Medical Director - Anti-Infectives

Medical Director - Anti-Infectives

Job Description
The Medical Director (anti-infectives) position will provide enhanced linkage to the Business Development function and will be focused on the assessment of in-licensing opportunities as well as the design and execution of early phase (Phase I & II) clinical trials. This position will be very scientifically oriented and as such, training in a scientific discipline, in addition to a medical degree would be desirable. Experience in a clinical pharmacology setting would be particularly advantageous. The ideal candidate in this early-phase role will be expected to initiate, and support the establishment and integration of some of the newer technologies including modeling and trial simulation, in order to enhance the transition of compounds from preclinical, into man, and establishing proof-of-concept.
Duties and Responsibilities
Act as medical lead for assigned product development programs. This includes designing clinical trials and an overall clinical development strategy.
Interpret results of Phases I-III clinical investigations in preparation for new drug applications to relevant regulatory authorities. Develop, draft and/or review clinical study reports and manage the presentation of key clinical findings to internal and external constituents.
Provide clinical development support for company activities and manage physician consultants and collaborators for each clinical research program.
Contribute in an active and ongoing manner to the scientific, clinical and commercial development of current and future product candidates (internally and externally developed).
Establish productive, interactive relationships with key internal departments, as well as the medical and scientific community.
Support on-going business development efforts by providing medical and scientific input for the due-diligence process.
Required Skills
Candidates must possess effective interpersonal skills; both one-on-one and in groups.
Candidates must be comfortable with rapidly changing organizational needs and adept at managing in this kind of environment. Candidates should be persuasive, effective and flexible in personal interactions, at all levels of the organization. Experience building personal collaborations, networks and teams inside and outside of the organization, is required.
Knowledge of worldwide regulatory requirements and submissions processes is required for the Sr. Medical Director, and highly desirable for the Medical Director. Prior direct interaction with international regulatory agencies and advisory boards is highly desirable.
Prior experience in a lean, smaller company environment, where both hands-on tactical activities and strategic responsibilities are routine, is highly desirable. Whether from large pharmaceutical or small development companies, candidates must be able to operate effectively, efficiently and comfortably within an open, informal structure where direct communication is valued, and behavior is transparent and consistent with Cubists shared values and culture.
An entrepreneurial spirit and a self-starting style, combined with the ability to generate positive group dynamics, are desirable traits.
We are seeking team players/builders with the ability and desire to grow and assume greater responsibility.
Candidates must demonstrate strong communication skills; verbal, written and presentation. Medical scientific writing skills must be strong. Must be a creative thinker and superior problem solver.
Required Experience
A Medical Degree and strong scientific acumen are required. Specialty training, or experience, in infectious diseases, immunology, oncology or cardiovascular diseases will be a plus.
Candidates must have state-of-the-art medical, scientific and clinical research knowledge. From 2-5 years of experience is desirable, gained either in academia (as a Principal Investigator) or in industry. Candidates with strong clinical experience but limited exposure to the pharmaceutical industry will be considered.
Work Environment: Office.
Physical Demands: None.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily within the context of the representative work environment and physical demands described above. Likewise, qualifications listed are representative of the knowledge, skills, and abilities required to perform the position’s essential functions. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Location: Greater Boston Area Compensation: NEGOTIABLE Principals only. Recruiters, please dont contact this job poster. Phone calls about this job are ok. Please do not contact job poster about other services, products or commercial interests.