Remote Operational Risk Manager Jobs in Bethlehem, PA

Reports to (Title):                          CEO

Location:                                        Remote 

Exempt/Non-Exempt:                    Exempt 

Direct Reports:                              No

Department:                                   Clinical Science

Job Summary: Responsible for driving the US or global clinical development strategies and execution for assigned investigational and/or marketed products in the Ophthalmology Therapeutic Area (TA). The incumbent will be responsible for providing critical input into the strategy, development, management and implementation of Phase 1-4 clinical studies by closely working with the Clinical Ops team; providing medical input on the clinical development plan. 

Essential Job Functions:

Clinical Development Expertise & Strategy

• The Medical Director, Ophthalmology, will provide overall clinical scientific leadership for Exegenesis Bio’s Ophthalmology programs and have responsibility for our clinical development strategy and execution of clinical trials in this area
• Develop the study protocol synopsis, leads the analysis of benefit/risk for clinical development protocols and the final study protocol validation and protocol amendments; Medical support to clinical operation team during the clinical feasibility
• Identifies and builds relationships with principal investigators (PI), key opinion leaders (KOL) in drug development. Identifies and cultivates thought leaders in order to gain their inputs on emerging science in drug and biomarker research, disease knowledge, and design of clinical development studies and programs
• Maintains a strong medical/scientific reputation within the assigned disease areas. Has in-depth knowledge of etiology, natural history, diagnosis, and treatment of the disorders. Holds strong expertise in the disease areas by attending scientific conferences and ongoing review of the literature
• Keeps abreast of development and regulatory issues related to other competitive or relevant compounds in development and how our portfolio fits into the competitive landscape

Medical Monitoring

• Leads medical data review of trial data, including eligibility review; ensure continuous medical review of aggregated data during clinical trial conduct (DSUR, medical safety, statistical outputs of unmasked/masked data)
• Serve as a Clinical Trial Lead, holds responsibility for site interactions such as medical questions and education (specific disease areas, drug mechanisms of action, protocol requirements, safety management guidelines etc.) Clinical training for internal stakeholders and clinical trial sites 
• Holds responsibility for assessment of key safety-related serious adverse events in partnership with Worldwide Patient Safety and oversees safety narratives
• Fulfills GCP and compliance obligations for clinical conduct and maintains all required training

Health Authority Interactions & Publications

•  Contributes to and serves as medical point of expertise in key Health Authority interactions and advisory board meetings 
•  Authors/drafts clinical content for CSRs, regulatory reports, briefing books and submission documents to support closure, clinical narratives, reporting and filling of the study

Job Requirements: 

Experience / Education    

• Bachelor Degree in related scientific field is required; US board-certified or-eligible (or foreign-equivalent) MD is strongly preferred;    

• Minimum of 3 years of clinical medicine experience; Minimum of 3 years of industry experience in drug development or biomedical research experience in academia; Ophthalmology experience is required; gene therapy experience is plus not required. 

Knowledge / Skills / Abilities:

• Recognized expertise in clinical trials: working understanding of statistical principles, medical monitoring; demonstrated ability to perform literature research, analyze and author clinical trial publications; Thorough knowledge of the whole processes of clinical trials, clinical research concepts, practices, and GCP and ICH Guidelines
• Has working knowledge of GCP, ICH, US FDA and EMEA regulations, knowledge of relevant FDA regulations and guidelines as well as those of the EU and other health authorities; experience in interactions with the FDA is essential
• Proven success record in Phase I-IV clinical research studies, trial design, IND submission, and marketing approval-directed filings

• Proven ability to represent the Company’s interests effectively in interactions with partners and regulatory agencies.

• Experience communicating and interacting with investigators, KOLs, and advisors
• Experience working with the principles and techniques of data analysis, interpretation and clinical relevance

• Must have strong consensus-building skills and the ability to lead multi-disciplinary teams towards sound decision-making.
• Ability to develop and implement strategic growth plans.

• Ability to work collaboratively with cross-functional team to support the management of large volumes of data
• Ability to operate and thrive in a fast-paced and hands-on environment; demonstrated flexibility.
• Demonstrated success of taking initiative in a team setting
• Comfortable with ambiguity, yet be self-motivated and timeline driven
• Ability to travel up to 25% as needed

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

About the company:

Exegenesis Bio is a clinical-stage global cell and gene therapy company that operates in Philadelphia, Boston, China, and Singapore. Founded in 2019 with strong financial backing, the company has built a broad pipeline of innovative genetic medicines and fully integrated manufacturing capabilities. The company is advancing an early to clinical-stage gene therapy pipeline with three initial focused therapeutic areas: CNS, ophthalmology, and Liver. The company’s vision is to develop and increase access to gene and cell therapies for patients around the world.

Benefits

•Medical, Dental and Vision Insurance and FSA

•Generous Paid Time Off options, including Vacation and Sick time, plus national holidays

•401(k) match and annual company contribution

• Company-paid life insurance, AD&D and LTD

•Employee wellness program- Gym reimbursement

•Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions

•Long Term Incentive Plan for eligible positions

•Referral bonus program