Senior Medical Director 9/8/2016
New York, NY
JOB DESCRIPTIONAPPLY Growing Pharmaceutical Company is seeking a Senior Medical Director.
The Senior Medical Director will lead the direction, planning, execution, and interpretation of clinical trials or research activities of one or more clinical development programs. Participates in and may lead cross-functional teams to generate, deliver, and disseminate high-quality clinical data supporting overall product, scientific and business strategy.
JOB RESPONSIBILITIES (KEY RESPONSIBILITIES):
* Leads and demonstrates ownership of the design and implementation of multiple clinical development programs (or one large, complex program) in support of the overall product development plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, Loxo customers, markets, business operations, and emerging issues. Oversees project-related education of investigators, study site personnel, and Loxo study staff. Responsibility may extend from early translational development activities to mature product lifecycle management strategies for internal and/or partnered programs.
* Has overall responsibility for leading clinical study teams, monitoring overall study integrity, and review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule. Along with Clinical Operations, is responsible for ensuring agreed-upon study enrollment and overall timelines for key deliverables. Responsible for assessment and reporting of serious adverse events.
* Primary responsibility for and ownership of design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study reports, regulatory submissions and responses, and other program documents.
* May oversee and/or be the direct manager of the work of Clinical Scientists working on the same or related programs.
* Serves as an in-house clinical expert for one or more molecules and diseases in the therapeutic area, coordinating and leading appropriate scientific and medical activities with internal stakeholders as they relate to ongoing projects. May participate in or lead clinical development contributions to due diligence or other business development activity. As required by program needs, contributes in partnership with research colleagues to design and implement translational strategies.
* Acts as clinical lead and actively solicits opinion leader interactions related to the disease area(s); partners with Medical Affairs, Commercial and 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. May represent Loxo at key external meetings.
* Responsible for understanding the regulatory requirements related to the 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.
JOB QUALIFICATIONS (YEARS OF EXPERIENCE, MANAGEMENT, ETC.):
* At least 5years of clinical trial experience in the pharmaceutical industry, academia, or equivalent, in a medical director role.
* Proven experience running a complex clinical research program independently.
* Proven leadership skills and ability to bring out the best in others on a cross-functional global team. Must be able to lead through influence.
* Proven ability to interact externally and internally to support a global scientific and business strategy.
* Extensive knowledge of phase 1-3 clinical trial methodology, regulatory and compliance requirements governing clinical trials, and experience in development of clinical strategy and the design of study protocols.
* Experience leading global regulatory interactions for preclinical, clinical and pivotal programs
* ONCOLOGY THERAPEUTIC AREA KNOWLEDGE REQUIRED
* Prior management experience preferred
EDUCATION AND SKILLS:
* MD, Board certification in Oncology or equivalent
* PhD would be an advantage
* Ability to exercise judgment and address complex problems and create solutions for one or more projects.
* Ability to develop collaborative working relationships with physicians, expert consultants, and contracted vendors.
* Strong analytical mind and problem-solving skills, attention to detail, strong organizational skills, and ability to work independently and as part of a team