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Executive Director Clinical Research Rare Neurological Disease (MD Required)


Cambridge, MA
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Job Details

The Rare Disease Research Unit is looking for a talented senior physician scientist to join our team developing transformational new treatments in rare Neuromuscular, Neurodevelopmental and Neurodegenerative diseases using AAV gene therapy. This individual will focus on the challenging translational, clinical and regulatory problems presented by gene therapy in rare (often) pediatric indications, including natural history studies, novel endpoint development and clinical trial design. The candidate will be accountable for the delivery of translational and clinical development plans for AAV gene therapy programs in multiple rare neurological indications, and will be skilled in early clinical program design and conduct from pre-clinical stages to POC. Similar activities will be required for programs exploiting other treatment modalities. Experience and proven collaborative skills with basic and clinical scientists, investigators, regulators and safety functions are essential.


In order of importance, indicate the primary responsibilities critical to the performance of the role. It is recommended not to list actual tasks but focus on 5-8 essential responsibilities that highlight accountability and level of judgment required.

+ Accountable for the development of translational and clinical development plans in rare Neuromuscular, Neurodevelopmental and Neurodegenerative diseases using AAV gene therapy and other modalities for RDRU projects

+ Lead interactions with colleagues in Global Product Development and Pfizer Innovative Health with regard to clinical development planning and product concept development for AAV gene therapies and other modalities.

+ Partner with functions in Early Clinical Development as needed to ensure that biomarker and quantitative development plans are enabled in all relevant Rare Neuro programs to help determine early signs of efficacy and proof of concept, patient stratification, etc.

+ Serve as a clinical champion for early development Rare Neuro programs in AAV gene therapy and other modalities

+ Help to build, develop, and lead motivated and engaged matrix teams

+ Provide oversight to clinical teams, including:

+ Lead preparation of clinical sections of all relevant regulatory filings (IND, Orphan designation, Fast track and breakthrough designations - including NDA/BLA when required).

+ Oversee management of studies and serve as expert on clinical and medical issues, including medical monitoring where necessary

+ Oversee review of study data, including safety monitoring and SAE reporting

+ Oversee writing of final study reports and preparation of documents for submission

+ Establish and support relationships with external experts, consultants, key opinion leaders, to ensure implementation of latest clinical thinking and guidelines into clinical development plans and study designs

+ Serve as medical and technical resource for clinical issues raised by internal and external collaborators, investigators, consultants and contractors

+ Mentor or supervise other clinicians to expand drug development understanding and provide development opportunities

+ Foster a transparent environment that encourages strong partnerships and mutual trust between teams, sub-teams, and therapeutic areas.

+ Represent the company at scientific meetings and presentations, interactions with rare 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.

+ Maintain up-to-date knowledge of scientific and clinical published literature in relevant therapeutic areas including the key clinical development issues.


Indicate qualifications that are job related, consistent with business necessity and necessary for the performance of an essential function of this role including: education/licenses/certifications, relevant experience (where legally permissible), technical and/or other job-related skills.

+ Requires MD, MD/PhD or equivalent

+ Board certified or eligible in Neurology or Pediatric Neurology preferred

+ Deep understanding of the biopharma environment and the drug development process; 14+ 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

+ A clear working knowledge of the clinical development process and its variation in rare diseases. Experience and knowledge of gene therapy approaches.

+ A proven track record of success within large pharma or biotech environment with a demonstrated ability to formulate and operationalize clinical strategies

+ Good understanding of relevant disciplines such as biostatistics, regulatory, clinical pharmacology, pre-clinical toxicology, pharmacogenomics and biomarker based approaches.

+ Demonstrated scientific productivity (publications, abstracts, etc.).

+ Good communication and presentation skills as well as proven scientific writing skills.

+ Results-oriented with demonstrated track record of success in clinical development

+ Ability to navigate a complex matrixed environment and manage teams that are diverse in terms of geography, background, and expertise

+ Entrepreneurial mindset with the ability to bring creative solutions to challenges

+ Ability to think and frame problems strategically; Quick action taker, able to involve the right team members in the right situation at the right time

**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.

**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.

**Other Job Details:**

+ **Last Date to Apply for Job: 12/13/2017** Eligible for Relocation Package - Yes

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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