The Director of Clinical Research will be responsible for the Phase 2 (POC) and early signal of efficacy (ESoE) trial designs and implementation of the study in collaboration with Pfizer development operations and the project team, to meet enrollment and study delivery timelines. POC study lead will be the primary liaison for investigators who have enrollment or extraordinary protocol issues that require escalation and may need to conduct study site visits to ensure timely delivery of the study.
The Director of Clinical Research will develop a disease specific global network of potential investigators and key opinion leaders for the new therapeutic before POC or ESoE trial conception to assist in trial design, as well as management and recruitment of study, analysis, interpretation and presentation of results.
Design POC studies in consultation with KOLs and Pfizer project team members.
Develop the primary and secondary endpoints for efficacy and safety, precision medicine and biomarker strategy as well contribute to the biostatistics analytic plan that is aligned with BU transition target product profile.
Sit on project teams from FIH/POM/ESoE through POC trial completion to ensure that clinical development strategies are in place, being implemented and are contributing to key development milestones, e.g. start-up and delivery of ESoE and PoC trials.
Accountable for safety across the study, including regular review of safety data (including but not limited to serious adverse events) and response to safety issues.
Provide leadership to the clinical function in preparation of critical documents, including but not limited to clinical protocol, clinical development plan, investigator brochure, statistical analysis plan and regulatory documents.
Expand the culture of collaboration between the clinical team and partners in both research and business units by maintaining open communications between the two groups and ensuring successful program transitions.
Foster a transparent environment that encourages strong partnerships and mutual trust between teams, sub-teams, and leaders.
Coordinate with other clinical research activities in PharmaTherapeutics and greater World-Wide Research and Development (WRD) organization.
Maintain up-to-date knowledge of scientific and clinical published literature in relevant therapeutic areas including the key clinical development issues.
Develop effective collaborations with key partners in Pfizer Discovery Research Unit (RU) (Rare Disease) as well as Centers for Therapeutic Innovation (CTI) and Precision Medicine.
Develop effective collaborations with project leaders and projects team members, including biostatistics, regulatory affairs, clinical pharmacology, genetics, PM and development operations.
Develop effective collaborations with key Business Unit (BU) partners in design of POC studies and develop target clinical goals to benchmark success of POC and ESoE studies.
Work on transition team with BU colleagues to analyze and interpret final POC clinical data in achieving study objectives and develop the phase 3 clinical strategy to support seamlessly transfer of the new therapy to the respective BU.
Establish relationships with external experts, consultants, opinion leaders, and regulators and disease specific investigator networks.
The applicant will have the opportunity to participate in strategic assessment of PharmaTherapeutics portfolio.
Basic Qualifications
MD or MD/PhD REQUIRED (Neurology experience preferred)
Neurology/Internal Medicine/Pediatric trained physicians with completed subspecialty training with industry experience in clinical trials.
Technical Skills: Experience in generating hypothesis driven research investigations
Two or more years of experience in biopharmaceutical sponsored clinical research is desirable. Biopharmaceutical experience as a medical monitor and clinical lead for translational medicine projects across therapeutic areas is desirable.
Strong background in Academic Clinical Research at least to Junior Faculty level required in the absence of biopharmaceutical experience.
Good understanding of relevant areas such as biostatistics, regulatory, clinical pharmacology, pre-clinical toxicology, pharmacogenomics and biomarker based approaches.
Ability to analyze and interpret complex datasets.
Ability to operate with a sense of pace and urgency in matrixed project teams.
Exercises initiative in meeting goals and drives innovation in projects.
Demonstrated scientific productivity (publications, abstracts, etc.).
Good communication and presentation skills as well as proven scientific writing skills.
Additional Offer Details:
Grade: 19
Eligible for Employee Referral Bonus - Yes
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