Exelixis, Inc.
Senior Vice President, Clinical Development MD
Exelixis, Inc., Alameda, California, United States, 94501
SUMMARY/JOB PURPOSE:
The Senior Vice President, Clinical Development MD is a strategic leadership role for a seasoned clinical development leader. This role is responsible for building and developing a high performing clinical team across both early and late development for our expanding and diverse pipeline and is a member of the Product Development and Medical Affairs senior leadership team.
This role will be located in Alameda, CA. Relocation will be provided for ideal candidate.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Accountable for leading and managing the clinical development group- comprised of physicians and clinical scientists including recruitment, development, and retention of a high performing group and ensuring right-sized resourcing of individuals with the appropriate skills and capabilities to advance our robust pipeline.
Capable of understanding company strategy and applying to the organization to effectively evolve the organizational structure as needed.
Partners and collaborates effectively across the company to create and nurture trusting relationships.
Provides expert clinical input and guidance to decision making in relevant governance committees.
Supports the success of program teams, business development activities and new target discovery by understanding the needs of the company. Trains and assigns clinical resources as appropriate.
Able to apply a portfolio-level strategic lens to develop, support, and ensure the success of clinical strategies for development assets.
Directly oversees the design of clinical trial protocols and supporting framework and documentation to compliantly and comprehensively deliver according to approved project plans/timelines and within global federal regulations, GCP and good medical practice.
Critically analyzes and correctly interprets clinical trial data and manages a group to successfully prepare documents for regulatory agencies and publications.
Has built and is capable of increasing and maintaining strong and trusted relationships with key opinion leaders, partners, and global health authorities in disease specific area.
Represents the company and our strategic imperatives externally.
Maintains the highest level of scientific and clinical knowledge in relevant disease specific area and applies that in an ethically robust manner.
SUPERVISORY RESPONSIBILITIES:
Leads and manages employees in the clinical development organization both directly and via other subordinate supervisors.
Oversees performance management and career development for the clinical development organization.
EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:
Education/Experience:
MD with board certification, or eligibility in Oncology or Hematology/Oncology or related specialty and a minimum of 16 years of post-residency experience in the field of drug development; or,
Equivalent combination of education and experience.
Experience/The Ideal for Successful Entry into Job:
Twelve or more years of drug development experience in biotechnology or pharmaceutical industry, or a combination of academia and industry.
Deep experience in the design, execution, evaluation and reporting of data and studies to support global regulatory submissions of clinical trials in oncology.
A track record of successful interactions with regulatory agencies is a plus.
Broad understanding of science relevant to clinical oncology and successful approvals in a variety of indications (biochemistry, immunology, molecular biology and/or genetics).
Direct experience in Companion Diagnostic development is a plus.
In-depth knowledge of GCP, ICH, CFR and other guidelines and regulations.
Knowledge/Skills:
Proven ability to effectively work in a cross-functional/matrix environment.
Uses broad expertise or unique knowledge and skills to contribute to development of company objectives and principles and to achieve goals in creative and effective ways.
Excellent communication skills that are individual appropriate, team appropriate, and organization appropriate.
Identifies issues and adeptly develops solutions to complex problems.
Proven ability to work collaboratively with and effectively influence peers and stakeholders.
Ability to think quickly, decide effectively and execute optimally in a fast paced, data-driven environment.
Embraces constructive contention as a means of continuous improvement.
Provides appropriate and clear based on organizational goals, company policy, and culture.
Takes accountability for the group and drives for results by driving engagement.
WORKING CONDITIONS:
Ability to travel globally.
DISCLAIMER:The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.
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The Senior Vice President, Clinical Development MD is a strategic leadership role for a seasoned clinical development leader. This role is responsible for building and developing a high performing clinical team across both early and late development for our expanding and diverse pipeline and is a member of the Product Development and Medical Affairs senior leadership team.
This role will be located in Alameda, CA. Relocation will be provided for ideal candidate.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Accountable for leading and managing the clinical development group- comprised of physicians and clinical scientists including recruitment, development, and retention of a high performing group and ensuring right-sized resourcing of individuals with the appropriate skills and capabilities to advance our robust pipeline.
Capable of understanding company strategy and applying to the organization to effectively evolve the organizational structure as needed.
Partners and collaborates effectively across the company to create and nurture trusting relationships.
Provides expert clinical input and guidance to decision making in relevant governance committees.
Supports the success of program teams, business development activities and new target discovery by understanding the needs of the company. Trains and assigns clinical resources as appropriate.
Able to apply a portfolio-level strategic lens to develop, support, and ensure the success of clinical strategies for development assets.
Directly oversees the design of clinical trial protocols and supporting framework and documentation to compliantly and comprehensively deliver according to approved project plans/timelines and within global federal regulations, GCP and good medical practice.
Critically analyzes and correctly interprets clinical trial data and manages a group to successfully prepare documents for regulatory agencies and publications.
Has built and is capable of increasing and maintaining strong and trusted relationships with key opinion leaders, partners, and global health authorities in disease specific area.
Represents the company and our strategic imperatives externally.
Maintains the highest level of scientific and clinical knowledge in relevant disease specific area and applies that in an ethically robust manner.
SUPERVISORY RESPONSIBILITIES:
Leads and manages employees in the clinical development organization both directly and via other subordinate supervisors.
Oversees performance management and career development for the clinical development organization.
EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:
Education/Experience:
MD with board certification, or eligibility in Oncology or Hematology/Oncology or related specialty and a minimum of 16 years of post-residency experience in the field of drug development; or,
Equivalent combination of education and experience.
Experience/The Ideal for Successful Entry into Job:
Twelve or more years of drug development experience in biotechnology or pharmaceutical industry, or a combination of academia and industry.
Deep experience in the design, execution, evaluation and reporting of data and studies to support global regulatory submissions of clinical trials in oncology.
A track record of successful interactions with regulatory agencies is a plus.
Broad understanding of science relevant to clinical oncology and successful approvals in a variety of indications (biochemistry, immunology, molecular biology and/or genetics).
Direct experience in Companion Diagnostic development is a plus.
In-depth knowledge of GCP, ICH, CFR and other guidelines and regulations.
Knowledge/Skills:
Proven ability to effectively work in a cross-functional/matrix environment.
Uses broad expertise or unique knowledge and skills to contribute to development of company objectives and principles and to achieve goals in creative and effective ways.
Excellent communication skills that are individual appropriate, team appropriate, and organization appropriate.
Identifies issues and adeptly develops solutions to complex problems.
Proven ability to work collaboratively with and effectively influence peers and stakeholders.
Ability to think quickly, decide effectively and execute optimally in a fast paced, data-driven environment.
Embraces constructive contention as a means of continuous improvement.
Provides appropriate and clear based on organizational goals, company policy, and culture.
Takes accountability for the group and drives for results by driving engagement.
WORKING CONDITIONS:
Ability to travel globally.
DISCLAIMER:The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.
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