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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical development, particularly in leading registration-stage programs and filing INDs, while effectively collaborating with cross-functional teams and engaging with global regulatory authorities. Holds an MD or MD, PhD with specialized training in immunology and significant experience in business development activities.
Highest-signal resume keywords
Clinical Development LeadershipIND Filing ExperienceGlobal Regulatory InteractionBusiness Development ExperienceResearch And Development Project Leadership
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Development Plan ImplementationRegistration-Stage Program LeadershipEarly Clinical Development Program ManagementClinical Insights ProvisionDue Diligence Participation
Soft Skills
Cross-Functional CollaborationStrategic InfluenceAccountability
Certifications & Qualifications
MDMD, PhD
Industry Keywords
ImmunologyPharmaBiotechRare IndicationsRheumatologyDermatologyPulmonaryInfectious DiseaseGastroenterology
About the role
Key responsibilities & impact- Develop and implement the Clinical Development Plan for clinical pipeline and research assets
- Lead and oversee the clinical development of early-stage assets through to registration and post-approval
- Provide clinical insights for early development assets that have not completed R2D transition
- Offer clinical input for assets in partnership with external partners and/or for in-licensing activities
- Act as Research and Development Project Lead, ensuring accountability for an asset throughout development activities
- Serve as a member of the functional leadership team, providing insights on broader strategy
- Influence senior cross-functional counterparts across research, development, medical business, and commercial functions
- Engage significantly with global regulatory authorities
- Lead registration-stage programs and/or early clinical development programs with experience filing INDs
- Participate in business development activities, including due diligence
- Collaborate closely with MSIDU leadership, Immunology Franchise, and external innovation partners
Requirements
What you’ll need- MD or MD, PhD, with training/experience in immunology, such as general medicine with a fellowship in rheumatology or dermatology, also considering pulmonary, ID, and GI
- 3 - 5 years in clinical development within pharma/biotech
- Experience leading registration-stage programs and/or early clinical development programs with experience filing INDs
- Significant interaction with global regulatory authorities
- Business development experience, including due diligence
- Experience in rare indications is a plus
- Ability to function as Research and Development Project Lead
Benefits
Comp & perks- Medical, Dental, Vision, & Life insurances
- Fitness & Wellness programs including a fitness reimbursement
- Short- and Long-Term Disability insurance
- A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
- Up to 12 company paid holidays + 3 paid days off for Personal Significance
- 80 hours of sick time per calendar year
- Paid Maternity and Parental Leave benefit
- 401(k) program participation with company matched contributions
- Employee stock purchase plan
- Tuition reimbursement of up to $10,000 per calendar year
- Employee Resource Groups participation
- Short term and long-term incentives, including cash bonus and equity incentive opportunities
