Director, Clinical Development
MacroGenics, Inc.
4 hours ago
Remote friendly (Rockville, MD)
United States
Clinical Research and Development
Summary of Position:
Director, Clinical Development provides medical leadership and oversight of all aspects of drug development. Serves as scientific/medical lead for clinical teams; oversees clinical strategy planning; implements and executes clinical study concepts; oversees medical third-party vendors; provides subject-matter expertise including drug safety oversight; develops clinical summaries and supporting documents for regulatory submissions and publications.
Responsibilities:
- Design innovative, feasible clinical trials with the Chief Medical Officer, clinical team, and external KOLs.
- Author clinical trial and regulatory documents (e.g., protocols, charters, safety monitoring plans, IND reports, briefing books, clinical study reports, investigator brochures, annual reports/updates).
- Support CRF design, unique CRFs, and Data Quality Plan.
- Serve as clinical development expert for study implementation, oversight, and medical monitoring.
- Review/analyze/interprete study results; track/analyze potential safety events across trials.
- Primary point of contact for site/CRO/staff inquiries (protocol, informed consent modifications, scientific/medical questions).
- Present at internal/external meetings; maintain awareness of developments impacting the Clinical Development Plan (conferences, competitive intelligence, literature review).
- Develop long-range strategic plans; serve as clinical representative in sub-team meetings.
- Guide biomarker study design and interpretation; collaborate with clinical pharmacology on PK/TK/toxicokinetics and clinical study implications.
- Support data analysis and preparation of abstracts, presentations, and manuscripts.
- Organize advisory boards, steering committees, and DSMBs (as required).
- Evaluate investigator-initiated proposals; develop clinical/scientific content for regulatory agency/IRB communications.
- Ensure study feasibility/ethics/standard of care consistency; maintain communications with clinical investigators.
- Provide leadership and ensure highest ethical standards (SOPs, local regulations, laws).
Qualifications:
- M.D., D.O., or international equivalent; preferably oncology subspecialty with board eligibility/certification.
- 5+ years clinical research and/or drug development (preferably biologics); early phase clinical development experience; industry or academic medical setting.
Required Skills:
- Collaborates effectively across functions.
- Strong understanding of product safety, clinical development, and regulatory requirements for biologics.
- Influencing/relationship management; creative/strategic thinking.
- Strong analytical/problem-solving; excellent written/oral communication.
- Knowledge of GCP, ICH, CFR; statistical principles for clinical trials.
Preferred:
- Late phase drug development; immuno-oncology clinical research; antibody-drug conjugate development.
Benefits (as stated):
- Discretionary bonus and discretionary equity incentives; medical/dental/vision/prescription coverage; wellness resources; 401(k) with match; ESPP; paid time off; paid parental leave; disability benefits.
Director, Clinical Development provides medical leadership and oversight of all aspects of drug development. Serves as scientific/medical lead for clinical teams; oversees clinical strategy planning; implements and executes clinical study concepts; oversees medical third-party vendors; provides subject-matter expertise including drug safety oversight; develops clinical summaries and supporting documents for regulatory submissions and publications.
Responsibilities:
- Design innovative, feasible clinical trials with the Chief Medical Officer, clinical team, and external KOLs.
- Author clinical trial and regulatory documents (e.g., protocols, charters, safety monitoring plans, IND reports, briefing books, clinical study reports, investigator brochures, annual reports/updates).
- Support CRF design, unique CRFs, and Data Quality Plan.
- Serve as clinical development expert for study implementation, oversight, and medical monitoring.
- Review/analyze/interprete study results; track/analyze potential safety events across trials.
- Primary point of contact for site/CRO/staff inquiries (protocol, informed consent modifications, scientific/medical questions).
- Present at internal/external meetings; maintain awareness of developments impacting the Clinical Development Plan (conferences, competitive intelligence, literature review).
- Develop long-range strategic plans; serve as clinical representative in sub-team meetings.
- Guide biomarker study design and interpretation; collaborate with clinical pharmacology on PK/TK/toxicokinetics and clinical study implications.
- Support data analysis and preparation of abstracts, presentations, and manuscripts.
- Organize advisory boards, steering committees, and DSMBs (as required).
- Evaluate investigator-initiated proposals; develop clinical/scientific content for regulatory agency/IRB communications.
- Ensure study feasibility/ethics/standard of care consistency; maintain communications with clinical investigators.
- Provide leadership and ensure highest ethical standards (SOPs, local regulations, laws).
Qualifications:
- M.D., D.O., or international equivalent; preferably oncology subspecialty with board eligibility/certification.
- 5+ years clinical research and/or drug development (preferably biologics); early phase clinical development experience; industry or academic medical setting.
Required Skills:
- Collaborates effectively across functions.
- Strong understanding of product safety, clinical development, and regulatory requirements for biologics.
- Influencing/relationship management; creative/strategic thinking.
- Strong analytical/problem-solving; excellent written/oral communication.
- Knowledge of GCP, ICH, CFR; statistical principles for clinical trials.
Preferred:
- Late phase drug development; immuno-oncology clinical research; antibody-drug conjugate development.
Benefits (as stated):
- Discretionary bonus and discretionary equity incentives; medical/dental/vision/prescription coverage; wellness resources; 401(k) with match; ESPP; paid time off; paid parental leave; disability benefits.