Senior Medical Director, Clinical Development - Oncology

Description

The Senior Medical Director, Clinical Development will be an essential contributor to the scientific, clinical, and operational scope of clinical development programs with an emphasis on study and program-specific activities.  The Senior Medical Director, Clinical Development will drive the design, planning, and implementation of study protocols for assigned investigational products and will play a key role in supporting related regulatory activities.  This role will work on cross-functional program development and study management teams for the design, execution, and (medical) monitoring of clinical trials, in close collaboration with our clinical science group, as well as assist with data interpretation and communication to both internal and external stakeholders. This individual may also help support internal process improvement initiatives within the clinical department.

Responsibilities

• Partner with cross-functional program (the project strategy teams (PST) and disease area teams (DAT), and study-level teams, both internally and within the joint execution team (JET) with our partner Gilead, with minimal oversight by our senior clinicians, to oversee the design and conduct of clinical studies, including operational feasibility, data management deliverables, preparation of meeting materials, communication plans, safety and medical monitoring, preparation of status update reports, and study close-out activities.
• Perform medical and related safety/efficacy data reviews with minimal oversight by our senior clinicians. May be responsible for analytical support of clinical trial data, including gathering, analyzing, reviewing, interpreting, and providing preliminary assessments and recommendations. Analyze information to assess issues relating to protocol conduct and/or individual subject safety. Prepare and communicate a clear overview of trial results for internal presentations, external scientific publications and regulatory purposes.
• Provide organizational support for Data Monitoring Committees and other applicable data review committees including operationalizing the charter, preparing updates and data reviews, execution of meetings and adjudications, and communication of synthesized data reports.
• Author protocols and contributes to authoring of clinical study reports, IBs, ICFs, training documents, and other clinical and regulatory documents.
• Interact with internal and external stakeholders (study sites, vendors, committees, etc.) in support of program-level development strategy as well as clinical trial objectives; responds to or triages questions for appropriate escalations.
• Act as recognized clinical expert for assigned programs both within and external to Arcus.
• Interact closely with Medical Affairs in support of ISTs and publication strategy and plan, acts as owner of clinical data as member of publication team. Write and/or review collaborative abstracts, posters, and content for scientific meetings, conferences and publications. Support publication strategy execution including collaboration with investigators, KOLs, and other internal/external stakeholders. Present at investigator meetings and scientific conferences.
• Interact closely with the Regulatory group and regulatory agencies, taking part in regulatory submissions, investigator brochure authorship and communication with US and international regulatory agencies
• Conduct literature reviews as needed.

Qualifications

• Must have an MD or MD/PhD with:
  •  3+ years (for a board eligible or certified oncologist) or 5+ years (if no formal oncology training) of experience at a pharmaceutical or biotechnology company as a (Associate) Medical Director.
  • Must have experience in oncology or malignant hematology 
  • Experience with interpretation of clinical research results including safety and efficacy required. Familiarity with pharmacovigilance and statistical principles desirable.
  • Experience with health authority interactions preferred, prior BLA and NDA experience not required, but is a strong plus.
• Ability to think strategically, innovatively, and tactically with an interest in clinical research and drug development.
• Demonstrated ability to evaluate, interpret and present complex scientific data (preclinical, clinical, translational) to inform scientific hypotheses and development strategy. Working knowledge of biostatistics, GCP, and regulatory requirements for clinical studies.
• Must be willing and possess the expertise to work effectively in a fast-paced, team-based matrix environment as well as the ability to function independently as appropriate. Flexible to accommodate changes in team and project needs.
• Ability to handle multiple projects at a time and have a strong attention to detail while understanding the higher-level strategy.
• Excellent interpersonal, verbal, and written communication skills.
• Ability to make independent, timely and appropriate decisions.

Must possess mobility to work in a standard office setting and use standard office equipment, including a computer; vision to read printed materials and a computer screen; and hearing and speech to communicate in person, before groups, and over the telephone. This is primarily a sedentary office classification although standing in work areas and walking between work areas may be required. Finger dexterity is needed to access, enter, and retrieve data using a computer keyboard, mouse, or calculator, and to operate standard office equipment. Positions in this classification occasionally bend, stoop, kneel, reach, push, and pull drawers open and closed to retrieve and file information. Employees must possess the ability to lift, carry, push, and pull materials and objects weighing up to 25 pounds. 

EOE