VICE PRESIDENT, CLINICAL DEVELOPMENT
3 weeks ago
At SalioGen, we are leveraging the intrinsic genome engineering features of human evolution to harness the power of genetic medicine. Our approach, which we call Gene Coding, is guided by our Exact DNA Integration Technology (EDIT): a genome engineering platform using the proprietary mammal-derived enzyme saliogase. With broad applicability, non-viral delivery capabilities of any size gene, redosability, and significant manufacturing advantages, our platform technology has the potential to transform genetic medicine. Join our team of leading scientists, expert drug developers, and biotech industry veterans. Together we are working to transform the treatment landscape of genetic diseases.
Position Summary:
The Vice President, Clinical Development will provide hands-on medical leadership to advance SalioGen's novel, in vivo genetic medicines into the clinic, with an initial focus on inherited retinal diseases, including a lead program for Stargardt disease entering the clinic in the first half of 2025. This clinical leader is responsible for the development and execution of translational medicine and clinical development strategies including the design, execution, monitoring, data analysis, and reporting of clinical studies for one or more programs. In addition, they will collaborate with other team members and functions to develop and execute upon long-range strategic plans for SalioGen's programs. Member of the Executive Team and potential for elevation to Chief Medical Officer based on performance.
Primary Responsibilities:
* Develop translational medicine and clinical development strategies for multiple clinical programs in severe genetic diseases, with an initial focus on inherited retinal diseases.
* Lead activities related to first in human through registrational clinical trials on a global basis (e.g., develop protocols, investigator brochures, review clinical trial documents, clinical support of regulatory interactions, and study pharmacovigilance, data analysis and reporting).
* Establish and lead clinical development capabilities at SalioGen though targeted hiring and retention clinical operations staff, consultants and other outsourced service providers to execute initial clinical trials through a CRO-supported outsourced model.
* As member of Program teams, collaborate with Portfolio & Program Management, Regulatory, Research and Manufacturing stakeholders to ensure timely and effective clinical and scientific input into all development programs.
* Lead advisory boards with key opinion leaders and investigator meetings with clinical trial investigators, and partner with Clinical Operations in driving enrollment into the clinical studies.
* Provide clinical input into statistical planning and lead data analysis and interpretation.
* Provide medical leadership as needed for clinical and scientific issues that may arise during clinical trial execution, including adverse events and pharmacovigilance.
* Create medical monitoring plans and oversee medical monitoring for one or more clinical studies.
* Provide medical leadership and support for publication of data (e.g., manuscripts, posters) and disease or technology-related scientific publications.
* Represent the company at medical and scientific meetings, patient advocacy events and presentations, as well as other external-facing activities (investors, business development, media).
Qualifications & Skills Required:
* 10+ years relevant biotechnology/pharmaceutical experience leading clinical drug development (first-in-human through approval), including developing clinical protocols, study design and successful regulatory approvals (INDs, CTAs, BLAs, NDAs) with US and international regulatory agencies.
* Strong scientific and medical background and ability to educate physicians and regulators on cutting-edge genetic medicine approaches.
* Proven clinical development experience designing, implementing and conducting gene therapy clinical trials in ophthalmology
* A history of strong collaboration and personal interaction with all levels of internal stakeholders including: Regulatory, Clinical Operations, Manufacturing, Research and Program Management.
* Outstanding leadership skills: comfortable navigating a dynamic, changing environment through creativity and collaboration.
* Experience working in smaller entrepreneurial biotechnology companies, with additional experience in larger biotechnology or pharmaceutical companies also valued.
* Demonstrated ability to manage multiple priorities to achieve results and meet milestones in a hands-on fashion.
* Willingness to travel ~25%, with occasional international travel at times.
* MD, with specialty training in Ophthalmology preferred
SalioGen Therapeutics is an equal opportunity employer. Qualified candidates will receive consideration for employment without regard to race, color, religion, national origin, gender, sexual orientation, gender identity or expression, age, mental or physical disability, and genetic information, marital status, citizenship status, military status, protected veteran status or any other category protected by law.
