Clinical Group Lead

JOB SUMMARY

The Clinical Group Lead will lead a group of Study Clinicians to ensure high quality cost efficient and timely delivery of clinical programs. They will work with the Development Head other Clinical Group Leads (GCLs) and Global Clinical Leads (GCLs) to ensure appropriate resourcing of studies and other Clinical projects. Depending on the TA the Clinical Group Lead may provide line management of up to 10 TA Clinicians the majority of whom are MDs and/or hold postgraduate degrees in biomedical sciences (PhD PharmD VMD etc.).

They will ensure that Clinicians within their group are well trained and compliant with requirements and regulations. They will develop the existing clinical staff and recruit additional clinical staff where needed. The Clinical Group Lead is a Subject Matter Expert in their TA and potentially across TAs. They will provide day to day oversight to ensure the progress of clinical studies in accordance with agreed clinical development plans. They will mentor and coach TA Clinicians on best practices and build the Clinical expertise in their group.

RESPONSIBILITIES

• Accountable for the high quality cost efficient and timely delivery of clinical studies within their assigned portfolio
• Ensures adequate resourcing of clinical studies in their assigned portfolio developing or recruiting additional Clinicians as needed
• Ensures effective conduct and medical/scientific oversight of studies and supports appropriate interpretation and communication of clinical trial data including high quality regulatory submissions and product defense activities
• Works with other cross functional lines to improve important quality aspects of studies including Case Report Forms (CRFs) Serious Adverse Event/Adverse Event (SAE/AE) reporting Informed Consent Document (ICD) development site selection Significant Quality Event (SQE) process adjudication Data Monitoring Committee (DMC) best standards etc. to simplify processes and ensure quality in the studies
• May also fulfill the role of TA Clinician
• Ensures compliance with internal and external standards proactively mitigates risk and manages emerging clinical issues
• Ensures technical excellence and functional competency of TA Clinicians within a TA through oversight coaching mentoring performance management and training
• Holds regular coaching and feedback sessions of TA Clinicians within group and maintains a diverse high-performing team
• May work with GCLs on Clinical Development Plan

QUALIFICATIONS/SKILLS

Education

• Medical degree PhD PharmD preferred Experience
• 10-15 years of experience and track record of success in designing and delivering clinical trials
• Experience supporting submission activities or other regulatory deliverables
• Experience managing groups of up to 15 people
• Demonstrated clinical/medical administrative and project management capabilities
• Proven scientific writing skills with strong inter-personal written/verbal communication skills including ability to evaluate interpret and present complex data
• Demonstrated ability to design initiate and conduct clinical studies as part of an integrated clinical plan
• Effective communicator with multiple senior stakeholders
• Able to create engaged teams and colleagues.

Skills

• Able to review and understand the emerging safety and efficacy profile of the drug candidate
• Able to set priorities and manage cross-functional teams and complex projects to deliver milestones according to set budgets
• Collaborative problem solving (handles conflict constructively)
• Creativity and/or ability to put innovative approaches into practice in clinical development

ORGANIZATIONAL RELATIONSHIPS

Reports to Development Head Internal Medicine

Interfaces with: Clinicians Clinical Study Team Leads Project Managers Clinical Operations Group Leads Global Clinical Trial Execution (GCTE) Stats/Programming Clinical Development Quality (CDQ) Clin Pharm Global Clinical Leads Medicine Team Leads Safety/Regulatory

RESOURCES MANAGED

Depending on TA may directly manage up to 15 Clinicians.

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.

PHYSICAL/MENTAL REQUIREMENTS

See job description

NON-STANDARD WORK SCHEDULE TRAVEL OR ENVIRONMENT REQUIREMENTS

Will need to travel occasionally. Will need to work with colleagues in different time zones e.g. Europe Asia.

Work Location Assignment:Hybrid

The annual base salary for this position ranges from $242000.00 to $403400.00. In addition this position is eligible for participation in Pfizers Global Performance Plan with a bonus target of 25.0% 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 lifes 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. Learn more at Pfizer Candidate Site U.S. Benefits (). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa FL or any location outside of the United States.

Relocation assistance may be available based on business needs and/or eligibility.

Medical