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Clinical Group Head

Employer
Pfizer
Location
Cambridge, Massachusetts
Salary
Competitive
Closing date
Feb 24, 2021

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Sector
Pharmaceutical, Physicians/Nurses
Hours
Full Time
Organization Type
Corporate
Jobseeker Type
Professional
ROLE SUMMARY

The overall function of the Group Head in the Early Clinical Development (ECD) Clinical Sciences (CS) organization is to manage ECD clinicians and lead the execution of studies and clinical drug development activities from FIH through POC.

The ECD Clinical Group Head will be responsible for managing a team of clinicians (3-8 individuals) to ensure clinical teams are adequately resourced. The Clinical Group Head will be a key member and/or contact for project teams to ensure collaboration and seamless connectivity between ECD, Research Units, and Clinical Development and Operations.

In addition, the ECD Clinical Group Head will participate as an individual contributor on clinical teams to meet enrollment and study delivery timelines. The ECD Clinical Group Head will work with other functional disciples to ensure the full scope and remit of ECD is represented as need within clinical study teams (e.g. Research Units, Biostatistics, Clinical Pharmacology, Precision Medicine, and Digital Medicine).

RESPONSIBILITIES
  • Provides scientific and operational leadership to a group of ECD clinicians involved in executing and delivering innovative clinical trial designs, high quality study execution, safety assessment, and interpretation of clinical study results.
  • Supports clinical strategy development and execution of post-FIH programs through proof of mechanism (POM), early signs of efficacy (ESoE), and proof-of concept (POC).
  • Develops and retains an outstanding ECD clinical research team to deliver the WRDM portfolio in an innovative, timely, compliant, and cost-effective manner.
  • Allocates and manages resources directly or indirectly to ensure the WRDM portfolio is appropriately resourced.
  • Sits on relevant study teams to support the implementation and execution of clinical development strategies and contribute to key development milestones, e.g. start-up and delivery of ESoE and PoC trials.
  • Serves as a technical resource for clinical and study execution issues raised by internal and external collaborators, investigators, consultants and contractors.
  • Provides leadership and input in the preparation of critical documents, including but not limited to clinical protocol, ICD, statistical analysis plan, and regulatory documents.
  • Ensures clinical trial execution activities are completed according to planned timelines and within Good Clinical Practice guidelines.
  • Expands the culture of collaboration with project leaders and team members, including research units, biostatistics, regulatory affairs, clinical pharmacology, precision medicine and clinical operations by maintaining open communications between the groups and ensuring successful program completion.
  • Contributes to colleague mentoring and training.
  • Maintains up-to-date knowledge of scientific and clinical published literature in relevant therapeutic areas including the key clinical development issues.
  • Develops and maintains effective collaborations with key partner lines in ECD, the Research Units (RU), and the Clinical Development and Operations organization in GPD.
  • Partners with Precision Medicine as needed to ensure biomarker plans are enabled in all relevant therapeutic area programs to help determine, POM, ESoE and POC.
  • Provides discipline expertise in the evaluation of external collaboration and acquisition opportunities as needed, including due diligence activities.
  • Fosters a transparent environment that encourages strong partnerships and mutual trust between teams, sub-teams, and therapeutic areas.
  • Establishes and supports 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.
  • Represents the ECD CS organization on appropriate governance bodies, e.g., TRC, PRC, CPSDC.
  • Serves as a member of the ECD CS Leadership Team.
  • Supports and assists in the development of publications, abstracts, and presentations.
  • Serves a Subject Matter Experts for review and implementation of clinically relevant process documents, as well as serve on limited duration committees evaluating process improvement activities.


BASIC QUALIFICATIONS

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.

  • Requires PhD, PharmD, MS and/or BS.
  • Deep understanding of the biopharmaceutical environment and the clinical drug development process.
  • 8-12 years of relevant experience in drug development with proven track record executing development programs to completion or targeted milestone.
  • Experience in leading/managing a group of clinicians involved in early drug development.
  • 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.
  • 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.
  • Ability to operate with a sense of pace and urgency in matrixed project teams.
  • Ability to review and interpret clinical data and identify potential safety signals.
  • Exercises initiative in meeting goals and drives innovation in projects.
  • Good communication and presentation skills, as well as proven scientific writing skills.


PREFERRED QUALIFICATIONS
  • Relevant experience in Immunology and Inflammation, Internal Medicine, Rare Diseases, Oncology.


Other Job Details:
  • Last Date to Apply for Job: February 26, 2021
  • Eligible for Relocation Package: YES
  • Eligible for Employee Referral Bonus: YES


#LI-PFE

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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