Clinical Development Scientist, Oncology

At Astellas, we try to grow to be a cutting-edge, value-driven life science innovator. This implies working on the forefront of healthcare change to show progressive science into VALUE for sufferers.

What units us aside is our give attention to sufferers, our pioneering innovation, our collaborative tradition, and the fervour of our gifted individuals.

Making a constructive impression on sufferers’ lives is the aim behind all the things we do. At Astellas, we’re relentless in our pursuit of scientific progress and in tackling unmet medical wants, demonstrated by our legacy in oncology, overactive bladder and transplant and our spectacular pipeline in ladies’s well being, blindness and regeneration, genetic regulation, immuno-oncology, mitochondria and focused protein degradation.

About Us:

We’re a world pharmaceutical firm headquartered in Japan, with a crew of greater than 14,000 managing operations in roughly 70 nations all over the world. We’re within the High 30 international biopharma firm based mostly on international revenues and are predicted to be one of many High 10 Most cancers Drug Makers of 2024 by Fierce Pharma.

In Canada, we’re rising to fulfill the thrilling alternatives realized by our legacy manufacturers and wealthy pipeline of progressive remedies.

We’re searching for candidates who will thrive in our entrepreneurial and empowering setting the place expertise and management flourish. Do your values align with our Astellas Approach – affected person focus, possession, outcomes, openness and integrity? Then we might love to listen to from you.

From the primary day in position, everybody at Astellas has a accountability for making a brighter future for sufferers all over the world. We nurture distinctive relationships with our staff to permit them to thrive, foster innovation, and ship distinctive enterprise outcomes. We work to create a tradition the place our individuals really feel empowered to pursue courageous concepts and impressive outcomes, to have the boldness to be accountable for the next normal of efficiency and embody a aggressive and solutions-oriented mindset.

Our experience, science and know-how make us a pharma firm. Our open and numerous tradition is what makes us uniquely Astellas.

Objective and Scope:

The first objective of the Growth Scientist will take part within the improvement of scientific methods for assigned modalities or indications inside the division. This place will work intently with the World Medical Lead (GML), Operations Lead, and Asset Lead, and Medical Monitor, and is accountable for the design, implementation, monitoring, and evaluation of scientific research carried out inside the assigned program. Growth Scientists are anticipated to carry out their tasks independently and have core information of scientific improvement to allow elevated participation in division and portfolio stage initiatives.

Important Job Duties:

• Accountable and accountable for actions associated to all present and deliberate scientific trials (e.g., develop protocols, investigator brochures, CRFs, knowledgeable consents, and scientific research stories and overview of scientific trial paperwork, research analyses, and reporting) on assigned improvement packages.
• Offers experience to cross-functional crew members to synthesize/contextualize information to facilitate dialogue and well timed resolution making.
• Serves on the scientific sub-team with GML, Operations Lead, and Medical Monitor/Research Doctor and helps preparation of scientific improvement plans, web site identification and administration, and DESC conferences.
• Below the steerage of research doctor/med lead, carry out medical monitoring actions (Assessment, analyze and triage affected person information, producing stories
• Capable of independently lead working teams and/or sub-team initiatives in assist of protocol, illness space, or scientific improvement plan.
• Companions with GML in getting ready for Well being Authority (HA) Conferences and assists in addressing HA inquiries.
• Along with the GML and Product Accountable Particular person might put together evaluation for DMC/DSMB/DEC boards or regulatory submissions.
• Offers coaching at investigator conferences and web site initiation visits with scientific trial workers, and companions with Scientific Operations and Medical Affairs in enabling applicable enrollment into the scientific research or registries. Collaborates cross-functionally to create, overview, and/or current scientific slides for inside conferences and exterior boards.
• Helps engagement with potential and present websites (e.g. SIVs, investigator conferences, conferences, steering committee, advisory board conferences).
• Early and/or late section research
• Displays experience associated to Research Information Assessment and Evaluation:
• Offers scientific enter into statistical planning, information evaluation and interpretation
• Offers scientific management and assist for publication of knowledge (manuscripts, shows) and illness or know-how associated scientific publications
• Works intently with operations group for web site and vendor feasibility, trial arrange and monitoring.
• Could lead the execution of contracts, significantly for investigator conferences and advisories.
• Helps efforts to develop strategic partnerships with Key Exterior Specialists (KEEs)
• Function key accomplice for Growth Division in evaluation of candidates inside discovery, figuring out alternatives and potential dangers with future improvement methods based mostly on modality, indication, unmet want, aggressive panorama and scientific traits.
• Could characterize improvement and help with scientific evaluation for due diligence(s) of recent property for potential in-licensing and acquisition.
• Helps strategic initiatives associated to assigned molecule(s), CDP, therapeutic space(s), or portfolio, if requested.
• Performs different duties as assigned or particular initiatives as wanted.
• This place stories to the Major Focus Medical Head (or different Leads relying on grade) for designated program.
• This place is usually a person contributor position, however might have direct stories based mostly on scope, accountabilities and complexity of assigned improvement packages. If place has direct stories, will align with Astellas tips for span of management and organizational ranges.

Required {Qualifications}:

• Superior diploma in a related scientific self-discipline; well being science or scientific self-discipline with sometimes 7-8 years scientific, scientific/analysis, pathology or {industry} associated expertise or mixture of academia and {industry}.
• Thorough information and demonstrated experience in biotechnology/pharmaceutical {industry} associated to scientific drug improvement (early-stage improvement by means of approval) from preliminary research design, research execution and regulatory submissions (INDs, BLAs, NDAs) with US and OUS regulatory companies.
• Expertise in scientific analysis and/or scientific observe (as evidenced by applicable {qualifications}, publications and/or related accreditations).
• Sturdy pc expertise together with MS Workplace Suite (Phrase, Excel, PowerPoint, Outlook, MS Groups and MS Mission) and in the usage of industry-standard software program (e.g. digital information seize methods [RAVE, InForm, etc.]) and proficient in information evaluation software program (Excel, SigmaPlot, SPSS, R, and so on.).
• Sturdy collaboration and interpersonal communication expertise; in a position to work together with all ranges of inside stakeholders and key purposeful areas together with, Regulatory Affairs, Medical Affairs, Scientific Operations, Information Sciences, Analysis, Translational Science and Pharmacovigilance (PV).
• Demonstrated success working with key exterior stakeholders (e.g., KEEs, investigators, researchers) together with presenting/responding to well being authorities.
• Data of world pharmacovigilance requirements and steerage paperwork.
• Snug working in a versatile, dynamically altering and (at occasions) difficult setting.
• Wonderful strategic planning, organizational and verbal and written communication expertise.
• Potential to train sound judgment, tact, diplomacy and professionalism in all interactions. Highest stage of scientific integrity.
• Potential to work independently with out important oversight or instruction to realize outcomes with a excessive diploma of accuracy and a focus to element.
• Capable of journey ~25%, with worldwide journey at occasions

Most well-liked {Qualifications}:

• PhD. or PharmD diploma, or different related Grasp’s diploma.
• Data and proficiency associated to Medical Affairs actions together with registries.

Further Data

Astellas Pharma Canada welcomes and encourages functions from individuals with disabilities. Lodging can be found on request for candidates collaborating in all points of the hiring course of.

Astellas Pharma Canada requires full Vaccination in opposition to COVID-19 as a situation of employment. Affordable lodging to this coverage could also be granted for a legitimate lodging request beneath human rights laws.

Class Oncology Growth

Astellas is dedicated to equality of alternative in all points of employment.

EOE together with Incapacity/Protected Veterans

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