Director, Head Study Start Up Europe

Vor 2 Tagen

Basel, Schweiz BeiGene Vollzeit

General Description:

- Provides leadership to the European Study Start Up team, including defining and implementing strategy and key priorities to ensure fast study start up timelines
- Establishes and maintains effective communication and collaboration with functional area peers in Clinical Operations (e.g. Monitoring Excellence, Regional Study Management) and other departments (e.g. Regulatory Affairs), as well as external stakeholders both within the region as well as global
- Accountable for performance against key metrics related to study start up and substantial submissions (including protocol, IB, ICF, IMPD) for trials in maintenance.
- Accountable for resourcing and capability development related to study start up in the region in collaboration with Monitoring Excellence
- Drives operational excellence, embeds innovation and continuous improvement in the area of study start up

Essential Functions of the Job:

- Provides leadership to a team of Study Start Up Managers, Study Start Up Leads, and Associates in charge of study start up activities in the region, including mentoring, coaching, managing performance and direct line management
- Develops an empowered study start up team that can navigate in a matrix environment, that delivers consistently whilst improving speed and quality, and that pivots in anticipation of business needs. Builds a team culture of expertise, excellence and agility
- Collaborates and liaises closely with all regional/global stakeholders (including but not limited to local country teams in charge of local study start up activities, Clinical Business Operations, Regional Study Management, Regional Monitoring Excellence, Regulatory Affairs,..) to ensure smooth delivery of study start up activities for all trials in the region on time, with quality and in line with the broader organizational goals
- Provides oversight and coordination of the study start up process in Europe, including development and maintenance of accurate start up planning and tracking, timeline optimization and risk mitigation actions
- Develops and maintains, in collaboration with local start up specialists, country level timelines and country regulatory and start up intelligence information
- Responsible for management and governance of translation vendors in the region, including oversight of translation processes to ensure high quality in the most competitive timelines possible
- Leads the resourcing process for the study start up team in close collaboration with FSP partners and other key stakeholders and ensures optimal resource allocation in alignment with business needs. Liaises closely with Monitoring Excellence to ensure efficient resourcing addressing both study needs as well as individual development needs through the principle of assigning the right person to the right study at the right point in time
- Acts as point of escalation for any issues related to study start up activities in the region
- Ensures team members are trained and adhere to required processes and SOPs, applicable ICH guidelines, Good Clinical Practice and regulatory agency requirements
- Actively encourages knowledge sharing within the study start up team and across other relevant regional/global stakeholders
- Monitors start up metrics and industry benchmarks, trends and regulations and utilizes this information to adapt processes, tools and organization as needed to deliver results
- Drives operational excellence, embeds innovation and continuous improvement in start up through process improvements in collaboration with other line functions

Supervisory Responsibilities:

- Ensures the competencies and skills required for the study start up team are consistent with the company defined requirements.
- Mentors team members as required, and supports set up of individual development plans
- Conducts mid-year and year end performance appraisals for direct reports which includes providing constructive feedback

Education Required:

- Bachelor’s degree in a scientific or healthcare discipline required, Higher Degree preferred

Other Qualifications:

- Minimum of 10 years of progressive experience in clinical operations, in pharmaceutical industry, biotech or CRO. Specific SSU experience preferred
- Solid leadership and extensive people management experience in matrix environment, proven track record to develop impactful teams
- Strong written and verbal communication skills
- Expert level knowledge of and experience with operational management, strong problem solving skills
- Proven ability to build strong effective relationships, demonstrated effective influencing and negotiation skills at all levels

Travel: Limited travel may be required

We are proud to be an equal opportunity employer and we value diversity. BeiGene does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employm

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