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About the Role

The Global Development Lead (GDL) is the single clinical point of accountability for clinical development within the Internal Medicine, Research & Development department at Pfizer. This role leads cross-functional teams in the design, execution, and interpretation of studies to support worldwide regulatory submissions. The GDL is responsible for creating and gaining endorsement for the Clinical Development Plan and associated protocol design documents, acting as a key partner throughout the study lifecycle and potentially with external companies. The individual is expected to be an internal subject matter expert in their therapeutic area and clinical drug development, and may also lead other clinical leadership opportunities within the Obesity portfolio.

Responsibilities

Lead the cross-functional Clinical Development Team in the design, execution, and interpretation of studies.
Create and gain endorsement for the Clinical Development Plan and associated protocol design documents.
Act as a key partner for other clinical and clinical operations colleagues.
Potentially act as a key partner to external companies.
Provide specialized monitoring support if required.
Lead efforts on regulatory submissions and contribute to submission deliverables.
Provide input for target product profiles and regulatory activities.
Partner effectively with the Medicine Team Lead to negotiate tradeoffs, milestones and ensure delivery of the clinical program in line with agreed timelines and budget.
Develop comprehensive clinical development plans for global approval and reimbursement.
Create pediatric investigation plans/pediatric study plans and associated protocol design documents.
Ensure trial feasibility and optimized operational execution.
Provide product/program specific input for target product profiles.
Bring innovative thinking and bold decision making across clinical development programs and individual studies.
Develop specific clinical development enabling strategies including digital/innovation and patient engagement approaches.
Partner with Trial clinicians on governance reviews.
Provide category clinical development strategy input and insights to trial clinicians.
Provide therapy area/indication expertise in support of clinical review of clinical data.
Provide specialized medical monitoring support for individual trial teams, if required.
Act as key partner in trial-level statistical analysis plan, table-listings-figures, database release in partnership with statistics and programming.
Develop submission level deliverables (IAP, IARP and submission TLFs).
Responsible for submission deliverables including SCE and SCS.
Support appropriate interpretation and communication of clinical trial data.
Review and approve submission level safety narrative plan.
Support product label development and maintenance.
Engage key external stakeholders to drive strategic insight generation.
Provide regulatory submission support (DSUR, PBRER) submission disclosure deliverables and product defense.
Ensure compliance with internal SOPs and external regulatory standards.
Review IIR proposals.

Requirements

MD or DO degree.
Background in chronic weight management, endocrinology or internal medicine.
Experience in Phase 1-3 clinical development and translational medicine.
8+ years of relevant experience and track record of success in academia and/or the biopharmaceutical industry in clinical research and development.
Extensive knowledge of clinical development, global and regional regulation, ICH/GCP, adverse event management.
Demonstrated clinical/medical, administrative, and project management capabilities.
Effective verbal and written communication skills.
Demonstrated experience managing and training large teams in clinical development.
Demonstrated experience in designing and launching large teams preferred.
Ability to influence and collaborate with peers.
Ability to develop and coach others.
Ability to oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
Track record of achievement in pharmaceutical development.
Able to coordinate and execute clinical development or lifecycle strategy.
Demonstrated understanding of the complexities and recent developments in the principal disease areas.
Confident discussing scientific / mechanistic aspects of drug development.
Comfortable discussing commercial and regulatory issues.
Able to work in a highly complex matrixed environment.
Able to influence cross-functional teams.
Persuasive and effective leader of staff.
Able to manage and motivate internal teams on clinical trials.
Able to act as mentor / coach to others to improve conflict management skills.
Steps up to conflicts, seeing them as opportunities.
Reads situations quickly.
Can hammer out tough agreements and settle disputes equitably.
Prepared to take responsibility for a decision made and support this, even though it may be unpopular.
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.
Takes personal responsibility for results, pushing self and others to exceed goals and deliver results.
Able to demonstrate perspective and poise in the face of uncertainty.
Effectively gets things done amidst organizational change.
Up to 30% travel may be required.
Permanent work authorization in the United States.
Candidates must be authorized to be employed in the U.S. by any employer.

Skills

Clinical development
Global and regional regulation
ICH/GCP
Adverse event management
Clinical/medical capabilities
Administrative capabilities
Project management capabilities
Verbal communication
Written communication
Team management
Team training
Team design
Team launch
Leadership
Influencing
Collaboration
Coaching
Conflict management
Team building
Accountability
Change agility
Medical/Scientific credibility/Excellence
Pharmaceutical development
Clinical development strategy
Lifecycle strategy
Disease area expertise
Scientific/mechanistic aspects of drug development
Commercial issues
Regulatory issues
Matrixed environment navigation
Cross-functional team influence
Staff leadership
Internal team motivation
Clinical trials management
Mentoring
Negotiation
Problem-solving
Strategic thinking
Digital/innovation strategy
Patient engagement strategy

Location

Hybrid

Work Type

Hybrid
Full-time

Experience Level

8+ years of relevant experience

Education Level

MD or DO

Salary/Compensations

$274,500.00 - $457,500.00
Eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 25.0% of the base salary
Eligibility to participate in our share based long term incentive program

Benefits

401(k) plan with Pfizer Matching Contributions
Additional Pfizer Retirement Savings Contribution
Paid vacation
Paid holiday
Paid personal days
Paid caregiver/parental leave
Paid medical leave
Health benefits (medical, prescription drug, dental, and vision coverage)
Relocation assistance may be available

About the Company

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.
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations.
Pfizer endeavors to make www.pfizer.com/careers accessible to all users.

Equal Opportunity

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.
This position requires permanent work authorization in the United States.
U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future.