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Celldex · 5 hours ago

Senior Director, Clinical Development

New Haven, CT

Full-time

Hybrid

Lead/Staff, Director/Executive

$310K/yr - $340K/yr

5+ years exp

Celldex is a biotechnology company focused on developing innovative therapies. The Senior Director leads clinical development activities for one or more compounds, overseeing study patient safety and providing medical and scientific leadership for clinical protocols.

BiotechnologyHealth CareOncologyPharmaceutical

Responsibilities

Creates clinical development strategy for one or more Celldex compounds

Responsible for medical content for clinical development plans, clinical protocols, and regulatory documents (IND, NDA, annual reports, etc)

Provides medical support to clinical operations, regulatory and preclinical programs

Medical monitoring with oversight of patient safety

Training and collaboration with staff within the areas of responsibility

Assesses external clinical research proposals involving company products and manuscripts that are being prepared for publication

Acts as a liaison between the company and clinical investigators

Qualification

MD with specializationClinical research experienceRegulatory submissions experienceClinical development experienceExperience in Biotech/PharmaFDA processes knowledgeIndependent working abilityMS Word proficiencyExcel proficiencyCommunication skillsInterpersonal skillsOrganizational skillsAttention to detailTeamwork ability

Required

MD, with specialization in allergy/dermatology/immunology/pulmonary related field preferred

Experience in Biotech and or Pharma (5 years minimum)

Demonstrated experience in clinical research, including creating clinical development plans, and designing, planning and monitoring clinical trials, Phases I-III

Strong experience reviewing & interpreting study data/reports

Experience with preparing clinical sections of regulatory submissions, including INDs and NDAs

The ability to function on an even scientific and clinical level with investigators and experts

Demonstrated ability to work effectively in cross-functional teams

Excellent oral and written communication skills

Excellent interpersonal and organizational skills and attention to details

Strong knowledge of MS Word, and Excel

Strong written and interpersonal skills

The ability to work independently and as part of a team

Preferred

Clinical development experience with biologics or small molecule agents addressing immunologic and allergic diseases preferred, such as chronic urticaria, allergic asthma, graft vs host disease, mast cell diseases

Experience with FDA processes (IND filing, NDA filings) desirable