Director, Development Counsel
Director, Development Counsel
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Salary Not Disclosed
1 Vacancy
Job Description
Position: Director Development Counsel
Reports to: Deputy General Counsel R&D and Privacy
Location: Waltham MA Remote or Hybrid
Position Summary:
Apellis Pharmaceuticals is seeking a strategic collaborative and business-minded attorney to join our Legal team as Director Development Counsel. Reporting to the Deputy General Counsel R&D and Privacy this attorney will serve as a trusted legal advisor to our Development and Medical Affairs organizations providing proactive and solutions-oriented counsel on a wide range of legal regulatory and compliance matters.
Key Responsibilities Include:
- Serve as legal counsel to the Development and Medical Affairs organizations advising clinical study teams contracting functions Medical Affairs and Regulatory Affairs departments and others on a broad spectrum of legal regulatory and compliance issues including FDA regulations Good Clinical Practice (GCP) regulations investigator-initiated studies and research collaborations
- Negotiate a wide variety ofagreements including clinical study agreements vendor and service contracts consulting agreements and other related contracts
- Contribute to the development implementation and revision of policies training materials contract templates and operational playbooks
- Interpret existing agreements and advise on transactional issues that arise throughout the contract lifecycle
- Collaborate with colleagues within the Legal team and cross-functional stakeholders and develop a thorough understanding of the Companys business people products markets facilities and customers to align legal strategy with business objectives
- Partner with the Global Compliance Team to support training monitoring activities and global coordination efforts
- Assist with external counsel engagements including defining objectives managing scope and overseeing project execution
Education Registration & Certification:
- Juris Doctor (JD) from an ABA-accredited law school; admitted and in good standing with at least one U.S. state bar
Experience:
- A minimum of 7 years of relevant legal experience ideally including in-house counsel experience within a global biotech life sciences or pharmaceutical company or advising such clients at a law firm
- Understanding and knowledge of the U.S. healthcare and life sciences regulatory frameworks including the FDA GCP the Anti-Kickback Statute privacy-laws and the Food Drug and Cosmetic Act; familiarity with international equivalents is a plus
- Demonstrated ability to provide clear business-oriented legal advice in a fast-paced highly regulated environment
- High integrity sound judgment and a pragmatic risk-balanced approach to problem-solving.
- Proven ability to manage multiple priorities set expectations and deliver results efficiently.
- Strong interpersonal skills and a collaborative mindset with the ability to build effective partnerships across departments and functions.
Benefits and Perks:
Apellis offers a comprehensive benefits package including a 401(k) plan with company match inclusive family building benefits flexible time off summer and winter shutdowns paid family leave disability and life insurance and more! Visit learn more.
Company Background:
Apellis Pharmaceuticals Inc. is a global biopharmaceutical company that combines courageous science and compassion to develop life-changing therapies for some of the most challenging diseases patients face. We ushered in the first new class of complement medicine in 15 years and now have two approved medicines targeting C3. These include the first and only therapy for geographic atrophy a leading cause of blindness around the world. With nearly a dozen clinical and pre-clinical programs underway we believe we have only begun to unlock the potential of targeting C3 across many serious diseases.
For more information please visit follow us onTwitterandLinkedIn
EEO Statement:
Apellis is an equal opportunity employer and complies with all applicable federal state and local fair employment practices laws. Apellis strictly prohibits and does not tolerate discrimination against employees applicants or any other covered persons because of race color religion creed national origin or ancestry ethnicity sex (including pregnancy) gender (including gender nonconformity and status as a transgender or transsexual individual) age physical or mental disability citizenship past current or prospective service in the uniformed services genetic information marital status AIDS/HIV status smoker/nonsmoker and occupational pneumoconiosis or any other characteristic protected under applicable federal state or local law.
For San Francisco postings: Pursuant to the San Francisco Fair Chance Ordinance we will consider for employment qualified applicants with arrest and conviction records.
Other Duties:
Please note this job description is not designed to cover or contain a comprehensive listing of activities duties or responsibilities that are required of the employee for this job. Duties responsibilities and activities may change at any time with or without notice.
Required Experience:
Director
Employment Type
Full Time
