form (ICF) design, site source documents, etc;
• Review and approve Statistical Analysis Plans (SAPs) and all tables/plots, prepared or designed by Department of Biostatistics for clinical statistical analysis;
• In conjunction with clinical operations, oversee the review and approval of the Clinical Study Reports
• Provide medical expertise in the review and approval of advertising for clinical trials
• Provide protocol specific medical training for the Clinical Research Associates/Site Monitors, as required
• Analysis, presentation and interpretation of study data, with integrated assessment as compared with published data
• Participation in the preparation of abstracts, posters and presentations for scientific meetings, congresses, and interactions with Key Opinion Leaders
• Attend kick-off meetings with investigational sites and provide medical/technical expertise to the sites during the clinical trial period, as needed.
• Interact with the site investigators when necessary
• Respond to FDA's possible questions regarding medical matters during FDA inspections
• Attend in-person meetings and teleconferences with the FDA or other regulatory or business entities in conjunction with other Company team members to represent the Company regarding clinical development, safety concerns, ADEs, clinical trial results, drug development pipeline, etc.;
• Contributes to the development of company strategic initiatives and specified Business Development activities.
Qualifications and Experience:
• Minimum of an M.D. or M.D., Ph.D degree(s), preferably in Cardiology/Rheumatology/Inflammation or rare disease field(s)
• Minimum of 10 years’ experience in clinical research, at least 5 years must have been spent in the biotech or pharmaceutical industry
• Previous work experience in biologics drug development
• Past work experience in late clinical stage development including Phase III trials
• Lead preparation of clinical sections of all relevant regulatory filings, BLA filing experience required
• Proven leadership, strong interpersonal skills and the ability to communicate effectively to scientific and non-scientific groups is required
• Experience working with health authorities in outcomes measures, presentations, negotiations and submissions
• Solid experience in medical research including experience in the conduct of global clinical trials
• Experience interpreting clinical data and generation of supporting regulatory submissions of clinical study documents
• Proven track record of delivery of experimental or novel studies
Other Competency Expectations
• High integrity, get-it-done-roll-up-your-sleeves attitude and committed to putting patients first
• Experience working effectively in a fast-paced, team-based environment
• Possesses sense of urgency; identifies challenges and problems and takes the initiative to identify solutions
• Strong verbal communication and technical writing skills
• Confidence in presenting at internal and external strategy meetings
• Project management skills and focus on delivering results.