-
Vice President, Clinical Development
3 weeks ago
Lexington, United States SalioGen Therapeutics Full timeAbout Us: At SalioGen, we are leveraging the intrinsic genome engineering features of human evolution to harness the power of genetic medicine. Our approach, which we call "Gene Coding", is guided by our Exact DNA Integration Technology (EDIT): a genome engineering platform using the proprietary mammal-derived enzyme saliogase. With broad applicability,...
-
Regional Vice President of Sales- Home Health
3 weeks ago
Lexington, United States PSG Global Solutions Full timeCompany Overview LHC Group is hiring for a Regional Vice President of Sales in Kentucky. The Regional Vice President of Salesprovides sales leadership and corporate presence within internal and external customer base. The RVPS communicate corporate d Sales, Vice President, Health, Regional, Home, President, Staffing, Healthcare
-
Lexington, United States Massachusetts Institute of Technology Full timeVICE PRESIDENT, COMPLIANCE AND RISK, MIT Federal Credit Union (MITFCU), to be responsible for strategic planning and implementing policies, processes, personnel, reports, and systems for managing and monitoring risk exposure derived from all banking Compliance, Vice President, IT, Risk, President, Credit, Education
-
Vice President, Transfer Pricing
2 weeks ago
Boston, MA, United States Kroll Full timeWe are currently seeking a Vice President (VP) to join the Transfer Pricing team. Please note, this position is equivalent to a Transfer Pricing Manager within major financial services firms. Vice Presidents provide unique solutions through the delivery of quality transfer pricing and economic consulting services that demonstrate the expertise and...
-
Lexington, MA, United States Massachusetts Institute of Technology Full timeJob Description VICE PRESIDENT, COMPLIANCE AND RISK, MIT Federal Credit Union (MITFCU), to be responsible for strategic planning and implementing policies, processes, personnel, reports, and systems for managing and monitoring risk exposure derived from all banking and financial services activities and risk reporting to senior management and the board. ...
-
Vice President, Software Engineering
1 month ago
Lexington, United States Xometry Full timeThe Vice President of Software Engineering will play a pivotal role in driving our software development strategy and execution, ensuring that our technology solutions are robust, scalable, and aligned with our business goals. This leadership position involves overseeing the software engineering organization for Thomasnet.com, fostering a culture of...
-
Lexington, United States Massachusetts Institute of Technology Full timeREQUIRED: bachelor's degree (master's preferred); ten years of related work experience; and experience managing a team or leading projects, programs, or functions. Job #23881-12 The position is located in Lexington, MA. 3/28/24 VICE PRESIDENT, COMPLIANCE AND RISK, MIT Federal Credit Union (MITFCU), to be responsible for strategic planning and implementing...
-
Vice Provost
6 days ago
Lexington, United States InsideHigherEd Full timeJob Title:Vice ProvostRequisition Number:FE03963Department Name:89000:ProvostWork Location:Lexington, KYType of Position:FacultyPosition Time Status :Full-TimeTenure Track Status:Tenure TrackRequired Education:A recognized tertiary degree in applicant’s field of study.Required Related Experience:The candidate must have progressive and broad experience in...
-
Vice Provost
6 days ago
Lexington, United States University of Kentucky Full timePosting DetailsPosting Details Job Title Vice Provost Requisition Number FE03963 Working Title Department Name 89000:Provost Work Location Lexington, KY Type of Position Faculty Position Time Status Full-Time Tenure Track Status Tenure Track Required Education A recognized tertiary degree in applicant's field of study. Required Related Experience...
-
Vice Provost
7 days ago
Lexington, Kentucky, United States University of Kentucky Full timePosting DetailsPosting Details Job Title Vice Provost Requisition Number FE03963 Working Title Department Name 89000:Provost Work Location Lexington, KY Type of Position Faculty Position Time Status Full-Time Tenure Track Status Tenure Track Required Education A recognized tertiary degree in applicant's field of study. Required Related Experience...
-
Associate VP for Philanthropy
5 days ago
Lexington, United States The University of Kentucky Full timeThe Associate Vice President of Philanthropy (AVP) at the University of Kentucky is a leadership position that will drive the institutions philanthropic efforts to the next level. As a key player in the dynamic field of development strategy, princip VP, Associate, Vice President, Administrative, Education
-
Oversight & Control, Vice President
5 days ago
Boston, MA, United States State Street Bank Full timeWho we are looking forGlobal Credit Finance has established an operational Risk and Compliance function that is focused on risk management in the first line of defense through the implementation of controls, assessment of risks in change projects, and ongoing oversight. This role acts as a valued partner to the business in the identification, assessment, and...
-
Vice President of Facility Projects
2 weeks ago
United States, MA, Norwell Clean Harbors Full timeThe Vice President of Facility Projects is responsible for leading organizational activities and capital projects to accomplish measurable business improvements across the Facilities network while concurrently leveraging best in class technology. In addition to being the key program leader, he/she will drive project selection, project design, development,...
-
Quincy, MA, United States State Street Corporation Full timeWho we are looking for State Street is embarking on a multi-year program to modernize the payment initiation experience of clients. In order to augment the team, we are looking for a senior engineering lead who has had experience developing and deploying highly performant web based applications and REST service end-points on cloud infrastructure. . Select...
-
Data Management IT Audit, Vice President
1 week ago
Boston, MA, United States State Street Corporation Full timeWho we are looking for We are looking for a Data Management IT Audit, Vice President. In this role you will provide leadership in executing the strategy for Audit's Data Management audit coverage. This role is responsible for maintaining effective partnerships with key senior leaders in the IT organization, such as the business CIOs and program leadership. ...
-
Vice Chair of Population Health and Strategy
6 days ago
Lexington, United States University of Kentucky Full timePosting DetailsPosting Details Job Title Vice Chair of Population Health and Strategy Requisition Number FE03826 Working Title Department Name 7H650:PEDIATRICS Work Location Lexington, KY Type of Position Faculty Position Time Status Full-Time Tenure Track Status Non-Tenure Track Required Education MD, DO or equivalent Required Related Experience...
-
Vice Chair of Population Health and Strategy
7 days ago
Lexington, Kentucky, United States University of Kentucky Full timePosting DetailsPosting Details Job Title Vice Chair of Population Health and Strategy Requisition Number FE03826 Working Title Department Name 7H650:PEDIATRICS Work Location Lexington, KY Type of Position Faculty Position Time Status Full-Time Tenure Track Status Non-Tenure Track Required Education MD, DO or equivalent Required Related Experience...
-
Boston, MA, United States State Street Bank Full timeGlobal Head of Financing Solutions, Executive Vice PresidentWho we are looking forState Street is looking for a dynamic and experienced Global Head of Financing Solutions to lead our Agency Lending, Prime Services and Secured (Repo) Financing for State Street Global Markets (SSGM). The ideal leader will possess in depth knowledge of agency lending program,...
-
Assistant VP/Deputy Chief of Staff
2 weeks ago
Lexington, United States The University of Kentucky Full timeThis position will be responsible for the Strategic Leadership Support for the Associate Vice President/ Chief of Staff and for the Office for Institutional Diversity (OID) Daily Operations, Program Development and Project Management, Create and Cult Staff, VP, Deputy, Chief, Leadership, Assistant, Administrative
-
Middle Office, Vice President
1 week ago
Quincy, MA, United States State Street Corporation Full timeWho we are looking for Looking for a hands-on manager who will be able to support middle office / post-trade functions for a major asset manager client. Expertise is required in one of the following functional areas: trade management / settlements, corporate actions, accounting, reconciliation, performance, dynamic and static reference data. Product...
