Medical Director / Senior Medical Director
Cambridge, MA
Job Type
Full-time
Description

Job Summary

Marengo is seeking an exceptionally talented, independent, and motivated clinician to help build the company’s clinical development. Reporting to the Chief Medical Officer, this is an opportunity to contribute significantly to a small, rapidly evolving company. You will serve as an internal and external clinical leader, including interactions with key academic advisors, principal investigators, patient groups, regulatory authorities, academic and industry collaborators as well as Marengo’s senior management and Board of Directors. This role includes being a thought partner for innovative oncology development strategies, as well as a collaborator with preclinical and translational researchers focused on development of novel immuno-oncology therapeutic agents. This position also offers the opportunity to take on a leadership role in a rapidly growing organization.


Responsibilities and Duties  

· Provide oncology drug development expertise to a rapidly expanding oncology portfolio

· Provide sound clinical development guidance to key stakeholders across Marengo

· Ensure that scientific rigor and innovation continues to be integrated into and drives Marengo’s oncology development strategies

· Demonstrate excellent scientific standing among peers and able to address issues with a very high level of scientific rigor and creative solutions

· Adeptly translate oncology development program strategies into clinical study concepts that can be executed without compromising the scientific rigor of the study

· Assist in driving the timely execution of multiple assets and studies within the oncology portfolio

· Ensure excellence in both strategy and execution by partnering closely with clinical operations, biostatistics, data management, program management, and research colleagues

· Work closely with regulatory leaders to support regulatory submissions and develop regulatory strategies

·  Be responsible for the clinical content of clinical and regulatory documents, including protocols, INDs, CTAs, investigator’s brochures, CRF’s, safety reports, annual IND reports, CSR’s, ISS’s, ISEs, and clinical expert reports

· Ensure the conduct of all Marengo’s clinical trials in compliance with applicable regulations of global regulatory agencies and GCP guidelines

· Serve as Medical Monitor and the Sponsor’s medical representative to multiple vendors and collaborators: CROs, PIs, core laboratories and other organizations involved in the implementation of clinical trials

· Be responsible for analysis and interpretation of clinical data, including safety monitoring 

· Develop and maintain relationships and serve as medical liaison with key opinion leaders and PIs

· Organize and present at relevant clinical advisory boards, DMCs, and medical/scientific meetings

· Be prepared to represent Marengo at joint development committee as well as in interactions with global regulatory agencies

· Provide leadership and mentor more junior members of the clinical development team

· Present Marengo programs to external parties and contribute as needed to business development efforts

Requirements

Qualifications and Skills

· M.D. or D.O. with expertise in Oncology or other related area, with at least 5 years’ experience working in the biotech and/or pharmaceutical industry; MD/PhD is a plus

· Hands-on oncology or I/O drug development experience within industry oncology in pharmaceutical and/or biotech company setting either for small molecules or large molecules

· Proven clinical development strategist with hands-on experience with designing, implementing, and conducting clinical trials

· Knowledge of carrying out oncology clinical trials, including knowledge of current treatment landscapes

· Strategic leadership and tactical skills, excellent initiative, and judgment, and demonstrated ability to positively represent Marengo’s mission 

· Demonstrated ability to develop and maintain excellent working relationships with both internal colleagues and external contacts/partners, including key thought leaders, and investigators

· Proven track record of strong collaboration skills and the ability to partner with others to implement innovative oncology development strategies

· Demonstrated capability to lead cross-functional teams

· Ability to communicate and work independently with scientific/technical personnel with excellent written and oral presentation skills

· Ability to think critically and demonstrated troubleshooting and problem-solving skills

· Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.