Clinical Director

2 weeks ago

Collegeville, Pennsylvania, United States Pfizer Full time
ROLE SUMMARY

The Clinical Lead (CL) will be the key figure driving clinical research for metabolic diseases at Pfizer. This individual will be responsible for creating the overarching strategy for early clinical development programs, focusing on innovative design, medical and scientific excellence, and the highest ethical standards.

The CL will lead clinical development strategy and program execution of research projects, with a particular focus on obesity and associated conditions. This includes translating pre-clinical observations into clinical experiments and studies designed to demonstrate proof of pharmacology, proof of mechanism, and proof of concept for new candidate medicines.

The CL will apply deep medical and clinical knowledge to translate clinical research ideas into high-quality decision-making data, working closely with subject matter experts from statistics, clinical pharmacology, and other team members.

The CL serves as a single clinical development point of contact to the Research Project Leader for each assigned project.

ROLE RESPONSIBILITIES
  • Uses deep medical and scientific knowledge and expertise to contribute to the selection of targets for progression from chemical/biologic synthesis to testing in humans.
  • Leads the creation of the clinical development plan from pre-clinical stages through to proof of concept.
  • Guides clinical team members to ensure excellence in development and translation of clinical research plans into efficiently delivered studies.
  • Creative in the conception of novel study designs and collaborates with the Clinician and Operations Manager to ensure these novel designs are optimized for operational effectiveness to ensure timely and cost-effective delivery.
  • Oversees the design and execution of clinical research studies, including development of outline/core elements prepared by Clinicians or other clinical team members.
  • Accountable for development of clinical documents, such as protocol, clinical report, and clinical components of regulatory submissions.
  • Serves as a Medically Qualified Individual (MQI) at Pfizer, reviewing clinical trial data for safety signal identification and tracking.
  • Provides input to the operational strategy and feasibility of clinical research studies, in conjunction with the Development Director, Operations Manager, and Clinician; accountable for final decision.
  • Establishes relationships with key clinical experts/sites and uses this information to advise the clinical team on site selection.
  • Flexible in supporting a dynamic research portfolio; may need to manage multiple programs in parallel, depending on the development stage of the programs.
  • Contributes to technical and protocol review committees across the portfolio.
QUALIFICATIONS
  • MD or MD/PhD (or equivalent degree(s)) with relevant postgraduate clinical training.
  • Approximately 8-10 years relevant experience.
  • Preference for established record in execution of clinical trials in the pharmaceutical industry environment; experience in managing complex projects.
  • Firm understanding of the drug development process with particular emphasis on early clinical development.
  • Scientific excellence; possesses deep knowledge of integrated metabolism biology and metabolic diseases such as obesity, diabetes, and cardiovascular/cardiometabolic disorders.
  • Superior clinical ability with relevant disease area knowledge and experience.
  • Ability to design, initiate, and conduct effective clinical studies applying novel principles as appropriate, and integrating these plans into a cohesive overall clinical development strategy.
  • Strong understanding of the complexities and current developments in the relevant disease/technical area, and skillfully applies this knowledge to drug development.
  • Firm understanding of clinical regulatory requirements, and knowledge of GCP and ICH guidelines.
  • Experienced with ownership of budgets and sound financial risk management.
  • Ability to review and understand emerging data and proactively implement measures to ensure delivery of quality study results.
  • Skilled communicator and team leader, able to clearly articulate ideas and integrate feedback.
  • Ability to navigate a complex matrixed environment and manage teams that are diverse in terms of expertise, background, and geography.
PREFERRED QUALIFICATIONS
  • Board eligibility/certification in Internal Medicine, with subspecialty training in obesity medicine and/or endocrinology (or analogous relevant subspecialty training) preferred.
  • Active medical license preferred.
COMPENSATION

The annual base salary for this position ranges from $213,500.00 to $355,000.00, in addition to participation in Pfizer's 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 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.

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.

SUNSHINE ACT

Pfizer reports payments and other transfers of value to healthcare 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 healthcare 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. This position requires permanent work authorization in the United States.

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