Clinician - Early Clinical Development

Remote, California, California
Closing date
Jun 15, 2023

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Pharmaceutical, Physicians/Nurses
Full Time
Organization Type
Jobseeker Type

The Early Clinical Development Clinician (ECD Clinician) supports the Global Clinical Lead in the development of the Clinical Development Plan and associated protocol design documents (PDDs). S/He partners closely with colleagues in other lines to ensure program feasibility and optimized operational planning and supports organization of expert panels and advisory board meetings to provide input into clinical plans, study design, or data analysis.

The ECD Clinician acts a key partner for other clinical and clinical operations colleagues through the study lifecycle. S/He provides advanced scientific knowledge, diagnostic and therapeutic area expertise to the development of the final protocol and associated deliverables. During study execution and reporting the Clinician provides ongoing support to other clinical colleagues as needed, including support of protocol interpretation, data review and signal analysis/evaluation. S/He may provide specialized monitoring support if required.

S/He will support the GCL on regulatory submissions and is a key clinical contributor/author for submission deliverables including the SCE, SCS and clinical overview.

The ECD Clinician will support various regulatory activities including product labels, core data sheets, Investigator Brochures, Assay Performance, Safety Update Reports, Periodic Benefit-Risk Evaluation Reports, and will provide clinical input to Label as Driver deliverables.

In addition, the ECD Clinician provides input for target product profile(s), and other critical deliverables used in decision making and aligning CDP to Commercial and Access/Reimbursement goals.

S/He will help identify potential business development opportunities in his/her area of expertise and will support due diligence activities on potential in-licensing opportunities; S/He may lead the technical team activities in collaboration with Business Development.

• Supports development of CDP including PIP / PSP and associated protocol design documents (PDD's) working closely with CD&O clinicians to ensure study feasibility and optimized operational execution.
• Develops medicine specific clinical development enabling strategies including diagnostic, digital / innovation and patient engagement approaches.
• Support GCL in leading preparation for engagement points for CDP with governance and incorporation of feedback from such interactions into final deliverables.
• Partners with CD&O clinician on governance reviews (including Sci/Ops) for assigned clinical studies with GCL support. Provides category clinical development strategy input and insights to CD&O clinicians for assigned clinical studies.
• Provides therapy area / diagnostic expertise in support of CD&O clinical review of clinical data - including CRF design, assistance in signal interpretation, contextualizing adverse events etc as required.
• Partners with Safety Risk Lead to contribute to benefit-risk analysis though participation in core safety working groups and benefit risk committees, as required
• Key partner in study level SAP, TLFs, BDRs in partnership with statistics and programing.
• Support GCL on submission level deliverables (IAP, IARP and submission TLFs). Key clinical contributor for submission deliverables including SCE, ISE, ISS, and SCS
• As a key contributor to the CSR and external presentations and/or manuscripts, supports appropriate interpretation and communication of clinical trial data.
• Review and approve submission level safety narrative plan (in partnership with GCL).
• Supports product label development and maintenance, including clinical input to Label as Driver deliverables
• Provides product/program specific input for target product profile(s), medicine differentiation indicator, and other Robust Decision-Making deliverables.
• Supports clinical due diligence activities on potential in- licensing, or partnership opportunities as delegated by the GCL.
• Engage key external stakeholders with GCL e.g Ad boards, Steering Committees, DMC, Adjudication Committees, patients and patient advocates and other external stakeholders, to drive strategic insight generation to support clinical development strategy and PDD development.

• Provides regulatory submission support (including IB, DSUR, PBRER) in partnership with the GCL, submission disclosure deliverables and product defense.
• Review ISR proposals (in partnership with GCL).

• Advanced degree or professional certification in a health care related, scientific or technical discipline required.

• 10 years of experience and track record of success in biopharmaceutical industry in clinical research anddevelopment, to include Phase 2b/3 development experience.
• Extensive knowledge of clinical development, global and regional regulation, ICH/GCP, adverse event management
• Demonstrated clinical/medical, administrative, and project management capabilities, as well as effective verbal and written communication skills in relating to individuals both inside and outside Pfizer.
• Demonstrated experience managing and guiding large cross-functional teams in clinical development
• Demonstrated experience with global regulatory submissions (e.g., NDA, BLA, MAA).
• Demonstrated experience in designing, conducting and reporting Phase 2b/3 clinical studies in the oncology therapeutic area preferred.
• Medical / Scientific credibility/Excellence - Track record of achievement in pharmaceutical development, able to coordinate and execute clinical development or lifecycle strategy. Demonstrated understanding of the complexities and recent developments in the principal disease areas; confident discussing scientific / mechanistic aspects of drug development, also comfortable in discussing commercial and regulatory issues pertinent to clinical development planning and execution.
• Management experience - Able to work in a highly complex matrixed environment and able to influence cross-functional teams.
• Leadership - Persuasive and effective leader of staff in a matrixed team setting.
• Influencing - Able to manage and motivate internal teams in clinical trials.
• Conflict Management - Able to act as mentor / coach to others to improve conflict management skills; steps up to conflicts, seeing them as opportunities; reads situationsquickly; can hammer out tough agreements and settle disputes equitably; prepared to take responsibility for a decision made and support this, even though it may be unpopular.
• Team Building - Shares wins and success; fosters open dialogue; lets people finish and be responsible for their work; defines success in terms of the whole team; creates strong morale and spirit in his/her team; creates a feeling of belonging to the team.
• Accountability - Take personal responsibility for results, pushing self and others to exceed goals and deliver results.
• Change agile - Able to demonstrate perspective and poise in the face of uncertainty and effectively get things done amidst organizational change.
• Excellent written and oral communication skills for non-native English speakers.

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.


Global travel required.

The annual base salary for this position ranges from $185,800.00 to $309,600.00. In addition, this position offers an annual bonus with a target of 22.5% of the base salary and eligibility to participate in our share based long term incentive program. Benefits offered include a retirement savings plan, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans. Salary range does not apply to the Tampa, FL location.

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.


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