Senior Director managing execution of clinical trial programs to advance gene therapy. Leading clinical operations, ensuring strategic execution, and mentoring clinical teams across multiple clinical programs.
About the role
- Associate Director role at Pfizer executing early clinical research studies for small molecules and novel therapies. Leading and collaborating on clinical protocol development and safety assessments.
Responsibilities
- Scientific leadership and execution of clinical studies, delivering innovative clinical study designs, high quality trial execution, safety assessment and interpretation of clinical study results
- Lead preparation of study related documents, including clinical protocol, informed consent document, and study training materials
- Conduct data review, analysis and interpretation of clinical trials data together with the GCL, Clinical Safety, and Biostatistics/Data Management
- Collaborate with the study team to maintain open transparent communications and ensure successful study completion
- Develop expertise working with Pfizer clinical checklists and Standard Operating Procedures (SOPs) to ensure compliance with good clinical practice (GCP), regulatory agencies, and Pfizer processes
- Apply knowledge gained within the Internal Medicine Early Clinical Research group by way of process improvement
- Develop expertise navigating Pfizer compliance systems, registries and other study systems related to the study
- Serve as technical resource for clinical issues raised by internal and external collaborators, investigators, consultants and contractors
- Support clinical development implementation and contribution to key development milestones
Requirements
- BA/BS/BSN with 4 years of clinical study experience OR MA/MBA/MS with 2 years of clinical study experience
- Two years of relevant experience in a clinician type role with a proven track record executing development programs to completion or targeted milestone preferred
- Demonstrated experience in (and understanding of) drug development especially in Early Development
- Familiarity with related disciplines (biostatistics, regulatory, clinical pharmacology, pharmaceutical sciences)
- Must have proven scientific writing skills and good communication skills
- Strong interpersonal skills and expert team player with demonstrated ability to build consensus and drive change across all levels of the organization including senior management
- Ability to work collaboratively in a fast-paced, team-based matrix environment and to function independently as appropriate
- Candidate demonstrates a breadth of diverse leadership experiences and capabilities including the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact
Benefits
- 401(k) plan with Pfizer Matching Contributions
- Additional Pfizer Retirement Savings Contribution
- Paid vacation, holiday, and personal days
- Paid caregiver/parental and medical leave
- Health benefits including medical, prescription drug, dental, and vision coverage
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