Sr Director, Clinical Operations

Location
San Diego, California
Posted
Oct 19, 2017
Ref
2017-1017
Required Education
Bachelors Degree
Position Type
Full time

The Opportunity

Reporting to the VP, Head of Clinical Operations, the Sr. Director of Clinical Operations will provide oversight of clinical trial operations with regards to planning, development, execution and outcome. Responsibility for successful coordination and execution of clinical trials involving clinical development personnel (physicians, data managers, biostatisticians, other clinical operations staff) and project management. Operational responsibility for execution of clinical trials in alignment with corporate objectives and clinical strategy (e.g. according to timelines and within budget). May directly manage complex clinical studies.

What you will dive into

• Direct and coordinate all aspects of clinical operations, including team leadership and direction, development and oversight of clinical study budgets, resourcing, timelines, and ensuring efficient and high-quality execution of work;

• Direct personnel activities, and provide guidance for professional development of staff, including resource distribution;

• Direct management of complex clinical trial(s);

• Proactively identify risks and mitigations and implement corrective action plans;

• Oversight over training and compliance with GCP and SOPs;

• Review and approve site contracts, work orders and invoices prior to department head approval;

• Interface with appropriate cross-functional departments to facilitate negotiation/issue resolution for clinical trial related issues;

• Oversight of development and implementation of internal policies & procedures to optimize the management of clinical trials;

• Review and input on trial design to ensure clinical strategies incorporate operational input; 

• Oversight over selection and management of external CROs and vendors

What we expect

• Bachelor’s degree; Masters preferred

• 10-15 years of pharmaceutical industry experience with a minimum of 8 years in clinical operations or related experience

• Demonstrated leadership of clinical operations and/or clinical development teams, knowledge of the drug development process, Health Authority regulations and ICH technical aspects of clinical study conduct;

• Must have excellent communication skills and be able to establish and maintain relationships with various intra-department and inter-department personnel.

What you’ll get

• To be a part a growing company and fantastic team passionate about developing novel drug therapies to improve people’s lives

• Opportunities to learn and contribute creative solutions

• Comprehensive health insurance ($0 premium on select medical plans)

• Matching 401k retirement plan

• Paid time off and holidays including a Summer & Winter break

• Company celebrations

Arena celebrates and supports our differences and is proud to be an Equal Employment Opportunity and Affirmative Action Workplace. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. Arena is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans in our job application procedures. If you need assistance due to a disability, you may contact us at jobs@arenapharm.com.