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 .
This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.
Purpose and Scope: We are looking for a passionate drug developer and experienced asset/program leader for our next generation immunotherapy programs (T cell engagers, ADCs and iADCs). The Asset Lead has overall and primary accountability for the development of an asset(s) from late preclinical through life cycle management who reports to the Primary Focus Development Head. The Asset lead is the leader of the matrix asset development team. This is a role for someone who is excited by the potential for immunotherapies and has the scientific background and business acumen to lead drug development teams for immunotherapy and cancer cell therapy assets. ( This is not a project management role)
Essential Job Responsibilities:
Leads the development of the program vision, provides strategic direction and executional oversight to asset team(s) translating Primary Focus level strategies into a comprehensive global development and registrational plan aligned with the corporate strategic plan.
Serves as the “asset CEO”; single point of accountability for program vision and strategy and for the execution of program deliverables and day-to-day decision making for the asset(s).
Accountable for leading a cross-functional asset team(s) including a medical, regulatory, CMC, research, operations, commercial, finance and data science to advance one or more assets from preclinical candidate nomination through clinical development, global/local regulatory submissions, and approval.
Effectively communicates with executive leadership through relevant Governance Committees and responsible for the approval of the program and or project plans on behalf of the asset team.
Develops clear, prospective Go/No-Go decision points and continually validates the viability of the program ensuring development plans maximize the value of the asset.
Accountable for effective leadership within a matrix environment for assigned asset(s), implements, and ensures key development, life cycle management milestones, and budget goals for assigned projects/programs are met.
Actively manages issues and risks and proactively identifies alternative strategies in collaboration with Asset Team representatives.
Ensures the programs have adequate resources and technical expertise to meet the strategic objectives.
Partners to develop a joint global strategy for co-development programs, representing Astellas’ position and minimizing escalation amongst the partners.
Guides and mentors asset team members, champions the global asset team model and ensures team health and effectiveness.
Advanced professional degree (Masters/ PhD, Pharm D, MD) plus 7 years’ experience in drug development team leadership n pharmaceuticals, biopharmaceuticals, or biotechnology is required.
Demonstrated success leading the development of one or more asset(s) in the early development space (through clinical PoC) preferably in immunotherapy or cell therapy.
Demonstrable experience leading IND/IMPD, NDA/MAA/BLA, or FDA Advisory Committee preparation or other CDE/PMDA/EMA meetings, or similar responsibilities.
Position is remote but must be willing to travel
Scientific and development knowledge to develop and present a program vision, critical deliverables, GO-NoGO criteria.
Broad understanding of the multidisciplinary functions across the drug development continuum contributing to effective and efficient drug development and commercialization.
Must have an in-depth understanding of drug discovery and development, maintain continued awareness of new directions, trends, and external developments and the ability to recognize the implications of these changes.
Business acumen to understand and assimilate data, recognize key variables, analyze complex situations, and make timely decisions with a sense of urgency
Must be a strong and effective strategic thinker and problem solver, requiring the ability to both recognize and anticipate problems, and help team members develop their own problem-solving skills and discipline.
Must also be able to identify and solve tactical problems and delve into high degree of detail when necessary.
Able to plan budgets and allocate resources internally and externally and can marshal those resources in a productive and efficient manner.
Ability to lead and motivate team members and build alliances from across functional areas; must be able to lead through influence and bring out the best in others.
Ability and willingness to respectfully challenge team members and functions, and manage conflict, to assess fully all opportunities, options, risks, and mitigations.
Demonstrated effectiveness in communication to Executive Level, with a style that builds unity within the organization and with corporate collaborators.
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
Category Therapeutic Area - Oncology, Development
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans