Total 2 job vacancies by 140 Pfizer Inc

• This position will be the global clinical lead for a medicine with one or more indications within the Oncology Research and Development organization and will provide strategic and technical guidance at an asset and/or indication level, as well as coordination and support to Oncology Clinical Leads, Medical Monitors and non-MD clinicians.
• Provides therapeutic area clinical expertise to a project(s) and maintains state of the art knowledge in Prostate Cancer.
• Provides oncology expertise and clinical leadership to the Global Medicine Teams.

Contribution to Projects:

• Accountable for developing and delivering the integrated clinical development plan that is consistent with the overarching strategy and vision for prostate cancer, with well-designed studies and the most efficient use of budget and resources, and risk and quality assessment. 
• Leads design, implementation, and interpretation of pivotal studies as part of the global clinical program (one or more indications) for a drug candidate to deliver a successful regulatory submission worldwide, working closely with the Development Head.
• Single point of contact for Clinical Development to the Medicine Team, and leader of the Clinical Sub-Team related to assigned assets or indications.
• Leads the preparations of the clinical content of regulatory submissions/documents (e.g., NDA, MAA, IND, sNDA, IB, AR/DSRU, label changes, Core Data Sheet, Package Insert).
• Provides clinical input in the preparation and execution of meetings with health authorities, including leading discussions with regulators and leading/contributing to regulatory query responses.
• Maintains and enhances knowledge in relevant therapeutic or technical areas and in global regulations/guidelines.
• Creates and maintains a network with key opinion leaders.
• May organize expert panel, consultant or advisory board meetings to provide input to clinical development plans.
• May be an active member of an alliance partnership team.
• Supports business development initiatives, as appropriate, and as such may design/conduct/review protocols as a member of a due diligence team.

• Represents the Clinical line on the Publication Sub-Committee and contributes to designing the publication strategy for the asset(s), including review of abstracts, posters, and presentations and ISRs for for scientific meetings and publications.

• Represents the clinical line on project-related teams and cross-divisional committees.
• Interfaces with other Pfizer sites, other TAs and other functions to share best practices, as appropriate.

Management:

• This position may have direct reports, including oncology clinical leads and clinicians

Leadership attributes:

• Articulate, inspiring, and decisive leader who can apply cost effective, time efficient and high-quality approaches to drug development.
• Excellent presentation, written and oral communication skills with the ability to adapt and deliver effective presentations in a wide variety of settings and audiences, tailoring presentations to the knowledge level of the audience to suits needs and maximize understanding.
• Significant degree of independence, willing to take on special projects; unique study designs such as incorporating RWE.
• Development and Fostering of Clinical Development Best Practices by establishing an effective network within the Pfizer ORD community, ensuring sharing of knowledge and best practices.
• Facilitate transparent and regular communication with Medical Monitors and non-MD clinicians with regard to study status to surface key risks and opportunities, escalating unresolved issues to the Development leadership.

Qualifications:

Training and Education:

• MD or MD/PhD
• Board certified/eligible in Oncology or equivalent qualification
• Prior development or academic expertise in prostate cancer required.
• Strong academic background as showcased through multiple publications in peer reviewed journals, strongly preferred.

Prior Experience:

• Demonstrated accomplishments or formal training in Oncology
• 10+ years of clinical development experience in the health sciences, preferably GU oncology stretching academic and industry career.
• 2+ years pharmaceutical industry experience (minimum depending on academic experience prior to industry)

Key Competencies and Characteristics:

• IND/NDA/MAA submission experience (absolute requirement)
• Proven ability to lead a team in a complex matrix environment
• Demonstrated business acumen
• Acts decisively
• People management experience

Location is hybrid - must be on site 2.5 days per week.

Multiple locations available.

#LI-PFE

Relocation assistance may be available based on business needs and/or eligibility.

ROLE SUMMARY

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 in Neurology focused programs. 

• 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 a focus on clinical drug 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 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), 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.
   
• 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 I&I RU and PRD 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 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, neurology specialty required, but other specialists with experience in neurology clinical trials will be considered.

Technical Skills: Experience in generating hypothesis-driven research investigations.

Five or more years of experience in biopharmaceutical sponsored clinical research, with a minimum of two in neurology. 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.

This role is relocation eligible.

Relocation assistance may be available based on business needs and/or eligibility.