Clinical Development Scientist Lead, Immuno-Oncology

Astellas Pharma

At Astellas, we try to turn into a cutting-edge, value-driven life science innovator. This implies working on the forefront of healthcare change to show modern 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 gifted individuals.

Making a constructive impression on sufferers’ lives is the aim behind the whole lot 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 staff of greater than 14,000 managing operations in roughly 70 international locations around the globe. We’re within the Prime 30 world biopharma firm primarily based on world revenues and are predicted to be one of many Prime 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 modern therapies.

We’re on the lookout for candidates who will thrive in our entrepreneurial and empowering surroundings the place expertise and management flourish. Do your values align with our Astellas Method – affected person focus, possession, outcomes, openness and integrity? Then we’d 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 around the globe. 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 impressive outcomes, to have the boldness to be accountable for a better customary of efficiency and embody a aggressive and solutions-oriented mindset.

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

Objective and Scope:

The first function of the Growth Scientist will take part within the improvement of medical methods for assigned modalities or indications throughout 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 medical research performed throughout the assigned program. Growth Scientists are anticipated to carry out their obligations independently and have core data of medical 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 medical trials (e.g., develop protocols, investigator brochures, CRFs, knowledgeable consents, and medical examine reviews and evaluation of medical trial paperwork, examine analyses, and reporting) on assigned improvement packages.
  • Supplies experience to cross-functional staff members to synthesize/contextualize knowledge to facilitate dialogue and well timed determination making.
  • Serves on the medical sub-team with GML, Operations Lead, and Medical Monitor/Research Doctor and helps preparation of medical improvement plans, website identification and administration, and DESC conferences.
  • Beneath the steerage of examine doctor/med lead, carry out medical monitoring actions (Assessment, analyze and triage affected person knowledge, producing reviews
  • Capable of independently lead working teams and/or sub-team initiatives in help of protocol, illness space, or medical 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.
  • Supplies coaching at investigator conferences and website initiation visits with medical trial workers, and companions with Scientific Operations and Medical Affairs in enabling applicable enrollment into the medical research or registries. Collaborates cross-functionally to create, evaluation, and/or current medical slides for inner 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
  • Reveals experience associated to Research Knowledge Assessment and Evaluation:
  • Supplies medical enter into statistical planning, knowledge evaluation and interpretation
  • Supplies medical management and help for publication of information (manuscripts, displays) and illness or expertise 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 associate 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 medical traits.
  • Might signify improvement and help with medical 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 reviews to the Major Focus Medical Head (or different Leads relying on grade) for designated program.
  • This place is usually a person contributor position, however could have direct reviews primarily based on scope, accountabilities and complexity of assigned improvement packages. If place has direct reviews, 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 medical self-discipline with usually 9-10 years medical, scientific/analysis, pathology or {industry} associated expertise or mixture of academia and {industry}.
  • Thorough data and demonstrated experience in biotechnology/pharmaceutical {industry} associated to medical drug improvement (early-stage improvement by 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 medical observe (as evidenced by applicable {qualifications}, publications and/or related accreditations).
  • Sturdy pc abilities together with MS Workplace Suite (Phrase, Excel, PowerPoint, Outlook, MS Groups and MS Venture) 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 inner stakeholders and key purposeful areas together with, Regulatory Affairs, Medical Affairs, Scientific Operations, Knowledge 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 instances) difficult surroundings.
  • Glorious strategic planning, organizational and verbal and written communication abilities.
  • Means to train sound judgment, tact, diplomacy and professionalism in all interactions. Highest stage of scientific integrity.
  • Means to work independently with out vital oversight or instruction to realize outcomes with a excessive diploma of accuracy and a spotlight to element.
  • Capable of journey ~25%, with worldwide journey at instances

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 facets of the hiring course of.

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

Class Therapeutica Space – Oncology Growth

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

EOE together with Incapacity/Protected Veterans

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