Senior Director/Director of Clinical Development (San Diego CA)

SNAPSHOT!

Looking for a chance to join a pioneering biotech company in a new class of oligonucleotide-based therapies that treats a wide range of serious diseases? Our client’s leadership includes seasoned scientists and executives with deep expertise in the fields of antibody conjugation, chemistry, formulations, oligonucleotide therapeutics, drug delivery, and cancer biology! In this role, The Sr. Director/Director, Clinical Development will work with key internal and external stakeholders to develop and execute clinical development plans (CDPs). This position will collaborate with clinical operations, regulatory, data management, and other groups as appropriate for study implementation along with overseeing the interpretation and dissemination of study results and related publications. They will serve as a core member of the clinical development team, contributing to the overall clinical strategy, providing guidance and direction to the team to ensure successful achievement of program goals and milestones and to ensure all activities occur in compliance with the appropriate regulations and ICH/GCP. Our client offers an excellent comprehensive benefits package that includes health insurance, paid holidays, paid vacation, sick leave, and a 401(k) plan!

Immediate direct hire opportunity in San Diego who possesses:

• PhD, PharmD or MD

• 6 years of experience in pharmaceutical/biotech in clinical sciences and clinical drug development

• Knowledge of clinical trial design and in-depth understanding of Phase 1 through 4 drug development

• Knowledge of FDA and EMEA guidelines

• Experience writing all types of clinical & regulatory documents and familiarity with registration dossiers

• for worldwide use

• Rare disease experience a plus

Key Responsibilities Include:

• Support Senior Management in providing scientific/medical input into the design of the CDP for investigational products in all phases of development.

• Responsible and accountable for scientific validity and integrity of the CDP and all clinical content, including writing and editing of protocols, IBs/, clinical data reviews, CSRs, regulatory submissions, and publications associated with the clinical trials.

• Responsible for developing and implementing study protocols in conjunction with the clinical development team.

• Collaborate and provide scientific input on development of informed consent forms (ICF), case report forms (CRFs), statistical analysis plans (SAPs), study manuals, and other clinical trial documents.

• Oversee clinical trial conduct in conjunction with clinical operations including vendors, CRO’s and KOL’s.

• Participate in the ongoing review of clinical data including protocol deviations.

• Lead development of clinical biomarker strategies for early development.

• Analyze, interpret, and present results of clinical studies to include manuscripts, abstracts, and posters.

• Maintain scientific and clinical knowledge in the relevant therapeutic and disease area(s).

• Communicate to management and relevant functions any potential issues or risks (e.g., changes or significant risks to the Clinical Development Plan, new safety concerns) in a timely manner.

• Contribute to key cross-functional and clinical meetings (e.g., investigator meetings, ad hoc meetings, scientific focus, or steering committee meetings).

• Identify potential collaborators and investigators.

• Consistently complies with regulations, ICH/GCP, and company SOPs.

For immediate consideration, please email your resume to admin@snapstaffing.com