Job description

Ophthalmology Director Clinical Development

Job LocationsUS-MA-Watertown | US
Job ID2022-1306Overview

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 person must possess ophthalmology experience.

This role is accountable for the developing and executing clinical development strategies and tactics which align with the broad pipeline strategy reporting to our Vice President Clinical Development. This role will lead multiple clinical studies in collaboration with the Clinical Operation team and external key opinion leaders and clinical advisors to drive start, conduct and full completion of clinical study reports in accordance to Good Clinical Practice (GCP) and United States FDA regulations. This position is reporting to the VP, Clinical Development.

Our HQ is located in Watertown, MA. This position may be remote, living on the East Coast or onsite and willing to travel 30-50%.
Responsibilities

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

Lead, Support and oversee the execution of clinical development and studies activities

• Develop the study protocol synopsis
• Review and validate the final study protocol and protocol amendments
• Review the informed consent form (ICF) and written subject information (WSI)
• Co-Develop the SAP in collaboration with the biostatistician
• Responsible for key results preparation and summary
• Review and provide input on the clinical study report
• Assisted by related functions such as project management, clinical operations and manufacturing operations, responsible for timelines, budgets and contingency/risk management plans to assure successful execution of the clinical trials in compliance with Good Clinical Practice (GCP), applicable laws and regulations as well as applicable standard operating procedures (SOPs)
• Medical support to clinical operation team during the clinical feasibility
• Review and provide clinical input across different study documents such as case report forms (CRF), e-diaries and monitoring plans
• Ensure continuous medical review of aggregated data during clinical trial conduct (DSUR, medical safety, statistical outputs of unmasked/masked data)
• Answer to medical questions raised by EC/IRBs and clinical sites

Contribute to the clinical development plan strategies:

• Internal Governance: Preparation of documents and presentations for internal governance meetings
• Responsible for the clinical development plans and clinical sections of integrated development plans
• Escalate study or project-level issues
• Contribute in the definition of the product value proposition (TVP), target product profile (TPP) and market access strategy (in collaboration with respective functions)
• Provide input on existing clinical needs and approaches to clinical development strategies for pre-clinical R&D projects
• Collaborate with external partners, regulators, and diverse internal stakeholders and collaborators
• Evaluates relevant medical literature and status from competitive products
• Participates in Clinical/Scientific Advisory Board meeting preparation

Scientific Data evaluation and authorship:

• Participate and author manuscripts and abstracts
• Establish and maintain appropriate collaborations with knowledge experts
• Contribute on an ad hoc basis to specific tasks such as the evaluation of potential in-licensing candidates and serves as the clinical advisor to pre-clinical R&D teams

Qualifications

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

• Ophthalmology experience in the pharmaceutical industry is required
• Team oriented, result driven with an ability to effectively interact with internal colleagues
• Excellent expertise in clinical development and methodology of clinical studies
• Excellent interpersonal and communication skills (verbal and written) for interactions across functional areas and with clinical advisors and key opinion leaders (KOLs)
• Knowledge of industry, regulatory compliance, and publication guidelines
• Travel may be required for clinical investigators’ meetings, medical conferences and internal meetings
• Travel – 30-50% domestically

Other Requirements:

This individual must have a positive attitude and be adaptable to a dynamic “startup” type of environment. Should be a strong and dependable team member who builds trust with management. Be transparent, ethical, and honest, and foster a culture of the same within their team.

Level of Education Required:

A doctoral degree (PharmD, OD, MD) is required

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

Director level: 8+ years

Associate Director/Director level: 5+ years

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.

• Success begins with our People
• Patients First
• Integrity
• Results-Driven
• Innovation
• Team Focus
• Diversity & Inclusion

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.

REMOTE

Job Type: Full-time

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible schedule
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Professional development assistance
• Vision insurance

Schedule:

• Monday to Friday

Education:

• Doctorate (Required)

Experience:

• Ophthalmology Pharma: 5 years (Required)

Willingness to travel:

• 50% (Required)

Work Location: Remote

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