Pfizer Immuno in New York, New York
A career at Pfizer offers opportunity, ownership and impact.
All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
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This role is a senior leadership position within Global Product Development Immuno-Oncology accountable for driving the clinical strategy for Gynecological Malignancies on the Immuno-Oncology Clinical Team. The IO-GCL will work closely with other functional lines (e.g. biostatistics, clinical pharmacology, pharmacovigilance, outcome research) in ensuring a differentiated strategy. Specifically taking on the leadership for 2 ongoing Phase 3 registrational trials in Ovarian Cancer, taking the clinical leadership role on the filling team and the Gynecological Core Clinical Team. Evaluating new opportunities, combination trials with internal and external assets. The IO-GCL will also review and coordinate the Investigator Initiated trials in Gynecological Malignancies and Gastro-Intestinal malignancies on the Global review committee. Lastly the IO-GCL will represent the clinical team on 1 or 2 sub-team (e.g. regulatory, publications).
This is a highly visible, critical position which requires strategic thinking, leadership and exceptional communication skills. Both internal and external leadership is expected in e.g. governance committees, ad-boards and regulatory interactions.
The leader will have responsibility for trials ranging from First-in-human studies through the achievement of Proof of Concept for pivotal registration development, subsequent registrations, post-approval trials &; life-cycle management
Specific Duties of the Immuno-oncology Global Clinical Leader (IO-GCL) role:
Strategic and Innovative Thinking:
• Accountable for developing and delivering the clinical development strategy for Gynecological Malignancies that is consistent with the overarching Strategy and Vision for immuno-oncology and for Pfizer Oncology.
• Able to develop unique insights and opportunities in the current IO landscape, the competitive environment and the standard of care to create a highly differentiated strategy
• Actively and continuously engages with external thought leaders, both formally and informally.
• Represents the clinical team during regulatory meetings
• Applies oncology drug development knowledge and experience to assure that the IO-assets are being utilized in the design and conduct of studies with high likelihood of technical, regulatory, and commercial success
• Coordinates with the Translational Oncology Lead on the (Asset) Team Lead to ensure thoughtful integration of biomarker and companion diagnostic studies into the clinical development strategy for the assets
• Promotes a culture of innovation within the cross-functional team(s) in order to bring forward differentiated development plans that maximize the potential of each asset
• Applies robust and evidence-based decision making principles in the development of new clinical concepts, programs, and strategies
• Leads design and execution of the clinical strategy for Gynecological malignancies leading to initial regulatory approval, expansion of regulatory approvals, and/or support of approved indications
• Leads the Gynecological Clinical Core Team. Works closely with MD and Non-MD clinicians and Operational Leads in Clinical Science and Operations to oversee protocol development, global study start-up and execution.
• Is responsible for mentoring junior MDs. Oversees medical monitoring in CS&;O.
• Will be core member of future submission team(s)
• Acts decisively making effective decisions by applying scientific and development acumen. Acts with urgency and removes barriers that hinder productivity
• Assures the quality of clinical deliverables to external health authorities
• Creates a motivated, committed and engaged clinical team
• Models leadership behavior and expects effective team behavior to achieve project goals
• Aligns on the integration of new findings/learnings (e.g. preclinical, clinical or safety) into planned and ongoing clinical programs
• Effectively informs, negotiates with and influences key internal stakeholders (including all levels of management as appropriate)
• Routinely engages with Regional colleagues (e.g. regional presidents, commercial &; medical, etc.) on clinical development strategy and regional execution
• Informs, negotiates with and influences key internal stakeholders
• In in continuous communications with colleagues in CS&;O to ensure time delivery of high quality clinical trials and data
• Takes leading role in regulatory interactions, preparation of briefing documents and addressing questions from health authorities.
• Able to represent the Asset and serve as lead presenter/moderator at regulatory defense proceedings (e.g. ODAC)
• Able to clearly and accurately articulate clinical strategy and clinical data, scenarios, and tactics in a way that is appropriate for the audience
• Encourages transparency and fosters and open dialogue with all stakeholders
• Interacts closely with colleagues across research, development, regulatory affairs, clinical pharmacology, commercial, medical affairs.
Duties Specific to the Immuno-Oncology Role:
• Work closely with leadership to contribute to the successful alliance partnership between Pfizer and EMD Serono
• Work closely with other Immuno Oncology (Asset) Team leaders across Pfizer and externally when required to ensure combination strategies have been considered and integrated into the clinical strategy
• Strategic leadership of any upcoming global health authority interactions in collaboration with the regulatory strategy lead and Asset team
• Brings new opportunities to Asset Leadership team for further discussion and endorsement
• Ensure timely start-up and execution delivery of the clinical trial per agreed plan
• Engage regional colleagues (regional presidents, regional commercial and medical) to align on and establish the global strategies and footprint for the go-forward clinical development program
• Prepare and dispatch avelumab global regulatory submissions with high quality according to timelines
Education and Experience
• MD required
• Either board certified or eligible in oncology specialty (medical oncology, hemato-oncology, radiation oncology or surgical/gynaecological oncology) and at least 5 years of clinical development in oncology, or MD with at least 8 years of clinical development in oncology (mix of early and late stage development)
• Prior experience in Immuno-oncology and/ or gynaecological malignancies (academia or industry) highly preferred
• Proven track record of regulatory interactions (IND, NDA/BLA)
• Broad understanding of immuno-oncology clinical development landscape
• Track record of leadership (direct reports, matrix leadership)
• Proven track record of designing clinical strategy for oncology development program from FIH to Registrational trials
• Proven ability to function effectively across a complex matrix organization with multiple stakeholders and constituents, with ability and gravitas to align team work towards a singular goal
• Deep understanding of Translational Oncology and its integration into clinical development programs.
Competency - Detail / Comments (Specific skills-expanded definition)
• Presentation, Analytical Skills and Communication: demonstrates ability to present clinical data, study plans, scenarios, and tactics clearly, succinctly and accurately to relevant audiences in order to obtain decision, input and feedback when required
• Influencing: Must be able to lead multi-disciplinary group in complex matrix environments
• Courage with decisiveness to Act: Bias towards action to achieving goals
• Team Building: Shares wins and success; fosters open dialogue; lets people finish and be responsible for their work; defines success in terms of the whole team; creates strong morale and spirit in his/her team; creates a feeling of belonging to the team
• Conflict Management: Good at focused listening; can find common ground and get cooperation with minimum noise
• Anticipates Issues: proactively anticipates emerging issues; knows how to take action to mitigate or resolve issues
• Uses Benchmarks: Adept at benchmarking previous submissions, regulatory precedents, recent publications, or competitive events to inform and evolve strategies
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Travel to external meetings and symposia required as appropriate or per business needRelocation is offered for this position
A career at Pfizer offers opportunity, ownership and impact.
All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the bio-pharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.