MEDICAL DIRECTOR, CLINICAL DEVELOPMENT STRATEGY

Incendia Therapeutics Inc

Cambridge, MA, USA

Published: 6/14/2022

Healthcare

Full Time

Job Description

Job DescriptionMedical Director, 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 highly skilled and experienced Medical Director, Clinical Development Strategy. This 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
This highly visible and impactful role will contribute directly to the design, execution, and strategic oversight of clinical programs across our pipeline. Reporting to Chief Medical Officer (CMO), the Medical Director will be a key clinical leader driving the advancement of early and mid-stage assets through clinical development and regulatory interactions.
Here's What You'll Do:

Clinical Development Strategy: Collaborate with the CMO and SVP of Development to develop and implement clinical development strategies for our oncology and immunology programs from IND through proof-of-concept and later-stage development.
Study Design & Execution: Support the design of clinical protocols and development plans, as well as supportive safety and monitoring plans, ensuring scientific integrity, clinical feasibility, and alignment with regulatory requirement. Serve as the medical lead on clinical trials, overseeing patient safety and quality.
Cross-functional Collaboration: Work closely with clinical operations, regulatory, translational medicine, biometrics, and external partners to ensure seamless execution of clinical trials and timely decision-making.
Regulatory Support: Contribute to regulatory submissions including INDs, CTAs, and briefing documents. Participate in regulatory meetings and support agency interactions.
Medical and Scientific Leadership: Serve as an internal subject matter expert in oncology and/or immunology. Engage with investigators, key opinion leaders (KOLs), and advisory boards to inform program strategy and ensure alignment with emerging clinical and scientific trends. Medical and safety oversight as well as support of eligibility and enrollment.
Data Analysis & Reporting: Collaborate with clinical and statistical teams to analyze and interpret clinical data. Support the preparation of clinical study reports, publications, and presentations. Period review of data including labs, imaging, and safety.
Team Contribution: Provide mentorship to junior clinical staff as needed and contribute to a collaborative, mission-driven culture focused on scientific excellence and patient impact.

REQUIREMENTS & QUALIFICATIONS
Qualificationsinclude:

Medical Degree (MD): Required, with a strong background in oncology.
Board Certification in oncology: Preferred
Experience: Minimum of 5+ years of direct industry 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.

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 diverseand 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.

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