Pfizer Collegeville , PA 19426
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 man (FIH), proof of mechanism (POM), early signals of efficacy (ESOE) and proof of concept (POC) studies in a given therapeutic areas: 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 if applicable, Global Product Development.
Responsible for execution of clinical studies and delivering on innovative clinical study designs, 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 clinical subteams from FIH/POM/ESoE through POC trial completion to support clinical development implementation and contribution to key development milestones, e.g. start-up and delivery of ESoE and PoC trials.
Support preparation of critical documents, including but not limited to clinical protocol, clinical development plan, investigator brochure, clinical study report, and regulatory documents.
Collaborate between the RU clinical group and ECD by maintaining open communications between the two groups and ensuring successful program completion.
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 Discovery Research Units (RU) as well as Centers for Therapeutic Innovation (CTI) and Precision Medicine.
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.
Requires PhD, PharmD, MSc or 10 years of experience in drug development (relevant experience in Immunology, Cardiovascular/Metabololic, or Rare Disease preferred)
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 team player with demonstrated ability to build consensus and thrive in a matrix team environment
A clear working knowledge of the clinical development process
Demonstrated ability to support the formulation and execution of clinical strategies;
Good understanding of relevant areas such as biostatistics, regulatory, clinical pharmacology, pre-clinical toxicology, pharmacogenomics and biomarker based approaches.
Ability to analyze and interpret complex datasets.
Ability to operate with a sense of pace and urgency in matrixed project teams.
Exercises initiative in meeting goals and drives innovation in projects.
Demonstrated scientific productivity (publications, abstracts, etc.).
Good communication and presentation skills as well as proven scientific writing skills.
Results-oriented with demonstrated track record of success in clinical development
Ability to navigate a complex matrixed environment and manage teams that are diverse in terms of expertise, background, and geography
Entrepreneurial mindset with the ability to bring creative solutions to challenges
Ability to think and frame problems strategically
Quick action taker, able to involve the right team members in the right situation at the right time with a fit for purpose attitude
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.
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.
Other Job Details:
Additional Location Information: Collegeville PA, Groton CT, Cambridge MA
Eligible for Employee Referral Bonus - Yes
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.