SUMMARY/JOB PURPOSE:

As a member of the biotherapeutics group, the incumbent plays a key role in leading and managing the efforts to evaluate drug candidates resulting from the Biologics discovery and development efforts at Exelixis from both an in vivo pharmacological perspective as well as relating to early research toxicology and safety.  The incumbent supports the head of biotherapeutics in research and development activities of ongoing and new projects in the biologics' portfolio including providing leadership for post-DC Translational sub-teams, supporting efforts to identify clinical indications for projects, and maintaining responsibility for writing Pharmacology sections in the IND.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Lead and execute antibody–based therapeutic programs.

• Interact and collaborate with other biotherapeutics department team members, internal departments in development (pharmacokinetics, toxicology, translational medicine, pharmaceutical development) and external collaboration colleagues to discuss and resolve project needs and issues in research and early development of biotherapeutics.

• Project lead in collaboration with scientific research and development.  Participates in cross-functional teams to implement research plans.

• Identify and manage critical path activities and resources for development candidate nomination.

• Identify and manage interdependencies and hand-offs.

• Identify and proactively mitigate roadblocks.

• Lead and manage projects in external collaborations

• Lead and oversee the design, execution, and analysis of in vivo studies to evaluate efficacy, PK/PD, and early toxicology assessments for biologics projects

• Expand the Pharm/Tox function with new hires, and manage, guide, and train hires for in-house lab expansion in Discovery Pharm/Tox and project team leadership in biologics programs.

• Accomplish goals under project team timelines

• Provide support in the evaluation of biologics research platforms and preclinical licensing candidates as needed.

• Maintain consistent, multi-level communication with Development Team Members, Senior Management, and the Executive Team.

• Support, teach, and mentor co-workers

• Follow company intellectual property and compliance policies and practices.

• Comply with company health and safety policies and general laboratory practices.

• Departmental activities such as budget planning, administrative management and employee performance development and planning if the position oversees internal employees.

SUPERVISORY RESPONSIBILITIES:

• Directly supervises employees

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education/Experience:

• Doctoral degree (Ph.D.) in related scientific discipline such as Pharmacology, biology, immunology, biochemistry, molecular biology or microbiology and a minimum of fifteen years of experience in the biotechnology/pharmaceutical industry post Ph.D.; or,

• Equivalent combination of education and experience

Experience/The Ideal for Successful Entry into Job:

• Strong background in biologics domain. Experience with biologics in Oncology is a must

• Experience leading and managing Oncology/ ADC/ Programs

• Research experience with antibody-based therapeutics from discovery to IND

• Experience writing intellectual property filings, reports, and non-clinical IND sections

Knowledge/Skills:

• Extensive scientific knowledge in field biologics in Oncology and experience taking biologics projects from discovery to IND

• Extensive knowledge of in vitro and in vivo characterization and translational pharmacology of ADCs and bispecifics

• Knowledge of intellectual property matters, and issues related to biotherapeutics.

• The knowledge to apply advanced scientific and technical principles, theories, and concepts, and contribute to the development of new principles and concepts.

• Ability to set goals with an understanding of priority and impact to program, department, and organization.

• Think strategically and solution oriented.

• Take a hands-on, “roll up your sleeves” approach.

• Ability to drive, facilitate, track, anticipate, influence, and implement team objectives; challenge the status quo where relevant.

• Ability to resolve conflicts within the team 

JOB COMPLEXITY:

• Works on extremely complex problems where analysis of situations or data requires an evaluation of intangible variables.

• Exercises independent judgment in developing methods, techniques, and evaluation criteria for obtaining results.

• Uses professional concepts to contribute to development of company concepts and principles and to achieve objectives in creative and effective ways.

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