Sr. Director, Clinical Development and Operations

Sr. Director, Clinical Development and Operations

Allakos Inc. is a clinical-stage company developing therapeutic antibodies for inhibitory receptors on the surface of immune effector cells involved in allergic, inflammatory and proliferative diseases.

Allakos is committed to developing innovative therapies that transform patients’ lives.  We are looking for bright and talented individuals to join our team and share in our passion and commitment to improving the lives of patients.

Position Summary:

The Sr Director of Clinical Development and Operations, reporting to the Vice President of Clinical Development and Operations, provides assistance to the Vice President, Clinical Development and Operations in ensuring leadership and management of resources to conduct Phase 1-3 investigational drug trials and ensures quality of the trials, trial conduct and clinical data.  In addition, the Sr Director of Clinical Development and Operations will ensure operational efficiency, timeline adherence and cross-functional collaboration for multiple development programs as well as ensure consistency and delivery of key study related documents including protocols and clinical study reports.

Your Role:

• Provides oversight and manages key areas of clinical operations at the direction of the Vice President, Clinical Development and Operations, allocating and directing internal resources and effectively utilize outsourcing to achieve project and business goals in a timely manner.
• Ensures activities are performed to launch, enroll and lock clinical studies according to timelines established by Allakos Management.
• Develops and implements procedures and activities to ensure quality and timeliness of clinical studies and clinical data as well as study reports.
• Provides support to the Clinical Program Managers as needed
• Participate in FDA inspections as needed.
• Demonstrate mastery of FDA and ICH rules, regulations and guidelines governing conduct of clinical studies, clinical protocols, investigator brochures and other materials.
• Responsible for ensuring overall clinical program management and execution as well as effective collaboration with project management.
• May include direct line management

Qualifications and Expertise:

• A minimum of a Bachelor’s degree in a scientific discipline is required; advanced degree preferred.
• Experience monitoring Phase 1-3 drug studies would be strongly preferred.
• A minimum of 5 years of experience implementing and successfully managing Phase 1-3 drug studies from feasibility through closeout.
• A minimum of 5 years of experience overseeing/supervising direct reports.
• Experience reviewing large sets of clinical data and/or prior experience with data management a plus but not necessary.
• Previous experience with small start-up biotech companies preferred, but not required.
• Demonstrable experience with project management, successful interactions with regulatory authorities and expert knowledge of current regulatory requirements and GCP required
• Drug safety experience and reporting requirements would be favorable
• Highly effective verbal and written communication in English language as well as strong negotiation skills.

The salary is competitive and commensurate with experience and qualifications.

The Allakos Values are: Selflessness, Drive, Clarity, Thoughtfulness, Fun, and Leadership

Allakos is an equal opportunity employer. Allakos will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.