BCBA delivering clinical - behavioral assessments and support plans for adults with disabilities at Vinfen. Collaborating with multidisciplinary teams to enhance clients' quality of life.
About the role
- Clinical Development Medical Director ensuring scientific integrity and well-being in clinical trials. Leading studies and delivering key clinical outcomes while maintaining compliance and managing risks.
Responsibilities
- Ensures medical & scientific integrity and the wellbeing of participants enrolled in clinical trials.
- Designs and executes high-quality studies, maintains compliance, manages risks and emerging clinical and medical issues, and supports interpretation and communication of clinical data.
- Acts as the primary contact for internal and external stakeholders for clinical and medical aspects the protocol.
- Supports strategic development and may provide matrix management.
- Autonomously and independently leads clinical execution of one or more studies of medium - high complexity and significant business impact.
- May be accountable for program level clinical deliverables.
- Contributes to continuous improvement / process enhancement activities and innovative approaches to maximize effectiveness of clinical trial execution.
- Provides clinical/medical input to support development of the protocol design document (PDD).
- Leads development of the protocol and ensures efficient protocols maximizing operational efficiency and minimizing the likelihood of amendments or quality issues.
- Performs medical monitoring on one or more clinical trials and provides study-related medical information and assistance.
- Responsible for providing clinical/medical input to statistical analysis plan (SAP), tables, listings, figures (TLFs), and blinded data review (BDR).
- Tracks and reconciles SAEs across a study and presents data during Safety Review Team meetings.
Requirements
- Obtained a primary medical degree (e.g., MD, DO, MBBS, MBChB) from a recognized medical school/university and has 4+ years of experience in biopharmaceutical industry in clinical research and development.
- Been licensed by a licensing body/health authority to prescribe medicines independent of supervision for at least 2 years post their intern/house officer/foundation period.
- Have maintained registration/Medical License to practice and always have been in good standing with their Medical Licensing Authority.
- Clinical research experience in phase 3/pivotal space.
- Demonstrated scientific writing skills; scientific productivity via publications, posters, abstracts, and/or presentations.
- Extensive knowledge of clinical development, global and regional regulation, ICH/GCP, adverse event management.
- Demonstrated clinical/medical, administrative, and project management capabilities, as well as excellent verbal and written communication skills in English, in relating to individuals both inside and outside Pfizer.
- Demonstrated experience establishing, managing, and training teams in clinical development.
Benefits
- Health benefits to include medical, prescription drug, dental and vision coverage.
- Paid vacation, holiday and personal days.
- Paid caregiver/parental and medical leave.
- 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution.
- Relocation support available.
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