Medical Director

Medical Director of Oncology Clinical Development

Key Responsibilities:

Serves as a Study Medical Monitor

Author Clinical Trial Documents including protocols, Investigator brochures, ICFs, training materials, and DSURs

Work closely with Clinical Operations to execute clinical trials with high quality, deliver results and meet target timelines

Drive contribution of clinical content for deliverables in support of regulatory submission activities and ensure flow and accuracy of key data for clinical module sections of the IND

Provide medical input for the clinical database build, CRFs, monitoring plan, data management plan, safety monitoring plan and statistical analysis plan

Contribute to the ongoing scientific review of clinical trial data and assist with query resolution and data analysis

Work closely with PV, Data Management, and other vendors to ensure appropriate review and documentation of clinical trial data

Maintain scientific and clinical knowledge in the specific oncology-focused therapeutic areas

Stay up to date with internal and external developments, trends, and other areas relevant to the work, maintaining a fully current view

Develop and maintain relationships with a variety of internal and external partners and stakeholders, including clinical investigators, study coordinators/CRAs and KOLs

Review and manage clinical development budgets and provide forecasts to the clinical development and finance team members

Qualifications:

Medical Degree (MD or DO), preferably board certified in medical oncology

5 years’ experience in clinical development with at least 2 years in the biopharmaceutical industry.

Experience in translational medicine/early phase oncology clinical trials is a plus

Solid understanding of GCP/ICH/IRB and local regulatory authority drug research and development guidelines and regulations

Proven ability to interact and work with external partners (PIs and consultants) with regards to clinical development functions

A solid understanding of the clinical trial processes, such as study start up, patient recruitment and safety, non-compliance, management, and monitoring of investigative sites

Excellent problem-solving skills, a strong sense of urgency and keen attention to detail. Well organized with the ability to effectively manage multiple priorities in a dynamic, cross-functional teamwork environment under time and resource pressures

A proven track record of successfully working within a collaborative team environment and building positive relationships as an individual contributor is required

Excellent oral and written communication skills and strong organizational skills are required

Ability to adapt to modification and changes to project plans, demonstrating flexibility to implement new strategies and tactics to accommodate these changes

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 (%20actalentaccommodation@actalentservices.com) for other accommodation options.