Description

Cubist Pharmaceuticals (NASDAQ: CBST) is a biopharmaceutical company focused on the research, development and commercialization of pharmaceutical products that address unmet medical needs in the acute care environment. Founded in 1992, Cubist is headquartered in Lexington, MA.

The Medical Director, Pharmacovigilance (PV) will assist the Senior Director of PV in the medically- and scientifically-related services needed to accomplish good Pharmacovigilance practice for Cubist products in development and commercialization, and may be assigned to some or all of the following named responsibilities as determined by the Senior Director:

Developing pharmacovigilance plans for planned or ongoing clinical studies;

Managing safety reporting activities outsourced to CROs or other service providers;

Working closely with project and study teams to ensure that PV needs are addressed;

Maintaining a comprehensive safety signaling program for delegated Cubist products;

Developing, implementing, and maintaining pre- and post-approval product-specific risk management plans;

Assisting with the development and critical review of various product documents (e.g., investigator brochures, protocols, core data sheets);

Participating in the development and monitoring of registry or epidemiologic studies associated with approved products;

Serving as product safety expert on assigned teams (e.g., product labeling committees);

Performing medical review of individual case safety reports; Analyzing aggregate safety data for periodic report (e.g., PSUR) preparation, internal clinical safety review, and preparation of ad hoc reports such as regulatory authority response documents;

Tracking and trending safety issues being monitored and maintaining appropriate documentation of activities and findings;

Formulating and implementing SOPs, process flow maps, and other quality documents.

Requirements

Education: MD degree with clinical practice experience (primary care or internal medicine subspecialty preferred).

Excellent interpersonal skills and communication skills, including oral presentation and technical manuscript writing

Competence with technology applications including commercial safety databases

Ability to work effectively as an individual contributor and as project team member; collaborative spirit

Thorough understanding of the regulatory environment for pharmacovigilance, with working knowledge of worldwide regulations and guidelines

Demonstrated record of incisive problem-solving

Ability to analyze and interpret complex and multivariate safety issues

Ability to understand and apply biostatistics and epidemiology methodology

Effective project management skills; ability to prioritize workload and work effectively, sometimes within resource constraints

Ability to recruit and manage external consultants as needed

Demonstrated ability to provide critical and timely insight

Familiarity with industry principles of drug development, pharmacology and toxicology


Required Experience:


A minimum of 3 years experience within the pharmaceutical industry, with the most recent 2 years within a global drug safety/pharmacovigilance department is required

2+ years ofexperience with safety signaling, assessment of drug risks and benefits, and safety assessment of marketed drugs and those in development is strongly preferred

Epidemiology training with related field experience is strongly preferred

Work Environment: This is a Lexington-based position that requires significant interactions with internal colleagues from other departments and with external colleagues and consultants. Works within Cubists established policies and procedures and ensures alignment of their work with Cubists values.

Physical Demands: Minimal travel may be required.

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 positions essential functions. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Total Rewards:

Our outstanding total rewards package includes: competitive base salary; annual incentive plan with payouts based on results; company-wide performance based equity program; choice of medical plan; dental, life and disability insurance; employee assistance program; flexible spending accounts; 100% vesting in our 401K plan with a competitive company match; employee stock purchase plan; tuition reimbursement; 12 paid holidays, 4 of which are floating; 3 weeks vacation; flexible work schedules; comprehensive reward and recognition program.


We are an Equal Opportunity Employer.

Note to Recruiters:

Relationships with professional recruiters are essential to the recruitment and staffing efforts at Cubist and we value the partnerships we have built with our preferred vendors. We are also interested in establishing new relationships with experienced life science recruiters. In order to recruit on Cubists behalf, each recruiting firm needs to have a written contract in place and agree to present candidates directly to Human Resources.