Description
**ROLE SUMMARY**
The purpose of Director of Clinical Research role is to coordinate and lead the development of end to end clinical development plans, first in man (FIH), proof of mechanism (POM), proof of clinical activity (SoCA),proof of concept (PoC), dose ranging, pivotal and post approval studies for novel biological and small molecule therapies in **Immunology, and Inflammation** **programs** .
+ The Director of Clinical Research will be responsible for phase 1, 2, PoM and SoCA, phase 3 and 4 trial designs that will be developed in collaboration with statistics and clinical pharmacology lines. They also will be involved in the implementation of the study in collaboration with Pfizer clinical development operations and the project team to meet enrollment and study delivery timelines.
+ The clinical study lead will be the primary liaison for investigators who have enrollment or extraordinary protocol issues that require escalation and may need to conduct study site visits to ensure timely delivery of the study.
+ The individual will be involved in activities from discovery research through study execution, approval/submission and post approval. They will be a key member on project teams.
**ROLE RESPONSIBILITIES**
The Director of Clinical Research will be responsible for the following:
-Design clinical studies in consultation with KOLs and Pfizer project team members (Stats, Clin Pharm, Regulatory, Operations, commercial development etc.).
+ Develop the primary and secondary endpoints for efficacy and safety and contribute to the precision medicine, biomarker strategy as well as to the biostatistics analytic plan, regulatory requirements, pricing, marketing and medical needs that is aligned with the transition target product profile.
+ Develop a network or consultants and KoLs for programs in new indications
+ Sit on project teams from FIH through post approval to ensure that clinical development strategies are in place, being implemented and are contributing to key development milestones, e.g., start-up and delivery of clinical trials.
+ Accountable for safety across the study, including regular review of safety data (including but not limited to serious adverse events) and response to safety issues.
+ Provide leadership to the clinical function in preparation of critical documents, including but not limited to clinical protocol, clinical development plan, investigator brochure, statistical analysis plan and regulatory documents.
+ Expand the culture of collaboration by maintaining open communications and ensuring successful program transitions.
+ Foster a transparent environment that encourages strong trust between teams, sub-teams, and leaders.
+ Coordinate with other clinical activities in I&I and the greater PRD organization.
+ Maintain up-to-date knowledge of scientific and clinical published literature in relevant therapeutic areas including the key clinical development issues.
+ Develop effective collaborations with projects team members, including biostatistics, regulatory affairs, clinical pharmacology, medical affairs, commercial development and development operations.
+ Develop effective collaborations with key PRD partners in design of clinical studies and develop target clinical goals to benchmark success of these studies.
+ Interpret final clinical data in achieving study objectives and develop the clinical strategy
+ Establish relationships with external experts, consultants, opinion leaders, regulators and disease specific investigator networks.
+ The applicant will have the opportunity to participate in strategic assessment of I&I portfolio, and Business Development activities.
+ 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.
**QUALIFICATIONS**
+ MD or MD/PhD (or equivalent degree(s)) with relevant postgraduate clinical training.
+ 4+ years’ relevant work experience preferred.
+ Preference for established record in execution of clinical trials in the pharmaceutical industry environment; experience in managing complex projects. Firm understanding of the drug development process with particular emphasis on early clinical development.
+ Scientific excellence; possesses deep knowledge of I&I and Dermatology.
+ Superior clinical ability with relevant disease area knowledge and experience.
+ Ability to design, initiate and conduct effective clinical studies applying novel principles as appropriate, and integrating these plans into a cohesive overall clinical development strategy.
+ Strong understanding of the complexities and current developments in the relevant disease/technical area and skillfully applies this knowledge to drug development.
+ Firm understanding of clinical regulatory requirements, and knowledge of GCP and ICH guidelines.
+ Experienced with ownership of budgets and sound financial risk management.
+ Ability to review and understand emerging data and proactively implement measures to ensure delivery of quality study results.
+ Skilled communicator and team leader, able to clearly articulate ideas and integrate feedback.
+ Ability to navigate a complex matrixed environment and manage teams that are diverse in terms of expertise, background, and geography.
PREFERRED QUALIFICATIONS
+ Board eligibility/certification in Dermatology.
+ Active medical license preferred.
**NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS**
+ Work Location Assignment:On premise
+ Relocation Support Available: Yes
The annual base salary for this position ranges from $226,300.00 to $377,100.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 25.0% 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.
Pfizer endeavors to make www.pfizer.com/careers accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email disabilityrecruitment@pfizer.com. This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned.
Medical
