Clinical Development Director
Remote, CA, USA | MacroGenics, Inc.
Industry:Pharmaceutical / Biotech
Job Description:60 people have viewed this job
MacroGenics is a leader in the discovery and development of innovative medicines that utilize our next generation antibody-based technologies. Our team of 400+ dedicated individuals is advancing a pipeline of product candidates to treat patients with cancer. Our products and platforms have attracted multiple partnerships with leading pharmaceutical and biotechnology companies around the globe.
The Company considers its employees to be its most valuable asset and we are committed to providing opportunities for individuals to learn and grow as a means to further their professional development. MacroGenics' corporate culture promotes an atmosphere of innovation, open communication and teamwork where employees can see firsthand how they contribute to the success of the organization.
Summary of Position
The Clinical Development Director provides medical input to all aspects of product development, for new and innovative treatments being developed in patients. This individual serves as scientific and medical member for clinical team(s) working closely with clinical project lead, the regulatory lead, and the operational lead(s) for overall programs within the therapeutic area. This individual develops clinical study concepts based on thorough scientific review and consultation with internal and external experts as well as senior scientists and acts as author/developer of clinical summary and other supporting documents for regulatory submissions and for publications.
Responsibilities and Job Duties:
- Collaborates with colleagues in clinical development and operations, research, bioPharma development and manufacturing, regulatory affairs, and product safety to participate in protocol development and the design of studies, statistical design, CRO selection and management, site monitoring, safety, clinical support of regulatory interaction, study reporting for new products that will ensure regulatory approval and commercial success.
- Ensures that study design is scientifically robust, suitable to test the trial's hypothesis, and likely to meet the objectives of the study while ensuring the safety of the patients participating in the Company’s sponsored clinical trials.
- Interacts closely with the pre-clinical team to understand the scientific basis of targeted therapy and the relationship to clinical practice decision-making.
- Provides medical guidance for the design of biomarker studies and provides a medical perspective to biomarker data interpretation.
- Collaborates with clinical pharmacologist to interpret pharmacokinetic and toxicokinetic data and the implications for clinical study design.
- Responsible for medical components of the design, execution, and reporting of study protocols as well as (in collaboration with other team members) labeling and regulatory communications.
- 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.
- Directs protocol implementation, including site identification, through communication with site investigators and their staff. Leads site initiation meetings and follow-up meetings with investigators.
- Supports data analysis and assembly and contributes to the preparation of abstracts, presentations, and manuscripts.
- Organizes clinical advisory boards, steering committees and data safety monitoring boards as required.
- Provides expert evaluation of investigator-initiated proposals.
- Acts as primary developer of clinical/scientific content for communications with regulatory agencies and IRBs/ethics boards.
- Ensures 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.
- Works with international colleagues and with external Alliance partners on research initiatives and regulatory issues.
- Serves as a technical 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.
Education & Credentials
- M.D., or D.O. with subspecialty and board eligibility/certification in oncology
- Significant experience in Oncology drug development may substitute for oncology specialization
- Minimum of 3 years of successful clinical research and/or drug development experience in biologics
- Experience in immuno-oncology clinical research
- 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
- Experience with late phase drug development
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.
Equal Opportunity Employer/Veterans/Disabled
We do not accept non-solicited resumes or candidate submittals from search/recruiting agencies.
To promote the health and well-being of our employees and ensure business continuity, MacroGenics requires all new hires to be fully vaccinated for COVID-19 by his/her start date.A new hire will need to either (a) establish that they have been fully vaccinated or (b) obtain an approved exemption as an accommodation.
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