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Vice President, Clinical Development

fully flexible
Remote: 
Full Remote
Contract: 
Experience: 
Expert & Leadership (>10 years)
Work from: 

Offer summary

Qualifications:

MD or equivalent required, 10+ years in ophthalmology clinical development, Experience with NDA/MAA submissions, Extensive knowledge of FDA regulations.

Key responsabilities:

  • Lead the clinical development function
  • Interact with regulatory agencies and partners
EyePoint Pharmaceuticals logo
EyePoint Pharmaceuticals Biotech: Biology + Technology SME https://eyepointpharma.com/
51 - 200 Employees
See more EyePoint Pharmaceuticals offers

Job description

Overview:

Be Seen and Heard at EyePoint Pharmaceuticals

 

At EyePoint, leadership trusts our employees to get the job done. The patient-centric and award-winning approach we’re taking in business fuels our success for:

 

  • preventing blindness through vision-saving medications
  • delivering best-in-class proprietary pharmaceutical technologies
  • transforming ocular drug delivery

 

We See You.

 

Your wellbeing

Your professional worth

Your future at EyePoint

 

EyePoint offers robust total rewards in a science-based entrepreneurial culture that empowers curiosity and innovation to help catapult your career. There’s space for every voice and perspective to be heard in our on-site and remote environments where a variety of strengths and diverse backgrounds are connected.

 

This position may be in Watertown, MA or remote. The VP, Clinical Development will report to the Chief Medical Officer and will provide leadership for the clinical development team and EyePoint drug development programs. The successful candidate will provide medical and scientific expertise on the strategy, design, execution and interpretation of data from early to late-stage clinical development programs. This leadership role will be responsible for the clinical development function; direct reports may include one or more physicians and clinical scientists.

 

This individual will be responsible for ensuring that all studies are conducted with the highest level of ethical and safety standards and are in compliance with GCP and all regulatory policies. Duties include primary interactions with regulatory agencies, clinical advisors, investigators, CROs, other vendors, and development partners, functioning as the medical representative on the integrated project team, and providing medical consultation as needed across the EyePoint portfolio of products and studies.

 

This individual will interact closely with company management. A genuine interest and understanding of the science, desire to work in a highly collaborative organization, and deep passion about making a difference in the lives of patients are essential. 

Responsibilities:

Primary responsibilities include, but are not limited to, the following:

 

Individual responsibilities

 

  • Lead the clinical development function and for one or more development assets
  • Participate in clinical leadership team meetings and provide medical guidance in the execution of clinical trials
  • Author/review, in collaboration with other EyePoint functions, protocols, ICFs, CRFs, CSRs, IBs, DSURs, PSURs, regulatory packages, NDAs, MAAs
  • Review and interpret clinical trial data
  • Secure, analyze and report on competitive intelligence related to successful conduct/execution of studies sponsored by other organizations and new data that may impact EyePoint programs
  • Provide mentorship and development opportunities to others within EyePoint
  • Responsible for resourcing clinical development programs within functional area
  • Responsible for medical monitoring of one or more clinical trials
  • Contribute to Clinical Development Plan for one or more assets
  • Represent clinical development to executive leadership, KOLs, investigators, regulatory agencies
  • Present findings internally and externally (e.g., investigator meetings, regulatory agency meetings) acting as a spokesperson for EyePoint
  • Work cross-functionally with clinical operations, biometrics and data management, drug safety, drug formulation development, regulatory, pre-clinical and clinical pharmacology, medical affairs,
  • Evaluate scientific information and new ideas to assist in identifying new research opportunities
  • Successfully interface with development partners
  • Contribute to determining global strategy for development of clinical development assets
  • Prepare manuscripts, abstracts and presentations for scientific meetings
Qualifications:

Primary skills and knowledge required include, but are not limited to the following:

  • 10+ years’ experience in ophthalmology clinical development, with experience in small and large pharma
  • Experience representing clinical development in regulatory interactions, including NDA/MAA submission
  • Global clinical trial experience, including 3 studies
  • Experience supervising other physicians and/or clinical scientists and supporting them in co-authoring study and regulatory documents
  • Extensive knowledge of ophthalmology clinical drug development, including FDA regulations, statistics, safety.
  • Experience in working with small molecule targeted agents; experience with VEGF inhibitors or other antiangiogenic agents a plus
  • Excellent written and verbal communication skills
  • Willing and able to travel, as needed

Level of Education Required:

  • MD (or equivalent) required
  • Training in ophthalmology

Number of Years of Experience in the Function and in the Industry:

  • 10+ years’ experience in ophthalmology clinical development, with experience in small and large pharma

Envision Your Future

 

With the exciting energy of a winning culture and an exhilarating pace, we are an ophthalmology company committed to preventing blindness by developing and commercializing innovative therapeutics.

 

The collective power of our values influences everything we do, and everything we do for you.

 

Transformational Innovation

We exist to change our patients’ lives through the power of sight. We are forward looking, embrace challenges with curiosity, and continuously seek to improve our products and ourselves by learning, problem-solving and pushing the limits of science and technology.

 

Unwavering Integrity

We recognize our responsibility to our patients, employees, and our community, and value the trust they put in us. We set a high ethical bar and expect responsible leadership at every level to ensure we serve those who matter most to us.

 

Compassionate Excellence

We believe that fun and excellence can coexist. We foster a culture where enjoying the work we do and caring for each other are as important as delivering exceptional outcomes.

 

Inclusive Collaboration

We strive to see through the eyes of others and work as one team. We appreciate one another’s differences and perspectives, and ensure everyone feels valued, respected and encouraged to bring their ideas forward.

 

EyePoint Pharmaceuticals is proud to be an equal opportunity employer. We believe that diversity and inclusion among our colleagues is critical to our success as a company, and we seek to recruit, develop, and retain the most talented people from a diverse candidate pool. All applicants will be considered for employment without attention to age, race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status.

 

#LI-Remote

Required profile

Experience

Level of experience: Expert & Leadership (>10 years)
Industry :
Biotech: Biology + Technology
Spoken language(s):
English
Check out the description to know which languages are mandatory.

Other Skills

  • Mentorship
  • Collaboration
  • Communication
  • Problem Solving

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