Senior Director, Clinical Research And Development, Counsel

Senior Director, Clinical Research and Development, Counsel

Categories: Legal

Crinetics is a pharmaceutical company based in San Diego, California, developing much-needed therapies for people with endocrine diseases and endocrine-related tumors. We were founded by a dedicated team of scientists with the simple belief that better therapies developed from rigorous innovation can lead to better lives. Our work continues to make a real difference in the lives of patients. We have a prolific discovery engine and a robust preclinical and clinical development pipeline. We are driven by science with a patient-centric and team-oriented culture. This is an exciting time to join Crinetics as we shape our organization into the world's premier fully-integrated endocrine company from discovery to patients. Join our team as we transform the lives of others.

Position Summary:

The Crinetics 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:

• (a) 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.

• (b) 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.

Physical Demands and Work Environment:

Physical Activities: On a continuous basis, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 25 lbs. may be required. The noise level in the work environment is typically low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities.

Laboratory Activities (if applicable): Biology and chemical laboratory environment experience needed. Environmental health and safety requirements also apply.

Travel:

You may be required to travel for up to 5% of your time.

The Anticipated Base Salary Range: $225,000 - $280,000

In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match. We also provide top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance, 20 days of PTO, 10 paid holidays, and a winter company shutdown.

The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience and education. Crinetics Pharmaceuticals is a multi-state employer, and this salary range may not reflect positions that work in other states. Your recruiter can share more about the specific salary range during the hiring process.

Equal Opportunity Employer:

Crinetics is proud to be an Equal Opportunity Employer. We provide equal employment opportunities to all employees and employment applicants without regard to unlawful considerations of sex, sexual orientation, gender (including gender identity and/or expression), pregnancy, race, color, creed, national or ethnic origin, citizenship status, religion or similar philosophical beliefs, disability, marital and civil union status, age, genetic information, veteran status or any personal attribute or characteristic that is protected by applicable local, state or federal laws.

Vaccination requirement:

Following extensive monitoring, research, consideration of business implications, and advice from internal and external experts, Crinetics requires that all employees and contractors be fully vaccinated and have received the COVID-19 vaccines as a condition of employment. "Full vaccination" is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.