The job below is no longer available.
You might also like
in Collegeville, PA
$41est. per hour Commonwealth Of Pennsylvania • 6h agoUrgently hiring 8.6 mi Use left and right arrow keys to navigate- $33
est. per hour Zoetis, Inc • 6h agoUrgently hiring 11.2 mi Use left and right arrow keys to navigate - CSL Behring • 13h ago
Urgently hiring 7.3 mi Use left and right arrow keys to navigate - $57
est. per hour CSL Behring • 13h agoUrgently hiring 7.3 mi Use left and right arrow keys to navigate - $34
est. per hour Aramark • 3d agoUrgently hiring 4.1 mi Use left and right arrow keys to navigate
Head of Neuromuscular Clinical Research
•30 days ago
| Hours | Full-time, Part-time |
|---|---|
| Location | collegeville, Pennsylvania |
About this job
Org Marketing Statement
All over the world, Pfizer colleagues are working together to positively impact health for everyone, everywhere. Each position at Pfizer touches and contributes to the success of our business and our world. That's why, as one of the global leaders in the biopharmaceutical industry, Pfizer is committed to seeking out inspired new talent who share our core values and mission of making the world a healthier place.
Role Description
We are seeking a proven leader to build and lead a team of clinicians within the rare disease research team whose remit is to direct the clinical evaluation of new drugs for neuromuscular rare diseases. The desired candidate will be accountable for the delivery of clinical development plans for all rare neuromuscular disease assets, and will be skilled in clinical program design and execution in the context of a large pharma development organization. Experience and knowledge in interaction with clinical investigators, collaboration with regulatory affairs, and FDA interactions is required. Experience in building and leading clinical development organizations in a matrixed pharma environment is required.
Responsibilities
Responsible for the clinical development process for rare neuromuscular disease projects - conceive and execute clinical strategy for Rare NMD projects.
Build, develop, and lead a motivated and engaged team of clinicians who are responsible for the day-to-day design and execution of rare neuromuscular disease clinical programs.
Interact with the broader Pfizer clinical development organization as needed to corral resources and share learnings.
Lead interactions with business unit and commercial colleagues with regard to clinical elements of transition agreements and product concept development for NMD.
Responsible for the development of natural history, biomarker, and translational strategies for rare NMD
Provide oversight to the NMD 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, including safety monitoring and SAE reporting.
- Oversee writing of final study reports and preparation of documents for submission.
Interact with key opinion leaders 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 NMD programs.
Manage strategic relationships with key partners, including Pfizer Alliance Partners (e.g., CROs) for NMD programs.
Represent the company at scientific meetings and presentations, interactions with NMD disease foundations, as well as other public relations opportunities.
Assist in the development of publications, abstracts, and presentations.
Support business development activities as needed, including due diligence activities.
Qualifications
Education and Experience:
* MD or equivalent medical qualification
* Deep understanding of the biopharma environment and the drug development process; 10+ 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
Technical Skills Requirements:
* A clear working knowledge of the clinical development process
* A proven track record of success within a matrixed large pharma environment
* Demonstrated ability to formulate and operationalize clinical strategies
* Clinical background in industry, academia, or private practice in Neurology or NMD area
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.
All over the world, Pfizer colleagues are working together to positively impact health for everyone, everywhere. Each position at Pfizer touches and contributes to the success of our business and our world. That's why, as one of the global leaders in the biopharmaceutical industry, Pfizer is committed to seeking out inspired new talent who share our core values and mission of making the world a healthier place.
Role Description
We are seeking a proven leader to build and lead a team of clinicians within the rare disease research team whose remit is to direct the clinical evaluation of new drugs for neuromuscular rare diseases. The desired candidate will be accountable for the delivery of clinical development plans for all rare neuromuscular disease assets, and will be skilled in clinical program design and execution in the context of a large pharma development organization. Experience and knowledge in interaction with clinical investigators, collaboration with regulatory affairs, and FDA interactions is required. Experience in building and leading clinical development organizations in a matrixed pharma environment is required.
Responsibilities
Responsible for the clinical development process for rare neuromuscular disease projects - conceive and execute clinical strategy for Rare NMD projects.
Build, develop, and lead a motivated and engaged team of clinicians who are responsible for the day-to-day design and execution of rare neuromuscular disease clinical programs.
Interact with the broader Pfizer clinical development organization as needed to corral resources and share learnings.
Lead interactions with business unit and commercial colleagues with regard to clinical elements of transition agreements and product concept development for NMD.
Responsible for the development of natural history, biomarker, and translational strategies for rare NMD
Provide oversight to the NMD 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, including safety monitoring and SAE reporting.
- Oversee writing of final study reports and preparation of documents for submission.
Interact with key opinion leaders 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 NMD programs.
Manage strategic relationships with key partners, including Pfizer Alliance Partners (e.g., CROs) for NMD programs.
Represent the company at scientific meetings and presentations, interactions with NMD disease foundations, as well as other public relations opportunities.
Assist in the development of publications, abstracts, and presentations.
Support business development activities as needed, including due diligence activities.
Qualifications
Education and Experience:
* MD or equivalent medical qualification
* Deep understanding of the biopharma environment and the drug development process; 10+ 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
Technical Skills Requirements:
* A clear working knowledge of the clinical development process
* A proven track record of success within a matrixed large pharma environment
* Demonstrated ability to formulate and operationalize clinical strategies
* Clinical background in industry, academia, or private practice in Neurology or NMD area
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.
Your Privacy Choices