Medical Director

Description:

Oversees the direction, planning, execution and interpretation of clinical trials or research activities of a clinical development program. Participates in cross-functional teams to generate, deliver, and interpret high-quality clinical data supporting overall product scientific and business strategy.
 
Key Responsibilities

Manages the design and implementation of one or more clinical development programs based on strong medical and scientific principles, knowledge of compliance and regulatory requirements. Oversees project-related education of investigators, study site personnel and internal study staff. Responsibility may extend from early development activities to phase 3 studies for internal and/or partnered programs.
Has overall responsibility for oversight of clinical studies, monitoring overall study integrity and review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the compound. Along with Clinical Operations, is responsible for oversight of study enrollment and overall timelines for key deliverables. Responsible for assessment and reporting of serious adverse events per corporate policy and regulations for those protocols on which assigned.
Responsible for design, analysis, interpretation and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses and other study/program documents.
Responsible, with limited supervision, for the proactive monitoring of clinical trial safety which is conducted in collaboration with the Safety team. Evaluates all safety data generated in clinical trials and responds to safety questions from investigator sites and IRBs regarding safety issues and queries.
May oversee the work of other Medical Director(s) and of Clinical Scientists working on the same or related study/programs.
Provides in-house clinical expertise for compound(s) and indications, coordinating appropriate scientific and medical activities with internal stakeholders as they relate to ongoing clinical study/projects. 
Serves as the medical representative/lead in Clinical Study Team (CST), with responsibility for development of a rigorous, cross- functionally-aligned medical oversight with full consideration of contingencies and alternative approaches. 
Acts as a clinical interface and actively solicits opinion leader interactions related to the compound and disease area; partners with other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Clinical Development Plans and protocols as appropriate.
Stays abreast of professional information and technology through conferences, medical literature, and other available training, to augment expertise in the therapeutic area.
Responsible for understanding the regulatory requirements related to clinical studies and global drug development and accountable for complying with those requirements. Serves as a clinical representative for key regulatory discussions.
Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research.
 
Requirements

M.D. or equivalent in ex-US countries
A minimum of 2 years for Director level and 4 years for Sr Director level of experience in medical monitoring of Oncology clinical trials is required, having relevant clinical development/pharma experience would be considered. Experience with Biologicals (ADCs and Immune Oncology preferred). 
Track record of successful management of product safety in phase 1 and/or 2 Oncology clinical trials (phase 3 experience would also be considered).
Experience in the clinical and drug development process in a global pharmaceutical/biotechnology company and preparation risk management plans, aggregate reports and company core safety information.
Advanced analytical skills.
Basic leadership and decision-making skills.
Advanced communication skills.
Sound medical judgment and experience in medical safety interpretation of safety findings for clinical trials.
Basic clinical and/or drug development expertise.
Good organizational and prioritization skills.
Intermediate skill in strategic thinking and planning activities.
Basic negotiation skills and capabilities to influence.
Good interpersonal skills (i.e. team player).
Intermediate computer skills (MS Office); knowledge of most common EDC systems, ARGUS, JReview is a plus.
Working knowledge of MedDRA.
Basic statistics and Pharmacoepidemiology.
Ability to work with limited supervision.
Ability to establish sound working relationships with people globally, in various functions with a wide variety disciplines and backgrounds.
Flexibility and ability to adapt and learn quickly.
Ability to work under pressure and to tight deadlines.
Must possess excellent oral and written English communication skills.
Willing to travel 20-30% of time.