The Senior Medical Director will lead the direction, planning, execution, and interpretation of clinical trials activities of novel compounds, in various indications through early development to global regulatory submissions
- Lead and demonstrate ownership of the design and implementation of a clinical development program or programs in support of the overall product development plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, markets, business operations, and emerging issues.
- Oversee project-related education of investigators, study site personnel, and study staff.
- Responsible for leading clinical study teams, monitoring overall study integrity, and review, interpretation, and communication of safety and efficacy data.
- 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 company’s planned regulatory filings including authoring clinical sections for INDs, NDAs, and other related documents.
- Partner with Drug Safety & 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.
- Author manuscripts and collaborate with cross-functional colleagues and thought leaders to meet publication plan objectives.
- 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.
- Participate in meetings and committees of parent company or other affiliates.
- Establish collaborative and productive relationships with the parent company, internal/external partners, and relevant affiliates.
- Work in close collaboration with the translational medicine and late stage development group
- Perform other duties as requested.
Professional Experience / Qualifications:
- Medical Doctor (M.D.), or non-US equivalent of M.D.
- Completion of a residency program strongly preferred.
- Completion of a subspecialty fellowship is desirable.
- Experience in solid tumors/or blood cancers desirable.
- 5 years of pharmaceutical drug development experience required.
- Ability to run a complex clinical research program with minimal direction.
- Extensive knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials, and experience in development of clinical strategy and the design of study protocols.
- Proven leadership skills and ability to bring out the best in others on a cross-functional team; highly collaborative, team oriented and decisive.
- Able to lead through influence.
- Excellent communication and presentation skills are essential.
Job Location: Cambridge, MA or Lehi, UT
Equal Opportunity Employer
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