Clinical Development Associate

Job Purpose                                                                                                                                                                                                                                         

The Clinical Development Associate (CDA) position will support clinical development activities across all of Ocugen Inc’s product platforms and is responsible for assisting in the design and implementation of clinical research projects for investigational pipeline.  The CDA will collaborate across functional areas within regulatory, clinical operations, project management, and commercial, and will coordinate communications where appropriate with Key Opinion Leaders (KOL) and external scientists. This position reports directly to the Associate Director of Clinical Development.

 Duties and responsibilities  

• Provides support activities within Clinical Development summarizing scientific evidence (clinical study data, epidemiology, disease burden, public health value, current available therapy etc.) and integrating information into clinical development deliverables (abstracts, clinical trial summaries, etc.)
• Supports the end to end (protocol concept to final study report) delivery of clinical development activities which ensure consistency with the clinical development strategy for regulatory approvals, reimbursable medicines, and successful lifecycle management.
• Supports development and review of key study documents including Study Protocols, Investigator’s Brochure, Target Product Profiles for products within Ocugen’s pipeline.
• Provide support in development of the clinical development plan (CDP) and review of other relevant study documents including informed consent forms (ICF), Assent Forms, protocol deviation management plan (PDMP), Dosing/Surgical Manual, and Site Feasibility.
• Formats study related documents in accordance with regulatory requirements.
• Develops and updates presentation slide decks for study clinical data for presentation to internal stakeholders.
• Communicates concise information of clinical research status with internal stakeholders using relevant platforms where necessary.
• Effectively communicates with external contributors to create key clinical development deliverables in a timely manner.
• Supports development and dissemination of core medical affairs resources including medical-to-medical slide decks, and other resources as needed.
• Contributes to gathering and integrating published scientific data necessary for developing Ocugen drug product labels.
• Participates in cross-functional collaborations supporting asset launches.
• Manages timelines and project workflow across product platforms.
• Additional tasks and projects as requested to ensure key deliverables are optimized.
  

 Qualifications

• Advanced and relevant terminal degree such as PharmD, MD, DO, or PhD
• 1 years of experience in clinical research or clinical research-related activities
• Documented ability to take a project from start to completion.
• Able to review, evaluate, interpret, and present complex data.
• Ability to quickly learn and apply new skills, meet short deadlines and multi-task in a fast-paced environment.
• The ideals candidate must demonstrate productivity, efficiency and quality.
• Excellent verbal and written communication skills including scientific writing.
• Proficiency in Microsoft Office Suite
• Fluent in English writing, reading, speaking; multiple languages a plus but is not required.

Working Conditions

This position operates in an office setting and may include 20% of travel.

Physical Requirements                                                                                                                                                                                                                           

external scientists. This position reports directly to the Associate Director of Clinical Development.

Ocugen is an equal opportunity employer. In order to provide equal employment and advancement opportunities to all individuals, we make all of our employment decisions based upon merit, qualifications, abilities, and an individual’s conduct and performance. We will not make any of our decisions, and will not discriminate against any employee or applicant, on the basis of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including sexual orientation, gender identity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, or any other characteristic protected from discrimination under the law. Ocugen complies with applicable federal, state and local laws governing nondiscrimination in employment.