VP, Head of Legal & Compliance
Legal/Compliance | Waltham, MA | Full Time
Oncopeptides is a pharmaceutical company focused on the development of targeted therapies for difficult-to-treat hematological cancers. The company is focusing on the development of the lead product candidate melflufen, a novel peptide-drug conjugate that rapidly delivers a cytotoxic payload into tumor cells. Melflufen is in development as a new treatment for the hematological cancer multiple myeloma and is currently being tested in multiple clinical studies including the pivotal phase 2 HORIZON study and the ongoing phase 3 OCEAN study. Oncopeptides’ US headquarters is based in Waltham, MA with an office in Mountain View, CA, and global headquarters is in Stockholm, Sweden. The company is listed in the Mid Cap segment on Nasdaq Stockholm with the ticker ONCO.
The company is in a strong financial position and has an effective Executive Team and Board of Directors. Discover more about Oncopeptides at www.oncopeptides.com
Position: VP, Head of Legal & Compliance, North America
We are currently seeking a qualified, highly motivated, experienced legal professional with pharmaceutical industry experience to lead the legal and compliance functions in North America. The VP, Head of Legal and Compliance will be a member of the Oncopeptides, Inc. leadership team reporting directly to the CEO of Oncopeptides, Inc.
The VP, Head of Legal and Compliance will provide guidance on business legal matters and support all North American functions as the in-house subject matter expert. S/he will develop legal and compliance strategies for N.A. operations, including commercial compliance oversight and employment law matters. S/he will develop functional plans for managing the company’s legal activities and minimize risk for the business. Additionally, s/he will oversee contract negotiations and other day-to-day legal matters in a small but growing organization. S/he will serve as the liaison with legal counsel at Oncopeptides, AB as well as with external counsel/partner firms.
This position is based in Waltham, MA
Domestic and international travel up to 20%
Key responsibilities include, but are not limited to:
- Provide advice and counsel to senior management and other business leaders on legal, regulatory and compliance issues related to the development, commercialization and sale of Oncopeptides products.
- Lead the development and implementation of Oncopeptide’s North American corporate compliance program, including development and implementation of relevant policies, procedures, training and auditing and monitoring programs.
- Advise North American teams regarding life-cycle management initiatives and interactions with regulators.
- Serve as the company’s subject matter expert in the areas of healthcare law and compliance, including all rules and regulations of the FDA, OIG and CMS, and all applicable anti-kickback, privacy, fraud and abuse, anti-bribery and product liability statutes and regulations
- Review and advise on programs, initiatives, and contracts related to sales, marketing reimbursement, market access, government price reporting, pricing, and non-promotional education.
- Serve as the Chair of the Compliance Committee and prepare Board briefings.
- Provide training to Oncopeptides’ personnel and vendors, including field sales personnel.
- Assess Healthcare Compliance training needs for Oncopeptides businesses in light of external developments and identified risk areas, develop content to meet these needs and assist with training.
- Assist with investigations relating to potential violations of policies, standards or procedures or other Healthcare Compliance issues in all areas, including but not limited to fraud and abuse, product promotion and other regulatory matters and government price reporting.
- Implement auditing and monitoring program related to Oncopeptides businesses and help ensure compliance with applicable reporting requirements.
- Review and advise on promotional materials, sales training materials, federal and state government price reports, and corporate communications.
- Draft, review, revise, and negotiate a wide range of agreements for the Company which may include confidentiality agreements, various vendor services agreements, manufacturing and supply agreements, consulting agreements, materials transfer agreements, change orders, task orders, license agreements, and software licenses.
- Handle other day-to-day legal issues arising including employment, intellectual property, and corporate governance.
- Define risks and efficiently communicate those risks to appropriate internal decision-makers for discussion and resolution.
- J.D. degree from an accredited law school required.
- Licensed to practice law in a US state, commonwealth, or DC.
- 15+ years of relevant experience in a law firm and/or corporate legal department; in-house corporate legal experience preferred.
- Ability to work independently and to communicate legal issues and solutions clearly and concisely.
- Excellent interpersonal, verbal and written communication skills.
- Ability to appropriately assess legal risk and develop good working relationships with clients to facilitate teamwork and achievement of mutual goals across organizational boundaries.
- Leadership skills in updating and advising Company stakeholders on changes in regulations, policies, enforcement which may impact the Company’s activities.
- Demonstrated success working in a high-performing, results-driven environment.