Senior Manager, Medical Affairs
Remote, CA, USA | Becton Dickinson & Company
Job Description:73 people have viewed this job
The Sr Manager, Medical Affairs is responsible for overseeing and managing both the clinical and administrative aspects of the medical division of business. This includes: innovation and new product/business development, lifecycle clinical evidence generation, market shaping and development, and safety and compliance. The position may directly or indirectly (matrix) manage supervisors, professional employees, business support, or technical staff.
- Develops processes and procedures to implement Medical Affairs strategies, including the execution of business operating plans.
- Accountable for setting own work direction and completing work tasks assigned by leadership team.
- Directly or indirectly (matrix) manages vendors, cross-functional project team members, and has medical process/program management/ownership.This includes project leadership, employee coaching, mentorship, and supervision of support and entry-level professional associates.
- Applies expertise to improve effectiveness and provide clinical and technical guidance to employees on the team.
- Has accountability for good stewardship of financial resources for personal and project expenses.
- Provides cross-regional support for medical activities, including global businesses.
- Innovation: Serves as the “Voice of the End User to help ensure that products released to market are safe and effective.Includes: Core Team representation, extended Core Team leadership for medical workstreams, and provides subject matter expertise (SME) input to Research & Development (R&D)/User Experience Design (UXD) on clinical operations and outcomes.
- Evidence generation: Serves as a leader for building & overseeing evidence generation activities, leading publication and dissemination strategy, and ensuring clinical trial excellence.Includes: study protocol development, evidence project execution, and presentation of study results at internal leadership and external professional meetings.
- Market-shaping: Engages and influences Key Opinion Leaders (KOLs) and other external stakeholders, influences clinical practice to improve outcomes, and drives appropriate global product adoption.Includes: support/develop KOL panels and other engagements, and support implementation of evidence for customer-facing materials and engagements.
- Safety and compliance: supports activities ensuring safety and compliance throughout product lifecycles, supports enterprise-wide medical policies and procedures, and ensures medical and clinical claims accuracy.Includes: serving as the Medical Affairs clinical delegate, attending Risk Management Board (RMB) meetings for the assigned product line; provide clinical input for RMB risk assessments: designation of hazardous situation severity; description of clinical workflow and assessment of situation and outcome probability; timely formal review and approval of RMB risk assessments for assigned product line.Provide input into product hazard analyses (HA): serve as the Independent Clinical Reviewer for final hazard analysis reviews; help to ensure validity and completeness of hazard analysis efforts; timely formal review and approval of HAs for the assigned product line.
- Performs other duties and assignments as required.
Professional Skills & Key Competencies
- Knowledge of and experience using and interpreting basic biomedical statistical methods.
- Conduct literature searches/reviews, design studies per scientific methods, and complete basic statistical analyses on results.
- Excellent verbal and written communication skills, including the ability to write scientific papers and present at professional conferences.
- Ability to build and lead KOL engagements, including expert panels, to support innovation and market shaping business goals.
- Ability to exercise independent judgment and discretion within a broadly defined range of policies and practices. This includes analytical problem solving.
- Demonstrated ability to juggle multiple tasks and to prioritize and schedule work to meet business needs.
- Demonstrated organizational, planning, and project management skills, including action oriented, focused urgency and driving for result.
- Ability to be effective in complex projects with ambiguity and/or rapid change.
- Orientation for detail work product, with emphasis on accuracy and completeness.
Education Qualifications & Previous Experience:
- Doctor of Pharmacy (PharmD) degree, or equivalent, required.
- Registered pharmacist with license in good standing in any US State.
- Advanced degree (MS, MBA, etc) strongly preferred.
- PGY-2 clinical pharmacy specialty residency or equivalent required.
- Board Certification in a pharmacotherapy specialty is strongly preferred
- Minimum 5 years practice (or equivalent) experience as a clinical pharmacy specialist required.
- Experience participating in and/or managing investigational drug or medical device studies required, including conducting literature reviews, study design and execution, and compliance monitoring.
- Experience in medication safety, continuous improvement projects, and project management required.
- Prior clinical practice experience with BD product categories strongly preferred.
- Prior people management preferred.
- Prior experience with medical product development preferred.
Any Additional Information
- Travel may range from 15-25%, overnight travel.
- Position requires flexible working hours, including some nights and weekends, as needed for support of customer and business activities.
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
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