This position is W2 hourly with Roth Staffing and will be part-time on a hybrid work schedule in Boston, MA. Our client is in the pharmaceutical industry and is requiring a board certified medical doctor, preferably specializing in hematology and oncology. No 3rd party candidates can be considered.

Our client is seeking a Medical Director to act as a Clinical Leader in our late stage and life cycle management development in our Hematology Program and to support business development R&D activities.

Key program deliverables include:

• Provide clinical expertise in ALL (adult and pediatric) to support completion of ongoing study (e.g. CSR)
• Provide strategic and clinical insights for data generation and potential new study designs
• Work collaboratively in cross-functional working group to deliver a strategic plan for internal governance decision making prior to year end
• Support regulatory interaction preparations in the event of a new sponsored study.

Primary Responsibilities

• Clinical Development Strategy and Execution
• Provide medical and strategic leadership for all clinical related initiatives including supporting regulatory interactions working closely with regulatory affairs and key cross-functional representatives
• Develop and lead presentation for internal governance meetings to support timely and efficient decision making
• Liaise with the DMPK colleagues to understand PK modelling application for dosing/schedule recommendations
• Perform literature searches and support data generation plan including key publications
• Support Business Development evaluations of promising late stage assets under consideration for in-licensing/acquisitions
• Medical Monitor
• Leads the design and the execution of clinical trials, ensuring they align with regulatory requirements and company objectives
• Provide medical monitoring oversight for clinical studies in accordance with GCP
• Participate in key review of data for critical clinical and/or safety endpoints and medical literature to evidence-based decision-making and communication
• Team collaboration
• Working closely with cross -functional teams, including the asset team, clinical sub-team, regulatory affairs, medical affairs, and commercial teams, to ensure alignment and successful product development
• KOL engagement, Investigatory led studies, and publication support
• Support interactions with KOLs and development of advisory board content
• Other duties as required or directed by the Manager or Functional Management

Education and Required Skills

• M.D. required with a strong preference for specialty training and board certification in Medical Hematology/Oncology.
• 3+ years in industry with strong preference for regulatory interactions experience.
• Demonstrated ability to lead clinical development efforts across phases of development within the Hematology/Oncology space.
• Excellent public speaking, writing, and communication skills required. Ability to teach and mentor is also critical and work in a cross-functional collaborative way.
• Problem solving mindset with the ability to be creative and to execute a vision that seeks to drive innovation
• Ability to organize and prioritize workstreams and guide teams through challenges
• Excellent operational execution and ability to meet critical timelines
• Team player who has strong matrix working capability.
• Proven track record practicing sound medical judgment as it relates to clinical acumen and risk assessment including but not limited to leading cohort safety evaluation meetings in early phase studies, co-authoring investigator brochures, providing clinical expertise on PV related documents.
• Core Competencies: Leadership, Execution, Strategy, Collaboration.

Travel and Location

• Anticipated travel <10% of the time.
• The position is open for candidates in Boston or remote on East Coast with periodic travel to Boston.

All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, and Los Angeles County Fair Chance Ordinance. For unincorporated Los Angeles county, to the extent our customers require a background check for certain positions, the Company faces a significant risk to its business operations and business reputation unless a review of criminal history is conducted for those specific job positions.