Senior Director Non Clinical Development

Location Massachusetts
Discipline: Regulatory Affairs
Job type: Permanent
Salary: £Salary: On application
Contact name: Sam Murphy

Contact email: sam.murphy@rbwconsulting.com
Contact phone: 16179821238
Job ref: 21400
Published: 29 days ago
Expiry date: 19 May 2021

Responsibilities

  • Lead the No-Clinical development team including the core disciplines (Pharmacology, Non-Clinical Biology, DMPK/ and in vivo Pharmacology/Toxicology) to ensure high quality, scientifically rigorous, and timely delivery of the Non-Clinical IND package to best align with the clinical and regulatory strategy.

  • Serve as a spokesperson for programs and remain accountable for team deliverables and value creation.

  • Create and own a product development plan in partnership with functional leaders to govern project strategy.

  • Drive strategies to inform and advance discovery, development, and regulatory affairs.

  • Provide leadership around the design, execution, interpretation, and reporting of toxicity and safety pharmacology studies including assessment of potential relevance of findings on human safety.

  • Maintain project timelines with input from the functional departments and scientific project leaders, ensuring that project timelines align with corporate goals.

  • Proactively identify and communicate risks in the project timelines regarding key milestones and deliverables and work closely with the scientific and functional leaders to mitigate downstream impacts.

  • Assist scientific project leaders foster high-performing teams through the creation of team norms and operating principles.

  • Facilitate effective, science-based business decisions including scenario planning, highlighting all potential downstream impacts of strategic decision making (including resource allocation, team capacity, risk and overall portfolio management).

  • Develop and coordinate ongoing resource planning across functions to ensure adequate resources are applied to the project at any given time.

  • Drive annual operating budget planning for programs. Together with Finance, support the tracking of actuals to budget and communicate deviations to budget and prospectively identify variations throughout the year.

  • Manage the scientific communications plans for the project(s) and integrate with overall corporate communications plan

  • Prepare and present monthly progress reports and ad hoc reports as required

  • Responsible for the conduct and deliverables of Project Team meetings.

  • Additional responsibilities as needed.

Qualifications

  • PhD and 10+ years of biotech/pharma experience or BS/MS in a scientific discipline with 15+ years of biotech/pharm experience. Prior involvement on biologics development programs required.

  • 4+ years of experience leading multi-disciplinary Non-Clinical Development Teams highly preferred.

  • Demonstrated leadership skills, has an easily recognized executive presence, and is a proven relationship builder who is effective via influence.

  • Deep experience working with and leading Pharmacology, Non-Clinical Biology, DMPK/ and in vivo Pharmacology/Toxicology.

  • Demonstrated experience leading successful scientific programs that have progressed from discovery to (and beyond) in – vivo studies. Prior experience with a variety of animal models.

  • Proven track record of effective interpersonal and communication skills with ability to develop strong positive relationship with all levels of the organization.

  • Ability to operate effectively within an entrepreneurial and science-driven company environment; self-motivated, assertive, able to inspire others, driven and hands-on with unquestionable integrity and the highest ethical standards.

  • Requires a strong understanding of overall drug development strategies, spanning across all critical product development disciplines (non-clinical, clinical, CMC, RA/QA, commercial strategy and development).

  • Working knowledge of GXPs and other applicable compliance requirements.

  • Core competency for the application of traditional program management principles and practices.

Salary: On application