VP, Clinical Development

MacroGenics is a leader in the discovery and development of innovative medicines that utilize our next generation antibody-based technologies. Our team of350 dedicated individuals is advancing a pipeline of product candidates to treat patients with products and platforms have attracted multiple partnerships with leading pharmaceuticaland biotechnologycompanies around the globe.

MacroGenics is a bold highly engaged and diverse team driven by a passion for improving the lives of patients through innovative science. We are committed to an inclusive workplace built on trust and respect. We value and nurture strong connections with one another and foster collaborative relationships. We empower our people and drive personal accountability. We encourage curiosity andembrace our entrepreneurial spirit. We celebrate our successes and create a learning environment where all employees can thrive!

Summary of Position

The VP Clinical Development will provide medical input to all aspects of product development from preclinical research through Phase I/II/III Clinical have full responsibility for the leadership planning implementation and daily operation of drug development projects and provide medical expertise and leadership necessary to complete clinical study programs leading to the filing of Biologics Licensing Applications (BLA) to FDA. This individual will develop a clinical development strategy advise management and participate in interactions with Regulatory agencies on behalf of the company. Will serve as the scientific and medical leader for clinical team(s) working closely with clinical project lead the regulatory lead and the operational lead(s) for overall programs and external principal investigators. Develops clinical study concepts based on thorough scientific review and consultation with internal and external experts as well as senior scientists. This position involves both high level strategic planning as well as hands-on responsibilities.

Responsibilities and Job Duties:

• In collaboration with colleagues in Clinical Development Research Product Development and Regulatory Affairs external experts and business partners in designing implementing conducting and reporting of clinical trials conducted with the Companys products (protocol development and the design of studies statistical design CRO selection and management site monitoring safety clinical support of regulatory interaction study reporting) that will maximize the potential for regulatory approval and commercial success
• Direct and oversee the design and implementation of early stage clinical projects as a member of our Product Development Team (PDT) and leader of the Product Steering Committee (PSC). Design scientifically rigorous and maximally cost-effective clinical protocols that are aligned with the clinical development plan are suitable to test the trials hypothesis and likely to meet the objectives of the trialwhile also ensuring study design elements that are ethical and consistent with standard of care and local practices
• Present and defend protocols and clinical development plans at internal governance forums.
• Responsible for the safety monitoring of clinical trials as the medical monitor and as medical expert for Phase I/II and III studies managing the process from protocol development thorough individual study report and integrated regulatory documentation.
• Interact closely with the pre-clinical team to understand the scientific basis of targeted therapy and to apply this knowledge to articulating therapeutic strategies and comprehending biomarker exploration.
• Ensures that study design is scientifically robust
• Direct protocol implementation including site identification and communication attend investigators meetings correspond with sites including IRBs and interact with operations teams.
• Present study updates interim results and final headline data to senior management as required.
• Establishes and maintains communications with prominent clinical investigators in his/her particular field of expertiseto continue learning about best practices and to build relationships for future studies
• Supports data analysis and assembly including clinical study report writing contribution to the preparation of abstracts presentations and manuscripts.
• Serves as the clinical/medical team expert to provide direction to all project team functions organizes Advisory Board meetings (e.g. agenda setting) steering committees and data safety monitoring boards as required. and identifies and liaises with KOL regarding program strategy and scientific advice
• Acts as primary developer of clinical/scientific content for communications with regulatory agencies and IRBs/ethics boards.
• Serves as an information resource to the Company with regard to the science of the field the competitive landscape in research and the current state of treatment in areas of unmet medical need.
• Directly develops or guides development of scientific/medical portions of clinical study reports safety reports and regulatory submissions to assure production of high quality documents.
• Review potential in-licensing candidates and present recommendations to Senior Management any needed due diligence and prepare/present medically sound strategy and plans associated with advanced opportunities.
• Contribute and support department and clinical initiatives to improve the quality and content of all clinical programs as well as the cross functional/organization processes designed to effectively deliver our R&D portfolio.
• Oversees mentors and provides leadership to subordinates and colleagues involved in clinical trial execution

Qualifications

Education & Credentials

M.D. or D.O. with extensive expertise in designing and running clinical trials.

Experience

• 10 years of professional level experience in clinical research in academia or industry
• Minimum of 7 years of clinical research experience (phases I-III) in oncology
• Prior experience in late stage clinical trials focused on immune-oncology and antibody-based product candidates
• Possesses both early and late phase clinical development experience in biologics
• Prior clinical development experience in the pharmaceutical/biotechnology industry setting required
• Prior experience supervising mentoring coaching and leading other physicians in clinical research

Knowledge Skills and Abilities

• Strategic thinker who can provide vision and purpose for teams
• Demonstrates managerial courage
• Well-regarded for intellectual strength and achievement as a clinical scientist
• Excellent working knowledge of drug development process
• Ability to successfully lead collaborative teams and drive for results
• Strong strategic and analytical abilities
• Ability to make sound and timely decisions
• Effective influence and relationship management skills with internal and external partners.
• Able to set priorities for team establish clear direction and objectives and maintain accountability
• Able to balance scientific & business perspectives
• Demonstrated success in fostering an environment that brings out the best in people
• The ability to communicate both orally and in writing to a high standard and handle group and individual presentations effectively
• Must have strong conceptual abilities and analytical skills
• Strong understanding of principles of GCP ICH and CFR.
• Working understanding of statistical principles and guidelines as these apply to clinical trials

Supervisory Responsibilities:

Clinical Development Scientist

Clinical Development Director (M.D.)

Preferences

Clinical experience and academic track record in solid tumors or hematologic malignancies is preferred

Additional Information

The annual rate of pay for this position ranges from $336200 $512500. For non-exempt roles and according to applicable regulations there may be the possibility for overtime pay. This role is eligible for the Companys discretionary bonus and discretionary equity incentives. Eligible employees may participate in the Companys benefits programs including medical / dental / vision / prescription coverage employee wellness resources 401(k) plan with employer match access to an Employee Stock Purchase Plan (ESPP) paid time off & paid parental leave benefits and disability benefits.

The annual pay rate range is described in good faith and the Company believes is the range of possible compensation for this role at the time of this posting depending on the candidates experience qualifications geographic location and other factors permitted by law. The Company may ultimately pay more or less than the posted range and this range may be modified in the future. No amount is considered to be wages or compensation until such amount is earned vested and determinable under the terms and conditions of the applicable policies and plans. The amount and availability of any bonus commission benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole discretion unless and until paid and may be modified at the Companys sole discretion consistent with the law.

Statement

MacroGenics is proud to be an equal opportunity employer. Employment selection and related decisions are made without regard to race color national origin sex gender identity sexual orientation religion age disability protected veteran status or any other characteristic protected by federal state or local law. We are committed to working with and providing reasonable accommodation to individuals with disabilities. If because of a medical condition or disability you need a reasonable accommodation for any part of the employment process please email or call and/or 711 for TTD/TTY service.

Equal Opportunity Employer/Veterans/Disabled

We do not accept non-solicited resumes or candidate submittals from search/recruiting agencies.

Required Experience:

Exec