Medical Director/ Senior Medical Director, Clinical Development (Oncology)

Job Title: Medical Director / Senior Medical Director, Clinical Development (Oncology)

Location: Rockville, MD (No Remote) 

Company Overview:

Our client is a cutting-edge biotech company specializing in innovative oncology therapeutics with a focus on solid tumors. With exciting candidates in the IND stage, we are dedicated to advancing science and bringing transformative therapies to patients in need.

Position Overview:

We are seeking a dynamic and experienced Medical Director or Senior Medical Director to join our Clinical Development team. This role is pivotal in shaping and executing our clinical programs, driving protocol development and study design, and expanding our oncology pipeline into new therapeutic areas. This position offers the opportunity to work on groundbreaking programs in gynecological, gastrointestinal, lung, and skin cancers.

Key Responsibilities:

• Lead the clinical development strategy for assigned oncology programs, focusing on protocol development, study design, and execution.
• Collaborate with cross-functional teams, including translational medicine and regulatory affairs, to integrate scientific and clinical insights into program development.
• Drive the expansion of clinical programs into new cancer areas, leveraging expertise in solid tumor biology and immunology.
• Establish and maintain relationships with Key Opinion Leaders (KOLs) in oncology, fostering collaboration and gaining insights into emerging trends.
• Author and review clinical trial protocols, investigator brochures, and other key regulatory documents.
• Contribute to IND submissions and support regulatory interactions as needed.
• Monitor and analyze clinical data to inform program strategy and decision-making.
• Represent the company at scientific and medical conferences, building external visibility for clinical programs.

Qualifications:

• MD or equivalent with a strong background in oncology, preferably with subspecialty expertise in gynecology, gastrointestinal, lung, or skin cancers.
• Minimum of 5+ years of clinical development experience in the biopharma industry, including protocol and study design.
• Strong knowledge of solid tumor biology, immunology, and translational science.
• Proven ability to drive clinical programs, from early development through advanced stages.
• Excellent written and verbal communication skills, with experience authoring clinical and regulatory documents.
• Established network of KOLs in oncology and a track record of effective collaboration with external experts.
• Strategic thinker with the ability to manage multiple priorities in a fast-paced environment.

Preferred Skills:

• Experience with IND-stage candidates and regulatory interactions.
• Familiarity with emerging oncology trends and innovative trial designs.
• Passion for advancing science and improving patient outcomes.

What We Offer:

• Opportunity to work at the forefront of oncology research and development.
• Collaborative and innovative culture that values input from diverse perspectives.
• Competitive compensation, including equity options and comprehensive benefits.

System One, and its subsidiaries including Joulé, ALTA IT Services, TeamPeople, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

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