Director , Clinical Research (MD required)- Immunology, and Inflammation

The purpose of Director of Clinical Research role is to coordinate and lead the development of first in man (FIH), proof of mechanism (POM), proof of clinical activity (SoCA) and proof of concept (PoC) and dose ranging studies for novel biological and small molecule therapies in Immunology, and Inflammation programs.  

·        The Director of Clinical Research will be responsible for phase  1, 2, PoM and SoCA trial designs that will e developed in collaboration with statistics and clinical pharmacology lines. They also will be involved in the  implementation of the study in collaboration with Pfizer clinical development operations and the project team to meet enrollment and study delivery timelines.  The clinical 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 individual will be involved in  in activities from discovery research through PoM, SoCA and PoC studies. They will be a key member on project teams to collaborate with Early Clinical Development (ECD) and ensure seamless transition of the new asset to the Pfizer Global Product Development (GPD) for Ph3 development. 

ROLE RESPONSIBILITIES  

The Director of Clinical Research will be responsible for the following:

-Design PoM, SoCA or POC studies in consultation with KOLs and Pfizer project team members (Stats, Clin Pharm, Regulatory, Operations, etc.). 

·        Develop the primary and secondary endpoints for efficacy and safety and contribute to the precision medicine and biomarker strategy as well as to the biostatistics analytic plan that is aligned with the transition target product profile. 

-Develop a net-wok or consultants and KoLs for programs in new indications

·        Sit on project teams from FIH/POM/SOCA 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 PoM, SOCA 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 the Inflammation and Immunology Research Unit (I&I RU) (Discovery, Pre-clinical and Systems Immunology), Clinical Pharmacology and Bioanalytics, Statistics, and Research and Developments (PRD) teams by maintaining open communications and ensuring successful program transitions.

• Foster a transparent environment that encourages strong trust between teams, sub-teams, and leaders.
• Coordinate with other clinical research activities in the I&I RU and greater PRD 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 research project leaders and projects team members, including biostatistics, regulatory affairs, clinical pharmacology, clinical scientists and development operations. 
   
• Develop effective collaborations with key PRD partners in design of POC studies and develop target clinical goals to benchmark success of POC and SoCA studies.  

• Work on transition team with Late-stage development colleagues to analyze and interpret final POC clinical data in achieving study objectives and develop the phase 3 clinical strategy to support seamless transfer of the asset to the respective Phase3 team. 

• Establish relationships with external experts, consultants, opinion leaders, regulators and disease specific investigator networks. 

The applicant will have the opportunity to participate in strategic assessment of I&I RU portfolio, and Business Development activities. 

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. 

QUALIFICATIONS  

Education: Requires MD or MD/PhD, specialists with experience in  Rheumatology, Allergy, Pulmonary,  Hematology, and  Dermatology clinical trials will be considered.