The purpose of the Senior 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.
The Senior Director of Clinical Research will be responsible for the Phase 2, PoM and SoCA trial designs and implementation of the study in collaboration with Pfizer 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 with the full scope of the Inflammation & Immunology Clinical drug development 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 phase development.ROLE RESPONSIBILITIES
- The Senior Director of Clinical Research will develop a disease specific global network of potential investigators and key opinion leaders (KoL) for the new therapeutic before PoM, SoCA or POC trial conception to assist in trial design, as well as management and recruitment of study, analysis, interpretation and presentation of results.
- 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.
- 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), ECD and GPD 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 the I&I RU 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 I&I RU as well as Centers for Therapeutic Innovation (CTI) and ECD.
- 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 GPD partners in design of POC studies and develop target clinical goals to benchmark success of POC and SoCA studies.
- Work on transition team with GPD 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 new therapy to the respective GDP.
- 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
Other Job Details
- Requires MD or MD/PhD (Dermatology specialty preferred, GI and other IM specialties (e.g, Rheumatology, Allergy/ Immunology, Hematology) also considered
- Technical Skills: Experience in generating hypothesis driven research investigations
- Five or more years of experience in biopharmaceutical sponsored clinical research is desirable. Biopharmaceutical experience as a medical monitor and clinical lead across therapeutic areas is desirable.
- 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.
Eligible for Relocation Package
Eligible for Employee Referral Bonus
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