vice president / senior vice president Clinical development Strategy
Incendia Therapeutics is a precision oncology company dedicated to reprogramming the tumor microenvironment with the express intent of bringing recalcitrant cancers into submission. We recognize that cancer cells create a hostile microenvironment to privilege their own survival at the expense of the host tissue. Incendia’s approach is to attack the structural and biochemical underpinnings of the tumor microenvironment to enable host immune cells and therapeutics to reach the tumor.
Our mission is to serve cancer patients who are the most in need of novel therapeutics. Everything we do is guided by caring for and doing the right thing for those patients. The Company’s most advanced clinical program is a clinical trial evaluating safety and potential efficacy of PRTH-101 in patients with advanced solid tumors (NCT05753722).
Visit www.incendiatx.com to learn more
LOCATION
Cambridge, MA
Description
Incendia Therapeutics is seeking a is seeking a highly skilled and experienced Vice President (VP) or Senior Vice President (SVP) of Clinical Development Strategy. This senior executive role will play a critical part in shaping and driving the clinical development strategy for our innovative drug pipeline and work alongside clinical operations to drive success.
Responsibilities
The successful candidate will bring extensive experience in oncology and immunology drug development, along with a deep understanding of clinical and regulatory strategies. Reporting directly to the Chief Medical Officer (CMO), this role will oversee the clinical development of our drug candidates from pre-clinical stages through to clinical trials and regulatory approval.
Here's What You'll Do:
- Strategic Leadership: Develop and implement comprehensive clinical development strategies for oncology and immunology drug candidates, ensuring alignment with company goals and objectives
- Team Leadership: Build and manage a high-performing team of clinical development professionals, fostering a collaborative and innovative work environment. Manage cross-functional teams to drive success
- Clinical Development: Oversee the design, execution, and interpretation of clinical trials, ensuring they meet regulatory requirements and scientific objectives. Collaborate with clinical operations to ensure the quality and integrity of clinical data
- Regulatory Strategy: Implement strategies for interactions with regulatory agencies, including IND submissions, clinical trial applications, and marketing authorization applications. Ensure compliance with regulatory guidelines and standards
- Stakeholder Communication: Communicate clinical development progress, challenges, and strategies to internal stakeholders, including the executive team, key opinion leaders, and Board of Directors. Represent the company in interactions with external partners, key opinion leaders, and regulatory bodies
- Innovation and Improvement: Incorporate innovative approaches and best practices to enhance clinical development processes and outcomes
Requirements & Qualifications
Qualifications include:
- Medical Degree (MD): Required
- Experience: Minimum of 10 years of direct experience in drug development within oncology and / or immunology fields with a proven track record of successfully advancing drug candidates through adaptive clinical trials.
- Leadership: Demonstrated experience in leading and managing clinical development teams and programs in a biotech or pharmaceutical setting
- Expertise: Extensive knowledge of clinical development processes, regulatory requirements, and drug development strategies
- Skills: Strategic thinking, problem-solving, and decision-making skills. Excellent communication and interpersonal abilities, experience presenting to external stakeholders
- Education: Board certification in oncology or advanced degrees in related fields
Benefits
- Competitive salary and benefits package
- Opportunity for professional development
- A supportive and innovative work environment
- Access to cutting-edge technology and research tools
At Incendia we strive to build a diverse and equitable workplace
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Powered by JazzHR
Ji5hXsSY3y
