Director, Clinical Affairs

Job Description
SUMMARY:
Epic Sciences is seeking a Director of Clinical Affairs to join our company in San Diego, CA. The Director of Clinical Affairs will manage and drive clinical decisions related to Epic’s oncology clinical trials. This person will be accountable for translating corporate strategy, translational research efforts, clinical unmet need into a clinical plan that leads to best-in-class predictive, prognostic or diagnostic tests incorporating physician, regulatory, and payer stakeholder requirements. This person will work independently, and in collaboration with others in a team oriented environment.

ESSENTIAL FUNCTIONS:

· Independently design, develop and execute Epic clinical trials
· Independently troubleshoots effectively and generate creative solutions in order to solve clinical problems
· Direct oversight of clinical trial program, participation in IVD product development team
· Authorship and delivery of clinical development plans, clinical protocol, IRB alignment, amendments, and related documentation; will lead key clinical documentation for regulatory submissions.
· Lead site CRO and operations strategy for clinical trials
· Able to clearly communicate results in oral and written presentations
· Expertise with process and outputs of general lab practice, such as immunofluorescent assays, IHC, FISH, fluorescent microscopy and cell-imaging
· Highly efficient at execution of tasks and multitask as well as accomplish tasks that require departmental effort to meet demanding timelines and workloads

ADDITIONAL DUTIES:
May perform additional duties as assigned or directed by management from time to time

EDUCATION/EXPERIENCE REQUIRED:

· Ph.D or M.D. (or equivalent) in relevant scientific/medical discipline with 5 to 8 years of relevant experience
· Clinical experience should include the development and approval of biomarkers for patient selection and drug efficacy
· Excellent working knowledge of FDA and EMA regulations and expectations, Good Clinical Practice, and clinical drug development.
· Demonstrated experience and expertise in the primary authorship of multiple clinical trial protocols and clinical study reports, including oversight of the generation of tables, figures and listings from the study database.
· Prior experience and expertise in the design of case report forms and the design of clinical data listing and tables for clinical trials preferred.

REQUIRED SKILLS:

· Excellent relationship management skills
· Excellent customer and market understanding (previous marketing experience preferred)
· Strong leadership skills
· Strong teaming skills
· Strong presentation and communication skills (oral and written)
· Strong technical acumen
· Strong process orientation
· Self-starter, capability to identify and resolve problems independently
· Experience with immunofluorescent assays, IHC, FISH, and fluorescent microscopy
· Experience working independently and with a team
· Demonstrated analytical and problem solving skills
· Demonstrated experience delivering results with KOLs

REQUIRED COMPETENCIES:

Performance Orientation – Is driven by personal performance; achieves all objectives detailed in scorecards and comfortable with quantifiable assessments.
Impact Orientation – Performs to stated objectives and driven to make an impact on company goals and patients’ lives.
Competitive – Dedicated to a competitive spirit that supports the Epic Sciences’ goal to be the premier CTC technology in the industry.
Sense of Urgency – Has the speed and agility dedicated to the company’s goals and performance.
Ability to Handle Pressure and Ambiguity – Comfortable with the pressure to be the best and the ability maintain composure and focus in situations of ambiguity and uncertainty.
Confidence - Confident in one’s skills and abilities; pursues everything with energy; demonstrates the drive and a need to finish especially in the face of resistance or setbacks.

Company

Epic Sciences

Job Code

State or Province

California

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