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Sr. Director/Executive Director Global Project Lead Immuno-Oncology

Company

Astellas Pharma US

Address United States
Employment type FULL_TIME
Salary
Category Higher Education,Hospitals and Health Care,Pharmaceutical Manufacturing
Expires 2023-06-11
Posted at 11 months ago
Job Description

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.


Purpose and Scope:

The Asset Lead serves as the matrix team leader with overall accountability for the development of an asset(s) from late preclinical through life cycle management who reports to the Primary Focus Development Head.


Essential Job Responsibilities:


  • Serves as the “asset CEO”; single point of accountability for the execution of program deliverables and for day-to-day decision making for the asset(s).
  • Ensures the programs have adequate resources and technical expertise to meet the strategic objectives.
  • Provides strategic direction and executional oversight to asset team(s) translating Primary Focus level strategies into a comprehensive global development, registrational plan aligned with the corporate strategic plan.
  • Actively manages issues and risks and proactively identifies alternative strategies in collaboration with Asset Team representatives.
  • 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.
  • 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 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.
  • Partners to develop a joint global strategy for co-development programs, representing Astellas’ position and minimizing escalation amongst the partners.


Qualifications:

Required

  • Recent experience leading at least one IND/IMPD, one NDA/MAA/BLA, or FDA Advisory Committee preparation or other CDE/PMDA/EMA meetings, or similar responsibilities.
  • Must be willing to travel
  • Demonstrated success leading the development of one or more asset.
  • A minimum of 5 years’ experience leading global cross functional matrix teams.
  • Bachelor’s Degree and Minimum of 10 years’ experience in drug development leadership in pharmaceuticals, biopharmaceuticals, or biotechnology. A doctoral or an advanced professional degree is preferable with a specialty in the assigned therapeutic area, or equivalent experience within industry.


Skill Set


  • 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.
  • 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 have an in-depth understanding of drug development and able to recognize the implications of new directions, trends, and developments.
  • Broad understanding of the multidisciplinary functions, contributing to effective and efficient drug development and commercialization.
  • Demonstrated effectiveness in communication to Executive Level, with a style that builds unity within the organization and with corporate collaborators.
  • Ability and willingness to respectfully challenge team members and functions, and manage conflict, to assess fully all opportunities, options, risks, and mitigations.
  • Ability to assimilate data, recognize key variables, analyze complex situations, and make timely decisions with a sense of urgency.
  • 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.


Benefits:

  • Referral bonus program
  • Medical, Dental and Vision Insurance
  • Company paid life insurance
  • Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
  • Long Term Incentive Plan for eligible positions
  • 401(k) match and annual company contribution
  • Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions