Vice President, Clinical Development, Ophthalmology (Springfield,MA)
Company: Aldeyra Therapeutics
Posted on: June 21, 2019
Reports to: Chief Medical OfficerLocation: Lexington, MACompany
Summary:. Aldeyra Therapeutics is a biotechnology company devoted
to developing and commercializing next-. generation medicines to
improve the lives of patients with immune-mediated diseases.
Aldeyra's lead. product candidate, reproxalap, is a first-in-class
treatment in late-stage development for dry eye. disease, allergic
conjunctivitis, noninfectious anterior uveitis, and Sjogren-Larsson
Syndrome. The. company is also developing other product candidates
for proliferative vitreoretinopathy and other. retinal diseases,
post-transplant lymphoproliferative disease, autoimmune disease,
metabolic disease,. and cancer. None of Aldeyra's product
candidates have been approved for sale in the U.S. or elsewhere..
Position Summary:. The Vice President, Clinical Development,
Ophthalmology, will report directly to the Chief Medical. Officer.
He/she will be responsible for all day-to-day aspects of Aldeyra's
ocular clinical drug. development programs, including the three
indications of Reproxalap Ocular. He/ she will work in cross-.
functional teams to assure the highest standards of clinical drug
development. This person will be. responsible for all medical
aspects of regulatory communications documents, as well as the
medical. review of ocular clinical trial data. The Vice President,
Clinical Development, Ophthalmology will work. alongside the Vice
President, Clinical Development, Non- Ocular Programs.. This
individual must be able to communicate both verbally and in writing
his or her medical expertise. to guide the development and
execution of clinical development plans, protocols, abstracts, and
clinical. trial reports for Aldeyra's ophthalmic clinical programs.
This will involve a deep knowledge and. understanding of Aldeyra's
Standard Operating Procedures, medical monitoring and the
monitoring of. competitor activities and data. He/she will serve as
the key individual providing medical expertise and. input into,
including authoring of, the clinical development plans, protocols,
abstracts, and clinical trial. reports for all ophthalmic
candidates. He/she will also contribute to pharmacovigilance review
of. clinical trial data as well as collect external data and
competitive intelligence in select aldehyde targets.. Furthermore
he/she will give clinical input in development activities related
to Aldeyra's pipeline and. will serve as an internal resource for
all Aldeyra functions requiring clinical input. For the right
individual. with the interest and/or experience, there will be an
additional opportunity to oversee the ocular. clinical operations
team at Aldeyra.. Responsibilities:. Directing the development,
presentation and publication of clinical data on the company's.
ocular therapeutic candidates, ensuring the highest quality and
consistency with corporate. strategy;. Medical monitoring, coding
and data cleaning together with clinical operations;. Medical
writing of clinical sections in regulatory documents not limited to
IND submission, IND. annual updates, briefing documents, study
protocols, investigator brochures and other. study-relevant
documents like patient informed consent documents;. Manuscript
writing of publications or other documents intended for external
audiences;. Supervision of external consultants if applicable;.
Primary point of contact for ocular clinical trial staff at study
sites, as well as for regulatory,. safety and clinical operations
and other functions requiring clinical input;. Review safety data
for clinical detection and prepare safety charters, DMC charters,
or other. specific management plans or manuals in a
cross-functional team if not primary author;. Support or
preparation of data interpretation and clinical trial reports;.
Together with Clinical Operations preparation of Investigator Alert
letters and SAE reports as. required; and, Medical affairs
activities as needed for the ophthalmic programs.. Education &
Experience:. The desired candidate will likely possess an M.D.
and/or Ph.D., though this is not a definitive. requirement of the
candidate. It is understood, that education, while an important
index of. achievement, orientation, and intellectual capacity, will
not serve as the primary variable in this. decision process.
Personal characteristics, common sense, work ethic, and
demonstrated. accomplishment in business and corporate development
will serve as key components in the. evaluation of candidates.. In
terms of professional experience, we are seeking an individual who
should possess significant. experience in clinical development with
publication in peer-reviewed journals. This person must. have
knowledge of clinical development, the FDA, international global
clinical trial regulations and. good clinical practices (GCP)
guidelines. Preference will be given to candidates who have
previous. experience with drug development within the
pharmaceutical or biotechnology industry, particularly. at
companies addressing ophthalmology.. Qualities & Characteristics:.
* Flexible and adaptable style with a willingness and eagerness to
take on challenges;. Entrepreneurial spirit with the ability to
take risks;. Ability to work as a true team player and be effective
in a collaborative culture;. Strong leadership and motivational
capabilities;. Personal versatility and flexibility as the program
and team evolve;. Ability to instill and quickly earn trust among
teams;. Complex thinker who has the ability to articulate options
for ambiguous situations and the. confidence to make decisions with
authority and with full understanding of potential. outcomes;.
Ability to anticipate adverse scenarios and provide contingency
plans to address them. Excellent communication skills, both oral
and written.. To Apply:. Please email your cover letter and resume
to ...@aldeyra.com or to send a resume via an. alternative method,
please mail it to our corporate address:. Aldeyra Therapeutics,
Inc.. Attention: Human Resources. 131 Hartwell Avenue. Suite 320.
Lexington, MA 02421 Associated topics: administrative assistant,
administrative officer, administrative support, assist, associate,
chief operations officer, document, operation, records management,
Keywords: Aldeyra Therapeutics, Schenectady , Vice President, Clinical Development, Ophthalmology (Springfield,MA), Other , Springfield, New York
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