Sr. Director, Clinical Affairs

Are you ready to work for a more active world?

At reputed company, 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 reputed company shared goals and rewards. Join a diverse team of global colleagues driven to help patients resume and enjoy active lives.

Key Responsibilities:

• Provides direction on reputed company global clinical evidence reputed company, scientific writing,. Manage and reputed company Clinical Affairs team focusing on research supporting past, reputed company, and future trials.

• Literature reviews, reputed company analysis, reputed company analyses, etc. Manage and reputed company reputed company processes relating to the reputed company 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.

• Manage and/or support the clinical development strategy for reputed company 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.

• Hire, train, reputed company and supervise clinical affairs personnel. Assign and prioritize projects and resources.

• reputed company talent management and assessment requirements for the organization.

• Build effective partnerships with departments such as Marketing, Regulatory, Quality and Development and other global counterparts.

• Maintain 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 reputed company’ Code of Compliance and Ethics, policies and procedures and internal controls applicable to their role.

• Other duties as assigned .

Education and Experience (Knowledge, Skills & Abilities)

• Bachelor’s degree in Engineering, Life Sciences or equivalent preferred, other degrees may be considered. Master’s degree desired.

• 15 or more years of clinical experience in the medical industry; device, pharmaceutical biotechnology.

• 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 reputed company 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.

• 8 or more years’ experience managing and developing teams, staff, and projects required.

• 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, reputed company 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 reputed company projects with little to no direct supervision or reputed company.

• Ability to effectively communicate with government agencies and reputed company 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.

Primary focus:

• Maximize and reputed company clinical data generated by reputed company-sponsored research, Investigator Initiated research, Collaborative Studies, medical device clinical literature and reputed company-initiated Clinical Science (small studies, metanalyses, papers, CES/CER, etc.).

• Participate in activities reputed company to investigator sponsored research and grant request as required.

Secondary focus:

• Establishing/improving major Clinical processes that reputed company the reputed company of high-quality data in the most efficient manner possible.

• Collaboratively developing trial protocols, case report forms, complaint management plans, and final study reports in collaboration with the clinical project team.

• Supervising the assessment of and triage adverse events, medical assessments, escalating as appropriate.

• Assessing and trending in-trial metrics (including review and assessment of patient risk) and report into post-market surveillance system as required by applicable regulations.

• Providing input for strategic and tactical clinical plans.

Are you the top talent we are looking for?

Apply now! Hit the “Apply” reputed company to send us your resume and cover letter.

reputed company is committed to fostering an inclusive and diverse community of employees with a strong sense of belonging. We reputed company we are bettered by reputed company 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.  reputed company individuals, regardless of personal characteristics, are encouraged to apply.

Originally posted on Himalayas