Senior Director, Clinical Research & Developmen...

Description:

Position Summary:
The A Pharmaceutical Company R&D Law Group is seeking an experienced R&D attorney to support our ongoing and upcoming clinical trials. As a partner and key business strategist, this individual will have deep experience supporting global clinical trials, complex transactional support and providing regulatory advice to support global strategies and activities related to product research and development.
As a member of the R&D Law Group, this individual will primarily support Crinetics' Research and Development, Clinical Operations, Clinical Research, CMC, and Medical Affairs functions by developing and executing a variety of contract templates in support of the R&D functions, drafting, negotiating and executing research agreements, including without limitation, Clinical Trial Agreements for US and ex-US Clinical Research sites, CMC research and development and commercial supply agreements, agreements for Investigator Initiated Studies, and other life sciences R&D agreements. The individual will also be responsible for providing strategic advice on legal topics during contract negotiation.
This position will be a hybrid position based in San Diego, California. Relocation benefits are available for this posting.
Essential Job Functions and Responsibilities:
Key responsibilities will include but will not be limited to:

• Provide legal advice, education, and actively resolve legal issues related to the following:
• Clinical Trial Expertise: GxP compliance, diversity in clinical trials, subject recruitment and retention, decentralized trials, patient safety and pharmacovigilance, informed consent, and research privacy, etc.
• Clinical Trial Agreement Execution:
• Lead the direct negotiation of clinical trial agreements and provide oversight of the applicable amendments and site level negotiation process to ensure ethical, fair and compliant practices are followed when developing, negotiating and executing clinical agreements.
• Work in close collaboration with study sites as well as the Clinical Trial Operations team to ensure clinical study agreement execution within the timelines and in an efficient manner. Build a partnership with site contract team, and lead discussions to resolve and finalize contracts in an expedited manner.
• Clinical Trial Operations Support: Identifying and eliminating any friction or potential inefficiencies in supporting Crinetics global clinical trial operations by working directly with clinical study investigators and study sites as well as with CROs; Improving the development and execution process of contracts and budgets in collaboration with internal and CRO partners.
• Proactively identify and address legal issues, foster trusted relationships with client groups, advise leaders in the research and development and medical affairs organizations and serve as a standing or ad hoc member of business teams.
• Consult and collaborate with internal and external stakeholders and subject matter experts to support the above activities, including IP, transactional, privacy and product attorneys, as well as business leadership, regulatory experts, etc.
• Translate business needs into strategic initiatives and drive quantifiable outcomes.
• Focus on immediate and short-term (<2 years) strategic planning horizon.
• Oversee policies and procedures for the law group, and design policies for cross functional legal departments as they pertain to Clinical Research and development.
• Key participant in headcount planning – determine functional/departmental needs to meet corporate objectives.
• Develop departmental processes to achieve objectives towards department and corporate goals.
• Other duties as assigned.

Education and Experience:
Required:

• For this position, we are seeking an attorney with the following qualifications:
• JD required, must be licensed and currently in good standing to practice law in one or more jurisdictions.
• Must have at least 13 years of providing direct legal support for pharmaceutical/biotechnology clinical trials.
• Must be able to work global working hours when necessary and appreciate that patients are waiting.
• Must have significant knowledge of the human subject protection laws, Federal Food, Drug and Cosmetic Act and related regulations, US and global privacy laws, and other applicable federal and state laws governing the research and development of human therapeutics.
• Must have significant transactional experience involving clinical development programs, data sharing arrangements, clinical supply arrangements, and complex research collaborations.
• Excellent verbal and written communication skills, awareness, and ability to engage with others of diverse backgrounds.
• Excellent judgment and superior client-relations skills, and the organizational savvy to effectively collaborate with and influence multidisciplinary, diverse and global clients and colleagues.
• Ability to deliver clear, concise, and practical advice regarding challenging legal issues to legal and non-legal colleagues, including senior management.
• Ability to prioritize and work with agility across multiple projects.
• Ability to work both in a team and independently.
• Aptitude and interest to learn the scientific/technical side of the business.
• Comfortable with getting outside of one's comfort zone and stepping into new areas of practice or business.
• High degree of business acumen and people acumen/insights, and ability to influence business leaders at all levels.

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