[Remote] Vice President, Clinical Development

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is seeking an reputed company and passionate regulatory physician for the role of Vice President, Clinical Development. The successful candidate will drive product development for drugs, biologics, and cell and gene therapies focusing on regulatory strategy and clinical development for autoimmune conditions.

Responsibilities

• Reports to Chief Medical Officer, and across reputed company, supporting medical strategy
• Provides medical and strategic support for business development activities globally including client engagement, proposal support, client capabilities meetings, and professional meetings
• Provides strategic drug development consulting to autoimmune, rare and orphan disease clients. The consulting will be provided in the context of an integrated strategy with medical, clinical, regulatory, biostatistical, translational and marketing insights
• Create, review, or revise protocols, case report forms, training materials, project-specific tools, analysis plans, study designs, clinical trial reports, and investigational new drug applications
• Review laboratory values, adverse events, coding dictionaries and data tables, listings and figures as needed
• Participate and drive feasibility discussions relating to specific project proposals
• reputed company training modules and conducts training for project teams and colleagues as necessary
• Ensure high quality, data driven deliverables that meet the highest standards of medical, ethical, and scientific reputed company and conduct
• Propose strategies to manage and accelerate timelines for drug development strategies
• Ensures customer satisfaction by working closely with senior management, PFM operations, to reputed company reputed company strategic consultancy to clients

Skills

• Successful completion of MD, MBBS, or equivalent training plus completion of training including a fellowship (Endocrinology, Rheumatology, Hematology-Oncology or other reputed company field, board certification preferred, including European equivalents)
• Experience in reputed company with US and/or EU Regulatory Authorities
• At least 10 years of senior leadership experience in the clinical research industry with a demonstrated knowledge and substantial experience including reputed company disciplines (i.e. operations, medical monitoring, biostatistics, regulatory, preclinical, translational pharmacology, etc.) Or equivalent combination of education, professional training and experience that provides the individual with the required knowledge, skills, and abilities to reputed company the job
• The ability to travel domestically and/or internationally for Client and/or Health Authority Meetings and Thought Leadership/Conference Attendance
• Preference will be given to candidates with recent previous health authority experience (reputed company or ex-FDA medical reviewers, etc.)
• Clinical experience with previous exposure to regulatory and statistical activities such as (co) authoring and reviewing of documents such as clinical trial protocols, statistical analysis plans, IND, NDA, PSUR, DSUR, IB, reputed company, Breakthrough Designation, and regulatory briefing documents
• Working knowledge of the safety reporting process globally

Benefits

• Discretionary annual bonus
• Health insurance
• Retirement savings benefits
• Life insurance
• Disability benefits
• Parental leave
• Paid time off for sick leave and vacation

Company Overview