Head of Rare Metabolic/Renal (MD) Clinical Research
Pfizer Rare Disease is pursuing projects in rare metabolic and renal indications with a view to expanding the clinical portfolio in these areas of very significant unmet patient need. Three early phase clinical programs (P1/2) are currently running with multiple programs proximal to first in human studies and in discovery. The programs span multiple indications and pharmacological modalities, including small molecules, biotherapeutics and AAV gene therapy. The Rare Disease Research Unit is keen to identify an creative, innovative research focused physician with significant experience in inborn errors of metabolism, or other metabolic, renal or bone disease with a background in genetics, clinical care or experimental medicine (biomarkers, imaging, clinical trial endpoint development) to lead the clinical translation and early development strategy for the selected indications. Some industry experience is essential although for the right candidate, further training may be provided to fill out any areas of relative inexperience in drug development.
To guide drug discovery and to lead the early clinical development of rare metabolic/renal/bone programs with a particular focus on monogenic disease.
To extend and build the current rare disease metabolic/renal/bone portfolio through new project initiation, in licensing and efficient progression of current programs
Responsible for the guidance of discovery teams in rare metabolic disease regarding indication selection, population identification, and target selection
Responsible for the formulation of clinical development plans at candidate selection
Responsible for the early clinical development of rare metabolic projects – conception and leadership of clinical strategy for Rare metabolic projects.
Partner with colleagues in clinical pharmacology, statistics, digital and precision medicine to optimize innovative plans for compound and efficacy evaluation.
Responsible for the development of natural history, biomarker, and translational strategies for rare metabolic/renal and bone disease
Build, develop, and lead a motivated and engaged team of line and matrixed clinicians who are responsible for the day-to-day design and execution of rare metabolic clinical programs
Provide oversight of the rare metabolic clinical team, including:
- Lead preparation of clinical sections of all relevant regulatory filings (IND, study reports, NDA/BLA, etc)
- Oversee management of studies and serve as expert on clinical and medical issues
- Oversee review of study data, sometimes including safety monitoring and SAE reporting
- Oversee writing of final study reports and preparation of documents for submission
Lead interactions with business unit and commercial colleagues with regard to clinical elements of progression agreements into late stage development including definition of POM/POC success criteria
Interact with key opinion leaders and clinician scientists to ensure implementation of latest clinical thinking and guidelines into clinical development plans
Serve as medical and technical resource for clinical issues raised by internal and external collaborators, investigators, consultants and contractors relevant to rare metabolic programs
Represent the company at scientific meetings and presentations, interactions with rare metabolic disease foundations and PAGs
Assist in the development of publications, abstracts, and presentations
Support business development activities as needed, including due diligence activities
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.
A clear working knowledge of the clinical development process
A proven track record of scientific and operational success within a large matrixed environment
Excellent understanding of pathophysiology, clinical phenotype and genetics of rare metabolic/renal or bone disease
Demonstrated ability to formulate research and development plans
Clinical background in industry or academia, in metabolic/renal or bone disease
Full grasp of the clinical development process
Strong organizational skills and attention to detail
Ability to interface with senior management and enhance the credibility of the rare disease unit
Excellent written and oral communication skills
MD or equivalent medical qualification (MD, PhD preferred)
Deep understanding of the biopharma environment and the drug development process; 5+ years of relevant experience in drug development with proven track record of success in executing development programs to completion
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
Other Job Details:
Eligible for Relocation Package
Eligible for Employee Referral Bonus
Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.Sunshine ActPfizer 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 EligibilityPfizer 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.Medical