Job Title: Associate Director of Clinical Science

Job Description

In collaboration with clinical and project teams, the Associate Director of Clinical Science designs, plans, and develops studies in early and/or late phase clinical oncology. This role involves preparing and authoring clinical development documents, summarizing study results, and supporting project teams with scientific information and progress updates related to assigned clinical studies.

Responsibilities

• Design, prepare, and initiate study protocols and other required documentation in compliance with project plans, federal regulations, GCP, and good medical practice.
• Interact with investigators and thought leaders in oncology to facilitate the design of clinical synopses and protocols.
• Research and assist in the selection of investigators for clinical studies.
• Conduct appropriate literature research for the assigned clinical product candidate.
• Collaborate with clinical operations and other internal study team members to develop Informed Consent Forms, Case Report Forms, and CRF instructions.
• Act as a contact for the clinical study team for medical monitor inquiries with guidance and oversight of the Medical Monitor assigned to the clinical program.
• Collaborate with clinical operations and other team members to develop agendas, training materials, and presentations for site visits, investigator meetings, and other study-related venues.
• Participate in internal safety meetings, analyze, and report potential safety events.
• Collaborate with team members in clinical review and interpretation of study data to support the preparation of reports for health authorities, including regulatory filing documentation and study close-out reports.
• Contribute to the writing and/or review of product-specific abstracts, publications, and support the development of presentations for scientific meetings.
• Provide feedback on emerging clinical and competitive trends.
• Coordinate and facilitate clinical oncology studies by developing and maintaining excellent working relationships with study investigators.
• Deliver high-quality scientific presentations on investigational agents to physicians and other key external customers.
• Provide clinical education support for internal customers.
• Maintain clinical and technical expertise in the therapeutic area of Oncology.

Essential Skills

• Pharm.D., PhD, or M.D. and a minimum of 8 years of related experience, or an equivalent combination of education and experience.
• 5-8 years of clinical development experience in the biotechnology or pharmaceutical industry or a combination of academia and industry.
• Participation in clinical oncology studies with molecular targeted or immunological therapies.
• Comprehensive and detailed knowledge of clinical trial implementation and the drug development process.
• Experience in the design, execution, and reporting of clinical trials in oncology with small and large molecule drug candidates.
• Strong analytical and business communication skills.
• Highly organized and able to work under tight timelines.
• Good public speaking and presentation skills.

Work Environment

This position is remote with a 10-25% travel requirement for group meetings. The role involves working on complex problems where analysis of situations or data requires an in-depth evaluation of various factors. The work environment promotes networking with key contacts outside one's area of expertise and collaboration with clinical operations and other team members.

Pay and Benefits

The pay range for this position is $95.00 - $113.00/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 Mar 7, 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.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

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 process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

Salary : $95 - $113