ASSISTANT GENERAL COUNSEL, RESEARCH AND DEVELOPMENT
Day One Biopharmaceuticals is an emerging, mission-driven, drug development company intentionally designed to identify, clinically evaluate, and successfully commercialize novel treatments for pediatric oncology patients, and ultimately to expand those benefits to patients of all ages. For more information, please visit our website at http://www.dayonebio.com.
POSITION SUMMARY:
Reporting to the General Counsel, this role will be part of the Law Department with responsibilities for providing legal advice to the Research & Developent organization, as well as other parts of the business.
As Assistant General Counsel, this individual will take ownership of legal issues in support of our Research & Development operations. We are looking for someone who has extensive experience in drafting and negotiating research and development agreements. You should be able to provide high quality legal advice and propose creative and compliant solutions to business issues.
Your role
Act as a business partner and provide high-quality legal support to the company’s Research & Development organization:
· Negotiate, draft and review R&D agreements of all types (including strategic collaboration agreements, license agreements, IST agreements, services agreements, clinical trial agreements, manufacturing and supply agreements)
· Interact with external stakeholders (e.g. universities, CROs, clinical trial sites)
· Support routine legal matters for other business units
· Assist the company in fulfilling its compliance with industry standards and regulatory requirements
· Stay current with and educating others in legislation and/or compliance in this field
This role is expected to build a strong compliance culture within the organization, consistent with the company’s mission and values, by partnering closely with other members of the Day One team and Board of Directors to ensure compliance with industry and regulatory requirements. The Assistant General Cousel will also proactively identify legal and compliance-related gaps and issues and drive implementation of change to mitigate potential risks.
This position has the potential to be fully remote. Occasional travel will be required for in person meetings.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
· Advise the Day One Research & Development team regarding corporate legal matters, including procurement and contracting.
· Manage and mitigate actual or threatened claims or litigation.
· Assist the Chief Technical Officer and Head of Research & Development, to help coordinate the company’s patent, copyright, and trademark portfolio, working closely with the company’s outside IP counsel.
· Ensure the Day One Compliance Program is effectively integrated into the Company’s culture and business operations by developing strong relationships with key stakeholders throughout the organization and promoting the Compliance Program.
· Serve as a trusted advisor and resource, providing advice to the business to ensure compliance with applicable U.S. laws and company policies, including federal and state anti-kickback and false claims laws, anti-bribery/anti-corruption laws, the Food Drug and Cosmetic Act, federal, state and international transparency laws, privacy laws, GxP and applicable industry codes.
· Identify potential gaps in compliance controls (e.g., policy, procedure or training) and implement appropriate enhancements.
QUALIFICATIONS
· JD required, additional degrees (e.g. MBA, MPH) a plus.
· 3+ years’ training at a top law firm working on relevant corporate matters, preferably in pharmaceuticals and/or biotech.
· 10+ years’ experience as an in-house lawyer, including at least 5 years in a biotech or pharmaceutical company with contracting responsibilities.
· Experience working at a commercial-stage, public biotech or pharmaceutical company is required.
· Understanding of Good Clincal Practices, Good Manufacturing Practices and Good Laboratory Practices; R&D, payor and distributor contracting; and the federal healthcare program reimbursement landscape; Federal Sunshine Act and state transparency laws; as well as the process for securing reimbursement and engaging with ex-US health authorities and payors.
· Knowledge of applicable commercial and compliance requirements, risk management practices, and methodologies.
· Confident in decision-making and solution oriented. Track record for driving innovative solutions to business challenges.
· Strong project management skills to proactively manage and prioritize multiple workstreams and initiatives.
· Comfortable working in a fast-paced and evolving environment and demonstrated ability to evolve and align the legal function with changing business needs.
· Strong writing, presentation, and communication skills, including, but not limited to, leading trainings and experience presenting to a board of directors and its committees, as appropriate.
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification.
COMPENSATION AND BENEFITS
The salary range for this position is $280,000 - $300,000. Day One considers a range of factors when determining base compensation. These considerations mean actual compensation will vary.
DISCLAIMER
Day One Biopharmaceuticals is committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants without regard to race, color, religion, sex, pregnancy (including childbirth and related medical conditions), national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information (including characteristics and testing), military and veteran status, and any other characteristic protected by applicable law.
Employment is conditioned upon full vaccination from the COVID-19 virus, including submission of documented proof thereof, as of the start date. Day One Biopharmaceuticals will comply with applicable law regarding the reasonable accommodation of individuals who are not vaccinated because of a disability and/or a sincerely held religious belief.
We are unable to sponsor or take over sponsorship of any applicant work visas at this time.
Recruitment & Staffing Agencies: Day One Biopharmaceuticals does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Day One Biopharmaceuticals or its employees is strictly prohibited unless contacted directly by Day One Biopharmaceutical’s internal HR team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Day One Biopharmaceuticals, and Day One Biopharmaceuticals will not owe any referral or other fees with respect thereto.
