Sr Dir Clinical & Regulatory Affairs at Bioventus LLC in Durham, North Carolina

Job Description:

Are you ready to work for a more active world?

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.

What we offer:

Purpose of the Role
The Sr. Director Clinical Affairs is responsible for creating, maintaining, managing, and overseeing all clinical processes responsible for the generation of clinical study reports, routine reports required by regulatory, required publications, podium clinical presentations, MDR-specific deliverables, and CER/CES, etc. for the Global Bioventus business. This role also oversees and develops all related staff and teams responsible for these areas.

Key Responsibilities:
1.\tProvides direction on all global clinical evidence generation, scientific writing, physician engagement and medical affairs.
2.\tManage and lead Clinical and Medical Affairs team focusing on research supporting past, current, and future trials.
3.\tLiterature reviews, ad-hoc analysis, meta analyses, etc.
4.\tManage and lead 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. Additional requirements for post market surveillance as defined in MDR Article 83.
5.\tManage and/or support the clinical development strategy for all stages of development including, but not limited to:
A.\tThe preparation of Investigational Device Exemptions (IDE), Product Development Protocols (PDP), Investigational New Drug (IND) protocols or other clinical investigation requests
B.\tSubmission 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.
6.\tEnsures 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.
7.\tHire, train, develop and supervise clinical and medical affairs personnel. Assign and prioritize projects and resources. Perform talent management and assessment requirements for the organization.
8.\tBuild effective partnerships with departments such as Marketing, Regulatory, Quality and Development and other global counterparts.
9.\tMaintain a working knowledge of internal procedures and existing (and proposed) regulations, standards and guidance documents.
10.\tHolds 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.
11.\tOther duties as assigned .

Other
Primary focus:
• \tMaximize and leverage clinical data generated by Bioventus-sponsored research, Investigator Initiated research, Collaborative Studies, medical device clinical literature and Bioventus-initiated Clinical Science (small studies, metanalyses, papers, CES/CER, etc.).
• \tParticipate in activities related to investigator sponsored research and grant request as required.

Secondary focus:
• \tEstablishing/improving major Clinical processes that enable the generation of high-quality data in the most efficient manner possible.
• \tCollaboratively developing trial protocols, case report forms, complaint management plans, and final study reports in collaboration with the clinical project team.
• \tSupervising the assessment of and triage adverse events, medical assessments, escalating as appropriate.
• \tAssessing and trending in-trial metrics (including review and assessment of patient risk) and report into post-market surveillance system as required by applicable regulations.
• \tProviding input for strategic and tactical clinical plans and oversight all medical affairs related activities.

What you'll bring to the table:
Education and Experience (Knowledge, Skills & Abilities)
• \tBachelor's degree in Engineering, Life Sciences or equivalent preferred, other degrees may be considered. Master's degree desired.
• \t15 or more years of clinical experience in the medical industry; device, pharmaceutical biotechnology.
• \tExtensive understanding of governance associated with conducting clinical trials, including but not limited to experience in clinical evidence, medical affairs, scientific writing, and medical safety.
• \tPossesses 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.
• \tExtensive knowledge of FDA and applicable international regulations is required. Direct work experience in another regulated industry or similar discipline may be considered.
• \t8 or more years' experience managing and developing teams, staff, and projects required.
• \tIn-depth experience with FDA and international medical device regulatory agencies is required.
• \tExcellent 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.
• \tSelf-motivated, demonstrated attention to detail, and ability to prioritize and manage multiple projects.
• \tAbility to lead projects with little to no direct supervision or oversight.
• \tAbility to effectively communicate with government agencies and all levels of the company.
• \tGood problem solving, planning, interpersonal and negotiating skills.
• \tOrthopedic Class III Medical device and Biologic experience desired.
• \tExperience with pharmaceutical clinical research/development and a demonstrable understanding of clinical trial operational methodology and data management techniques.
Are you the top talent we are looking for?

Apply now! Hit the "Apply" button to send us your resume and cover letter.

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.