The Global Clinical Lead (GCL) for Rare Neurology is a Senior Director role that is focused on advancing the Rare Neurology portfolio. The GCL represents Clinical Development on the Global Medicine Team (GMT) and is accountable for driving the strategic and technical aspects of global asset clinical development in Rare Neurology, particularly later stage clinical development . They apply technical excellence in the design of cost-efficient clinical trials and programs to meet the needs of internal and external stakeholders, ensure effective conduct and medical/scientific oversight of studies (in partnership with Development Operations) and support appropriate interpretation and communication of clinical trial data (including high quality regulatory submissions and product defense activities). They ensure compliance with internal and external standards, proactively mitigate risk and manage emerging clinical issues.
- Leads design, implementation and interpretation of the global clinical program for a drug candidate to deliver a successful regulatory submission worldwide through regulatory submission and approval (i.e., Phase 2, 3, pediatric and interventional Phase 4 studies) consistent with the overarching medicine plan.
- Supports and contributes to strategic clinical planning for early development candidates with an emphasis on effective transition of early candidates into Global Product Development and/or external BD (Business Development) opportunities.
- Conducts technical review of licensing opportunities, including due diligence activities.
- Provides innovative options to design and execute clinical programs.
- Ensures alignment of regional clinical development strategy with global strategies and oversees medical execution of regional studies for a development drug candidate.
- Representative on the GMT; chairs the clinical sub-team of the GMT; provides clear vision, strategies and goals to clinicians and clinical scientists to gather input in the development of clinical strategies and programs.
- Negotiates milestones with Medicine Team Lead (MTL) and ensures delivery of clinical programs in line with agreed timelines; identifies needs and proposes solutions to keep the development programs on time and within budget.
- Identifies and assesses program risks and, in conjunction with the Transition or Medicine Team and Clinical Development & Operations (CD&O), develops effective mitigation plans.
- In conjunction with the Safety Risk Lead, ensures patient safety during clinical trial conduct plus consistent, timely and focused medical review and reporting of adverse events, including serious adverse events, and other safety data.
- Accountable for operational excellence and timely production and approval of quality clinical deliverables, including clinical plans, protocols, clinical study reports and regulatory submission documents (e.g., NDA, MAA, AR, briefing documents, investigator's brochures) and, working with Medical Affairs, international meeting abstracts or manuscripts intended for external publication that are based on Pfizer-sponsored clinical trials.
- Interprets clinical data in support of asset strategy, working with the clinical Triad (clinical pharmacology, statistician and clinician).
- Act as a senior company representative interacting with external scientific leaders and/or regulatory authorities.
- Organizes expert panel, consultant or advisory board meetings to provide input into clinical plans, study designs or data analysis; may also maximize opportunities for cross-indication consultancies or advisory boards by working closely with partner lines.
- Grows/maintains state of the art knowledge in the TA.
- May serve as key scientific member of the Therapeutic Area Scientific Outreach Team (TASOT) and leader of Disease Area Working Groups (DAWG) or sub-teams.
- May serve as the clinical development representative on the clinical research team.
- May contribute to the design of innovative early development studies (Phases 1, 1b and 2a) in collaboration with the Research Unit (RU), with the aim of making strategic go/no go decisions efficiently and at low cost.
- May participate in the review of Investigator Initiated Trial Proposals relevant to medicine development.
• MD (or MD/PhD) degree or equivalent and demonstrated depth and breadth of knowledge and experience in clinical research in the academic, clinical practice, or industry setting.
• Board certification in Neurology and/or drug development experience in Neurology.
• 5+ years of drug development or equivalent experience.
• Proven scientific writing skills and exceptional communication skills. Proven leadership skills with ability to defend the clinical development plan in front of strategic and technical governance committees.
• Proven ability to function effectively across a complex matrix organization with multiple stakeholders and constituents, with the expertise and the gravitas to align clinical team work towards a singular goal.Preferred Qualifications:
• Prior experience in rare disease drug development (academia or industry) and track record of regulatory interactions.
• Experience as a medical monitor for a clinical trial.
• Prior experience managing an external collaboration.
• C andidate 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. NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Occasional business travel to attend scientific congresses, advisory boards, meetings with Regulatory Agencies and internal department meetings
Relocation support availablePfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.Sunshine Act
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Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.