Clinical Team Leader - Biosimilars (987436) La Jolla, California
Org Marketing Statement
All over the world, Pfizer colleagues are working together to positively impact health for everyone, everywhere. Each position at Pfizer touches and contributes to the success of our business and our world. That’s why, as one of the global leaders in the biopharmaceutical industry, Pfizer is committed to seeking out inspired new talent who share our core values and mission of making the world a healthier place.
•CTL BioSimilars, in collaboration with the Chief Development Officer of BioSimilars and the Clinical Head of Biosimilars, ensures delivery of the clinical components of the assigned segment of portfolio of Biosimilars assets
•Manages and oversees the Study Clinicians assigned to the assets from FIH through registration
•Sets the standard for and ensures execution of clinical trials and submission packages
•Provides strategic input to the Clinical Development Plans for the portfolio of assets
•Ensures knowledge sharing and alignment of Clinical Subteams across the larger portfolio of assets
•Manages and oversees Study Clinicians in planning, content, execution, and delivery of clinical trials from FIH through registration
•Plans short and long-term Study Clinician resource needs
•Supports delivery of Clinical program milestones across assigned assets
•Models and ensures the quality and content of Study Clinician leadership and contributions to study conduct
•Networks clinicians, biostatisticians, clinical pharmacologists, medical affairs, regulatory, safety risk management, and Development Operations to ensure alignment of approaches and processes across functions in the Biosimilars asset teams
•Ensures application of fit-for-purpose trial designs
•Oversight of functioning, efficiency and health of Clinical Subteams responsible for the development of biosimilars assets
•Supports alignment of parties and helps to address issues in the implementation of clinical development plans and strategies, working with Asset management and Development Operations
•Individual Leadership Contribution
•May be assigned as a lead or contribute aspects of Study Clinician and Clinical Subteam Facilitator functions as needed to support the portfolio of assets
•Collaborates with BioSimilars Clinical Research Head in preparation of strategy presentations for governance and management purposes
•Maintains up to date knowledge of biosimilars regulatory standards, published literature and competitive landscape in relevant therapeutic areas including the key development issues
•Interfaces with asset management, biopharmaceutics, non-clinical safety sciences, medical affairs, commercial, regulatory, safety, development operations and other members of extended project teams to support alignment / understanding of plans and line activities supporting delivery of key milestones
•In collaboration with functional line heads, establishes relationships with internal groups such as advisory, governance, commercial, and BUs
•Establishes relationships with key external experts and consultants
•Study Clinician Contribution
•Integrates scientific knowledge and operational expertise to ensure excellence in development and translation of clinical research plans into efficiently delivered studies.
•Works collaboratively with the clinical leader, physician and members of the development team to establish the Clinical Development Plans for one or more compounds from Phase I clinical trials through registration.
•Develops methodologies to support biosimilarity studies.
•Provides input to the operational strategy and feasibility of clinical research studies, in conjunction with development operations.
•Responsible for formulation of clinical development plans, trial design, protocols, amendments, review, study oversight, analysis and interpretation.
•In collaboration with the clinical leader, prepares strategy decisions, present and discuss data at relevant team, governance, external consultants, KOLs and potentially regulatory meetings.
•Leads or participates in efforts to author clinical sections of regulatory documents including the Investigator Brochure, Annual Reports, IND sections.
•Consistent with Safety Review Plans, performs and documents regular review of individual subject safety data and performs review of cumulative safety data with the safety risk lead or as delegated by the clinical leader.
•Responds and contributes to novel study designs and ensures these novel designs are optimized for operational effectiveness to ensure timely and cost effective delivery.
•Analyzes emerging study data to ensure appropriateness of the chosen subject population and proactively assesses the performance of techniques used for endpoint measures on an ongoing basis to ensure data quality.
•Analyzes emerging safety profile of the drug, keeping the physician clinician informed of changes in the safety profile as they occur in the assigned study(ies). Must be fully knowledgeable about the safety profile of allocated drugs on which studies are being conducted, or which are called for in the protocol.
•Advanced degree in life sciences (PhD, PharmD, MPH, MSc) preferred
•Experience in late stage drug development and market application submissions
•Experience in Oncology and/or Inflammation drug development
•Ability to incorporate scientific information into strategic discussions
•Ability to work with groups of people to accomplish goals
•Ability to lead and facilitate discussions resulting in consensus statements
•Strong leadership and good communication skills
•Understanding of related disciplines such as biopharmaceutics, pharmacokinetics, biostatistics, and regulatory science
Equal Employment Opportunity
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 employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must be authorized to work for Pfizer in the U.S. at the time of the commencement of employment. Foreign national applicants who will need employer immigration sponsorship to obtain or continue work authorization must disclose that fact as part of the application process. Pfizer may consider in its sole discretion sponsoring a foreign national applicant for work authorization and/or permanent residence (green card) depending on its business needs.