Head of Clinical Development

Job Title: Head of Clinical Development
Location: Camrbidge, MA
Employment Type: Full-time

About Our Client:
Our client is a leading biopharmaceutical company focused on pioneering innovative therapies to address unmet needs in oncology. Their mission is to transform the treatment landscape through cutting-edge research and clinical advancements. They are seeking a highly experienced and dynamic individual to join their team as the Head of Clinical Development.

Position Overview:
The Head of Clinical Development will play a pivotal leadership role in the strategic direction and execution of oncology clinical trials. With over 20 years of experience in clinical development, including a deep background in oncology and IND submission, this position requires a seasoned leader to drive the development of novel therapies through clinical phases while ensuring alignment with regulatory standards and organizational goals.

Key Responsibilities:

• Lead and oversee the clinical development strategy for oncology programs, including design, execution, and monitoring of clinical trials from preclinical stages to late-phase development.
• Drive the development of clinical trial protocols, regulatory submissions, IND filings, and other related documents to ensure smooth regulatory approval processes.
• Collaborate closely with internal teams, including R&D, regulatory affairs, and business development, to align on program goals and ensure seamless progression of clinical programs.
• Provide expert guidance on clinical trial design, methodology, and statistical approaches, ensuring high-quality and scientifically rigorous studies.
• Serve as a key point of contact for regulatory agencies, ensuring successful IND submissions and compliance with evolving regulatory requirements.
• Develop and lead clinical development teams, mentor junior staff, and manage cross-functional project teams to ensure the successful delivery of clinical programs.
• Contribute to the preparation of clinical development plans, timelines, budgets, and resources, ensuring programs are on track and within scope.
• Interface with external stakeholders, including CROs, academic collaborators, and key opinion leaders, to drive the success of clinical trials.
• Prepare and present clinical development updates to executive leadership and the board of directors.
• Stay abreast of the latest trends and advancements in oncology and clinical research to continually improve development strategies and outcomes.

Qualifications:

• MD with board certification in oncology (or equivalent clinical background) required.
• At least 20 years of experience in clinical development, with a focus on oncology.
• Extensive experience with IND submissions and working closely with regulatory agencies (FDA, EMA, etc.).
• Proven track record of leading and managing complex oncology clinical trials through all phases (Phase 1-3).
• Strong leadership skills with experience managing cross-functional teams, both internally and externally.
• Exceptional knowledge of GxP, ICH guidelines, and regulatory requirements in clinical development.
• Demonstrated success in building and executing clinical development strategies that lead to IND approval and successful clinical trial outcomes.
• Excellent communication and presentation skills, with the ability to effectively interact with internal teams, external partners, and regulatory bodies.
• Strong decision-making abilities, problem-solving skills, and a solution-oriented mindset.
• Ability to thrive in a fast-paced, high-performance environment with shifting priorities.

Preferred Qualifications:

• Experience with biologics, gene therapy, or immuno-oncology is a plus.
• Previous experience working at a biotech or pharmaceutical company with direct involvement in IND filings and clinical trial design.
• Knowledge of the latest technological advancements in clinical trial management, such as eClinical solutions or decentralized trials.

Why Join Our Client?

• Competitive salary and benefits package.
• Opportunity to work on groundbreaking oncology therapies with a highly innovative team.
• Work in a dynamic, fast-paced, and collaborative environment.
• Contribute to a meaningful mission aimed at transforming cancer treatment for patients in need.

If you have the requisite experience and are passionate about advancing clinical development in oncology, we encourage you to apply and be part of this transformative work in the fight against cancer.

Our client is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.