Director Clinical Development Scientist, Early Clinical Development

Pfizer • Cambridge, MA

4d • Hybrid

About The Position

ROLE SUMMARY The overall role of the Clinical Development Scientist, Director Early Clinical Research is to lead and coordinate the development and execution of multiple studies for small molecule and/or novel biological therapies, spanning from first in human (FIH), proof of mechanism (PoM), early signals of efficacy (ESoE) and proof of concept (PoC) studies. The Clinical Development Scientist will independently lead the development of the clinical protocol and participate as an individual contributor on clinical study teams to meet enrollment and study delivery timelines. The Clinical Development Scientist will work with other functional disciplines (e.g. Clinical Operations, Global Development Leads/Medical Monitors, Biostatistics, Data Management, Clinical Pharmacology, and Digital Medicine) to ensure the full scope and remit of Early Clinical Research is represented as needed within clinical study teams. ROLE RESPONSIBILITIES Scientific leadership and execution of clinical studies and deliver on innovative clinical study designs, high quality trial execution, safety assessment and interpretation of clinical study results Hold colleagues accountable, manage conflicting priorities with stakeholders and exhibit strong clinical judgement to ensure scientific oversight, data integrity and quality of clinical program(s). Lead preparation of study related documents, including but not limited to clinical protocol, informed consent document, and study training materials. May contribute to preparation of other study related documents, including but not limited to clinical development plan, investigator brochure, statistical analysis plan and regulatory documents. Develop and implement clinical data review strategy, ensure quality clinical data and conduct review of emerging data and trends. 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 FIH/PoM/ESoE/PoC trials. Collaborate with the study team and various functional lines (e.g., Clinical Operations, Global Development Leads/Medical Monitors, Biostatistics/Data Management, Clinical Pharmacology, and Digital Medicine) to maintain open transparent communications and ensure successful study completion. Accountable to multiple project/core study teams and clinical sub-teams and manages his/her own time to support the start-up, conduct, and close-out of individual clinical trial plans and processes. Develop expertise working with Pfizer clinical checklists and Standard Operating Procedures (SOPs) to ensure compliance with good clinical practice (GCP), regulatory agencies, Institutional Review Boards (IRBs), and Pfizer processes. Apply knowledge gained within the Internal Medicine Early Clinical Research group by way of process improvement. Develop expertise navigating Pfizer compliance systems, registries (e.g. GDMS, pTMF, Clinical Trial Registries, etc.) and other study systems related to the study (e.g., CORD, JReview, Signal Management etc.), and apply lessons learned within the Internal Medicine Early Clinical Research group. 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.

Requirements

• MD/BS/BA/BSN and 8+; MS/MA/MSN and 7+; PhD/PharmD and 5+ years of experience in clinical development.
• 3-5 of these years should be in a clinician type role with a proven track record executing programs to completion or targeted milestone.
• Understanding of the biopharmaceutical environment and drug development especially in Early Development; familiarity with related disciplines (biostatistics, regulatory, clinical pharmacology, pharmaceutical sciences).
• Demonstrate 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.
• Proven scientific writing skills.
• Strong communication/interpersonal skills.
• Strong team player with experience building consensus and driving change across all levels of the organization including senior management.

Responsibilities

• Scientific leadership and execution of clinical studies and deliver on innovative clinical study designs, high quality trial execution, safety assessment and interpretation of clinical study results
• Hold colleagues accountable, manage conflicting priorities with stakeholders and exhibit strong clinical judgement to ensure scientific oversight, data integrity and quality of clinical program(s).
• Lead preparation of study related documents, including but not limited to clinical protocol, informed consent document, and study training materials.
• May contribute to preparation of other study related documents, including but not limited to clinical development plan, investigator brochure, statistical analysis plan and regulatory documents.
• Develop and implement clinical data review strategy, ensure quality clinical data and conduct review of emerging data and trends.
• 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 FIH/PoM/ESoE/PoC trials.
• Collaborate with the study team and various functional lines (e.g., Clinical Operations, Global Development Leads/Medical Monitors, Biostatistics/Data Management, Clinical Pharmacology, and Digital Medicine) to maintain open transparent communications and ensure successful study completion.
• Accountable to multiple project/core study teams and clinical sub-teams and manages his/her own time to support the start-up, conduct, and close-out of individual clinical trial plans and processes.
• Develop expertise working with Pfizer clinical checklists and Standard Operating Procedures (SOPs) to ensure compliance with good clinical practice (GCP), regulatory agencies, Institutional Review Boards (IRBs), and Pfizer processes.
• Apply knowledge gained within the Internal Medicine Early Clinical Research group by way of process improvement.
• Develop expertise navigating Pfizer compliance systems, registries (e.g. GDMS, pTMF, Clinical Trial Registries, etc.) and other study systems related to the study (e.g., CORD, JReview, Signal Management etc.), and apply lessons learned within the Internal Medicine Early Clinical Research group.
• 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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree
• Number of Employees: 5,001-10,000 employees