Description

At Bioventus, our business depends on developing our people. We invest in you and challenge you to be the best. We value our colleagues for their different perspectives and individual contributions, and our leaders listen. Our success rests on working together to achieve shared goals and rewards. Join a diverse team of global colleagues driven to help patients resume and enjoy active lives.

The Director Clinical Affairs is responsible for creating, maintaining, managing, and overseeing all clinical processes responsible for the generation of clinical evidence via studies and reports, , required publications, support for podium clinical presentations, CER/CES , and routine reports required by regulatory including MDR-specific deliverables for the Global Bioventus business. This position partners closely with the business marketing leaders to understand the product value positions and the clinical evidence needed to support and/or enhance those positions.

• Develops a clinical evidence strategy to support the value propositions established by the business leaders. Collaborates with Medical Affairs leaders for clinical insights on those value propositions and provides recommendations, as appropriate from a clinical evidence perspective. Ensures all clinical evidence strategies align with related Regulatory strategies.
• Provides direction on all global clinical evidence generation activities and scientific writing.
• Manages and leads Clinical Affairs team focusing on research supporting past, current, and future trials. Literature reviews, ad-hoc analysis, meta analyses, etc.
• Manages and leads all processes relating to the generation of Clinical Study reports (SSR, IIR, Collaborative Studies, etc.), CER/CES, regulatory-required annual reports, Summary of Safety & Clinical Performance (MDR), Periodic Safety Update Reports (MDR), Post Market Clinical Follow up plan and report and additional requirements for post market surveillance as defined in MDR Article 83.
• Manages and/or supports the clinical development strategy for all stages of development including, but not limited to:
• The preparation of Investigational Device Exemptions (IDE), Product Development Protocols (PDP), Investigational New Drug (IND) protocols or other clinical investigation requests
• Submission of clinical sections of PMA/PDP, BLA, CTD or other pre-market application(s) to the competent authorities, including the clinical sections of other supplemental applications to the FDA (i.e., PMA Supplements; IND amendments) or other competent authorities.
• Ensures strategic alliances with physicians, key opinion leaders, third-party monitors, core laboratories, CROs, consultants, etc. as appropriate to ensure safe, compliant and successful clinical trial conduct.
• Hires, trains, develops and supervises clinical affairs personnel. Assign and prioritize projects and resources. Perform talent management and assessment requirements for the organization.
• Builds strong partnerships Marketing, Regulatory, Quality and Development and other global counterparts.
• Maintains a working knowledge of internal procedures and existing (and proposed) regulations, standards and guidance documents.
• Holds oneself and others accountable to conduct business in a manner compliant with Bioventus' Code of Compliance and Ethics, policies and procedures and internal controls applicable to their role.
• Other duties as assigned.

• Bachelor's degree in Engineering, Life Sciences or equivalent subject area preferred, other degrees may be considered. Master's degree desired.
• 10 or more years of clinical experience in the medical industry; device, pharmaceutical biotechnology.
• 5 or more years' experience managing and developing teams, staff, and projects required.
• Extensive understanding of governance associated with conducting clinical trials, including but not limited to experience in clinical evidence, scientific writing, and medical safety.
• Possesses knowledge of global clinical requirements and an in-depth understanding of clinical trial methodology gained through experience and can perform the essential duties and responsibilities expected of this role with no direct supervision.
• Extensive knowledge of FDA and applicable international regulations is required. Direct work experience in another regulated industry or similar discipline may be considered.
• In-depth experience with FDA and international medical device regulatory agencies is required.
• Excellent English written and verbal communication skills including one-on-one and group presentation skills, Microsoft Office application skills. Experience in building successful relationships with KOLs, HCPs and internal stakeholders.
• Self-motivated, demonstrated attention to detail, and ability to prioritize and manage multiple projects.
• Ability to lead projects with little to no direct supervision or oversight.
• Ability to effectively communicate with government agencies and all levels of the company.
• Good problem solving, planning, interpersonal and negotiating skills.
• Orthopedic Class III Medical device and Biologic experience desired.
• Experience with pharmaceutical clinical research/development and a demonstrable understanding of clinical trial operational methodology and data management techniques.

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Bioventus is committed to fostering an inclusive and diverse community of employees with a strong sense of belonging. We believe we are bettered by all forms of diversity and take pride in working with top talent from every walk of life. In the spirit of inclusivity, qualified applicants will be considered without regard to age, ethnicity, disability, gender, veteran status, gender expression, gender identity, nationality, race, religion or sexual orientation. All individuals, regardless of personal characteristics, are encouraged to apply.