1+ months

Director Clinician, Early Clinical Development (Non

Pfizer
Cambridge, MA 02139
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The overall role of the Early Clinical Development (ECD) Clinician is to lead and coordinate the development of multiple studies for novel biological and small molecule therapies for first in human (FIH), proof of mechanism (POM), early signal of efficacy (ESOE) and proof of concept (POC) studies in a given therapeutic area: e.g., Internal Medicine, Immunology and Inflammation, and Rare Diseases.



The ECD Clinician will participate as an individual contributor on clinical teams with Pfizer development operations to meet enrollment and study delivery timelines. The ECD Clinician will work with other functional disciples as needed (e.g. Research Units, Biostatistics, Clinical Pharmacology, Precision Medicine, and Digital Medicine).



The individual will be involved with clinical drug development activities from FIH through POC. They will be a key member of clinical subteams to ensure collaboration and seamless connectivity between ECD, Research Units and Global Product Development.



+ Responsible for scientific leadership and execution of clinical studies and delivering on innovative clinical study designs, high quality trial execution, safety assessment and interpretation of clinical study results Supports execution for all post-FIH programs through proof-of concept Serve as technical resource for clinical issues raised by internal and external collaborators, investigators, consultants and contractors Support and assist in the development of publications, abstracts, and presentations Sit on project teams to support clinical development implementation and contribution to key development milestones, e.g. start-up and delivery of ESoE and PoC trials. Lead preparation of clinical protocol and lead or support other critical documents, including clinical development plan, investigator brochure, statistical analysis plan and regulatory documents. Foster a transparent environment that encourages strong partnerships and mutual trust between teams, sub-teams, and therapeutic areas. Coordinate with other clinical research activities in ECD and greater World-Wide Research and Development (WRD) organization. Develop effective collaborations with key partners in Pfizer Research Units (RU) and Operations. Develop effective collaborations with project leaders and projects team members, including research units, biostatistics, regulatory affairs, clinical pharmacology, human genetics, precision medicine and development operations. Partner with Precision Medicine as needed to ensure that biomarker plans are enabled in all relevant therapeutic area programs to help determine early signs of efficacy and proof of concept, patient stratification, etc. Establish and support relationships with external experts, consultants, key opinion leaders, regulators and disease specific investigator networks to ensure implementation of latest clinical thinking and guidelines into clinical development plans and study designs, as well as management and recruitment of study, analysis, interpretation and presentation of results. Maintain up-to-date knowledge of scientific and clinical published literature in relevant therapeutic areas including the key clinical development issues



**Qualifications**

Requires PhD, PharmD, MSc, BSc

Deep understanding of the biopharmaceutical environment and the drug development

5-8 years of relevant experience in drug development; 3-5 years of relevant experience in a clinician type role with a proven track record executing development programs to completion or targeted milestone

Strong interpersonal skills and expert team player with demonstrated ability to build consensus and drive change across all levels of the organization including senior management

\#LI-PFE



**Other Job Details:**



+ Additional Location Information: Cambridge, MA, Groton CT, Collegeville PA

+ Relocation Package - Yes

+ Eligible for Employee Referral Bonus - Yes



**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.



Medical
Posted: 2020-01-10 Expires: 2020-08-06
Sponsored by:
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Director Clinician, Early Clinical Development (Non

Pfizer
Cambridge, MA 02139

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