Clinical Development Physician, Ophthalmology (Medical Director)

About Astellas

Astellas is a global life sciences company committed to turning innovative
science into VALUE for patients. We provide transformative therapies in disease
areas that include oncology, ophthalmology, urology, immunology and women's
health. Through our research and development programs, we are pioneering new
healthcare solutions for diseases with high unmet medical need. Learn more at
Astellas.com.

Are you driven to make a real difference in the lives of patients?

We're seeking passionate individuals who thrive in dynamic environments, embrace
new ideas, and aren't afraid to take intelligent risks. People who act with
unwavering integrity and are deeply committed to making a tangible impact.

Purpose and Scope

The primary objective for the Development Physician is to provide input into the
design and conduct of clinical trials, review and/or generate key study
documents (such as medical monitoring and safety management plans, treatment
manuals, etc.), assess and interpret safety data, and contribute to
investigator, site staff and clinical study team training.

Responsibilities and Accountabilities

* In collaboration with the Medical Lead, responsible for designing and making
recommendations in the clinical development plan that are aligned with the
asset development strategy, after soliciting appropriate input and review
from Medical and Clinical Operations colleagues as well as other contributing
line functions (Regulatory Affairs, Statistics, Clinical Operations,
Commercial).
* Be available to advise on assigned clinical trial(s) related medical
questions or problems during the trial, including 24/7 emergency coverage for
safety-related matters.
* Reviews and analyzes the eligibility of participants per inclusion/exclusion
requirements of a clinical trial.
* Reviews all adverse events to look for trends or risks, reviews all serious
adverse events (SAEs), including review of the narrative, investigators’
assessment on causality, and applicable regulatory reporting, with close
collaboration with the study’s Global Safety Officer.
* Provides review of study protocols and ongoing medical oversight of clinical
trials to ensure that safety concerns and/or adverse events are identified
and appropriate responses to such concerns are developed and executed.
Ensures activities related to Serious Adverse Events (SAEs) are conducted in
accordance with applicable SOPs and regulations. Includes writing and/or
reviewing Safety Narratives, Investigator Letters, and other safety
documentation for site-reported safety events.
* Consults with internal and external stakeholders in the development of
clinical trial design and conduct, including drafting of protocols and
amendments.
* Develops and/or reviews operational, medical monitoring, and safety plans for
studies.
* Leads and/or participates in scientific and medical training of other team
members and external clients, investigators, and other site staff as it
pertains to assigned studies.
* Generates safety-related documents, such as medical monitoring reports and
the safety database, to ensure that the reporting of SAEs is current and
complete.
* In collaboration with the Medical Lead:
* Health Authorities communication: the Development Physician is responsible
for clinical written feedback/response to deficiency letter, pre-IND/NDA
communication meeting, or panel review meeting
* Investigators/KOL engagement: Development Physician is responsible for
KOL/investigators scientific engagement.

Qualifications

Required Qualifications

* Medical Degree (or Medically Qualified) with completion of residency in
Ophthalmology 
* Willingness to work across different ophthalmic indications
* Should have at least 8 years relevant experience in drug development in a
biotech/pharmaceutical company or equivalent experience in an academic
clinical research institute (NCI, NIH, Academic Research groups, etc) with at
least 5 years working in clinical development
* Excellent scientific writing skills
* Ability to read and analyze ocular images
* Experience analyzing, synthesizing, and communicating clinical trial data
* Proficiency with ICH/GCP guidelines and other applicable regulatory rules and
guidelines as well as of medical terminology, drug development, clinical
trials, and clinical research.

Preferred Qualifications

* Active or prior Board Certification
* Prior experience working at another Biotechnology, Pharmaceutical company or
CRO
* Experience working in cell or gene therapy drug development

Location and Working Environment

This position is based in Northbrook, IL. Remote work from anywhere in the US is
available.

At Astellas we recognize the importance of work/life balance, and we are proud
to offer a hybrid working solution allowing time to connect with colleagues at
the office with the flexibility to also work from home. We believe this will
optimize the most productive work environment for all employees to succeed and
deliver. Hybrid work from certain locations may be permitted in accordance with
Astellas’ Responsible Flexibility Guidelines.

This position is a global role with strong interaction with various disciplines
and international stakeholders

* Highly matrixed environment requiring cross-regional coordination.
* Frequent interaction with senior leadership and governance bodies.
* Collaboration across EU, US, and Japan time zones.

What awaits you at Astellas?

* Global collaboration: Become part of a connected global business of
like-minded life science leaders, all dedicated to improving patients' lives
worldwide.
* Real-world patient impact: Contribute to transformative therapies that reach
patients around the world, knowing your work makes a difference every day.
* Relentless Innovation: Join a company at the forefront of scientific
breakthroughs, where you'll have the opportunity to shape the future of
healthcare.
* A Culture of Growth: Chart your own course within a supportive environment
that values your contributions, champions your development, and empowers you
to pursue your passions.

Our Organizational Values and Behaviors

Values: Innovation, Integrity and Impact sit at the heart of what we do.

Behaviors: We come together as ‘One Astellas’, working with courage and a sense
of urgency.  We are outcome focused and consistently take accountability for our
personal contribution.

Salary Range

$207,192 - $295,988 (Final compensation will be determined based on a variety of
factors, including but not limited to skills, experience and organizational
equity considerations) 

*The salary range provided applies to US only and does not apply to any other
locations outside of the US

Benefits

* Medical, Dental and Vision Insurance
* Generous Paid Time Off options, including Vacation and Sick time, plus
national holidays including year-end shut down
* 401(k) match and annual company contribution
* Company paid life insurance
* Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
* Long Term Incentive Plan for eligible positions
* Company fleet vehicle for eligible positions
* Referral bonus program

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