General Counsel

General Counsel Location: Menlo Park, San Francisco CA Our Mission: To build a viable long-lasting health care organization that assumes full responsibility for designing, developing, trial enrollment, regulatory approval and commercializing patient, physician, caregiver, payor, and societal friendly medicinal therapy intended to improve quality of life, increase potential duration of life and resolve serious medical healthcare needs.
We will accomplish this by building a team of world class scientists and business administrators that apply themselves to this mission.
Summit Activities We have in-licensed Ivonescimab, which is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule.
We plan to initiate phase-III clinical studies in the following NSCLC indications: Ivonescimab combined with chemotherapy in patients with epidermal growth factor receptor (EGFR)-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a third-generation EGFR tyrosine kinase inhibitor (TKI) (“HARMONi”) Ivonescimab combined with chemotherapy in first-line metastatic squamous NSCLC patients (“HARMONi-3”) Ivonescimab is an investigational therapy that is not approved by any regulatory authority.
It is currently being investigated in Phase III clinical studies.
This role will report into the COO Role and Responsibilities: Provide legal direction on FDA promotional matters, healthcare fraud and abuse laws, product liability, antitrust, privacy and other laws impacting the commercialization of biotech products.
Provide legal direction for corporate governance matters, including board meetings, NYSE listing standards, and compliance with corporate governance standards.
Advise on business strategies, tactical plan development and implementation, and other business issues, including development of legal assessments and solutions-oriented risk mitigation strategies.
and strategic transactions, including mergers and acquisitions Counsel on appropriate relationships with healthcare professionals, patients, managed care entities, academic institutions, and government entities.
Draft, review, negotiate and interpret a wide range of commercial, Regulatory and Development related agreements, master service, and consulting agreements, licensing and research collaborations, and other strategic alliances for Quality Assurance, drug development, clinical manufacture, Supply Chain, and Market Access as it relates to Government and payer drug rebate agreements as well as Affordability programs (e.
g.
, Savings Card, Patient Assistance Program) Proactively inform business clients of important legal, enforcement and other industry developments; actively respond to inquiries and requests for advice.
Provide legal support to outside counsel on designated practice areas/business clients; consult with outside counsel on discrete issues.
Collaborate across global Legal Department as necessary to support business clients/practice area.
Advising on commercial and intellectual property litigation; employment law, pharmaceutical regulatory law and competition law; Advising on legal and compliance matters; Drafting, reviewing and negotiating pharmaceutical and medical device license agreements, share purchase agreements, asset purchase agreements, vendor agreements, and other commercial contracts; Advising on the prosecution, maintenance and enforcement of the Group’s intellectual property portfolio; Advises Executive Management regarding risk mitigation pertaining to business and marketing activities, litigation matters, and special projects/events.
Collaborates with commercial, corporate communications and the Medical Affairs teams regarding communications with customers and media as it pertains to existing or potential litigation and the associated risk to the business.
Supports Summit’s strategic business development initiatives, including discovery, development and/or commercial-stage collaborations, in-bound and out-bound license agreements, M&A, joint venture, supply, manufacturing, distribution, quality, and safety agreements and ongoing alliances; Drafts and negotiates confidentiality and material transfer agreements; Drafts and negotiates preliminary transaction documents, including term sheets; Drafts, negotiates and closes definitive agreements; Performs legal due diligence in support of Business Development activities; Works closely with Summit’s Executive Management, Business Development, IP, Finance, Tax, R&D, Regulatory, Drug Safety and Quality, Manufacturing, Commercial, and other key internal stakeholders; Possesses and maintains a strong working knowledge of licensing and collaboration structures, provisions, and “what’s market” for drug discovery, development, commercialization, distribution, supply, and manufacturing transactions (both large and small molecules, as well as companion diagnostics and data sharing); Provides ongoing legal support to Summit’s teams responsible for multiple collaborations, including negotiating and drafting amendments to existing agreements; Assists with the development and upkeep of transaction templates and forms; Assists with public disclosures and securities filings related to transactions; and Oversees outside counsel and advisors to ensure quality, timeliness and efficiency.
Experience, Education and Specialized Knowledge and Skills: Juris Doctor from an accredited U.
S.
law school, and licensed with at least one state bar 15+ years of relevant experience at a leading law firm and/or in-house legal department of a biopharmaceutical or life sciences company, with at least 3 years at a leading law firm Knowledge/experience of the pharmaceutical industry would be an advantage and preferably required.
Some experience with compliance issues (FCPA, Bribery Act, EFPIA, GDPR) is preferred but not essential.
Proactive and agile to work in a fast-paced environment Candidates should be able to demonstrate ability to work collaboratively with cross-functional team members.
Excellent communication and interpersonal skills Other Qualifications: Strong negotiation, communication, drafting and interpersonal skills.
Significant experience with global and territory-specific business development transactions, including collaborations, licensing, M&A, joint venture, supply, manufacturing, distribution, quality and safety agreements.
Working knowledge of biology and chemistry, pharmaceutical regulations, and patent and IP laws relevant to strategic transactions involving therapeutic drugs.
Significant experience providing strategic, well-reasoned and insightful counselling on complex legal and business issues, with a focus on providing constructive solutions.
Highly adept at resolving challenging legal issues and delivering sound, clear, and practical advice.
Ability to work collaboratively and effectively with key executives and business partners.
Strong organizational and time management skills in order to balance working on multiple projects in parallel.
Self-directed individual who is able to work in a dynamic, fast-paced, high volume environment and meet deadlines.
Highly effective communication skills (both verbal and written).
Ability to understand complicated laws and regulations and translate them into practical, business-oriented legal counsel.
Detail-oriented.
Ability to handle confidential and proprietary information using excellent discretion and judgment.
Self-motivated, able to work independently and be reliable and responsive.
Ability to be flexible and willing to accept new responsibilities as needed.
Competencies: Ethics - Treats people with respect; Inspires the trust of others; Works with integrity and ethically in accordance with Summit’s Code of Business Conduct and Ethics, policies and procedures.
Planning/Organizing Prioritizes and plans work activities; Uses time efficiently; Completes administrative tasks correctly and on time; Follows instructions and responds to management direction.
Communication - Listens and gets clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations; Writes clearly and informatively; Able to read and interpret written information.
Teamwork- Balances team and individual responsibilities; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Supports everyone's efforts to succeed; Contributes to building a positive team spirit; Shares expertise with others.
Adaptability– Able to adapt to changes in the work environment; Manages competing demands; Changes approach or method to best fit the situation; Able to deal with frequent change, delays, or unexpected events.
Technical Skills- Assesses own strengths and development areas; Pursues training and opportunities for growth; Strives to continuously build knowledge and skills; Shares expertise with others.
Dependability- Follows instructions and responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.
Quality- Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data.
Problem Solving - Identifies and resolves problems in a timely manner; gathers and analyses information skillfully.
Project Management- Communicates changes and progress; Completes projects on time and within budget.
We are proud to be an equal opportunity employer and we value diversity.
Summit Therapeutics does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law.
All employment is decided on the basis of qualifications, merit, and business need.