26 days old

Director, GI Research

Sebela Pharmaceuticals Inc.
Braintree, MA 02184
































 


Job Description


 


 


 


 


 


Job Title:


Director, GI Research


Department:


R & D


Reports to:


Head of R&D


FSLA Status:


Exempt


 


 


 


 



SUMMARY


The Director, GI Research will serve as a primary contributor in the scientific, clinical, and regulatory evaluation of external business opportunities. Represent the GI R&D group in cross-functional diligence teams, summarizing and communicating diligence findings and opinions to executive management. Provide additional scientific support to the R&D department in the form of scientific writing, presentation, and review of internal development programs when necessary.


 


PRINCIPAL DUTIES AND RESPONSIBILITIES



  • Represents the GI R&D group in the evaluation of business development (BD) opportunities

  • As part of BD diligence activities, is responsible for critical review of scientific documents and regulatory filings including but not limited to: Investigation New Drug Applications (INDs), New Drug Applications (NDAs), Biologic License Applications (BLAs), device Premarket Approvals (PMAs), clinical study reports, study protocols.

  • Summarizing and presentation of diligence findings

  • Perform literature searches to support diligence and clinical development activities or internal regulatory filings

  • Assists in additional medical writing activities when necessary (e.g., abstracts, manuscripts, results summaries)











  • Provide support for internal development programs and commercialized products when necessary

  • Attends scientific meetings, presents on behalf of company, and brings back knowledge and information on competitive technologies/clinical studies.




 


QUALIFICATIONS


 


To perform this job successfully, an individual must be able to perform each essential function satisfactorily, be flexible in terms of work hours, and have strong knowledge and experience in pharmaceutical development. The requirements listed below are representative of the knowledge, skills and/or abilities required. 


 



  • MD or PhD in a relevant scientific discipline

  • Minimum of 10 years ongoing experience in drug development with experience in clinical/regulatory strategy

  • Experience performing clinical/regulatory evaluation of BD opportunities

  • Strong medical writing experience required (e.g., protocols, CSRs, FDA correspondence)

  • Thorough understanding of FDA regulations and Good Clinical Practices is preferred



 


 


WORK ENVIRONMENT


 


The work environment described here are representative of those an employee encounters while performing the essential function of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. This position will be in an office environment and the schedule will be a flexible combination of office/remote working.


 


PHYSICAL REQUIREMENTS


 


The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this Job, the employee is regularly required to sit for long periods of time. The employee is occasionally required to stand, walk, stoop, kneel, crouch, or crawl. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds.


 


 


 


ABOUT BRAINTREE, A PART OF SEBELA PHARMACEUTICALS


 


Braintree is the GI division of Sebela Pharmaceuticals, a leading specialty pharmaceutical company focused on three core therapeutic areas: gastroenterology, dermatology and womens health.  As part of Sebela, Braintree is a market leader in GI, including the #1 prescribed, branded bowel prep product, SUPREP and five marketed GI products as well as a rich near-term GI pipeline of products for diarrhea, constipation, and next generation colonoscopy preps providing multiple product launches over the next three to four years.


 


Sebelas growth is fueled through acquisitions, targeted promotion, and judicious investment in infrastructure.  As a result of our business model, our culture is characterized by a high degree of urgency, open dialogue, and discussion across all levels of the team, willingness to challenge the traditional approach, and shared ownership of the organization were building and our results.  We operate with a lean approach, focusing on investments that drive the growth of our business.  We are all willing to step in and do whatever is needed on any given day, regardless of the title we hold. Sebela offers a competitive compensation package including base salary, bonus based on personal and company performance, options (both upon hiring and potential in future years based on performance), and a comprehensive health benefits package.







 

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Posted: 2022-04-30 Expires: 2022-05-30

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Director, GI Research

Sebela Pharmaceuticals Inc.
Braintree, MA 02184

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