Senior Director Legal

Job details

Job type full-time

Full job description

Avania is a leading, global full-service contract research organization focused on the management of clinical studies for medical devices, ivds, biologics, and device-drug combination products internationallyAvania supports products from the first-in-human phase through the post-market phase with the same customized approachWhen you need to advance your medical technology, it takes avaniaAvania’s vision is to be your trusted global partner in the evolution of your medical technology from innovation to commercialization to improving patient health and well-being.

Purpose

The operational, finance and business teams deal with complex legal issuesThe main responsibilities of this new position consist of

Managing, leading, drafting, negotiating and closing (international) sponsor (sales) contracts, change orders, vendor contracts, confidentiality agreements, site agreements, and other avania contracts, including the subsequent execution and retention of those contracts, ensuring the protection of the of avania’s interests.
Developing and maintaining new templates, processes and tools to lead and guide an effective contracting process, secure and maintain in-house legal housekeeping and support our m&a activities from a legal angle (diligence, corporate documentation, etc).
Leading and guiding together with our dpo the data protection practices to also further enhance a data protection culture.

The senior director legal works under the supervision of the chief financial officer and stays in close collaboration with other key leaders in global management, business development, operations, budgets and proposals (bap), our dpo and finance teamsThe incumbent ensures that contracts comply with avania policies and procedures, and takes ownership of the contracting lifecycle, including communications and process improvements.

Duties and responsibilities

Development and ongoing maintenance of templates and tools to lead the management of the contract processes, e.gTemplate cda, msa, cta, qa.
Suggest improvements to contractual templates on an ongoing basis in response to emerging trends, customer preferences, and avania’s risk management posture.
Periodically review approved template agreements and recommend/implement standardized changes as new needs are identified or issues are discovered.
Production and negotiation of client specific contracts and vendor contracts in avania template.
Review, revision, and negotiation of client specific contracts and vendor contracts in client template amended to protect the interests of avania, as required.
Production and negotiation of clinical trial agreements and site agreements as well as negotiation of site budgets.
Responsible for the daily maintenance and input of signed contractsWork with budget and proposal staff to ensure that all values reported are accurate prior to closing contracts.
Draft, review and comment on company standard operating procedures, business operating procedures, departmental practices, and other systemic documentation as requested.
Provide guidance and support to the global bd team and lead contract negotiation process.
Work closely with appropriate business development staff to keep them informed of progress of agreements and to avoid any delays in execution.
Ensure all contracts have been through the correct internal governance review procedure prior to sign-off, per business controls.
Provide support and guidance to the global bap team to ensure they understand and apply appropriate terms and conditions.
Provide support and guidance to both the global bap team and operations to ensure they understand and apply appropriate payment types as client needs dictate, including time & materials, fixed priced, and unit priced.
Provide support and guidance to both the global bap team and operations to build appropriate inflation and exchange rate protection into avania contracts, consistently, and to include payment schedules which enable avania to remain cash neutral.
Participate in client contract negotiation, including group negotiation calls and direct client communication.
Ensure regular contact with bd to stay aware of potential new awards and new business contractsEnsure regular contact with operations to stay aware of potential change orders.
Collaborate with avania operational staff to obtain all information required for the production or review of contracts, including scopes of work, budgets, and payment schedules.
Attend and provide proactive updates and input on the monthly bd-bap-ops meeting.
Provide management with regular status updates on all open contracts and any outstanding legal issues.
Monitor expiration dates of master service agreements and other agreements, and work with management to determine appropriate follow up steps prior to expiration.
Attend frequently scheduled project review meetings to stay aware of change order needs and provide status updates.
Liaise extensively with budgets and proposals, business development, finance and operations.
Communicate with external counsel(s), as needed, during the contract negotiation process and/or other legal dossiers.
Perform contract administration functions including assisting with obtaining approvals on authorization forms as required; maintaining a contract tracking system to report contract status updates and signing status; providing notice of all executed contracts to the appropriate team members along with contract values; and filing executed contracts in the shared electronic storage area in a timely manner for access by other staff members as appropriate.

General duties:

Draft, negotiate, review, and process contracts in a commercially reasonable manner that protects avania’s fundamental interests and in a manner consistent with company rules, practices, and policiesExecute agreements as appropriate under applicable business controls.
Negotiate contractual terms with other contracting parties in a professional manner.
Identify potential obstacles in the contracting process promptly and request assistance of budgets and proposals staff, business development staff, project management staff, or higher management as necessary to minimize delays and to facilitate the prompt conclusion of contractual negotiations.
Facilitate the internal review/revision/sign-off process on contracts prior to forwarding to external parties.
Support corporate initiatives (e.gM & a, legal due diligences) as assigned including entity establishment and maintenance, lease negotiations, review insurances, and transaction support.
Bring and maintain the legal in-housekeeping at diligence-able level.
Promotes and maintains a data protection culture.
Make sure we comply with data protection laws and practices with taking into account gdpr, australian privacy act, us hipaa and (international) data transfers.

Function requirements

Bachelor’s degree (llb, llm, jd, ba, or bs) required; university-level law degree preferred (us or eu); paralegal experience preferred (us or eu)Qualified lawyer.
At least 6-9 years of experience, or an equivalent combination of education and experience to effectively perform the position responsibilities preferred.
Ability to understand the technical (tech-savvy), financial and commercial aspects of a contract.
Experience in multiple jurisdictions (e.gUs/aus/eu).
Must have cro industry experience.
Ability to read, comprehend, write, and speak english clearly and preciselyDutch as second language is beneficial.
Strong capabilities with ms office programs.
Ability to apply knowledge of the principles of ich gcp to their work and follow quality standard procedures.
Knowledge of m&a processes.
Knowledge of data protection laws, gdpr, hipaa.
Thorough understanding and familiarity with excel-based bid models for management of clinical trials.

Competencies

Demonstrated experience with contract management principles.
Excellent communication skills are required as well as demonstrated ability to interact with internal and external clients with tact and discretion.
Highly organized with excellent time management skills.
Ability to multi-task and juggle multiple priorities/deadlines
Demonstration of sound judgement and critical thinking skills are essential.
Attention to detail, flexibility and openness to suggestions are required.
Knowledge of the cro industry, based understanding of clinical operations, and the ability to follow up on all issues in a timely fashion are necessary.
Ability to concentrate and work under the pressure of meeting deadlines.
Confident to deal with all internal staff levels.
Ability to participate in internal and client meetings.
Self-starter capable of identifying challenges, responding to issues, and implementing effective solutions with limited supervision.
Sound judgment in identifying risks, developing solutions, and implementing successful strategies to mitigate risk while achieving the organization’s commercial goals.
Ability to maintain confidentiality of information during interactions with staff at all levels.
Able to be proactive and take initiative in completing work or escalating issues.
Practical, creative, results-oriented thinking style with an ability to understand issues from both the legal and business perspective..