Clinical Development Scientist Lead, Immuno-Oncology

Astellas Pharma

At Astellas, we attempt to turn out to be 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 eagerness 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 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 crew of greater than 14,000 managing operations in roughly 70 international locations world wide. We’re within the High 30 world biopharma firm primarily based on world 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 Approach – affected person focus, possession, outcomes, openness and integrity? Then we might love to listen to from you.

From the primary day in function, everybody at Astellas has a accountability 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 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 various tradition is what makes us uniquely Astellas.

Goal and Scope:

The first objective of the Improvement Scientist will take part within the improvement of medical methods for assigned modalities or indications throughout the division. This place will work carefully 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 medical research performed throughout the assigned program. Improvement Scientists are anticipated to carry out their obligations independently and have core information of medical improvement to allow elevated participation in division and portfolio degree 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 research studies and overview of medical trial paperwork, research analyses, and reporting) on assigned improvement applications.
  • Gives experience to cross-functional crew members to synthesize/contextualize information to facilitate dialogue and well timed determination making.
  • Serves on the medical sub-team with GML, Operations Lead, and Medical Monitor/Examine Doctor and helps preparation of medical improvement plans, website identification and administration, and DESC conferences.
  • Beneath the steerage of research doctor/med lead, carry out medical monitoring actions (Assessment, analyze and triage affected person information, producing studies
  • 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 Individual might put together evaluation for DMC/DSMB/DEC boards or regulatory submissions.
  • Gives coaching at investigator conferences and website initiation visits with medical trial employees, and companions with Medical Operations and Medical Affairs in enabling applicable enrollment into the medical research or registries. Collaborates cross-functionally to create, overview, 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 part research
  • Displays experience associated to Examine Information Assessment and Evaluation:
  • Gives medical enter into statistical planning, information evaluation and interpretation
  • Gives medical management and help for publication of knowledge (manuscripts, displays) and illness or know-how associated scientific publications
  • Works carefully with operations group for website and vendor feasibility, trial arrange and monitoring.
  • Could lead the execution of contracts, notably for investigator conferences and advisories.
  • Helps efforts to develop strategic partnerships with Key Exterior Specialists (KEEs)
  • Function key companion for Improvement 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.
  • Could signify improvement and help with medical evaluation for due diligence(s) of recent belongings 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 Main Focus Medical Head (or different Leads relying on grade) for designated program.
  • This place is often a person contributor function, however might have direct studies primarily based on scope, accountabilities and complexity of assigned improvement applications. 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 medical self-discipline with sometimes 9-10 years medical, scientific/analysis, pathology or {industry} associated expertise or mixture of academia and {industry}.
  • Thorough information and demonstrated experience in biotechnology/pharmaceutical {industry} associated to medical drug improvement (early-stage improvement by way 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 medical observe (as evidenced by applicable {qualifications}, publications and/or related accreditations).
  • Sturdy laptop expertise 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 information seize programs [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 inner 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 instances) difficult surroundings.
  • Wonderful strategic planning, organizational and verbal and written communication expertise.
  • Capability to train sound judgment, tact, diplomacy and professionalism in all interactions. Highest degree of scientific integrity.
  • Capability to work independently with out important oversight or instruction to attain outcomes with a excessive diploma of accuracy and a focus 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.

Further Info

Astellas Pharma Canada welcomes and encourages functions 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. Affordable lodging to this coverage could also be granted for a legitimate lodging request underneath human rights laws.

Class Therapeutica Space – Oncology Improvement

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

EOE together with Incapacity/Protected Veterans

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