Associate Vice President, Clinical Development
Company: Reata Pharmaceuticals
Location: Plano
Posted on: January 27, 2023
Job Description:
The Associate Vice President, Clinical Development will be a key
leader supporting strategy and operational implementation of
clinical activities to support the development of Reata's clinical
assets. This position will involve extensive coordination with the
Chief Medical Officer, external CROs and Reata's Clinical
Development Team, Medical Directors, Biostatistics, Clinical
Pharmacology, Clinical Program Operations, Bioinformatics,
Regulatory Affairs, and Quality Assurance.
RESPONSIBILITIES:
- Contribute medical and scientific clinical research experience
to the development of overall strategy and objectives of the
clinical development programs
- Serve as the NDA Lead for the Clinical Development group and is
responsible for conceptualizing and operationalizing the NDA
process, modules, and other deliverables as they pertain to
Clinical Development
- Partner with regulatory department, driving IND and NDA
submissions, IB authorship and updating, and communication with US
and international regulatory agencies
- Direct protocol development, including writing and reviewing
protocols, and working closely with data management in constructing
and supporting materials
- Review/evaluate clinical data
- Support of data analysis and assembly, including clinical study
report writing, and contribute to the preparation of abstracts,
presentations, and manuscripts
- Lead program development, including working cross-functionally
with all of the disciplines necessary for successful drug
development, including manufacturing, quality assurance,
regulatory, marketing, product development, legal, biostatistics,
data management, and clinical operations
- Maintain complete and in-depth knowledge of the scientific and
technical characteristics of assigned compounds in development or
planning phase
- Participate on key committees, and be responsible for
presenting successfully at high-level internal meetings and
reviews
- Forge alliances with Data Management, Pharmacovigilance,
Medical Directors, and Medical Affairs to coordinate real-time
availability of clinical trial data, assuring data integrity,
including safety, efficacy, pharmacokinetic, and correlative
studies data to provide consolidated information for trial
progress
- Review statements of work, master service agreements, and
quality agreements as related to clinical programs
- Responsible for clinical development plans, clinical trial
protocols, clinical pharmacology, data analyses, clinical study
reports, and other related clinical documents
- Ensure with QA that all company clinical trials are conducted
according to GCP and all applicable regulatory requirements, with a
focus on the safety and medical monitoring aspects of the
trials
- Drive creation of and be accountable for clinical sections of
regulatory documents like Investigators' Brochures, briefing books,
safety updates, IND/BLA submission documents, responses to Health
Authorities' questions
- Collaborate with Medical Affairs and Commercial Teams to
develop a strong group of Key Opinion Leaders
- Develop publication plan and directly oversee timely clinical
data communication
- Support relationships among the clinical/scientific community
and with external experts including Key Opinion Leaders
AND/OR
- Serve as an external spokesperson of the clinical programs in
interactions with development partners, investigator meetings, and
advisory boards
CORPORATE COMMITMENTS:
- Demonstrate commitment and support for company and department
goals, objectives, and procedures
- Represent Reata by developing collaborative relationships with
industry colleagues and vendors
- Demonstrate professionalism and adherence to moral, ethical,
and quality principles
- Participate in corporate and departmental meetings
- Comply with applicable regulations, GCP, and corporate policies
and procedures
QUALIFICATIONS:
- MD or MD/PhD, with strong academic qualifications, and
demonstrated clinical development experience in a pharmaceutical or
biotechnology setting
- Knowledge of clinical development process and methods of
scientific investigation, GCP, the FDA regulatory environment and
guidelines, including study and protocol design
- Board certification in Internal Medicine is required
- Full subspecialty training in Nephrology is preferred, however
other suitable training in Cardiovascular, Pulmonary,
Endocrinology, or Diabetes, may be appropriate
- Excellent working knowledge of FDA, EMA, and PMDA regulations
and expectations, Good Clinical Practice, ICH guidelines, and
clinical drug development. Experience in representing the sponsor
in front of regulatory agencies
- Experience leading cross-functional members (CMC, Clinical
Pharmacology, Medical Affairs, Regulatory, and Commercial) in
program teams
- Demonstrate expertise in clinical design and implementation of
Phase 1 to Pivotal Clinical studies, with evidence-direct
leadership of trials that meet the timelines, budget, and expected
outcomes and lead to the regulatory success of innovative
medicines
- Significant Phase I-IV clinical trial experience and a strong
history of involvement and contribution in the filing of
NDAs
- Sound medical/scientific writing skills and ability to analyze
and interpret efficacy and safety data
- Direct experience in clinical development of biologics and
small molecules
- Knowledge of statistical concepts as they relate to clinical
plans
- Knowledge of clinical pharmacology
- Knowledge of adaptive trials and design of trial to support
accelerated approval under accelerated and Restricted Approvals
Under Subpart H and Subpart E
- Experience managing clinical CROs from RFP to statements of
work to coordinating execution
- Knowledge of the day-to-day medical monitoring of clinical
trials (e.g., responding to questions about patient eligibility and
protocol waivers; review of safety parameters; receiving and
processing SAEs, including the composition of SAE narratives; and
IND expedited safety reports)
- Knowledge in pharmacovigilance, including the receipt and
processing of ADRs, completion of MedWatch forms, and generation of
Periodic Safety Update Reports
- Strong communication and collaboration skills
- The ideal candidate will have a network of external thought
leaders, who serve as advisers
- Excellent leadership, management, and organizational skills,
along with problem-solving, conflict resolution, and team
building
- Must demonstrate highly refined analytic and communication
skills, and the ability to work effectively, both independently and
in a team environment
- Willing to travel to support clinical and corporate
activities
Keywords: Reata Pharmaceuticals, Plano , Associate Vice President, Clinical Development, Executive , Plano, Texas
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