Pfizer Senior Director, Early Clinical Development (MD) in La Jolla, California
To develop clinical development plan from first in human clinical trial to proof-of-concept, including assessment of appropriate combinations, as well as evaluation of potential predictive and pharmacodynamics biomarker plans
To work collaboratively with the functional groups within Oncology Clinical Development.
To ensure the clinical components of the clinical plans and clinical expertise are provided to project teams, including medical monitoring of clinical trials.
To support projects from Research to Proof of Concept (typically phase 2) at which point molecule may be handed to the Oncology Global Product Development for post-POC (typically phase 3) development. Major activities of the group are on new generation small molecules (e.g., epigenetic modifiers), and on immunotherapies, from naked immune monoclonal antibody to cell-based therapy.
To provide and utilize innovative methods to integrate knowledge, patient characteristics and diseases for rational development strategies and decisions.
Provides leadership to the clinical function for preparation of critical documents, including but not limited to clinical protocol, clinical development 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 at least two clinical projects and will support the development and provide consultation regarding multiple research projects, possibly including some at a preclinical stage.
Provide administrative and technical oversight of clinical function within his/her Group.
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 Senior 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
"Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact."
Requires MD/PhD or MD and demonstrated depth and breadth of knowledge and experience in clinical research in the academic, clinical practice or industry setting.
Prior specialized training in Medical Oncology; Board Certification in Oncology is desirable
At least 8 year's experience in the pharmaceutical industry with a track record in early phase drug development through to phase 2 Proof of Concept.
Particular experience in the development of Immuno-therapeutics in Oncology is helpful but not required.
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
• Relocation eligible
• Eligible for employee referral bonus
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