Do you want to be part of an inclusive team that works to develop innovative
therapies for patients? Every day, we are driven to develop and deliver
innovative and effective new medicines to patients and physicians. If you want
to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more
than 70 countries around the world. We are committed to turning innovative
science into medical solutions that bring value and hope to patients and their
families. Keeping our focus on addressing unmet medical needs and conducting our
business with ethics and integrity enables us to improve the health of people
throughout the world. For more information on Astellas, please visit our website
at www.astellas.com
[https://nam12.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.astellas.com%2F&data=04%7C01%7Cseth%40recruitrooster.com%7C59d7121876474762797c08d92ce14af5%7Cf4e1fd9942ea4d61957ae47394505924%7C1%7C0%7C637590168405503237%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C1000&sdata=iaBVZrKeN7JRw3YZwXpqm%2FiJYBkbTiB0bxaXAq7xeLw%3D&reserved=0].
This position is based in Ontario, Canada. Remote work from Ontario may be
permitted in accordance with Astellas’ Responsible Flexibility Guidelines.
Candidates interested in remote work are encouraged to apply.
Purpose and Scope:
- Responsible for overseeing the design and delivery of trials within a given
late phase program or multiple early-phase programs in the Immuno-Oncology
group.
- Reports to the Medical Lead/disease area strategy head for the given
program(s) and is accountable for defining the strategy and execution of
assigned trials.
- Clinical team leader with clear understanding of areas of responsibilities
and accountabilities of the role. Team player who is comfortable in
situations where the role serves as a consultant and support to other
functions and particularly the asset area. Understands the criticality of
information and knowledge management, partnership and collaboration required
in drug development.
Essential Job Responsibilities:
- Collaborates effectively with key internal and external stakeholders as a
member of the asset team and leader of the clinical study team to advance one
or more clinical trials. Serves as Medical Monitor w/ responsibility for
safety monitoring.
- Ensures patient safety on clinical study is maintained. Generates safety
related documents, such as medical monitoring reports and the safety
database, to ensure that the reporting of SAEs is current and complete.
- Collaborates closely with safety officer in writing and/or reviewing Safety
Narratives, Investigator Letters, and other safety documentation for
site-reported safety events.
- Coordinates with Safety Officer on program for appropriate benefit-risk
assessments, planning FIH study dose selection and escalation path for
early-phase programs, safety management on trials, provides clinical input
and review of clinical documents, statistical analysis plans, interim and
final analyses on trials, publications, CSRs, DSURs and other critical
documents.
- Able to assimilate Research, Clinical Pharmacology, Biomarker, medical
safety, Toxicology (early phase programs) regulatory, biostatistics, medical
affairs, Health Economics, commercial perspectives into clinical development
strategies and trial designs.
- Responsible for managing the process of development of protocol and necessary
regulatory documents.
- Accountable and responsible for development and implementation, and execution
of clinical trials as part of a large complex late phase (post POC,
established market) program or a group of earlier stage programs, in
alignment with Asset and overall clinical strategy.
- In late phase program serves as the Lead for an indication specific clinical
development team and is responsible and accountable for both strategy and
execution of the clinical development plan for that indication or line of
therapy.
- In earlier phases, serves as the clinical lead for the entire clinical
development strategy and execution for a given program.
- Acquires public knowledge regarding therapeutic landscape, potential
competitor products and serves as clinical voice regarding the potential for
impact on planned clinical, medical affairs and commercial strategies.
- Creates and maintains scientific/clinical networks and seeks external opinion
leader as appropriate. Serve as the clinical interface during clinical
advisory boards, investigator meetings, and interactions with opinion
leaders. ? Serves as the clinical interface in regulatory authority
interactions.
- Accountable for clinical development milestones for their given trials.
Supports Medical lead and Asset team at governance meetings and can present
the clinical development plan in a succinct and clear manner at such
meetings.
- Works with Development Scientists and Clinical Operation Leads to ensure
efficient and streamlined execution of clinical trials and acquisition and
interpretation of high-quality clinical data to inform program-level decision
making and overall development strategies.
- Designs scientifically rigorous, cost-effective, and patient-centric clinical
trials in accordance with the Clinical development Plan. Accountable for
Clinical trial scope development and authoring of the protocol, IB, ICF as
appropriate, in coordination with development scientists, clinical
operations, medical writing and regulatory.
- Responsible for keeping medical lead, asset lead and Development Head
informed on progress of trials, risks, planned/required mitigations, and
changes to timelines and budgets.
- Supports clinical development related initiatives as needed. Leads and/or
participates in scientific and medical training to other team members and
external clients, investigators, and other site staff as it pertains to
assigned studies.
Qualifications
Qualifications:
Required
- MD or MD/PhD with oncology fellowship complete. Board certified with patient
treatment experience beyond fellowship preferred.
- Must have 5 years of pharmaceutical industry or academia experience
specifically in clinical trial design and execution in a bio-pharmaceutical
development organization or a balance of experience at an academic
institution and a pharmaceutical company.
- Proven record of designing clinical trials that can produce high quality data
in a timely manner for decision making.
- Documented experience planning and managing clinical trials, serving as
medical monitor, managing trial execution in coordination with clinical
operations.
- Excellent verbal and written communication skills in English.
- Experience working in global teams and a global matrixed, remote working
environment.
- Aware of cultural diversity and how to influence and manage in a
multi-cultural organization.
- Highest level of scientific integrity and impeccable work ethics
Preferred:
- Extensive experience in gastroesophageal or thoracic oncology or
immuno-oncology in solid tumors
- Prior clinical research experience in an academic setting
- Experience in all phases of Clinical Development and interfaces with Drug
Discovery through Marketing.
- Direct experience leading global regulatory marketing authorization
submissions and defense of those submissions
Salary Range
$220K – $290K (NOTE: Final salary could be more or less, based on experience)
Benefits:
- Medical, Dental and Vision Insurance
- Generous Paid Time Off options, including Vacation, Sick time, plus national
holidays including Heritage Days, and Summer and Winter Breaks
- 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
- Referral bonus program
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