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Director Clinical Immuno


San Francisco, CA
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Job Details

Job Title Director Clinical Immuno

JobID 1042886

Location: San Francisco, CA

Description + The Director is responsible for working collaboratively with the functional groups within Oncology Clinical Development.

+ The Director ensures the clinical components of the clinical plans and clinical expertise are provided to project teams.

+ The Director will support projects through Research to Proof of Concept (typically phase 2) at which point molecule will be handed on to the Oncology Global Product Development for post-POC (typically phase 3) development .The focus of the group is on new generation immunotherapies from naked immune monoclonal antibody to cell-based therapy.

The Director provides and utilizes innovative methods to integrate knowledge, patient characteristics and diseases for rational development strategies and decisions.

+ Provide administrative and technical oversight of clinical function within his/her Group

+ Provides leadership to the clinical function for preparation of critical documents, including but not limited to clinical protocol, clinical plan, investigator brochure, statistical analysis plan, and regulatory documents.

+ He/she will closely work in a matrix team environment, including other clinicians, statisticians, clinical pharmacologists, translational biologists and others at an international level. The candidate will work on 2 or more projects and will support the development of clinical plans for each one.

+ Ensure that all activities are conducted in compliance with relevant regulatory requirements.

+ Monitor and report on implementation of Global clinical initiatives in his/her group

+ Develop charters, resource utilization and project plans to achieve clinical project -specific goals

+ Implement site organizational design and develop succession planning for clinical area.

+ Develop people, including recruitment, retention, and career development as directed by Oncology Clinical Development Head.

+ Ensures development of and adherence to Safety Review Plan (SRP). Consistent with SRP, performs regular review of individual subject safety data, and performs review of cumulative safety data with the safety risk lead or as delegated by the clinical leader. As appropriate, the Director may delegate these responsibilities to a physician study clinician identified in the SRP.

+ Be accountable for clinical analyses, programmed outputs, and integrated scientific reports for clinical trial results and support for publication activities, for assigned projects.

+ Implement strategies to ensure that the clinicians are collaborative, strategic partners with scientific and clinical colleagues.

+ Implement strategies to ensure appropriate consistent processes in strong collaboration with associated RU partners.

+ Develop effective collaborations with Clinical Leads in Oncology Research & Development and Global Product Development organizations, and external regulatory, industry, professional and academic organizations.

+ Provide a strong presence in regulatory and professional circles to influence content of regulatory guidelines and their interpretation in practice.

Implement aligned strategies and consistent processes to optimize the use of corporate standards


+ Requires MD or equivalent and demonstrated depth and breadth of knowledge and experience in clinical research in the academic, clinical practice or industry setting.

+ Board Certification in Oncology is desirable

+ At least 3-year experience in the pharmaceutical industry with a track record in early phase drug development through to phase 2 Proof of Concept.

+ Experience in the development of Immunotherapeutics in Oncology

+ Understanding of related disciplines (e.g. biostatistics, regulatory, pre-clinical pharmacology, pharmaceutical sciences).

+ Demonstrated scientific productivity (publications, abstracts, etc.)

+ Proven scientific writing skills and good communication skills

+ Proven leadership skills with ability to defend the clinical plan at governance meetings is essential

Capacity to adapt to a fast-paced and changing environment

EEO & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

Additional Offer Details:

- Grade: 19

- Eligible for Relocation Package

- Eligible for Employee Referral Bonus

A career at Pfizer offers opportunity, ownership and impact.

All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the bio-pharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

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