Pfizer Senior Director Global Clin Lead (Non in Collegeville, Pennsylvania
At Pfizer, a brighter future isn't just something you can look forward to. It's something you can influence. Something you can help to shape. Something you can actively define. A career with us is about improving the health of people everywhere. We're bringing therapies to patients that have the power to improve their lives. Whatever your role, you'll be part of that - driving the healthcare industry in the right direction, and making a positive difference to the world as a whole through both our work and our commitment to helping those in need. To do that, you need to believe that amazing things are possible. We know you'll feel that potential in the world-class people around you. When you engage your head, heart and guts, you'll be supported by our quality resources and talent to turn that conviction into a reality. JOB SUMMARY The GCL position in topical dermatology is for clinical development leadership of the topical combination of crisaborole and tofacitinib for atopic dermatitis program. This program is entering Phase 2 with PoC/Dose Ranging Phase 2b and Maximal Usage Trial studies in 3Q2018. Atopic dermatitis, a common chronic inflammatory skin disease affecting pediatric and adult patients, is under intensely active development in the Pharma industry. Additionally, development of topical formulations is progressing rapidly in the Research Unit for atopic dermatitis and other dermatologic conditions amendable to topical treatment, ultimately leading to other clinical development programs for topical formulations in dermatology.
The Global Clinical Lead (GCL) for Topical Dermatology is a leadership role that represents I&I clinical development on the Global Medicine Team as the single point of accountability for clinical development strategy, program oversight and execution for a product(s) that is being delivered topically for the treatment of dermatological diseases.
Leads the Global Clinical Team towards the common goal of approvable worldwide regulatory submissions that meet customer (patient, payer, prescriber) needs, ensuring alignment of regional clinical development strategies with global strategies.
Works closely with therapeutic area Clinical Development & Operations to meet clinical development program deliverables. JOB RESPONSIBILITIES
Provides clinical expertise and technical excellence for asset development, clinical strategy, ensuring compliance with internal and external standards (regulatory authority requirements, stakehold requirements and quality standards). Dermatology and topical development expertise desired but not necessary.
Leads design, implementation and interpretation of the global clinical program for a topical drug candidate to deliver successful regulatory submissions worldwide (through regulatory submission and approval (i.e., Phase 2, 3, pediatric and interventional Phase 4 studies)
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
Leads execution for overall clinical development program for the asset
Grows/maintains state of the art knowledge in Dermatology and topical development
Representative on the Medicine Team; chairs the clinical sub-team of the Medicine Team; provides clear vision to clinicians and clinical scientists about the goals of the clinical program
Negotiates milestones with Asset Team Lead (ATL) and ensures delivery of clinical programs in line with agreed timelines
Identifies and assesses program risks and, in conjunction with the Medicine Team and Clinical Development & Operations, 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 the Clinical Development Plan, protocols, clinical study reports and regulatory submission documents (e.g., NDA, MAA, AR) and, working wih 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 sub-team (clinical pharmacology, statistician, clinician, and clinical scientist)
Leads cross-functional clinical sub-team in the design and execution of studies to support worldwide regulatory submissions
Act as a senior company representative interacting with external scientific leaders and/or regulatory authorities
Organizes expert panel, consultant or advisory board meetings (including the patients' voice) to provide input into clinical plans, study designs or data analysis
May serve as key scientific member of the Therapeutic Area Scientific Outreach Team (TASOT) and leader of Disease Area Working Groups or sub-teams
May contribute to the design of innovative early development studies (Phases 1, 1b and 2a) in collaboration with the RU, with the aim of making strategic go/no go decisions efficiently and at low cost
May conduct technical review of licensing opportunities and/or due diligence activities
Participates in the review of Investigator Initiated Trial Proposals relevant to asset development in Topical Dermatology QUALIFICATIONS / SKILLS
PharmD, PhD, DVM or MS (or equivalent training/experience)
8 or more years Medical and scientific expertise in the relevant disease area (rheumatology, medical dermatology including topicals, gastroenterology) preferred
Demonstrated scientific productivity (e.g., publications, research reports, etc.); excellent independent writing and verbal communication skills a must
Thorough understanding of local and international regulations applicable to clinical development
Track record of excellence in designing, defending and executing clinical development plans and clinical studies
Demonstrated expertise in managing clinical programs, either pre- or post-approval; expertise in managing adaptive clinical trials and programs seeking conditional approval preferred
Previous leadership/management training, documented experience and proficiency in managing direct reports and/or matrix teams and elevating the enthusiasm of all team members
Comfortable discussing scientific/mechanistic aspects of drug development as well as strategic, regulatory or commercial aspects, and conversant of the interplay between the categories
Demonstrated ability to lead the translation of patient, marketing and product positioning needs into scientific hypotheses to be tested and ability to translate these into clinical plans
Demonstrated ability to anticipate issues related to the delivery of clinical project goals and manage risks
Demonstrated ability to establish clear directions, set objectives, distribute the workload appropriately, and bring out the best in people
Demonstrated ability to work across many interfaces within a complex matrix organization, and to help others to do so
Demonstrated ability to work with (understand needs and concerns of) commercial, regulatory and operational colleagues, senior management, regulatory agencies and other stakeholders to balance conflicting priorities among these diverse parts of the organization, and line them up behind the most appropriate development and/or lifecycle plan for a medicine
Demonstrated ability to coach and/or mentor clinical colleagues for success in technical and behavioral domains
Demonstrated ability to present complex, technical ideas and concepts, both verbally and in writing, in such a way that they are understood by colleagues and stakeholders at all levels and/or from other disciplines
Demonstrated ability in collaborative problem solving (handles conflict constructively)
If a current Pfizer employee, demonstrated ability to embody Pfizer leader behaviors and the OWNIT culture
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Additional Locations: Collegeville, PA, New York, New York
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