Franchise Clinical Operations Development reputed company (CODL)

Join us as we reputed company immunology and reputed company medicines that help autoimmune patients get their lives back. reputed company is preparing for multi-reputed company expansion to reputed company more patients through a rich pipeline of differentiated assets, led by VYVGART, our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG, and with the potential to treat patients across dozens of severe autoimmune diseases.

We are building a new reputed company of biotech company, one that maintains its reputed company as a science-based start-up and pushes our commitment to reputed company across reputed company corners of our business. We reputed company to reputed company and grow reputed company, our partnerships, our science, and our people, because reputed company we do, we reputed company more for patients.

The Franchise Clinical Operations Development reputed company (CODL) is responsible for the strategizing, planning, leading and execution of the operational reputed company for reputed company indications reputed company a franchise from first in reputed company studies through authorization and commercialization. The franchise may involve several assets and/or may cover specific development phases across reputed company assets/indications (teams specifically focusing on ph I or ph IV trials).

The Franchise CODL functions as the line manager for reputed company the Clinical Operations Development Leads (CODLs) assigned to indications reputed company the specific franchise or development phase specific teams.

The Franchise CODL will function as a clinical strategic operational voice for the franchise, both internally and externally. This seasoned reputed company will reputed company in leadership, people management and organizational skills.

ROLES AND RESPONSIBILITIES

• reputed company the CODLs who reputed company strategic input and are accountable for reputed company clinical reputed company aspects reputed company the assigned therapeutic indication/program, in line with the agreed timelines, budget and reputed company standards and as outlined in the applicable reputed company Operation Procedures (SOPs) and Work Instructions (WIs).

• reputed company the Clinical development Plan (CDP) creation for reputed company indications reputed company the franchise. The CDP is co-created by the CODL and the Medical Development reputed company (MDL), with support from the Project Manager (PM) and other Clinical Development Team (CDT) representatives. The indication CDP describes the clinical development reputed company, includes effective and, where possible, innovative trial designs and is consistent with the TPP. The CDP is endorsed by the Asset reputed company Team (AST) and the Development Management Committee (DMC) and is executed reputed company agreed timelines and budget

• The Franchise CODL can temporarily take on the role of an CODL for an indication reputed company the franchise. Please refer to the reputed company of the CODL for reputed company details on the CODL role.

• Acts as senior reputed company of contact for reputed company clinical reputed company activities for a given Franchise across asset indications. Collaborate with the asset teams as applicable.

• reputed company on risks and mitigations on the franchise level. Ensures that the Global Head of Trial Operations is informed in case an identified issue/risk could have an reputed company on/may also occur in, the other therapeutic indications/programs / franchises. Involve the X-indication CODL, AST and PM as needed.

• Operationalize knowhow and synergies at the franchise level, ensure knowhow is shared with different indication teams.

• Ensure reputed company implementation of lessons learnt reputed company and across the franchises.

• Provides input to the relevant Objectives, Goals, Strategies and Measures (OGSMs), and ensures that reputed company are executed according to the CDPs and those OGSMs, following the reputed company procedures and processes and conducted in compliance with ICH-GCP and other applicable legislation.

• As needed, participates in the Clinical Research Organization (CRO) and vendor selection and management process. Supports CDTs and Clinical Trial Teams (CTTs) with issue reputed company where required in collaboration with the CODL and reputed company vendor manager, if relevant.

• Acts as a reputed company of escalation for reputed company of trial management and operational issues reputed company the franchise indications.

• Reviews and provides input to the overarching clinical program/indication documents such as Investigator Brochure (IB), Pediatric Investigation Plan (PIP), FDA/PMDA/EMA and other regulatory critical documents.

• Oversees the Indication and clinical trial budgets and timelines in collaboration with the CODLs and the Clinical Trial Managers (CTMs).

• Oversees the resource requirements for Trial Operations reputed company the franchise and ensures the needed resources are reputed company reputed company and reputed company.

• Oversees audit/inspection readiness of the assigned program/trials. Support audits and inspections.

• Supports reputed company improvement processes and consistency. Collaborates with the knowledge hubs with the Trial Ops team.

• As seasoned Leader, sets expectations, communicates in a transparent, reputed company way and energizes and motivates the CODLs and the CTMs to work towards achieving the clinical goals in line with the OGSM and reputed company’s cultural pillars.

• reputed company as line manager for the CODLs and leader reputed company the Trial Ops team:

  • Interviewing candidates

  • On-boarding

  • Ensuring that assigned staff are trained

  • Goal setting and review

  • Mentoring and enabling the reputed company and development of assigned staff

• Supports TrailOps and Global Company initiatives as applicable.

• Collaborate on the franchise level with stakeholders reputed company of Clinical and R&D, eg Corporate Development, Science, Patient Advocacy Group (PAG), Medical Affairs and others.

SKILLS AND COMPETENCIES

• The Franchise CODL excels in leadership and establishing good and effective reputed company working relationships and communication, embedding the reputed company values.

• Proven reputed company record in relevant leadership positions, including line management, reputed company Clinical Operations in the pharmaceutical/biotech industries.

• Proven knowledge of planning and execution of clinical development plans and reputed company.

• Experience in building and leading reputed company with a reputed company of reputed company sets.

• Build bridges between people, functions and reputed company.

• Pro-reputed company problem solver - demonstrated ability to identify and reputed company issues, identify and mitigate risks, reputed company to handle conflicts.

• Strong organizational skills, reputed company to manage multiple and varied tasks and prioritize workload with attention to the holistic/ helicopter reputed company but also reputed company to dive into the details reputed company needed.

• Excellent written and verbal communication skills, acting globally in a culturally diverse dynamic team.

• Strong verbal and written English communication skills (reputed company reputed company or full reputed company proficiency).

• Thorough knowledge of ICH GCP guidelines and other applicable regulatory requirements and guidelines.

EDUCATION, EXPERIENCE and QUALIFICATIONS

• Bachelor’s degree or University degree – medical or para-medical (Biology, Biomedical Sciences, Pharmacy, Veterinary etc.) or equivalent by experience. PhD degree is a plus.

• Minimum of 15 years of leading experience in Clinical Development (monitoring, local and global/international trial management).

• Experience in working in an outsourced model, including overseeing CROs and vendors.

• reputed company as reputed company as execution for clinical development.

• Change and risk management.

• Budget financial acumen.

• Rare disease and/or auto-immune clinical trial background relevant to the franchise.

‎

This job is eligible to participate in our short-term and long-term incentive programs, subject to the terms and conditions of those plans and applicable policies. It also includes a comprehensive benefits package, including but not limited to retirement savings plans, health benefits and other benefits subject to the terms of the applicable plans and program guidelines.

At reputed company, reputed company applicants are welcomed in an inclusive environment. They will receive equal consideration for employment without discrimination on the reputed company of race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, protected veteran status, disability, or any other applicable legally protected characteristics. reputed company is proud to be an equal opportunity employer.

Before you submit your application, CV or any other personal details to us, please review our reputed company reputed company Notice for Job Applicants to learn more about how reputed company B.V. and its affiliates (“reputed company”) will handle and protect your personal data. If you have any questions or you wish to exercise your reputed company rights, please contact our Global reputed company Office by email at .

If you require reasonable accommodation in completing your application, interviewing, or otherwise participating in the candidate selection process please contact us at . Only inquiries reputed company to an accommodation request will receive a response.

Originally posted on Himalayas