VP, Clinical Development
Remote, MA 02459 US
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Title: VP, Clinical Development
Hiring Organization: Connexion Systems & Engineering
- Duration: Perm
- Pay rate: $375-400k
- Job Location: Remote (MA)
- Job# 14671
VP, Clinical Development
Summary: The VP of Clinical Development will serve as the primary medical lead for development assets across indications with cross-functional study teams on clinical trial strategy, analysis design and execution. Along with this, the VP. Clinical Development will support medical directors responsible for monitoring the assigned trials. This individual will work across the organization working with the PV, Regulatory, QA, Commercial, Medical Affairs and Clinical Operations.
- Lead trial design, analysis and execution for all company assets.
- Serve as the key partner and contributor for the strategic planning, support early and translational development; and prepare specific strategic plans and initiatives.
- Closely collaborate with Program Leads and Medical Strategy Leads the development of new strategic options for assets in late development
- Participate in the development of Study Protocols, Investigator's Brochures, Clinical Development Plans and other key study documents in conjunction with other line functions and with minimal guidance.
- Serve on cross-functional teams for assigned trials, working with other team members to achieve efficient, high-quality study execution.
- Participate in the preparation of regulatory documents in support of regulatory submissions, including clinical section of IND’s and CTA’s, IND safety reports and annual reports for assigned trials, responses to regulatory authorities and Ethics Committees/IRBs, and other documents as appropriate.
- Provide scientific and clinical input to study-related documents and analysis plans including Informed consent forms (ICF), clinical research forms (CRF), statistical analysis plans (SAP), clinical pharmacology analysis plans (CPAP), and clinical study reports (CSR).
- Act as liaison between Clinical Development and other internal groups (e.g., Regulatory Affairs, Clinical Operations, Clinical Data Management) for assigned studies.
- Develop and execute life-cycle management plan, lead data generation activities such as medical affairs studies to unmet medical needs and data gaps
- Support Medical Affairs: Working with field medical, Scientific Communication and Publication, Medical Information and Communication teams and provide support including reactive material development to address external stakeholder questions
- Help identify and effectively interact with thought leaders to engage in scientific and medical exchange as well as understand unmet medical needs and data gaps
- Review of concepts, trial designs, and interpretation of study results for IST program
- Partner with pharmacovigilance to assess the safety profile of compounds
- Maintain a high level of clinical and scientific expertise in the disease area(s) by reviewing the literature, attending medical/scientific meetings, and through personal interchanges with consultants, thought leaders, investigators and internal stakeholders.
- Maintain ethical standards of the highest level and have the knowledge and ability to comply with all relevant ethical, regulatory, and legal standards
- May participate in or lead clinical development contributions to due diligence or other business development activity
- As required by program needs, contribute in partnership with Discovery colleagues to the design and implementation of translational strategies
- Supports clinical study teams, monitoring overall study integrity, and review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule
- Present at scientific, medical and regulatory meetings globally
- Develop and maintain relationships with academic investigators, pharmaceutical partners/sponsors, KOL’s, and patient advocacy groups
- Contribute to activities in support of the company’s planned NDA submissions. Author clinical sections for INDs, NDAs, and other related documents
- MD, DO or equivalent ex-US medical degree.
- Minimum of 15 years of clinical research experience in industrial setting with a focus on oncology (both solid tumor and hematological malignancies)
- Experience in analysis of research data and publications; working knowledge of biostatistics and pharmacokinetics; working knowledge of GCP, scientific and clinical research methods and clinical study design, regulatory requirements for clinical studies
- Pharmaceutical/Biotech industry experience, including time managing clinical trials and/or clinical development programs
- Excellent oral and written communication skills
- Ability to work collaboratively in a fast-paced, team-based matrix environment and to function independently as appropriate
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