Director, Clinical Development

The Director, Clinical Development provides medical leadership and oversight of all aspects of drug development. This individual serves as scientific and medical lead for clinical team(s) and oversees clinical strategy planning to ensure effective development. In addition, the responsibilities include implementation, and execution of clinical study concepts based on thorough scientific review and consultation with internal and external experts as well as senior scientists. The incumbent is also responsible for all medical third-party vendors; serves as subject matter expert and performs other tasks including but not limited to oversight of drug safety, addressing complex medical issues related to safety, and acts as author/developer of clinical summary and other supporting documents for regulatory submissions and for publications.

Responsibilities and Job Duties:

• Participate in the design of innovative and feasible clinical trials in collaboration with Chief Medical Officer, clinical team members, and external KOLs.
• Author clinical trial documents including but not limited to protocols, charters, safety monitoring plans, IND reports, process documents, meeting presentations, publications, and clinical sections of regulatory documents such as INDs, briefing books, clinical study reports, investigator brochures, annual reports and updates, and clinical sections of regulatory submissions to support product approvals.
• Review and aid in development of case report form (CRF) design, instructions for unique CRFs, and Data Quality Plan.
• Participate actively as the clinical development expert in study implementation, study oversight and study medical monitoring.
• Conduct regular reviews, analysis, and interpretation of study results.
• Participate in tracking/analysis of any potential safety events across trials.
• Serve as primary point of contact for clinical study inquiries from site staff, CROs and site monitors regarding the study protocol, modifications to informed consent, and scientific or medically related questions.
• Present at internal and external meetings (e.g., portfolio reviews, clinical advisory boards, investigator meetings, pre-study site selection visits and site initiation visits, Study Coordinator and CRA training, and internal and external medical/scientific meetings).
• Maintain awareness and keep program team informed of internal and external developments that may impact on the investigational agent Clinical Development Plan, including attendance at major scientific conferences, participation in competitive intelligence activities, and periodic literature review.
• Maintain current knowledge of the external environment to ensure scientific innovations are considered and/or incorporated into clinical trial development strategy.
• Participate in development of the long-range strategic plans for the assigned program(s).
• Participate as the clinical representative in clinical sub-team meetings.
• Interact closely with the pre-clinical team to understand the scientific basis of targeted therapy and the relationship to clinical practice decision-making.
• Provide medical guidance for the design of biomarker studies and provides a medical perspective to biomarker data interpretation.
• Collaborate with clinical pharmacology to interpret pharmacokinetic and toxicokinetic data and the implications for clinical study design.
• Support data analysis and assembly and contributes to the preparation of abstracts, presentations, and manuscripts.
• Organize clinical advisory boards, steering committees and data safety monitoring boards as required.
• Provide expert evaluation of investigator-initiated proposals.
• Function as primary developer of clinical/scientific content for communications with regulatory agencies and IRBs/ethics boards.
• Ensure the feasibility of the study by incorporating study design elements that are ethical and consistent with standard of care and applicable local practices.
• Responsible for establishing and maintaining communications with prominent clinical investigators in his/her particular field of expertise.
• Serves as a medical-scientific 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.
• Oversees and provides leadership to colleagues involved in clinical trial execution.
• Ensures consistent practices with the highest ethical standards in compliance with internal SOPs, local regulations, and laws.

Qualifications

Education & Credentials

• M.D., D.O., or international equivalent. Preferably with subspecialty and board eligibility/certification in oncology.
• Significant experience in Oncology drug development may substitute for oncology specialization

Experience

• Minimum of 5 years of successful clinical research and/or drug development experience, preferably in biologics
• Possesses early phase clinical development experience
• Clinical development experience in the pharmaceutical/biotechnology industry or academic medical setting

Knowledge, Skills and Abilities

• Ability to collaborate effectively with many functional areas and a positive track record of working within the team setting
• Understanding of the unique product safety, clinical development and regulatory requirements of biological products
• Well-regarded for intellectual strength and achievement as a clinical scientist
• Effective influence and relationship management skills with internal and external partners
• Demonstrate the ability to think creatively and strategically
• Strong analytical and problem-solving skills
• Excellent written and oral communication skills demonstrating ability to organize, interpret and communicate complex information effectively and succinctly including formal and informal presentations
• Strong understanding of principles of GCP, ICH and CFR
• Working understanding of statistical principles and guidelines as these apply to clinical trials

Supervisory Responsibilities:

None

Preferred Qualification

• Experience with late phase drug development
• Experience with immuno-oncology clinical research
• Experience with clinical development of antibody-drug conjugates

Additional Information

The annual rate of pay for this position ranges from $233,700 - $356,300. For non-exempt roles, and according to applicable regulations, there may be the possibility for overtime pay. This role is eligible for the Company's discretionary bonus and discretionary equity incentives. Eligible employees may participate in the Company's 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 candidate's 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 Company's sole discretion unless and until paid and may be modified at the Company's 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 info@macrogenics.com or call (301) 354-3566 and/or 711 for TTD/TTY service.