Senior Director of Clinical Science
Location: San Diego
Posted on: June 25, 2022
Position Description We are seeking an experienced, independent
and highly motivated clinical science professional. The successful
candidate will be a member of the clinical development team,
working closely with both the clinical and research groups (medical
monitor, statistician, regulatory, translational research) to
support and deliver clinical development strategies. The position
contributes to the trial development strategy and execution,
assisting with protocol development, study design and clinical
study supporting functions. The successful candidate will be
familiar with current approaches regarding oncology treatment
modalities, drug mechanism of action, approaches to drug
development, and regulatory and operational requirements. The ideal
candidate should have experience in hematologic oncology, with
experience in the design and conduct of clinical studies in this
therapeutic area. Experience with cellular therapies is desirable.
The position reports to the VP, Clinical Development and is based
at the Company's corporate headquarters in San Diego, California or
remotely from the San Francisco, California area.Major
- Analyze and interpret study data from individual study and
translate study-level clinical data across the program of studies
for a particular compound ensuring that all studies are conducted
with the highest level of ethical and safety standards and are in
compliance with GCP and all regulatory policies.
- Work with Medical Director(s) to create key strategic documents
including clinical development plans, protocol synopses and full
protocols for defined product(s), in addition to amendments and
- Contribute to the development of clinical sections of
regulatory documents including Investigators' Brochures, briefing
books, safety updates, IND/NDA submission documents, study
protocols, informed consents, eCRFs, statistical analysis plans,
regulatory approval submissions, serious and non-serious adverse
event evaluation, and supporting responses to Health Authorities
- Maintain familiarity with standards of practice in the relevant
therapeutic areas in order to contribute to strategic discussion
and decision-making for the program.
- Contribute to data activities including data cleaning and
database locking; review of safety fields for reconciliation (if
needed), working with data group to reconcile SAE events (as
needed); review of medical coding of adverse events, laboratory
data and concomitant medications for accuracy, coherence,
consistency, and trends; review of data tables, listings, and
figures; review and/ or writing portions of final clinical study
- Develop effective working relationships with key investigators
in assigned programs to optimize scientific quality/ innovation of
clinical study design, execution, reporting and publication.
- Contribute to trial-related advisory boards, investigators
meetings, DMC and protocol training meetings.
- Coordinate the real-time availability of quality clinical trial
data, including safety, efficacy, pharmacokinetic and biomarker
data, to provide consolidated information for Senior
- Assist in forecasting trial resource needs (external
- MS, RN, PhD, or PharmD with a minimum 5 years technical,
operational and managerial experience in planning, executing,
reporting, and publishing clinical studies in a biotech,
pharmaceutical, or CRO environment.
- 5+ years of experience in the design and conduct of hematologic
oncology clinical trials is desirable.
- Experience in novel combinations and innovative designs for
early phase studies. Phase 3 trial experience is a strong
- A hands-on, independent and driven individual who can take
charge of the work and is willing to contribute at different
levels; e.g., engage with investigators, KOLs, etc. one-on-one as
well as dig into the data.
- Ability to produce written scientific communications with
clarity, accuracy and rigor.
- Experience with U.S. and European regulatory authorities and
submissions is desirable.
- Experience or exposure to the development of cell therapies is
- Self-motivation, good judgment, strong follow up,
organizational, analytical, and problem-solving skills; capable of
identifying risks; creative and innovative thinker.
- Ability to work, lead and motivate a cross-functional matrix
- Excellent written and oral communication skills. Ability to
communicate effectively through formal presentation and through
informal scientific discussion with credibility, accuracy, and
confidence with internal and external stakeholders and
experts.Working Conditions and Physical Requirements
- Travel between office locations as required
- Occasional travel to meetings and conferences as required
- Occasional evening and weekend work will be required
Keywords: Partnology, San Diego , Senior Director of Clinical Science, Healthcare , San Diego, California
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