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Job Title: Director of Clinical Development

We are seeking a highly skilled Director of Clinical Development with a focus on early oncology development. This role involves collaborating with clinical leaders to write clinical development concepts and plans, drafting protocol synopses, and reviewing informed consent forms. Additionally, you will partner with Clinical Operations, lead the writing of investigator brochures, and review clinical sections of regulatory submissions.

Responsibilities

+ Collaborate with clinical leaders to draft clinical development concepts and plans for molecules, focusing on early oncology development.

+ Write and review protocol synopses, protocols, and protocol amendments.

+ Review informed consent forms and adjudicate site-specific ICF requests.

+ Partner with Clinical Operations for site selection, start-up, and communication.

+ Lead the writing of clinical sections of investigator brochures and manage annual updates.

+ Write and review clinical and safety sections of NDAs/MAAs.

+ Represent the medical function on clinical study teams and serve as a member of the clinical sub-team.

+ Review and interpret data listings, including safety data and serious adverse events.

+ Author or assist in writing clinical study reports and related publications.

+ Create clinical study or program-related presentations for internal and external use.

+ Train colleagues, CRO, and study site staff on therapeutic areas, molecules, and protocols.

+ Organize and participate in opinion leader advisory boards.

+ Conduct therapeutic area or indication research and competitor analysis.

+ Build and maintain networks with opinion leaders and investigators.

+ Support Health Authority interactions and provide responses to inspection observations and audits.

+ Assist in the design, execution, and reporting of Phase 2 or 3 clinical trials, ensuring patient safety.

+ Present study results to internal and external committees, at scientific meetings, and publish in peer-reviewed journals.

Essential Skills

+ Bachelor’s degree with strong knowledge of clinical oncology.

+ At least 4 years of industry experience in oncology.

+ Experience in clinical development programs, preferably across all stages of clinical trials.

+ Skilled in protocol design, interpretation, and medical monitoring.

+ Knowledge of Good Clinical Practice (GCP).

+ Excellent written and oral communication skills.

Additional Skills & Qualifications

+ Postgraduate qualification in clinical oncology (e.g., Master’s degree) is advantageous.

+ Advanced degrees such as MD, Nurse Practitioner’s License, PharmD, or PhD are welcomed.

+ Experience with small molecule clinical trials.

+ Experience in assessing adverse events and ensuring patient safety in clinical trials.

+ Capacity to adapt to a fast-paced and changing environment.

Work Environment

This position is remote, providing flexibility and the ability to work from anywhere. The role requires the use of digital communication tools to collaborate with teams and manage clinical development tasks efficiently.

Job Type & Location

This is a Contract position based out of South San Francisco, CA.

Pay and Benefits

The pay range for this position is $90.00 - $120.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully remote position.

Application Deadline

This position is anticipated to close on Dec 31, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email [email protected] (%[email protected]) for other accommodation options.