Clinical Site Manager - New Haven, United States - Connecticut Innovations

Description

Come join Veradermics, a Connecticut Innovations portfolio company

About Veradermics

Veradermics is a well-funded medical dermatology company driven to develop innovative therapeutics aimed at transforming the standard of care for a wide range of common skin conditions. Founded by dermatologists, Veradermics leverages its front-line clinical experience to identify and advance novel drugs that address specific patient needs and solve pervasive treatment challenges in dermatology practice. The company has cultivated a pipeline of diverse, first-in-class, single-molecule therapeutics for highly prevalent dermatologic conditions seen in adults and children. Target indications include common warts, alopecia areata, molluscum contagiosum, and androgenetic alopecia (pattern hair loss). Veradermics' lead product candidate, VDMN Patch, offers a new, patient-friendly, injection-free approach for the treatment of common warts. Veradermics is led by an executive team of board-certified dermatologists supported by a board of directors comprised of recognized biopharmaceutical industry leaders.

Why Work at Veradermics

• You Can Be Part of a Meaningful Mission - Veradermics aims to create a paradigm shift in medical dermatology by bringing pharmaceutical innovation to the treatment of common skin conditions that currently lack meaningful therapeutic advances and have been neglected by traditional pharma.
• Veradermics Has Significant Growth Potential – Veradermics' Product Candidates Have Cumulative Revenue Estimates of > $6B/Year.
• Veradermics' Has a Proven Track Record – Since our inception in 2019, Veradermics has advanced its lead asset, VDMN-21, into the most advanced dissolvable microneedle clinical trial ever conducted in the United States
• Veradermics is Well Funded – We have raised > $25 million to date. Our investors include J.W. Childs Associates, LP, Vlad Coric, Connecticut Innovations, Werth Ventures, and Northpoint Advisors
• We have been featured in Forbes, Slate, The Hartford Courant, The Kansas City Star, and many other multi-media platforms.

Clinical Site Manager

VeraDermics is seeking an experienced Clinical Site Manager (CSM) to oversee site and study level tasks for assigned Phase 1-3 clinical studies. The CSM will work closely with Investigators, CRO staff, and internal leadership team to monitor study progress and drive performance to study timeline with high quality.

Candidates must have strong ability to form positive relationships with a variety of team members, including clinical trial Investigators, Study Coordinators, Recruitment Leads, and CRO personnel. Candidates must have experience managing multi-layered advertising campaigns, and proven success in motivating sites to identify and enroll appropriate subjects within planned enrollment period.

Experience in dermatological indications such as androgenetic alopecia, alopecia areata, and atopic dermatitis is highly desired.

This individual will bring a minimum of 5 years of successful study management experience in phase 2-3 trials. Candidates will have at a minimum a bachelor's degree in a scientific or related healthcare field.

This is a full-time hybrid position (3 days/week at the office in New Haven, CT and 2 days/week remotely).

Opportunity for additional remote days (up to 4 days/week) may be considered at the discretion of the Director of Clinical Operations. Travel, including Investigator Meetings and site visits, may be required up to 20% based on business need.

Key Activities and Responsibilities:

• Assists the Study Team to design, develop and deliver assigned studies to agreed upon timelines in accordance with SOPs, ICH Guidelines, and GCP
• Builds strong relationships with Investigators, Study Coordinators and Recruitment Leads at assigned sites
• Works closely with assigned sites to execute multi-tiered advertising campaigns; calls Investigator and/or recruitment lead weekly at all assigned sites to reinforce enrollment goals and hold sites accountable to targets set in individual site recruitment plans; documents site contacts, and provides weekly status updates and metrics to study team
• In collaboration with CRO PM, works with sites to maximize site recruitment tactics and budget
• Oversees and monitors the management of clinical studies ensuring they are conducted in compliance with agreed upon study plans through regular CRO and investigator site contact
• Monitors progress of clinical activity and reports on progress of assigned clinical trials including study budget and timelines
• Coordinates and leads all aspects of internal project meetings, including agenda drafting and clear documentation of key discussion points, decisions, and action items
• Champions best practices in Project Management, including use of agendas, minutes, maintaining document repository, establishing, and implementing templates, tools, and processes to drive efficiency, alignment, communication, and effective planning
• Reviews Site Qualification Visit Reports, Site Monitor Visit Reports, etc., to ensure all open items are addressed and closed promptly
• Conducts routine reviews of Investigator payments to confirm payments are accurate and match work completed
• Monitors adjudication process for study endpoints as applicable
• As needed, supports oversight of contracts and outsourced activities with vendors and business partners
• Monitors status of clinical data collection of assigned clinical trials
• Reviews and approves study-related plans generated by CROs/vendors
• Ensures documentation is in accordance with GCP, regulatory requirements and consistent with the protocol
• Assists study team with preparation for audits/inspections
• Participates in the review and finalization of clinical study-related documents such as protocols, protocol amendments, and CSRs
• Prepares and delivers program/study updates
• Anticipates bottlenecks, potential study issues and clears barriers to progress project level scenario planning and risk management
• Contributes to development of RFPs and participates in selection of CROs/vendors
• Provides oversight for setup, maintenance, and close out of the Trial Master File and ensures its completion and inspection readiness
• Assures compliance with internal SOPs, FDA regulations and GCP
• Provides input as the subject matter expert for assigned studies during regulatory inspections
• May simultaneously lead/manage more than one clinical trial

Qualifications:

• BA/BS degree with ≥3 years of experience in pharmaceutical related drug development or direct equivalent experience
• 5 years of site monitoring and/or site management experience
• Strong working knowledge of GCP, local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines.
• Strong critical thinking and problem solving skills.
• Willingness to travel with overnight stay away from home.
• Proficient in speaking and writing English.
• Strong written and oral communication.

Preferred

• Experience working cross-functionally and in matrix teams
• Experience developing a monitoring or site management organization
• Experience working in early development studies

Company Culture

Veradermics is a small and tight-knit operation where our team works tirelessly to develop innovative new therapeutics for dermatology. We hold ourselves to an incredibly high standard and are looking for an exceptional person who is ready to be an integral team member and make a positive impact on the practice of medicine. We strongly appreciate positivity, curiosity, and, above all else, the ability to stay organized and get things done at the highest level and on time. We are incredibly conscious of creating a comfortable, flexible environment that cultivates the desire to be engaged, ask questions, and feel a vested interest in our team's success. Most importantly, you should value honest and direct communication as you recognize that this is the best way for any individual or team to continuously learn and grow. Accomplishing our collective goals will be fun but also complex; you should pursue an ongoing and rewarding challenge

We're passionate about dermatology and about improving the lives of individuals suffering from common skin conditions. The therapeutics you help us develop will impact the quality of life of millions of people suffering from conditions ranging from common warts to alopecia areata. We believe always striving to do our personal best and to encourage others to be their best. We also believe in treating others with respect and want to create a company that people are excited to work for. Both Cofounders have worked in jobs they dreaded thinking about all Sunday long, we do not want Veradermics to be that for anyone