Head of Clinical Excellence will report to the Head of EODCR within the Oncology R&D (ORD) organization. He/she will play a key leadership role in EODCR efforts to implement innovative first in human clinical trials of novel oncology agents integrated into overall clinical portfolio strategies, reduce clinical study cycle times, understand and address roadblocks efficiently, enable rigor, objectivity and innovation to be practiced by EODCR members, and establish early alignment with other key cross-functional leaders and stakeholders across multiple research units in the organization.ROLE RESPONSIBILITIES/DELIVERABLES
Implement innovative first in human clinical trials
- Partner with teams/team leaders to implement innovative, expedited, cost-effective early clinical development approaches with input from key stakeholders.
- Coordinate EODCR efforts to clinically influence ORD oncology development concepts as early as possible (e.g. from Discovery phase)
- Drive innovations in early clinical development, and the application of translational oncology and precision medicine Approaches.
- Member of Technical Review Committee (TRC) and Protocol Review Committee (PRC) to contribute to rigor, objectivity and innovation in clinical development plans and protocols.
- Together with EODCR head, keep r leaders across the organization informed about priorities for and progress in early oncology clinical development
- Improve communication and interactions among the different Pfizer oncology clinical development teams: ORD, GPD and Boulder RU.
- Implementation of PK-guided dose escalation, early combination strategies and emerging innovations on all ORD first-in-human clinical trials with input from preclinical, GPD, regulatory, clin ops, pharm sci, asset teams.
- Meet regularly with ORD group leaders/surrogates in Tumor Biology, Cancer Immunology, Cancer Vaccines, Translational Sciences, Discovery and Operations to increase mutual awareness and influence of emerging program targets, priorities and status.
- Coordinate regular (at least quarterly and as needed) interactions with preferred clinical trials network and KOL advisory board and efforts to objectively consider and implement feedback.
- As member of TRC and PRC, review and contribute to every clinical trial approach and study protocol.
- Implement and lead quarterly oncology portfolio review meeting with EODCR, GDP and Boulder RU; summarize and present feedback to key stakeholders, including ORD-LT.
Reduce phase 1 oncology cycle times and understand and address roadblocks efficiently
- Identify and address rate-limiting steps (RLS) in early clinical development: IND-enabling nonclinical study timelines, response to FDA IND comments, site/PI selection/activation, risk management, data review, dose escalation times, protocol amendment times, early combinations, governance, alignment with GPD.
- Serve as primary interface between EODCR and Project ROCYT
- Scientific, Clinical, Strategic input to CDP (TRC), protocols (PRC).
- Assemble RLS review team, undertake regular review and regularly present findings to ORD leadership (and other stakeholders)
- Achieve measurable improvement in cycle times using objective, goal-oriented criteria established in partnership with Portfolio and Operations
- Establish an EODCR preferred phase 1 site network expanded from current 10 US sites (goal ~20-30 sites in the US and ~10 sites ex US). In this role collaborate and align with leadership in Clin Ops and GSSO.
Enable rigor, objectivity and innovation
- Provide continuous competitive assessment of ORD assets utilizing all available sources of information: manuscripts, conferences, quarterly update, analyst reviews, etc.
- Engage with EODCR/ ORD colleagues to ensure relevant presentations are "covered", summarized and disseminated to key stakeholders.
- Collaborate with Portfolio & Operations to implement new format for EODCR Quarterly reports summarizing current state of ongoing programs
- Maintain up-to-date knowledge and review of the latest developments within the broader field of Oncology and other therapeutic areas.
- Summary deck and presentation to ORD/EODCR for relevant meetings (ASCO (Annual, GI, GU), AACR (Annual, Triple Meeting), Annual Meetings of ESMO, ASH, SABCC, Investor Meetings (JPM), manuscripts as they are published.
- New monthly/quarterly report
- Establish alignment across the organization
- EODCR Scientific and Strategic leader for BD diligence efforts
- Partner with stakeholders to provide clinical data review of early stage BD opportunities. Organize deeper diligence efforts requiring EODCR input.
- Represent EODCR head on Oncology TASOT and late stage commercial BD teams.
- EODCR representative on key teams/projects across ORD and Pfizer, including:
- EODCR Patient Engagement Team (Chair)
Pfizer - AbbVie PTK7 JSC
- Oncology Diagnostics Development Advisory Forum (Comprising Leadership from EODCR and GPD)
- Relevant Franchise Teams (eg Prostate)
- Pfizer - MD Anderson Strategic Alliance Clinical and Translational Oncology JSC
- Pfizer ORD Digital Steering Committee
- EODCR Global Strategy Engagement Team (Chair)
- Regular written output of diligence efforts to be shared with key stakeholders (EODCR, ORD leadership) as appropriate.
- Organize and Conduct engagement activities with patients, patient advocacy groups and EODCR members with longer term Goal of incorporation of Patient input into Protocol and Informed Consent documents.
- In alignment with ROCYT / BM 2.3, (i) identify and engage potential additional US clinical sites for inclusion in the current Phase 1 Network, and (ii) identify and engage additional clinical sites to establish a similar and complementary ex-US Network.
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.
- Candidates with MD, PhD, DVM, PharmD or MS, with post-graduate clinical training/development as well as experience in clinical medicine and drug development.
- At least 15 years of experience in Drug Development with a strong understanding of the elements of drug development programs, experience in the design and execution of programs and the successful execution of a major component of a drug development program.
- A minimum of 15 years of relevant post graduate experience in the pharmaceutical, academic and/or medical research environment.
- Significant industry leadership experience in clinical, translational or basic research in biomedical sciences or one of the disciplines related to drug development.
- Demonstrated history of effective leadership; including cross functional and matrixed teams, managing direct reports, and experience in seeking and maintaining alignment with cross-functional leaders.
- This position requires a decisive leader who can apply sound scientific judgment, together with cost-effective, time-efficient and high-quality approaches to drug development.
- Ability to build consensus and resolve challenges together with other leaders, while maintaining positive working relationships across functions.
Other Job Details:
- • Reports directly to the Head of Early Oncology Development and Clinical Research
- • Sits on the EODCR Leadership Group to establish Clinical and Development Strategy and Goals in alignment with broader ORD Goals, consistent with the 'One ORD Model".
- Establishes collaborative relationships and alignment with the ORD CSO, ORD Research Heads, ORD PTL and ATL Leadership, as well as leadership of key cross-functional partner groups within Pfizer, such as EODCR Clinical, Boulder RU Clinical, GPD Oncology Leadership, Clinical Pharmacology, Translational Oncology, Biostatistics, Clinical Operations, Project Management, Pharmaceutical Sciences, Regulatory Affairs, DSRD, Commercial, Field Medical, Medical Affairs, Publications and other functions as needed.
- Eligible for Relocation Package
- Eligible for Employee Referral Bonus
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Research and Development