Why Patients Need You
Pfizer's Worldwide Medical and Safety colleagues play a key role in connecting evidence based medical decision support with colleagues and stakeholders to enable better health and treatment outcomes. Whether you are creating framework necessary to ensure our evidence is scientifically sound, providing unbiased, medically necessary expertise or investigating how to close gaps in data, our mission is simple. Empower healthcare decisions regarding the safe and appropriate use of medicines for patients.
What You Will Achieve
You will ensure that the clinical studies conducted in the Pfizer Biopharma Group are within time, budget and scope. You will help us plan and direct the clinical studies. You will create the timelines of the study and also communicate these timelines to the team. Your ability to meet agreed targets will help us develop plans for short-term work activities like deliverables, workplan, and timelines.
As a Director of Study Management, you are a subject matter expert in Obesity trials and leverage your knowledge of industry, customer requirements and general business environment to adapt and implement strategic actions for the division. Your ability to interpret your division's strategy will establish business priorities that support and set long-term direction for the division. Your managerial skills will help us manage and lead people, technological and financial resources within the division.
Through your expertise and extensive knowledge, you will be able to foster a culture that promotes innovation and thrives on doing better for patients and healthcare.
How You Will Achieve It
Set objectives for and manage multiple projects and the ongoing work activities within a Global Business Unit/Global Operating Unit.
Act as a single, authoritative source of study information and leads study level status reporting per organizational norms and expectations.
Lead the study team and associated deliverables across all functions; accountable for managing and driving overall study timelines, budgets and quality targets to meet or exceed business needs.
Accountable to ensure effective study team scheduling, records and communications.
Accountable for strategic planning, decision making at the study level in line with program objectives.
Utilize negotiation, facilitation, meeting management and conflict resolution skills to enhance cross-functional study team performance and accountable for effective study team operations.
Represent clinical operations on the asset level teams as per the organizational expectations and asset team charter, serve as a single point of accountability for operational delivery of clinical programs.
Lead clinical operations' sub-team(s) where appropriate, e.g. for large programs with multiple studies, in accordance with the organizational expectations and asset team charter
Define optimal operational strategy and define timeline, resourcing and budget needs for execution of the clinical plan for the asset/program including early development candidates, concept plans (such as in support of the lifecycle and operating plan process) and for the licensing and partnership opportunities.
Establish and ensure adherence to operational standards and best practices for the asset or program.
Serve as a member of the business unit due diligence team for business development opportunities.
Partner with business unit leaders to assess development program timelines and budgets to inform the assessment of opportunities for the category.
Review annual individual objectives and development plans and perform periodic performance evaluation of direct reports following global or local corporate policy.
Qualifications
Must-Have
Bachelor's Degree (BA/BS) and 14+ years of experience.
Current experience overseeing Obesity trials IS required for this role.
Knowledge of GCP and a good understanding of the processes associated with study/project management, monitoring, clinical and regulatory operations.
Well-developed planning, observation, analytical and problem-solving skills.
Nice-to-Have
Master’s (MS) degree and 12+ years relevant pharmaceutical experience.
Doctorate (PhD/PharmD) and 9+ years of experience.
Detail oriented & possesses technical expertise (e.g., spreadsheets, metrics & data flow management).
Exceptional interpersonal skills, including ability to persuade, negotiate and moderate conflict.
Successful experience working with outside vendors contracted to perform clinical operations activities desired.
Experienced with ownership of budgets.
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.
Work Location Assignment: Remote Status Available for this r
The annual base salary for this position ranges from $161,600.00 to $269,400.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 20.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.Relocation assistance may be available based on business needs and/or eligibility.
Sunshine Act
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.
EEO & Employment Eligibility
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.
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