Clinical Development Scientist, Oncology

Astellas Pharma

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

What units us aside is our concentrate on sufferers, our pioneering innovation, our collaborative tradition, and the fervour of our proficient individuals.

Making a optimistic influence on sufferers’ lives is the aim behind all the pieces 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 girls’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 group of greater than 14,000 managing operations in roughly 70 international locations world wide. We’re within the High 30 international biopharma firm primarily based 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 satisfy the thrilling alternatives realized by our legacy manufacturers and wealthy pipeline of revolutionary remedies.

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

From the primary day in function, everybody at Astellas has a duty for making a brighter future for sufferers world wide. We nurture distinctive relationships with our workers 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 bold outcomes, to have the arrogance 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.

Function and Scope:

The first goal 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 International 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 duties 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 examine studies and evaluation of scientific trial paperwork, examine analyses, and reporting) on assigned improvement packages.
  • Gives experience to cross-functional group members to synthesize/contextualize knowledge to facilitate dialogue and well timed resolution making.
  • Serves on the scientific sub-team with GML, Operations Lead, and Medical Monitor/Examine Doctor and helps preparation of scientific improvement plans, website identification and administration, and DESC conferences.
  • Below the steerage of examine doctor/med lead, carry out medical monitoring actions (Evaluation, analyze and triage affected person knowledge, producing studies
  • 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 could put together evaluation for DMC/DSMB/DEC boards or regulatory submissions.
  • Gives coaching at investigator conferences and website initiation visits with scientific trial workers, and companions with Medical Operations and Medical Affairs in enabling acceptable enrollment into the scientific research or registries. Collaborates cross-functionally to create, evaluation, 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 part research
  • Displays experience associated to Examine Information Evaluation and Evaluation:
  • Gives scientific enter into statistical planning, knowledge evaluation and interpretation
  • Gives scientific management and assist for publication of information (manuscripts, shows) and illness or know-how associated scientific publications
  • Works intently with operations group for website and vendor feasibility, trial arrange and monitoring.
  • Might lead the execution of contracts, notably for investigator conferences and advisories.
  • Helps efforts to develop strategic partnerships with Key Exterior Consultants (KEEs)
  • Function key accomplice for Growth Division in evaluation of candidates inside discovery, figuring out alternatives and potential dangers with future improvement methods primarily based on modality, indication, unmet want, aggressive panorama and scientific traits.
  • Might symbolize 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 tasks as wanted.
  • This place studies to the Major Focus Medical Head (or different Leads relying on grade) for designated program.
  • This place is usually a person contributor function, however could have direct studies primarily based on scope, accountabilities and complexity of assigned improvement packages. If place has direct studies, will align with Astellas pointers 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 usually 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 way of approval) from preliminary examine design, examine execution and regulatory submissions (INDs, BLAs, NDAs) with US and OUS regulatory companies.
  • Expertise in scientific analysis and/or scientific observe (as evidenced by acceptable {qualifications}, publications and/or related accreditations).
  • Sturdy laptop abilities together with MS Workplace Suite (Phrase, Excel, PowerPoint, Outlook, MS Groups and MS Undertaking) and in the usage of industry-standard software program (e.g. digital knowledge seize programs [RAVE, InForm, etc.]) and proficient in knowledge evaluation software program (Excel, SigmaPlot, SPSS, R, and so on.).
  • Sturdy collaboration and interpersonal communication abilities; in a position to work together with all ranges of inside stakeholders and key purposeful areas together with, Regulatory Affairs, Medical Affairs, Medical 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 worldwide pharmacovigilance requirements and steerage paperwork.
  • Snug working in a versatile, dynamically altering and (at occasions) difficult surroundings.
  • Wonderful strategic planning, organizational and verbal and written communication abilities.
  • 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 popular {Qualifications}:

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

Extra Data

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

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

Class Oncology Growth

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

EOE together with Incapacity/Protected Veterans

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