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Sr Director, Dev Sci Mgmt

Senior Director, Preclinical Safety Assessment

Description:
We are seeking a highly motivated, dynamic leader for the Preclinical Safety Assessment function at Genentech. The Safety Assessment function composes of three critical organizations of toxicology, pathology and investigative safety. The Senior Director of Preclinical Safety Assesment will develop and lead the strategy and execution of efforts for the preclinical safety evaluation of drug candidates and molecules in the Development pipeline. The successful candidate will have a strong and compelling vision for the Safety Assessment organization which ensures meeting very critical needs for the company and its pipeline development.  She/He will oversee an organization of dynamic individuals ranging from Associate Directors to Scientists and Research Associates applying their technical expertise in team settings.  With an increase in the number of small molecules in our discovery and Development portfolio, we expect the leader to provide rich experiences in small molecule safety evaluation while also managing a healthy large molecule (antibodies, fragments, proteins) portfolio.

Scope of the Position
Reporting to the Vice President of Development Sciences, the Senior Director of Safety Assessment will be responsible for the oversight of the development of pre-clinical toxicology strategies - from lead optimization to product approval. Additionally, the incumbent will provide management oversight for all toxicology programs.  

Responsibilities
This position carries the following responsibilities:
- Be a key member of the organization's core leadership in drug development.
- As a member of key decision making committees, represent nonclinical safety in strategic decisions.
- Top level accountability for the strategy, experimental design, result interpretation, troubling shooting, and report writing of safety studies.  
- Partner directly with project/program teams in research (discovery), Early Development (to IND filing and Phase I) and full development (Phase I through POC to Market) to design and interpret the nonclinical safety aspects of drug development, including decision analysis, regulatory acceptability and issue resolution.
- Understand the needs of and strongly influence partners in discovery and clinical development functions for the success of the programs.
- Clearly identifiy and communicate potential project hurdles, suggests solutions and establishes priorities and contingency plans in collaboration with line function management, key partners in Research and Clinical and project team participants.
- Negotiate with Health Authorities (HA) worldwide regarding safety issues, scientific interpretation and acceptability of the sponsor's data.
- Assure support to all assigned projects is optimal in terms of quality, timing and cost; negotiates effectively as necessary. Monitor deliverables including timelines, objectives and budgets and ensure their alignment with development team goals.
- Ensures the successful preparation and presentation of all internal and external documentation relating to nonclinical safety (e.g. Investigator's Brochure, IND, CTD, IMPD, Health Authority briefing books) documentation.
- Manage communications and relationship-building with regulatory authorities worldwide in collaboration with Drug Regulatory Affairs (DRA) and the Head of Safety Assessment.
- Maintain scientific and regulatory expertise in the fields of drug development and safety assessment.  
- Advises and mentors staff.

Requirements
Candidate should have a Ph.D. DVM or an equivalent degree in life sciences with a minimum of 10-15 years of experience in toxicology experience, preferably in a small molecule environment.  Proven leadership strength and potential is important.  A solid track record in successful scientific publications.   Candidate should have experience in managing IND-enabling pharm/tox program and regulatory submissions.  In depth understanding of the drug development process and regulatory experience. This person should have very strong verbal communication skills accompanied by writing skills.  Ability to relate, interact with senior leaders in the Discovery and Clinical development environment is critical for success.  Candidate should enjoy and work well in a fast-paced, multi-tasked, and hands-on environment.


DIVISION:  Development - Dev. Science
REQUISITION NUMBER:  08-1000022127